The Emerson Global Life Sciences Blog

US Chamber of Commerce 4th Annual Life Sciences Awards – April 5th Deadline!

2011-03-18T17:00:00.001-04:00

I was recently contacted by Michael Billet of the U.S. Chamber of Commerce. Four years ago the U.S. Chamber of Commerce in conjunction with the Christopher Columbus Fellowship Foundation began to provide monetary awards to individuals that have provided exemplary education and research in the Life Science Industry. In looking through the past winners it's inspiring to see the dedication and contributions they've made and have been recognized for.

The purpose and vision for the awards are outlined on the Christopher Columbus Fellowship Foundation website:

“The U.S. Chamber of Commerce strongly supports American industry dedicated to protecting human health through the testing, manufacturing and marketing of biomedical products. As scientific innovation of biomedical products begins at the lab bench, the Chamber has formed a partnership with the Christopher Columbus Fellowship Foundation, a Federal government agency with the mission of promoting and encouraging new discoveries, to recognize, through seven monetary awards, one adult scientist; three secondary school educators; and three secondary school students who are judged to exemplify excellence in the field of life sciences”

Act quickly the nomination process closes on Tuesday, April 5th.

The 4th annual Life Sciences Awards event will take place on July 11th in Washington D.C. The program will reward approximately $95,000 in total to a prominent American scientist, three high school educators, and three high school students who are judged to exemplify excellence in the life sciences field. A link to the nomination process and the awards event are provided below:

Nomination process-http://www.columbusfdn.org/lifesciences/

Event website- http://www.uschamber.com/events/4th-annual-life-sciences-award

Changing of the Guard

2011-03-18T08:47:00.000-04:00

I wish to extend best wishes to Alan Babbitt in his future endeavors. Alan was instrumental with initiating the Emerson Life Sciences blog as an extension of the Life Sciences Industry Solutions Group after its formation several years ago. Alan brought some unique perspectives to a business that is undergoing major challenges and changes across the globe.

The blog will be continued in the same spirit and I’ll be providing my own unique perspectives as well as highlighting the value and importance of how the Emerson Team solves business problems at the automation and operations layers of the S95 context model. I’ll also try to share some of the interesting global trends that we run across in our research as the face of health care and the Life Sciences industry is reshaped before us.

Enjoy and we look forward to your feedback

Happy New Year!

2011-01-03T08:30:00.000-05:00

Can you believe it's 2011 already? If you're like me, you are scratching your head wondering about how time seems to be telescoping. When one looks back . . . it just feels like things have moved so fast.

Of course, there has been quite a bit of shifting over the last year and decade in the life sciences industry. In a sense, the movement has been at tectonic plate proportions.

Arguably, many global manufacturers are looking over their shoulder at the Asia Pacific region with the increasing amount of investment coming from that part of the world. Much of what is happening in the Pacific rim has and will continue to shape how we will soldier on to outpace the competition in our served market.

Our team is very optimistic about 2011. We have learned a great deal from the past, we appreciate the many opportunities that stand before us, and most importantly, remain prepared to realize the goals we have set forth for the coming year. Many thanks to all of the readers of this blog and the Emerson Global Life Sciences Team would like to wish a Happy New Year to you all!

New Emerson Storefront on Pharmaceutical and Bioresearch Online

2010-12-30T08:16:00.003-05:00

VertMarkets, Inc. and Emerson Process Management have collaborated on a Plantweb® device initiative that gives Emerson a storefront presence on Pharmaceutical Online and Bioresearch Online. VertMarkets is a leader in e-commerce enablement, with marketplace solutions that attract and connect buyers and suppliers online through its 68 industry-specific marketplaces. The storefront initiative is a web marketing program that further enables the branding of our leadership position in markets we serve. The storefront provides a comprehensive listing of all products on each portal which will enable users to source Emerson’s offerings as individual products or complete solutions. The sites go live on January 1, 2011.

The Pharmaceutical and Bioresearch Online storefront sites act as yet another showcase for Emerson's promotional efforts and content. They are customizable marketplaces that have approximately combined 135,000 visitors per month. The visitors are life sciences industry professionals that are typically looking for product information, whitepapers, industry event content, and webinars among others. As the user navigates through the site and clicks on a topic that pertains to Emerson, they will engage with an interactive form that provides more detail about the individual’s requirements. They are subsequently presented a menu of a la carte items that are available to help them solve their particular business problem or information need. The sites include:

A company description that displays key information highlighting corporate and product advantages of Emerson’s offerings.
Easily accessed contact information that provides multiple channels through which our qualified users can communicate directly with the Emerson life sciences team.
Featured Products that will highlight all of Emerson’s products along with an image, features and downloadable specification information. All of Emerson’s Plantweb® products can also be seen on Drug Discovery Online, Laboratory Network and Medical Design Online as part of the Emerson and VertMarkets collaboration.
Featured Articles and Videos that will highlight Emerson’s editorial, press releases, white papers, videos and case studies.
Bulliten board features that promote significant product releases, events and thought leadership pieces.
An archive of Emerson’s downloadable thought-leadership articles and videos.

The Pharmaceutical Online (41,800 subscribers), Bioresearch Online (21,250 subscribers), E-Newsletters are broadcast weekly. They will provide repeated opportunities for Emerson to promote its branding message, as well as generate interest in Emerson products, services and thought leadership pieces to our opt-in subscribers.

We look forward to your participation in this exciting initiative. For more information on this program you can contact me by clicking here.

The Maturing of Syncade

2010-12-09T15:29:00.002-05:00

ARC recently published a report, Syncade Matures into a Powerful Level 3 Production Management Platform. John Blanchard, ARC Analyst, states: “It is evident that Syncade has become an integrated production management layer for the DeltaV process automation system, with functionality that extends well beyond its early days as a document management and pharmaceutical industry solution… The Syncade suite of software modules provides integrated solutions in four functional areas: resource management, operations optimization, integrated information, and quality and compliance. ARC sees some of its differentiators as document management, recipe authoring and execution, and its capability to minimize the number of interfaces to other production management applications.”

To read the entire report, please click here.

Destination Asia

2010-11-30T11:32:00.000-05:00

The Emerson Global Life Sciences Team recently visited Bejing, China in an effort to mobilize our Asia Pacific organization for “Destination Asia.” The trip was designed to identify product gaps and barriers, to capitalize on our leadership in the Asia Pacific region, and to attend the 15th annual China-Pharm Pharmaceutical Industry Exhibition held at the China National Convention Center in Bejing.

Prior to the exhibition, Emerson Process Management Division representatives prepared update presentations on Emerson’s products and services Life Sciences roadmap. Product and service gaps were identified with plans for closing them. The presentations were pointed at the specific needs of the Life Science industry and its emerging trends including generics, OEMs and other areas. The primary focus was centered on the business value (i.e. savings and benefits) derived by specific Asia pacific customers.

The China-Pharm exhibition targets a wide variety of product groups including API, Secondary, Process Control Systems, Cleaning technology and equipment, and Packaging, among others. Approximately 400 exhibitors from over 20 countries participated including Emerson. An estimated 18,000 visitors attended the event including domestic and MNC manufacturers, academia, and a host of Agency and government officials. Shenling Yang, Life Sciences Business Leader in Asia Pacific did a great job coordinating our efforts with a number of meetings we had with the SFDA in China. Emerson country managers and executives participated in an Emerson Life Sciences seminar hosted by Vice President and General Manager, SweeChee Lee. SweeChee provided an introduction and overview of Emerson China. Saroj Patnaik presented ideas around the topic of reducing risk for export while Dr. Ali Afnan articulated some of the science related issues that offer opportunities for Process Analytical Technology solutions. David Liu, from our Regulator Technologies division wrapped up the day with a presentation about building up a modern biotech facility in China by leveraging DeltaV Batch Control Systems. Overall, the reponse from seminar participants was very well received.

The team (shown below) had a blast . . . especially during a special tour of the Forbiden City and Great Wall. We are looking forward to continuing to create focus and deliver results in the Asia Pacific region.

Fighting for Capital

2010-08-31T10:36:00.007-04:00

The great industrialist Andrew Carnegie (1835- 1919) once spoke about the old proverb “Don’t put all your eggs in one basket.” During the speech which took place circa 1885, he said “Don’t put all your eggs in one basket is all wrong. I tell you, put all your eggs in one basket, and then watch the basket.” One can argue with the statement, but as it turns out, Carnegie was pretty successful primarily because he focused his basket of energy, mindset, and capital on providing business value to the customer.

The Emerson Life Sciences global team recognizes the ongoing competitive nature of the business and the need to fight for capital. Our “basket” is enabling the customer’s business success by discovering and delivering business value. We consistently look to become a trusted advisor in enabling customers to achieve their regulatory, quality, and cost related business requirements. Flawless execution and FDA conformance is a must; consequently, our customers need to effectively measure and control their processes to eliminate variability and improve efficiency.

There’s a must read article titled What Will the FDA Say? at PharmaQbD.com posted on August 24, 2010, authored by Ali Afnan, former Senior Fellow with the FDA’s Center for Drug Evaluation and Research. He offers a unique perspective on the regulator (FDA) and the regulated (pharmaceutical companies).

He writes:

“A culture of operational excellence and continual improvement can only be achieved, within industry and even, perhaps, within FDA, when our first question changes from “What will the FDA say?” to “Can I demonstrate knowledge and control of the process and product to the FDA?”.

His observations suggest pharmaceutical companies need to be more proactive about addressing process understanding and control issues.

He further writes:

“Unless firms are willing to use or learn this language—to be open with the Agency, proactively communicate process and product knowledge and demonstrate real-time process control, all regulation-dependent activities will continue to depend on what the FDA says.”

Currently, most manufacturers define their processes based on successful production and testing of a limited number of batches. This results in a fixed process which is not responsive to certain types of variability such as input material variability.

Emerson understands this new language. The picture below shows that it’s a very different conversation including provocative tactical pain point questions about fixed processes and measurement and control strategies. These tactical pain points evolve into consequential pain points including uncertain and lengthy process validation, variability, and increased manufacturing cycles. Of course, all of this stands in the way of the customer’s key business requirements that include product quality, improving execution, and enhancing process efficiencies.

As long as the conversation stays focused on business value, Emerson will win the fight for our customer’s capital in this difficult economy. Customers will be able to partner with a viable company that has a strong end to end footprint and vision, superior products, and exemplary technical and execution capabilities.

For more information on this topic, feel free to contact me by clicking on this link.

Thank you Michalle Adkins, Senior Consultant, Emerson Life Sciences Industry Group for keeping me honest on the ideas presented in this post.

Solving Life Sciences Problems with Automation

2010-08-23T15:42:00.007-04:00

Make plans now to attend Emerson Global Users Exchange September 27–October 1 in San Antonio, Texas.

The conference hosts more than 300+ presentations, CEU-certified short courses, and workshops on selecting and applying technologies, justifying investments, and developing automation strategies. Many sessions are geared specifically to the day-to-day challenges of Life Sciences manufacturers.

When & Where: September 27 - October 1, 2010 Henry B. Gonzalez Convention Center San Antonio, TX, USA

Whether you currently use selected Emerson technologies or have a complete PlantWeb™ architecture installation, this event is for you. There's no better place to discover a new idea or discuss the latest technologies with your peers -- the scientists, users, engineers, and other experts -- who have implemented them.

Build on your Life Sciences Knowledge

With more than 40 training sessions tailored to the needs of your industry, you can learn new ways to gain flexibility in manufacturing, avoid deviations and quality issues, improve scheduling and failure tracking, and gain a better understanding of what is happening during the release process.

You can also attend two Life Sciences Industry Forums:

"Patient safety in a flat world" will bring together global regulatory leaders to discuss the impact of patient safety in a global manufacturing economy.
In "Automation strategy in an island manufacturing model," OEMs and end users will discuss considerations for incorporating skid-based technology into your overall automation strategy.

After each forum there will be an informal Q&A session and the opportunity to speak directly with panel members.

Who should attend?

Technology & Engineering
Quality Management
Manufacturing/Operations
Maintenance

Also be sure to visit the Life Sciences Industry Solution Area at the exhibition hall to learn more about increasing manufacturing flexibility with skid-based solutions, deploying the latest QbD advances with Process Analytical Technology, and how Emerson's Life Sciences Engineering Center experts can help you implement solutions that will increase your bottom line.
There's no better way to learn about end-to-end solutions to help you achieve regulatory and quality requirements. Register and make your travel and hotel arrangements today.

Crystallization and Emerson PAT Solutions

2010-07-07T15:32:00.008-04:00

Pharmaceutical companies use a technique called crystallization to purify solid compounds. It’s a fairly basic process; however, its success relies on a combination of science and art involving particle size and purity. Particle size and purity are critical to producing a quality API (Active Pharmaceutical Ingredient) product. The process looks to accomplish three things:

Purify the product (separate the good from the bad)
Manage the crystal physical size and shape (impacts how the drug dissolves in the body
Manage the crystal chemical form that is shown to have safety and efficacy

The bottom line is to produce the API with maximum purity in as little time as possible. The wrong physical or chemical form will result in impurities. The more impurities, the more degradation of the finished product which ultimately affects asset yields. Asset yields are one of the leading key performance indicators in pharmaceutical manufacturing. If a firm produces ten batches of a product in a given year that result in 90% purity and produces ten batches the next year with 80% purity, they are throwing money away. Today, quality is often tested instead of designed into many of these products and processes. Truly understanding and controlling the manufacturing process removes this issue as a major concern.

Emerson agrees! Quality by Design (QbD) with an end game of Process Analytical Technology (PAT) will provide much needed relief to these pressures while maintaining patient safety. Over the past 2 years, Emerson has developed an offering which provides the ability to apply PAT to any process (including crystallization) within the pharmaceutical industry anywhere in the world. The solution is comprised of Syncade and DeltaV as two legs of the PAT ‘stool’. The vital third leg is Emerson’s alliance partner Optimal’s offering called ‘synTQ’ which provides real-time, on-line data management for complex univariate and multivariate PAT data sets. The solution offers the ability to integrate a wide variety of instruments and third-party analysis packages. The three components link together easily, providing a well integrated system dealing with all aspects of the PAT environment. Said differently, Syncade is a king, filled with wisdom. Its wisdom comes from an adviser (synTQ) that is filled with all sorts of data. The adviser gets its data from a variety of instruments measuring what’s going on in the process. DeltaV is there to enforce whatever it is told based on the wisdom and data received.

The Emerson architecture depicted below and deployment methodology provide the following key differentiators:

Scalability from lab to production
Cost commensurate with scalability
Instrument and modeling package independence
Flexible and modular implementation approach and integration with existing products
Easy data import and export in a variety of formats

For more information on how Emerson’s PAT solution can help improve product quality with real time monitoring and control, contact me by clicking here.

Emerson Joins National Science Foundation Funded C-SOPS University Program

2010-05-28T10:59:00.006-04:00

In a major step forward with our University Program initiative, Emerson has joined the Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) as an industrial member. C-SOPS is a National Science Foundation (NSF) funded center consisting of Rutgers University, Purdue University, the New Jersey Institute of Technology, and the University of Puerto Rico at Mayaguez.

The Center has a dual mission. The first part is to build the fundamental science base for the rational design, development, and manufacture of multi-component particulate products for the pharmaceutical, food, agrochemical, nutraceutical and other industries. The second aim is to develop the technology so the science can be incorporated into industrial manufacturing practice. A pharmaceutical tablet is a common example of a multi-component particulate system; a better understanding of the science behind powder flow, blending, and compression into tablets will allow improved design and manufacture of this major dosage form.

The LSIG team is very pleased to be part of this multi-company, multi-institute effort to advance the science of particulate products. The team recently participated in the Industrial Advisory Board meetings held at Purdue University. The meeting objective included updates on the various projects and test beds that are central to the program's efforts. The advances made at the center will enable manufacturers to be more efficient and return better value to their stakeholders. As a leading supplier of process automation technology, that is Emerson’s mission as well.

Scientific and technology advances made at the center will enable the development of less expensive, more efficient manufacturing processes, with less wasted material. With an increased understanding of the role of structure on the properties and function of the final structure, manufacturers can design enhanced products. In some cases, such as pharmaceuticals, entirely new dosage forms can be developed.

Emerson joins a distinguished list of 30 industry members who bring their resources and knowledge to work with the cross-disciplinary team of over 40 faculty members from all four partner schools. Industrial members include finished goods manufacturers and the companies who supply them with equipment, raw materials, instruments, and software.

Emerson is providing a DeltaV system to aid in process development. Dr Fernando Muzzio, director of the C-SOPS and professor of Chemical and Biochemical Engineering at Rutgers states, “We are pleased to welcome Emerson as a new member of the C-SOPS family. The state of the art DeltaV automation system will enable us to fully automate our prototype continuous manufacturing processes and run in closed loop mode. This will be a major advance in the manufacturing practice in many industries.”

FDA Workshop - A Partnering Success

2010-05-19T10:58:00.007-04:00

Last week, the Emerson Life Sciences team participated in an exciting 2-day conference with the Food and Drug Administration (FDA). The FDA and co-sponsors, University of Rhode Island (URI) College of Pharmacy and Pharma Conference Inc., held the event at the Hyatt Regency, Bethesda, MD. The mission was to disseminate current and accurate information on Process Analytical Technology (PAT) to the pharmaceutical industry and create a venue for dialogue between PAT users, suppliers and the FDA. The conference featured the FDA’s perspective on where PAT will be applicable in the manufacturing process and the FDA’s current thinking on how PAT will be reviewed in new and abbreviated new drug applications, amendments, or supplements to an application.

Several top FDA officials were on hand to present current and accurate information on PAT, as well as answers to many firsthand questions. These officials included Janet Woodcock, Director, Center for Drug Evaluation and Research; Rebeca Rodriguez, National Drug Expert Investigator from the Division of Field Investigations; and Christopher Watts, Ph.D. Office of Pharmaceutical Science, CDER. All agreed it was a must-attend conference for anyone involved in PAT and manufacturing.

Most manufacturers understand the potential advantages of Process Analytical Technology – timely measurement of critical quality attributes, faster release times, and lower costs. But widespread adoption of PAT has been slowed by practical questions about how to implement it while ensuring FDA approval. The conference provided many answers to those questions. Attendees benefited from the experience of other manufacturers who are already putting PAT to work and learned from selected industry specialists and suppliers – including Emerson – about building a business case and leveraging technology to maximize return on PAT.

As a leading supplier of PAT solutions, Emerson was thrilled to participate in this far reaching event. Presenters included Melissa Herkt, President and COO, PlantWeb® Solutions Group, who offered perspectives on technology challenges and supplier partnership alternatives. The agenda also featured Emerson’s Terry Blevins, Principal Technologist, who talked about data analytics in pharmaceutical manufacturing. Emerson’s marketing alliance partner, Optimal Industrial Automation also provided an overview of process understanding and control using a PAT framework.

The Emerson team held a networking event at the end of the first day of the conference. Attendees had the opportunity to interact directly with Emerson’s life sciences experts as well as view three demo scenarios, each demonstrating the capabilities of an integrated PAT solution based on a DeltaV control system and an Optimal synTQ data management system. The demos included:

Blender Demo — This demonstration shows a ‘Process’ model in synTQ and a ‘Control’ model in DeltaV. A spectrometer is used to ensure that the mixture in the mixing tank is of the required percentages of the three feed materials. Corrections are made to the feed rates from the feeder tanks to ensure these remain the case. DeltaV performs all the standard control tasks associated with maintaining levels etc.
Fluidized Bed Demo — This is an example of both the ‘Process’ and ‘Control’ model being part of a synTQ orchestration. The demo runs in two stages. The first stage demonstrates synTQ using only data acquired from the NIR and the second stage demonstrates synTQ using data from both the NIR and a Lasentech particle sizer to then control extra settings on the Fluid Bed Dryer.
Bioreactor Demo — the demonstration shows a ‘Process’ model in synTQ and a ‘Control’ model in DeltaV. The cell culture system simulated in DeltaV and synTQ as part of this demonstration is an animal cell culture system.

All three demos expand Emerson's capability to show a best-in-class solution for PAT opportunities. For more information on the demo or additional information on Emerson’s PAT solutions, you can contact Chris Amstutz or Alan Babbitt.

Shanghai Update from Shenling

2010-05-13T16:27:00.008-04:00

The 9th Annual China Pharma, Life Science & Healthcare industry summit was held recently in Shanghai, China.

Shenling Yang was given the opportunity to meet key officials and industry leaders to obtain first hand information on all the recent regulatory changes, new reform initiatives, future industry trends and successful strategies as well as solutions for continuous growth and profitability in China. Shenling writes:

"Although China’s pharmaceutical market has continued its rapid expansion in recent years and projected to grow at over 20% CAGR during the next four years, many challenges remain in the local market. Stricter drug regulations, increased pressure on price vs. cost, changing demographics and emerging issues brought by the new health system reform will significantly alter the playing field in the years to come. In 2008, China’s pharmaceutical sector grew by 26%. US $125 billion incremental government funding is targeted for improvement to the nation’s healthcare infrastructure and near universal health coverage by 2011. By 2013, China is projected to become the third largest Pharma market right after US and Japan."

Among 137 guest speakers and delegates, there were State Food and Drug Administration (SFDA) officers (5%), industry players (Both MNCs and Domestics, 58%) and solution providers (37%). Emerson was the only automation vendor attending this year’s meeting.

Executives from BMS, Pfizer, Novo Nordisk, GSK, Roche, Johnson & Johnson, Merck, Novartis, Eisai shared their insights. The focus was on winning strategies and future outlook for various life science industry segments in China for the next decade. Many of them participated in building their company’s first plant in China.

Four SFDA directors discussed upcoming regulatory changes on drug administration, registration, safety surveillance, GXP supervision and hospital reform.

The Chinese government announced continued plans to invest RMB 850 billion stimulus package on healthcare through 2011. Healthcare reform plans in China covers five areas:

Basic medical insurance system – increase coverage of medical insurance coverage up to over 90% of population by 2011
National Essential drug (EDL) system – essential drug list will be centrally purchased and distributed by the government
Primary health care provision – more investment in Community Healthcare Centers (CHC), drive primary care patients from hospitals to CHCs
More basic healthcare provision – enlarge new rural cooperative medical insurance system, build more county hospitals
Public hospital reforms – pilot reforms in public hospitals with zero mark up and roll out by 2011

According to the director of Policy & Regulations for Ministry of Health, the new SFDA GMP guidelines will be out by end of this year. In order to receive the GMP certificate, maintaining and increasing drug quality will have to be a central theme for manufacturers. Consistent manufacturing, new equipment and systems will need to be purchased, people need to be trained, and SOPs and Batch Production Records need to be maintained.

Emerson will maintain a vigilant eye in these areas as our platforms (field instruments, DeltaV, Syncade, and PAT) provide considerable business value and stands apart from the competition. Shenling is facilitating a multi-portfolio strategy as the China market continues to mature and customers require broader based solutions. Thanks Shenling and good selling!

Key Trends in the Pharmaceutical Industry

2010-04-27T09:03:00.006-04:00

The Global Life Sciences Team is continually trying to align itself with shifting trends in the industry. We have seen momentous change over the past couple of years. Government run health care, cross border importation, and decreased patent years have triggered a significant amount of industry consolidation. There is an expectation of a capacity shortage of generics by 2012 given the approximately $120B of patent expiration, and the grey factor; 24% of population will be over 60 by 2012. Innovation has softened the regulatory sting of the FDA making ASTM E2500 methodologies (eliminates duplication of testing) and Process Analytical Technology (PAT) more viable. Disease profiles are becoming demographically specific with fewer blockbusters and smaller batches on the horizon.

A recently posted SupplyChainBrain video below highlights Janice Abel, Principal Analyst at ARC Advisory Group who does an exceptional job at summarizing some of these recent events and key trends in the Pharmaceutical Industry. Some of the central points addressed include:

Sales and Automation growth
What is the industry doing to improve its portfolio?
Merger & Acquisitions and related capital requirements
Capacity and efficiency challenges of manufacturers
Risk-based methodologies

Janice's final comments on technology investment having to show business merit, underscores much of what we advocate as we strive to present value-based solutions to our customer base. Enjoy the video!

Document Control & Archiving Made Simple

2010-04-22T14:18:00.008-04:00

Shawn Opatka, Regional Sales Manager, Syncade Platform Group recently shared his thoughts with the Global Life Sciences Team about DCA Express, Emerson’s newest stand alone Syncade Life Sciences solution for Document Control and Archiving (DCA). The solution is quickly being adopted across the industry to increase quality, productivity, and compliance.

Q. What is DCA Express?

A. DCA Express is a document management system for storing large volumes of documents and is designed specifically to meet regulatory requirements, including the U.S. Food & Drug Administration (FDA) regulations. With DCA Express, users can quickly find and instantly access the documents they need. The solution supports multiple document types including:

Standard Operating Procedures
Electronic Work Instructions and Electronic Batch Records
Material Safety Data Sheets
Manufacturing records
Safety and training documents and videos
Equipment specifications

Q. What is the basic business problem?

A. The problem typically involves the time spent on document and change request management as well as the subsequent review and approval cycles. There are inherently quite a number of non-value added activities involved throughout these processes primarily due to the nature of what we are dealing with – paper!

Q. Who is affected?

A. The impact cuts across the enterprise. Documentation is the heart of quality management. Documents are used to define quality specifications, manufacturing procedures, and QA release procedures. Tight control and change management of documentation has become a fundamental part of quality management practice. The consequences include document rework and handling time, deviations, and the cost of personnel, a very hot topic in today’s challenging economy. Everyone from the VP of Quality who is looking to reduce mistakes on the plant floor to the VP of Information Technology who is challenged with creating a collaborative environment for document control is affected by this business problem.

Q. What is the solution and how is it configured?

A. It’s a pre-configured solution. A server class PC (supplied with DCA Express) with Internet Explorer is needed to support the DCA Express solution. Microsoft SQL Server is the underlying database. For client access, a PC with Internet Explorer is needed. All other hardware and third party software comes bundled with DCA Express. All that is required is installation of the server onto the appropriate corporate layer. The solution is highly scalable from a single department or plant site to an entire global enterprise.

Q. What value does a Pharma or BioTech customer realize once the solution is installed?

Using a standard web browser, DCA Express provides an efficient way to manage the complete document lifecycle including single and multi-document change control, automatic routing, document check-in and check-out, version management, and archived records management. The value is a dramatic reduction in time and cost of document change control, enabling personnel to find documents faster, eliminate the cost of printing and maintaining documents in binders, and eliminate the cost of storing paper.

A sophisticated change request management system offers flexibility with highly configurable change request workflows, including a conditional review option, serial and parallel review and approval, role and user-specific assignment feature, and delegation management of review and approval assignments. The benefit includes increased productivity. Document control with automated version management and change control is streamlined.

DCA Express eliminates the need for physical paper, larger document storage rooms, and off-site document storage. This solution is a fast and easy way to control and manage documents. The true zero-client architecture provides lower cost of ownership and simplified validation.

Shawn is part of Emerson’s Syncade, Smart Operations Management team. He is leading the development and release of DCA Express. Prior to joining Emerson Shawn was involved with formulation, recipe management and batch processes for over 10 years. Shawn earned his Marketing degree from California State University, Northridge. If you would like more information, click here to contact Shawn directly. Thanks Shawn!

Syncade Road Shows

2010-04-08T14:08:00.007-04:00

I spoke to Jonathan Lustri recently about a number of Syncade road shows his team has organized to increase awareness of Emerson’s operations management capabilities. The seminar series is designed to help educate process manufacturing companies on how the use of manufacturing IT software can improve plant operations. Many process manufacturing facilities have already invested in process control and batch automation. But now what? The need for being more efficient has not stopped and it is necessary to look at overall manufacturing operations to continue to achieve additional manufacturing efficiencies. The seminar is called “Beyond Process Automation; Improving Manufacturing Performance with Smart Operations Management”

Emphasis will be on how the application of manufacturing IT systems can improve production, material, and quality operations; increasing capacity utilization, productivity, and quality; while also reducing costs.

The process industries are transitioning from paper driven operations, to electronic operations using barcode scanners and mobile worker terminals. This seminar combines presentations and demonstrations to help the industry understand how moving from paper to electronic execution of plant operations can be applied to solving their manufacturing problems.

Seminars will be held at following locations and dates. Click on the links for more information:

Proconex Baltimore, MD on April 28, 2010
Control Associates Allendale, NJ on April 30, 2010
New England Controls Cambridge, MA on May 20, 2010

Join Emerson Process Management and Proconex, Control Associates, and New England Controls to see how Syncade Smart Operations Management Suite capabilities can be deployed to improve plant performance. This event is for Manufactruing, Qulaity, and IT personnel who are interested in reducing operational errors, speeding up product relelase, and lowering cost of operations.

For further information, contact Jonathan Lustri, Syncade Brand Manager by clicking here.

FDA and PAT for Pharma Manufacturing: FDA Partnering with Industry

2010-03-23T08:45:00.007-04:00

The Food and Drug Administration (FDA) has announced a 2-day Process Analytical Technology (PAT) conference scheduled for May 11-12, 2010 at the Hyatt Regency Bethesda, Bethesda, Maryland. This 2-day conference is co-sponsored by the FDA, the University of Rhode Island College of Pharmacy, and Pharma Conference Inc.

The objective of the conference is to bring regulators, manufacturers, and suppliers together to make PAT a reality. The conference is intended to disseminate current and accurate information on PAT to the pharmaceutical industry and create a venue for dialogue between PAT users and FDA. The conference will feature FDA’s perspective on where PAT will be applicable in the manufacturing process and FDA’s current thinking on how PAT will be reviewed in new and abbreviated new drug applications, amendments, or supplements to an application.

As a leading supplier of PAT solutions, Emerson is excited to participate in this compelling event. Presenters will include Melissa Herkt, President and COO, PlantWeb® Solutions Group, who will offer perspectives on technology challenges and supplier partnership alternatives. The agenda will also feature Emerson’s Terry Blevins, Principal Technologist, who will speak about data analytics in pharmaceutical manufacturing. Emerson’s marketing alliance partner, Optimal Industrial Automation will also provide an overview of process understanding and control using a PAT framework.

Why attend this conference?

To get the FDA’s perspective on where PAT will be applicable in the manufacturing process. There will be an opportunity to ask questions and interact directly with FDA personnel, and talk with Emerson’s life sciences experts about specific solutions for manufacturing operations. Attendees will benefit from the experience of other manufacturers who are already putting PAT to work. They will learn from selected industry specialists and suppliers – including Emerson – about building a business case and leveraging technology to maximize return on PAT.

Who should attend?

All pharmaceutical personnel involved with PAT with the desire to improve their knowledge of the manufacturing process.

Most manufacturers understand the potential advantages of PAT – timely measurement of critical quality attributes, faster release times, and lower costs. But widespread adoption of PAT has been slowed by practical questions about how to implement it while ensuring FDA approval. This joint FDA/University of Rhode Island conference provides answers to those questions.
Prospective attendees will learn about turning PAT’s potential advantages into real-world benefits. Registration can be completed online at the Pharma Conference Inc. web site. Click here for the full conference brochure.

We look forward to seeing you at this exciting event.

Tecnología inalámbrica en Puerto Rico

2010-03-17T12:40:00.008-04:00

As always, there’s lots of upbeat customer activity on the Island of Puerto Rico. Most recently, Vivian Freytes and team has focused much of their attention on Tecnología inalámbrica (Wireless technology) applications. The benefits cover a wide spectrum and extend PlantWeb predictive intelligence into areas that were previously out of physical or economic reach, opening the door for new possibilities in process improvement. Remote locations, physical obstructions, and the high cost of engineering and integrating new technologies are no longer the barriers they were.

One customer looked for utility area solutions to replace existing pressure and temperature gauges for 4 to 20 mA transmitters. The application provides greater efficiency to the process while monitoring air with acetone residues needing to be stripped out. Temperature and pressure conditions need to meet the right conditions to properly separate the acetone. If it’s not done properly, time is wasted and costs will rise. In this case, installation and integration was seamless while overall costs were dramatically reduced.

Another wireless customer needed to improve temperature monitoring and documentation systems in raw material active ingredient storage areas. Storage compliance requires raw material to remain within specific storage temperature limits. Not complying becomes a quality issue. Our wireless solution with AMS wireless SNAP-ON technology provided an easy way to install transmitters in the desired location without the need of wiring while providing actual process readings and alarms when conditions are out of specification. The benefit is clear – more for less with real time monitoring and documenting of temperature limits.

The team is actively pursuing many other possibilities for wireless applications on the island. They include the following:

Vibration Monitoring

The problem involves monitoring of rotating equipment. Rotating equipment (pumps, blenders, agitators, etc.) would be monitored for vibrations that would provide an indication of equipment failure or potential failure.

An example would be CIP (Clean In Place) pumps, along with Return Pumps, that are used between batches to clean out the system. The CIP application is one where once a product batch is complete they utilize these pumps to clean out the system. Mechanical problems with the CIP pumps sometimes cause problems in the subsequent production of the next batch of product causing the rejection of the entire batch. High vibration levels on the equipment indicates developing problems that can now be fixed before they result in the rejection of finished product.

Storage Room /Freezer Monitoring

The problem involves prohibitive wiring costs for conventional transmitters used to monitor storage rooms distributed across a production facility. Wireless transmitters also provide solutions to the inherent problems associated with portable freezer/cooler units.

This application involves the monitoring of critical parameters for products stored throughout large multi-building sites. The storage room data is required for reporting to the Food and Drug Administration as well as internal quality control. Typical monitored parameters include pressure, temperature, humidity, visible and UV light, airflow, CO2 and the open / shut status of doors. Freezer parameters monitored would include low-stage and high-stage compressor amperage, internal chamber temperature, and door open/close status. The data collected is intended to provide early indication of refrigerant leaks or door seal issues, which lead to freezer failures.

Portable Equipment

The problem involves the management of moving platform measurements. There is a need to continually re-configure process systems to account for instruments that move with portable process skids (pumps, filtration, CIP/SIP packages).

For disposable bioreactors, this would include WirelessHART transmitters for pressure, temperature, pH, and dissolved oxygen measurement. The flexibility of being able to work on reactors without disconnecting cables can provide on-going benefit by reducing downtime and maintenance. Also, the accuracy and reliability the pH and dissolved oxygen measurement may be improved since battery power wireless transmitters are not as susceptible to ground loops that often plague a wired installation.

Mobile Worker Productivity

The problem involves operators who work on the plant floor outside of the traditional control room and need visibility into the current state of the process. The solution is to provide a DeltaV client on mobile devices for operators working outside the control room. This is also applicable for remote data collection applications where an operator manually records data from a gauge or chart.

As customers on the island continue to pursue cost effective solutions and avoid expensive and lengthy installations, Vivian and team will be there offering alternatives that cut through the maze of challenges. Thanks Vivian!

IFPAC Baltimore

2010-02-15T11:56:00.006-05:00

Chris Amstutz and I attended the International Forum Process Analysis & Control (IFPAC) event last week at the Baltimore Marriott Waterfront Hotel. IFPAC is a premier event and the leading conference in process analysis and technology. Process Analytical Technology (PAT)is a key to an effective implementation of Quality by Design (QbD) initiatives as a way to achieve effective process understanding and control. IFPAC-2010 was an exciting forum allowing attendees to learn about recent developments in control applications for a variety of industries, including life sciences. The event featured over 150 presenters with over 20 sessions. Its overall objective was to promote dialogue of real life applications of PAT.

Plenary sessions on the first day set the stage with a cross section of presentations from industry, government, and academia. There were perspectives on regulatory concerns and how PAT may be utilized to improve product quality and life cycles. The conference tracks covered multiple topics of interest including control strategies, continuous processes, modeling, and PAT and process control, among others.

Emerson participated in a comprehensive exhibition of PAT equipment and services providing opportunities for networking and informal meetings. Emerson was joined by our Marketing Alliance partner, Optimal Industrial Automation demonstrating an array of synTQ PAT solutions. Our booth demonstrated synTQ tightly integrated with DeltaV. synTQ is a natural extension of Emerson's overall PlantWeb architecture. While Emerson’s existing products, DeltaV and SynCade, are two legs of the PAT ‘stool’, the vital third leg is ‘synTQ’ which provides real-time, on-line data management for complex PAT data sets (they often include spectra, or even 2D arrays of data), and the ability to integrate a wide variety of instruments and third-party analysis packages. The three components link together easily, providing a well integrated system dealing with all aspects of the PAT environment.

Gawayne Mahboubian-Jones, Product Development Manager, Optimal pointed out "the quality and the quantity of attendees at this year's event was very high." Chris Amstutz suggested "the conference is further evidence of the industry developing more and more momentum toward widespread adoption of QbD with an end game of PAT. The value stream is quickly moving from Research to Production in life sciences with greater awareness of how it adds value to the overall process."

IFPAC looks to continue to bring together practitioners from industry, academia, and the government to engage in active discussion of new trends in this developing arena. Emerson will be sure to participate in future events as we continue to take a leadership role in value based PAT solutions.

Huckman on BIO CEO Investor Conference

2010-02-09T11:36:00.009-05:00

I wanted to provide a quick post on an interesting report by Mike Huckman at CNBC about the BIO CEO & Investor Conference being held February 8-9, at the Waldorf Astoria in New York City. The 2 day conference is one of the largest investor conferences focused on publicly traded biotech companies and represents the sector's main lobbying group, Biotechnology Industry Organization (BIO). BIO is the world's largest biotechnology organizations that provides advocacy, business development and communications services for more than 1,200 members worldwide. 26% of the attendees are C-Level executives along with 46% of investors. The event's mission is designed to promote industry wide success. BIO senior executives and key opinion leaders are discussing (among many other topics) current elements of health care reform legislation and its impact on the industry.

Huckman reports much of the attention is given to smaller companies that "often don't get big investment bank attention, their moment in the Sun." Biotech stocks in general have been out performing the languid market and he reports there are a number of events that could propel the sector even higher this year. Apart from the stock market perspective, the sector is still a case of the haves and have nots as there are 100 fewer publicly traded biotech companies today than there were just two years ago. One half of them have been swallowed up by the big players and the other half has gone belly up.

Take a look at the video below as it offers some interesting insights.

More for Less with Emerson Valve Automation

2010-02-01T18:32:00.002-05:00

Increased demands and reduced resources seem to be the norm in the life sciences industry while many firms are being asked to do more with less. Along the way, companies actively consider factors such as process variability, among others. Design and maintenance engineers as well as plant operations are all affected. Consequently, they continue to reach out for solutions from competent vendors that provide reliable, best-practice solutions coupled with strong service capabilities, at a reasonable cost. As part of a broad base of solutions from Emerson Process Management, the Valve Automation Group provides high quality actuation and controls to pharmaceutical on-off valve applications.

Often referred to as automated block valves, on-off valves act as a final control element as their all important impact on processes and plant operations can be significant. If a critical on-off valve has a problem . . . plant operations can be stopped. On-off valves can be a major source of process variability in pharmaceutical processes and require active maintenance. Additionally, they can increase start-up cycle time and require a variety of spare parts to be available and on-hand.

The Valve Automation Group provides solutions to these issues with its FieldQ integrated actuator/controls package, designed to make an engineering staff’s life easier. The simplified design reduces design engineering hours in selecting and comparing different kinds of actuators, solenoid valves, and switch boxes. The integrated solutions make start-up simple with a few push-buttons as opposed to traditional test-and-see commissioning. The maintenance engineer team at the plant will have less spare parts to deal with, thus saving dollars in engineering hours, training and inventory carrying costs.

FieldQ solutions represent both brain and muscle for on-off valve applications. They provide the torques to open/close the valve and diagnostics for preventive and predictive maintenance preventing unscheduled and costly outages. FieldQ also expands the reach of PlantWeb® leveraging your DeltaV investment from instruments to control valves to now on-off valves. With FieldQ’s diagnostic capabilities, highly critical, expensive valves are safeguarded. Wireless is on the way to further reduce the cost of monitoring on-off valve tags for stranded information on valve position, cycles, and status.
FieldQ's state-of-the-art "fully integrated" concept with smart technology reduces total costs over the product life-cycle by:

Eliminating administration costs of using multiple vendors
Reducing stock-keeping units on the shelf
Reducing maintenance and plant down-time by using "Plug and Play" modules
Lowering labor costs involved in maintenance and repair by the elimination of common failure points
Avoiding major costs associated with plant down-time, when using its predictive diagnostic capabilities

With its extensive distributor network; knowledgeable sales and support teams; configuration and service centers and broad product portfolio – containing many of the world’s best known actuator brands – Emerson Process Management is ideally placed as the supplier of choice for valve automation needs.

Frank Feng, Director of Key Accounts for Process Industries resides in St. Louis, MO. He attended Washington University based in St. Louis and holds an MBA in Finance. For more information you can contact Frank by clicking here.

Hurtling Toward Operational Excellence

2010-01-22T11:42:00.005-05:00

The term operational excellence has become very popular in the life sciences industry. It is often tied to the big picture vision everyone is striving to achieve with the ultimate goal of producing both the product and the accompanying documentation correctly the first time. Attaining this goal can be challenging but demonstrable approaches are available showing how possible it is to move companies closer to achieving "right-the-first-time" every time (RTFT-ET). The challenges include the daily battles to meet product delivery commitments that often focus on associated documentation required. Michalle Adkins recently published an article on BioProcess International's web site titled Hurry Up And Wait. The central theme is tied to the FDA's QbD initiative that focused on quality systems. She writes:

"Making a product according to its predefined specifications - and doing it as efficiently as possible - is a battle that can often be won predominantly by replacing as many manual processing steps with instrumentation and automation as possible. Simultaneously, producing the necessary documentation that proves a drug or biologic was manufactured in accordance with its predefined specifications is a battle that can be won through organizational commitment and the proper design and use of automation and manufacturing execution systems."

Michalle does a great job of posing a series of exigent questions about daily skirmishes that tend to get in the way of RTFT-ET. Inefficient use of resources for document related issues tend to lead the way because of missing and/or illegible signatures and data entries, numbers being transposed improperly etc. Suffice it to say, if existing production and documentation processes are manual, attention should be given to her thought process. She continues:

"Here are some common excuses describing why lot release is delayed. If your production and documentation processes are mostly manual, it is likely these and/or similar issues occur:

"Changes to the master batch record were not implemented and approved on time, so we need to mark up the existing record and log a deviation or open a change request to use it."
"We were distracted during manual addition and overshot the target."
"We did not realize that an instrument needed to be calibrated before we began to add material."

. . . What those winning companies have learned to use is a proven methodology that defines, measures, analyzes, and institutes permanent controls that help them win the RTFT-ET battle. This methodology is called lean six sigma (LSS), and it is based on conducting real time, in-depth analysis of business problems."

Michalle provides a series of structured approaches leveraging years of experience to help manufacturers plow through these business problems. You'll want to take a closer look at her thoughts and read the full text PDF document located here.

Michalle Adkins is a Senior Consultant in the Life Sciences Global Industry Solutions group at Emerson Process Management. She has 18 years of experience in consulting, project management, planning, manufacturing, automation, and engineering. Ms. Adkins has a B.S. in Chemical Engineering and an M.E. in Industrial Engineering and can be contacted by clicking here.

Intelligent Manufacturing with Control Techniques Drives

2010-01-12T11:06:00.011-05:00

Pharmaceutical manufacturing can be very complex with many key processes and operations. These processes often utilize automation equipment containing fans, pumps, compressors, centrifuges, fluidized dryers, and conveyors powered by induction motors. In some early manufacturing facilities, these applications were controlled with motor starters, which only provided the ability to start and stop the motor with no other control capabilities. As technology evolved, process control engineers started to use smart switches. These switches provided a digital link so information could be gathered about the control system performance. However, they did not provide the plant operators with the ability to perform closed loop motor control and to get predictive diagnostic information. Emerson Control Techniques provides a complete solution by putting the digital control interface within the drive itself.

CT Powers PlantWeb

By using a Control Techniques VFD in the PlantWeb environment, pharma plant engineers can employ a complete digital control strategy enabling functionality such as real-time control, predictive diagnostics, quick drive commissioning, and easy system troubling shooting.

Two new PlantWeb solutions, The AMS / CT EDDL interface and the DeltaV / PCSD Library Modules enables CT Drives to plug and play within the PlantWeb environment. The PCSD library modules enable quick installation of the CT drives into the DeltaV process control architecture, provides a graphical faceplate to monitor critical process data, implements advanced control functions such as interlocks, permissives, and modelocking, and has been tested by the PCSD development team so it is guaranteed to work.

The new EDDL modules allow easy interface with AMS Device Manager, the best-in-class commissioning and diagnostic software. With AMS, users can detect plant equipment problems before they occur, reducing or eliminated unwanted down time. “Guided Setup” methods can be used to configure the drive for their intended application such as fan, pumps, or compressors. The digital interface provides real-time information on control performance and PlantWeb alerts giving operators timely information to make informed decisions.

This greatly benefits plant control and maintenance engineers by reducing risk, allowing quicker development and commissioning time.

Energy Savings

By being a part of the PlantWeb architecture, the use of the VFD’s can save significant amount of energy which translates into a cleaner environment and holding on to hard earned profits. As can be seen by the chart below, running induction motors at a reduced speed saves significant power. At 80% speed, only 50% of the power is used, and at 50% speed only 12.5% is used! So by varying the speed setpoint using the DeltaV control system, a significant amount of energy can be saved over the life of the manufacturing line.

Climate Controls for Clean Rooms and More

CT also offers a complete line of HVAC drives which are ideally suited for clean room controls. The Affinity drive has special features built in such as building automation protocols, fire mode, real-time clocks, and multiple PID loops. One of the key benefits of using the CT Affinity drive is the ability to communicate with a building automation controllers using Bacnet and the DeltaV controller simultaneously without the need of a gateway.

A part of Emerson Industrial Automation, Control Techniques has a single minded focus on the design and manufacture of variable speed drives. Control Techniques has been creating ground breaking technology since introducing the first digital DC drive over thirty years ago. Control Techniques combines extensive industry experience, modular drive design, powerful technology and advanced tool kits to provide complete industrial automation solutions.

Steve Bartz is located in Eden Prairie Minnesota and is the Director of the Motion Control Product Line for Emerson Control Techniques. He has over 18 years of experience with Control Techniques in both in R&D Engineering and Product Management departments and is a graduate of the University of Minnesota Electrical Engineering Department. For more information, you can contact Steve by clicking here.

Looking Forward

2009-12-31T08:59:00.011-05:00

As we wind down the year, like most, there's a bit of reflection. The Life Sciences Industry Solutions Group has made great strides in developing a cross divisional, world wide team looking to share ideas for the greater good of Emerson. We continue to learn from the past, appreciate the present and are aggressively preparing for more good things to come.

As we look at the past, we can't help but survey the change that has occurred in the industry. Innovation has softened the sting of the FDA with technologies like PAT and methodologies such as ASTM E2500. There has been a tremendous amount of consolidation, particularly over the past couple of years - Roche-Genentech, Pfizer-Wyeth, Merck-Schering etc. Much of this and continued consolidation can be tied to decreased patent years and the need to maximize profits. Disease profiles are becoming more demographically specific resulting in fewer blockbusters and smaller batches. To say the least, 2010 will close out a remarkable decade of change. Here's a great video from CNBC highlighting some of the past years seminal events while touching on expectations for the future.

There was an interesting report by Peter Benesh in the December 28, 2009 issue of Investors Business Daily. He talks about Big Pharma righting its ship as Big Biotech struggles to win the Street's approval. Big Pharma has realized fairly solid gains in 2009 (e.g. Roche up 12%, Merck up 22%, Sanofi-Aventis up 24%) while the 5 biggest biotechs have not ( e.g. Genzyme down 27%, Gilead down 16%). One reason, he points out, is because they face the same problems that hit pharma in the last several years, specifically, the need to manage costs with limited pipelines. Pharma has adjusted largely through acquisitions and huge mergers. With the value of patent expiration in biotech estimated to be $15 billion in the next five years, Big Biotech will need to adjust accordingly. The (sort of) good news is the absence of a regulatory framework to approve follow on biologics, known as biosimilars. Benesh points out that US regulators have not figured out what standards must apply for a generic maker to claim its version is similar enough to the original work as advertised.

Looking ahead, government-run healthcare will continue to take center stage. Lots of implications to be sure. Segmentation will continue and consolidation will undoubtedly persist. The need for flexibility, more for less, and implementing projects faster positions Emerson to preserve a leadership role in the future. We have the capital, a profusion of smart people, and an integrated ISA 95 approach and architecture that brings the field level, the process control level, as well as the manufacturing execution level into place with one integrated database.

Here's to a great 2010!

Faster Commissioning with AMS Suite

2009-12-14T14:19:00.000-05:00

As new life sciences projects enter the horizon, customers are faced with the need to implement projects faster with fewer and fewer resources. Laura Briggs, AMS Suite: Intelligent Device Manager Product Manager for Emerson, tells us how Emerson is addressing the growing need to execute pharma and biotech industry projects faster by leveraging AMS Suite.

Q. Laura, what is the basic business problem that AMS Suite addresses?

A. Customers are looking to deliver automation projects faster than ever before. In many instances, we find project life cycle time lines being reduced from 18 months to 10 months. Consequently, customers are faced with the burden of doing more with less. This includes the people and capital required for faster commissioning. Available personnel tend to have more and more generalist vs. specialist skills as technology becomes more complex.

Q. Who is typically affected at the customer site by these challenges?

A. While there are many, I'll mention three different key roles. They include the Plant Manager, the Maintenance Manager, and the VP of Engineering. The Plant Manager tends to focus on reducing the money and time required to get things done to allow the plant to achieve other business goals. The Maintenance Manager is charged with getting the most value out of dollars spent on maintenance, while minimizing downtime with fewer resources. The VP of Engineering is dedicated to faster execution methods and "right first time" commissioning.

Q. What are some of the benefits to life science projects from AMS Suite?

A. AMS Device Manager has features such as QuickCheck SNAP-ON, Audit Trail, Calibration Management, and device configuration capabilities that deliver immediate benefits in this industry.

Commissioning time at a pharma or biotech plant can be reduced by as much as 50% by downloading configuration information from a single database to a new device using drag-and-drop techniques rather than keying in configuration parameters one at a time.

Users can further streamline work practices and create an accurate historical record with the AMS Device Manager Audit Trail option. The Audit Trail automatically generates and saves a historical record of device alerts, device configurations, calibration tests, and diagnostics information. All records are date- and time-stamped and include user and PC correlation. Users can review all configuration changes or focus on a few specific changes to analyze problem areas. In addition, they can view records for an entire plant or for a specific device. To ensure data integrity, historical records cannot be edited.

The QuickCheck SNAP-ON application allows users to greatly reduce time needed to verify interlocks by providing the ability to fix the output of multiple devices for interlock validation. It can also be used to create macros for stepping multiple transmitters through validation tests, such as 2oo3 voting logic.

Users can set up calibration routes for maintenance activities, track activities, and produce printable calibration reports with the Calibration Assistant SNAP-ON application. By automating and streamlining many common maintenance tasks, AMS Device Manager helps to ensure that work is done efficiently and effectively while automatically creating an historical record of tasks. This gives maintenance staff the time to focus on high priority tasks.

Q. How would you describe Emerson's overall value with respect to plant asset management?

A. There are two major components. The first is project startup and commissioning, where AMS Suite reduces time spent in this phase through easier device configuration. The second is ongoing maintenance, availability and up time.

AMS Suite uses predictive intelligence to improve the availability and performance of a life sciences user’s key production assets. It is an integrated family of best-in-class diagnostic software applications that enable users to detect plant equipment problems before they occur. Whether users are in plant management, operations, or maintenance and reliability, AMS Suite delivers the timely information needed to make informed decisions and implement projects faster.

Laura is based in Eden Prairie, Minnesota and has worked for Emerson for over 6 years in customer service, sales support, and product management roles. Laura has a BS in Computer Science and an MBA with a marketing focus, both from the University of Minnesota. Many thanks, Laura!

Deals

2009-12-07T14:28:00.004-05:00

I wanted to offer up this quick post pointing to Mike Huckman's Pharma's Market article on deals in the Pharma Industry. Huckman is a CNBC journalist that does quite a bit of insightful reporting on the Pharma Industry and has a pretty cool blog where he comments on daily industry happenings offering a fresh look at the industry. He talks about on-going deals in our industry and focuses on a recent one between Pfizer and Protalix as well as AstraZeneca and Targacept. Much of this, of course, is being driven by competitive positioning and maximizing profits. He offers some pretty good insight on the state of the industry as it relates to partnerships and acquisitions vs. the normal parlance of mergers and acquisitions. Interesting stuff . . . here's a video from CNBC with Huckman reinforcing the point.

Faster Projects With Human Centered Design

2009-11-30T19:35:00.001-05:00

Much has been written about the application of Human Centered Design (HCD) concepts and technology in the life sciences industry. Emerson Process Management has been leading the way with significant progress in making process control technology easier to use with the introduction of its new DeltaV S-Series technology. This new technology series demonstrates Emerson's commitment to HCD while leveraging these concepts toward implementing faster projects. Take a look at the video below from our colleague Juan Carlos Bravo. Juan, provides us with an overview of DeltaV S-series control solutions highlighting how Emerson has delivered on changes that have a dramatic impact on project efficiencies.

So how does all of this relate to a faster project in our life sciences customer base? Simply put, this new design eliminates work and reduces complexity with snap-on I/O on demand electronic marshalling. Time to market is becoming more urgent than before in the life sciences industry as customers are looking to deliver automation projects faster. This is especially true in the Generics market where customers look to harvest profits faster from the patent pull. With Emerson's new design principles embedded in DeltaV S-series technology, cabinets, wire, terminations, cable tray design, installation drawings and a series of other activities are now eliminated. The result . . . late process changes are no longer a problem, significant wiring costs are eliminated and the entire project engineering process is streamlined. It's been estimated that 10% to 20% of a project's cost can come from late wiring changes that can cause commensurate delays on a project.

Here's a closer look at DeltaV S-series and specifically the Characterization Module (CHARM) that's central to some of the productivity improvements presented by our colleague Nathan Pettus.

In general, this new model means users don't have to rewire their I/O nearly as much, don't have to buy as many I/O cards, and can now reassign up to 50 signals in a matter of seconds by virtue of point and click. All of this new functionality comes with a set of HCD focused operator displays that boost operator performance with more intuitive recognition of alerts and easy access to information to understand the data and act on it in a timely fashion.

Cheers!

Una actualización de nuestros amigos en Puerto Rico

2009-11-12T13:35:00.006-05:00

Here's a quick update from our friend Vivian Freytes in Puerto Rico on some of the activities around Syncade. She writes:

"Here in Puerto Rico, pharmaceutical and biotech industries are continually challenged to improve their manufacturing quality, productivity and annual growth for key stakeholders while assuring regulatory compliance. Consequently, this highly regulated industry needs to have easy operational procedures that provide fast and accurate responses, resulting in high quality and safe products. Based on this principle many pharmaceutical companies in Latin America are searching for ways to optimize their manufacturing operations and systems. This is the case of a local pharmaceutical customer site which was selected by their corporate headquarters as a pilot plant for the implementation of Syncade. Syncade Smart Operations management suite is a group off-the -shelf modules designed specifically for cGXP- regulated industries."

She adds:

"Our local customer was searching for ways to reduce documentation errors, manual operations, rework and downtime. They needed a uniform system that provided minimum human error during their manufacturing operations. The plant completed Phase 1 of the implementation with the Syncade - Electronic Batch Record (EBR) module. The emphasis was on automating their processes by creating recipes integrated to their existing control systems such as Delta V as well as PLCs at the parenteral production area. This module provides completely paperless manufacturing records for good manufacturing facilities. With the EBR module and use of electronic work instructions, typical paper document execution and management error are eliminated. The solution provided by Emerson also includes a Recipe Authoring application, Workflow and Order Management capabilities. Moreover, the solution provides seamless integration with the customer’s Enterprise Resource Planning (ERP) system (used for product orders and business strategies). Going forward the facility is implementing other Syncade modules as they look to build on an all encompassing right first time manufacturing capabilities. Lastly, the solution has provided management at the site with greater visibility of their operations and support better business strategies decisions."

We understand that since the first set of modules have been successfully deployed . . . the customer is implementing similar solutions at other local and global sites. Gracias for the update, Vivian!

Faster Projects - A More Efficient Approach

2009-11-04T19:52:00.013-05:00

The Life Sciences Industry continues to drive automation projects toward reduced time to market and total installed cost goals while maintaining highly aggressive schedules.

The FDA Guidance on cGMPs for the 21st Century and the evolution of ASTM 2500-07, GAMP 5, and ICH guidelines have been instrumental in achievement of these goals by introducing the concepts and practices behind Risk-Based Approaches. These streamlined methodologies have enabled Emerson to deliver highly efficient solutions for the Automation System Life Cycle from initial FEED through support of Performance Qualification on major projects.

Traditionally, Life Science companies have had difficulty maintaining schedule and cost control on automation projects that had been impeded by multiple layers of redundant testing and associated high volumes of documentation, coupled with an unacceptable level of field deviation resolution activities. The picture above depicts the real world advantage of Risk-Based versus traditional approach.

Risk-Based approaches provide a framework for Life Science customers to streamline the System Life Cycle activities associated with automation projects. They enable the reduction of testing, documentation and time lines associated with the traditional FAT, Commissioning, Qualification and Validation (CQV) phases of the project.

Effectively, Risk-Based approaches enable project teams to focus on the most critical process aspects affecting patient safety and product quality. It is a paradigm shift from the ‘test-it-all’ validation mentality to the use of assessments to determine what is critical and high risk. The results of these assessments allow the focus to shift to a ‘test what matters’ strategy.
A number of our major life sciences customers have begun to adopt this paradigm shift and Team Emerson with its Alliance Partner VALSPEC are uniquely qualified to support our customer base with developing their Risk-Based projects.

The projects typically included:

Utilization of standard Emerson test procedures as part of the overall Verification approach.
Leveraging of testing during cFAT for items of moderate risk.
Develop and execution of Qualification level testing used in the cFAT environment to more robustly test the system and minimize field deviations.
Full utilization of S88 designs to optimize test strategy and reduce test volume.
Development of Requirements Traceability Matrices that map the Emerson automation engineering deliverables against the project’s specific requirements and subsequent test protocols.
Elimination of unnecessary system testing by identifying specific requirements as Commercial Off the Shelf functionality that is covered under Emerson’s existing Quality Management System.
Utilization of tools to efficiently migrate data while maintaining compliance.

VALSPEC has a group of Subject Matter Experts (SME)s in this area and as part of Team Emerson is experienced in leading the consultative process in establishing the unique Risk-Based project plan tailored to each customer-specific environment. This holistic approach has been highly effective in managing customer expectations to create an environment where everyone wins! For more information you can contact VALSPEC by clicking on this link.

Justifying the Switch to Single-Use Technology

2009-10-28T15:44:00.002-04:00

I ran into Juliette Schick, Ph.D., President, SciLog Inc. 2 weeks ago at the BioProcess International show and she offered a number of comments regarding the OEM relationship with Emerson and the application of single use technology in the life sciences industry.

Q. Juliette, can you talk about the problem space as it relates to single-use technology?

A. Many promises have been made concerning the cost and time savings of single-use components (e.g. bags, tubing, filters, fittings). Most calculations of cost and time savings have been based on comparing single-use components with comparable stainless steel components and how they impact facility usage/design. The majority of savings are associated with decreased fixed costs (investment in facilities) of implementing single-use platforms. It has been established that single-use platforms significantly decrease fixed costs (facility investments) while increasing variable costs. Increasing variable costs is desirable, because variable costs are directly linked to output and occur only when there is a production run. Thus, single-use platforms upfront costs are less and the cost of consumables tend to be considered a variable cost, occurs only when used in production.

Q. Can you give us your insights on the integration of single-use technology with automation systems such as Emerson's DeltaV platform?

A. An additional factor should be considered when implementing single-use platforms – the effect that automation has on costs. Combining single-use platforms with automation achieves additional cost savings by increasing yield, reproducibility, and product quality of biologicals. All three of these cost savings come with the utilization of automated single-use platforms.

Q. Can you talk about your capability to automate single use platforms?

A. While manually operated, single-use purification platforms have been enthusiastically embraced by the biopharm industry, fully automated single-use platforms have, until recently, not been commercially available. It was only with the availability of SciLog’s pre-calibrated single-use sensors (for monitoring/controlling pressure, conductivity, temperature) that the automation of single-use platforms has been made possible. Automated data acquisition, implementing feedback loops, documentation of parameters in real-time, and the control and monitoring of important parameters have been critically important in optimizing single-use purification (downstream) applications.

Q. What's the value proposition of this automation opportunity?

A. The true value proposition of single-use technology comes from increased process performance, which is obtained with automated control systems and the associated software. It is well-documented that automation of processes have the highest effect on decreasing COGs and results in:

increased reproducibility & product quality
increased product yield
reduced human intervention
reduced user error
reduce paperwork/validation protocol

Q. What specific SciLog solutions are you referring to?

A. SciLog has paired automation of purification applications with single-use technology in its SciPure platform. The SciPure protein purification platform provides the ability to easily switch from manufacturing one product to another. Traditionally, the biopharm industry has avoided utilizing automation for this purpose, because of the threat of cross-contamination. However, cross-contamination risks have been greatly reduced and/or eliminated with the utilization of single-use components and manifolds.

SciLog’s purification platform goes beyond giving the users an island of automation. SciLog’s purification system provides an automated single-use platform which utilizes Emerson’s DeltaV control system. This is the first commercially available automated single-use platform for automating protein purification (both diafiltration and concentration) in the DeltaV format.

Q. Are there any other process knowledge and product quality improvements that can be realized?

A. Improved process knowledge is directly dependent upon the data quality generated by sensors used in an automated platform. Do not be misled because of the term “single-use.” SciLog’s single-use sensors are robust, are pre-calibrated and are NIST-traceable!

SciLog’s single-use sensors were designed to exhibit high response stability. SciLog’s sensors are able to generate a real-time data stream and provide improved data quality without need for in-field calibration! SciLog’s sensors: SciPres (Pressure), SciCon (Conductivity), and SciTemp (Temperature) are in-line sensors which are modestly priced, can be used once or multiple times – depending upon the application.

In summary, the blending of SciLog’s single-use sensors and automation provides a significant decrease in COGs with an increase in product quality/production. Considering the value addition which numerous other industries have found by embracing automation and the special values that single-use technology brings to the biopharm industry - this is a combination that will strengthen the biopharm industry.

Juliette Schick is founder and president of SciLog, Inc., located near Madison, Wisconsin. She may be contacted at: js@scilog.com.

BioProcess International Conference

2009-10-19T10:23:00.005-04:00

Chris Amstutz and I had the good fortune of attending the BioProcess International Conference held last week in Raleigh, North Carolina last week. It was held at the Raleigh Convention Center. The conference organizers did a fantastic job pulling together a far reaching number of timely and relevant topics. Areas of interest included Manufacturing Efficiency and Supply Chain Security, Cell Culture and Upstream Processing, and an array of Strategy Discussion Forums. Conference attendees had access to selected keynote presentations, poster presentations, exhibit floor product demonstrations, and technology workshops. I spent most of my time on the Manufacturing Efficiency thread while Chris focused on the Cell Culture and Upstream Processing thread.

Chris commented " the conference suggests the industry is clearly developing momentum toward single use technology and widespread adoption of QbD (Quality by Design) with an end game of PAT (Process Analytical Technology)." One couldn't help wonder . . . what would the biotech plant look like 10 years from now? Conclusions easily drawn include:

1/2 the CAPEX
1/2 the size
1/2 the resources (people) and utilities

An additional perspective from Chris . . . "if you are moving towards QbD and PAT - data management becomes huge given you are looking at snapshots of the spectra (multivariate data) and critical process parameters that enable greater predictability and trending of critical quality attributes."

Of particular interest was a plenary presentation given by Ali M. Afnan, Ph.D., Senior Staff Fellow, OPS, CDER, US FDA. It was clear Ali is one of the forward thinkers in this space. His trenchant and provocative observations and questions posed during his presentation were extremely well received. He talked about the common goals of consumers, manufacturers, and regulators in pursuit of quality. These common goals center around product quality, innovation, stability, oversight, and cost among others. The irony is that other industries have been doing this for quite some time and our industry needs to aggressively shift from tradition to innovation including a shift from end process testing to in process control. Emerson is fully on board with this message, continuing to lead with solutions that allow for quality to be built in the process (by design) as noted in prior PAT related blog posts.

There was so much more including pre-conference symposia discussing Technology Transfer for Biopharmaceuticals, Driving Out Cost from Biomanufacturing, and Practical Aspects of Implementing Quality by Design. Great stuff!

Eye Opening Exchange

2009-10-04T08:03:00.000-04:00

We have been away for the last couple of weeks preparing for, then attending the 2009 Emerson Global Users Exchange held in Orlando, Florida. The event wrapped up this past Friday with lots of exciting developments. It allowed the Emerson Life Sciences Industry Group to further demonstrate our domain expertise and talk about some exciting enhancements to Emerson's broad-based solutions.

During the conference, our customers shared a number of pain points. They continued to emphasize patient safety is number 1 along with getting more for less in a competitive landscape. They also stressed they are hindered by the need to reduce their plant's footprint cost and complexity. Moreover, when new projects come on the horizon, they need to implement projects faster in a quest to harvest profits sooner. Technology transfer costs continue to increase due to distributed manufacturing processes. Last but not least, they reinforced the requirement of a consistently available and healthy plant with predictability and redundancy.

So . . . what were the key messages we provided during the event that addressed these pain points?

Pain 1 – Patient Safety

As patient safety is the FDA’s primary concern, “Right first Time” is a term often used to describe flawless execution and FDA conformance particularly at plant start up. The product attributes must match the specification and the “2nd time” is not an option.

How do we uniquely solve this pain?

The first is by ensuring the customer knows what’s going on in the process. One of Emerson’s key solutions in this area is Process Analytical Technology (PAT). To achieve the ideal state, an integrated PAT architecture is crucial. While Emerson’s existing products, DeltaV and Syncade, are two legs of the PAT ‘stool’, the vital third leg is ‘synTQ’ which provides real-time, on-line data management for complex PAT data sets (they often include spectra, or even 2D arrays of data), and the ability to integrate a wide variety of instruments and third-party analysis packages. The three components link together easily, providing a well integrated system dealing with all aspects of the PAT environment. Emerson’s integrated PAT application architecture is shown below.

The second is through the use of V11 enhancements such as Batch Redundancy and SMX functionality. Comprised of inexpensive, easily replaceable PC hardware, Batch Redundancy protects drug intellectual property (IP). SMX connectivity provides a robust firewall as secured connectivity is critical for patient safety. SMX utilizes Windows Communication Foundation (WCF) technology providing secure transmission of real time control data.

Pain 2 – More for Less

Customers are looking to produce more products for less cost. Cost pressures require customers to roll out different products from the same asset thus building a flexible infrastructure to increase yield and adjust to changing markets.

How do we uniquely solve this pain?

A key solution to this pain point is leveraging “single use technology” representing the next generation of technology as well as enhanced Recipe Management. Components of the Emerson solution include:

PlantWeb® Experience Licenses
Baumann Control & Pinch Valves for single use
Driftless pH Sensors with Wireless Transmitter

Pain 3 – Faster Projects

Customers are looking to deliver automation projects faster, i.e., in 10 months vs. 18 months. Time to market is becoming more and more urgent than before. Particularly in the Generics market segment, customers need to harvest profits more quickly from the patent pull. The adjoining chart shows the rapid fall off of available Generic patent pull profit potential when a particular product comes off of patent classification.

How do we uniquely solve this pain?

Help our customers reduce the plant’s complexity and footprint while reducing start up time and cost with V11 enhancements.
Provide I/O on demand with CHARMS snap on modules (vs. screwed in) that eliminate I/O cards and saves marshalling space.
Decrease execution and start up time with AMS features such as Loop Checkout, Audit Trail, and Calibration Management etc.
Present Emerson’s ASTM E2500 methods and capabilities. Current trends initiated by the issuance ASTM E2500 are pushing most, if not all, of the requirements into Good Engineering Design practices, testing and development activities that are the primary responsibility of a Pharma company's engineering group, which supports other industry practices such as Quality by Design (QbD). The result is that commissioning and qualification activities are changing to a more holistic system-level test of the system functionality against its specified requirements. Reliance on Supplier Quality Management Systems is a must if a Pharma company intends to minimize traditional C&Q activities into verification-level activities.

Pain 4 – Technology Transfer Cost

Life Sciences industry manufacturing processes are typically distributed across the world to leverage tax savings. Within this context, transfer of knowledge R&D through Clinical to Bulk manufacturing to Fill Finish is primarily a paper based process. Tactically, paper based processes inherently create deviations, cumbersome levels of document handling, non-value added functions, and rework. This often results in tying up resources in reviewing and approving documents and can be a time consuming and costly process.

How do we uniquely solve this pain?

Syncade – an out-of-the-box, single data model, integrated platform that provides greater efficiencies and operational excellence around human capital management, materials management, equipment management, and document control and archiving.

Syncade is easy to use, designed and developed specifically for the Life Sciences industry.
Low total cost of ownership, browser based, Microsoft.Net platform
Mimics the paper paradigm

Pain 5 – Availability

Life Sciences companies require maximum availability of assets to ensure maximum profits. Many LS plants report that downtime is the biggest source of lost revenue and lost profit opportunity. When plants operate below their maximum profit potential, often because of inadequate process availability, improving availability can significantly improve plant financial performance. Even small improvements in availability can create large improvements in profit margin, with up to half of each incremental revenue dollar going to the profit line. In addition, improving availability can result in lower overall cost of operation. This combination of improved margin and lower costs makes improved availability a powerful tool to improve a LS company’s financial performance.

How do we uniquely solve this pain?

Predictive maintenance helps plants avoid unplanned shutdowns that eat away at profits. AMS Device Manager helps avoid unnecessary costs with a window into the health of intelligent field devices. It gives maintenance and operations personnel the ability to work smarter. Based on real-time condition data from intelligent field devices, plant staff will respond faster and make informed decisions on whether to maintain or replace field devices.
Redundancy in solutions available at every stage. Controller, I/O, and Network redundancy and now have it at the Batch Executive.
Longer software upgrade time – Emerson now provides LS customers a 5 year upgrade window. Migration and upgrade costs can be expensive; however, money is not as important as the time and validation effort required.

There's so much more to add. Emerson Exchange was a real eye opener for many . . . realizing Emerson continues to provide innovative PlantWeb® solutions that provide sustainable value.

Uniquely Singapore

2009-09-16T12:31:00.004-04:00

Shenling Yang continues to provide us with market perspective. She recently took notice of Business Monitor International’s “Singapore Pharmaceuticals & Healthcare Report Q1 2009”, which pretty much covers all aspects of the industry.

She writes:

“I personally think Singapore is very unique and very important to our Life Sciences business. As many foreigners know, Singapore is a trusted base for companies to explore opportunities in Asia. it offers excellent Intellectual Property (IP) protection, a mature market, a skilled workforce and a stable political and civic environment. More than 10 leading pharmaceutical and biotechnology companies have established regional headquarters in Singapore. They include AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, Genzyme, GSK, Merck, Novartis, Quintiles, Sanofi-Aventis and Schering-Plough. 11 of the world’s top pharmaceutical and biotechnology companies have invested in more than 25 commercial-scale manufacturing facilities in Singapore. They include Abbott, Alcon, Genentech, GSK, Lonza, Merck, Sharp & Dohme, Novartis, Pfizer, Sanofi-Aventis, Schering-Plough and Wyeth. These facilities are validated by regulatory authorities from the US and Europe, and produce products for the global market.”

Shenling adds:

“Emerson Singapore serves as the Pharmaceutical/Biopharmaceutical industry knowledge center for all of Asia Pacific. We have a skilled team of professionals that can execute a full scope Pharmaceutical/Biopharmaceutical project throughout Asia Pacific. The capabilities include automation design and implementation, DeltaV, and Syncade software implementations. Emerson Singapore is on the path to become a full service provider to Pharmaceutical/Biopharmaceutical customers from Supplier Audit to IQ, OQ, PQ activities.”

For some additional insight on the talent pool coming out of Singapore, here’s an interesting video with Dr. Chan Sui Yung, who is the Head of Pharmacy at the National University of Singapore.

Delivering Consistent Results Through Better Instrumentation

2009-09-08T10:15:00.001-04:00

Caitlin Thelemann, Global Marketing Engineer for Rosemount, Inc., a division of Emerson Process Management, recently offered her thoughts on Rosemount Instrumentation solutions. She is part of a team that delivers industry specific results - one of those being Life Sciences. One of the key issues in the industry is the expectation of delivering more with less. The process needs to keep running reliably and efficiently, with fewer resources. Rosemount has taken historically reliable Rosemount measurement technologies and packaged them specifically for the Life Sciences industry, making them easy to configure, support and operate. Caitlin expands on this theme with some insightful answers to series of timely questions.

Q. Can you talk a little bit about the Rosemount Division?

A. Rosemount is recognized not only as the world leader in the design and manufacture of instrumentation - including pressure, temperature, flow and level products, but also as the after-sale global service leader. The basis for Rosemount's success is our commitment to product quality and reliability in the most demanding industrial environments.

Q. What are the business drivers in the life sciences industry? Also, your thoughts about the tactical and consequential pain points you tend to address?

A. A huge risk for the Life Sciences Industry is producing a non-compliant batch. Many manufacturing facilities have batch cycles that are on the order of days to months. Going through an entire batch cycle just to produce a product that cannot be sold is a large loss. We understand that potential loss and have a suite of hygienic products that enable industry-leading best practices to reduce this risk.

Q. What’s the reason for these problems?

A. Process contamination is a large contributor to non-compliant batches. Steam/Sterilize in Place (SIP) process is performed regularly in order to sterilize the process piping and vessels. The SIP process involves injecting steam and heating the process piping to a kill temperature, often around 121C. The process is held at this temperature for 30 minutes to complete the cycle. This cycle is critical to avoid process contamination and requires a lot of temperature measurements (200 to 300 on average) to continuously monitor the temperature.

Any abnormal conditions that occur during the batch cycle can also lead to an inconsistent or non-conforming product. These can range from a charging a vessel with too much or too little reactant from the control room or human error in the loading of reactants for the batch.

Q. Who is typically affected at the plant?

A. Certainly the plant operators who control the batch - since it is their responsibility to ensure the process is repeated the same way every time in order to produce a consistent end product. But if a batch is non-complaint then it affects the production manager, and ultimately the plant manager.

Q. What capabilities can Rosemount deliver to the customer?

A. The Rosemount 848T eight input temperature transmitter is an ideal solution for the high density temperature measurement SIP application. It enables accurate, continuous monitoring at each measurement point to ensure the kill temperature is reached and sustained during the SIP cycle.

The Rosemount 3051S-L Liquid Level transmitter is a high performance pressure transmitter whose best-in-class seal design improves performance and reliability. This enables a more accurate and repeatable level measurement for every batch.

Q. What business value does the end user see?

A. Utilizing the Rosemount 848T for SIP applications rather than a manual surface indicator provides a more accurate measurement, as well as reducing the SIP cycle time by 20%. This means starting another batch sooner and increasing the facility's production. Both of these solutions help our customers achieve a reduction in process variability due to tighter control and that ultimately leads to a more consistent end product.

One thing that sets Rosemount apart in hygienic industries is the ability to provide reliable instruments for the entire campus of a biopharmaceutical plant. Not only can Rosemount offer hygienic products for biopharmaceutical manufacturing systems, but also the facility's utility applications where aseptic requirements are not as strict. That means one vendor for the customer's entire campus.

Based out of Chanhassen, MN, Caitlin Thelemann is a graduate of Michigan Technological University with a degree in Chemical Engineering. If you would like more information on Rosemount Instrumentation solutions, you can contact Caitlin by clicking here.

The Global Life Sciences Team At Emerson Exchange

2009-08-27T18:12:00.007-04:00

The Life Sciences Industry Solutions Group has been hard at work putting together an outstanding program at this year’s Emerson’s Global Users Exchange. The user meeting provides a multitude of industry forums, workshops, presentations, demonstrations and exhibits that cover the gamut of the Life Sciences Industry. Over 60 different Life Science companies have registered to attend providing an excellent networking forum between the outstanding programs offered during exchange.

Industry Forum

The life Sciences Industry Forum is sure to be a highlight of the entire conference with the Keynote address “Quality by Design (QbD): A Practical Approach to Change” by FDA Director Dr. Helen N. Winkle followed by two different panel discussions with industry leaders and FDA’s Dr. Ali Afnan.

Emerson’s own President & COO Melissa Herkt leads the first industry panel “Emerging Trends along the Path of Molecules to Medicines” with FDA’s Dr Ali Afnan, Mr. Lars Petersen, Genentech Director of Corporate Automation, Dr. Gawayne Mahboubian-Jones, Optimal Industrial Automation Product Development Manager, and Mr. Frank Grywalski: President, DMI/Emerson Process Management.

Mr. Mark Hassenplug ,Global Life Sciences Advisory Leader from Ernst & Young chairs the next panel discussion “Is single use technology the next generation of manufacturing?” with Dr. Karl Schick: SciLog Inc.Chairman and R&D Director, Mr. Brian Hartman, Eli Lilly and Company Consultant Engineer Process Automation, Mr. Scott Broadley: Broadley-James Corporation President, and Emerson’s own Terry Blevins Principal Technologist.

Industry Solutions Group Exhibits

In the Exhibition hall, everyone is invited to stop by the Life Sciences Industry Group interactive exhibits to hear and see first-hand Emerson’s newest initiatives, OEM Disposables (aka Single Use Technology), Process Analytical Technology( PAT) with SynTQ, Smart Wireless technology and of course Operational Excellence (OpX). Working demonstrations include:

An integrated working PAT demo with analyzer, SynTQ, Syncade, and DeltaV.
An Emerson “Cactus” that demonstrates Delta V, Delta V SIS, Smart field devices, Smart Wireless devices and Asset Management, all of which are the various elements of Plantweb. Be sure to stop by and meet all the Emerson Life Science Industry Group consultants at the exhibit booth.

Workshops and Presentations

This year Emerson Global User Exchange has over 325 workshops and short courses that feature speakers ranging from end users to OEM customers to academics, to market researchers. Over 35 of these workshops address Life Sciences Industry topics from successful Syncade projects to Advanced Applications of DeltaV in Cell Culture. You are invited to come and hear first-hand how forward thinkers of our industry are gearing up for today’s uncertain economic times and beyond. If your involved in process automation, operations management, safety systems, operations excellence then you should plan to attend the Emerson Global Users Exchange 2009 in Orlando, FL from September 28-October 2 where “Engaging Minds, Amazing Results”

Follow the link to Emerson Global Users Exchange.

OEM Partners

Life Science OEM partners Broadley-James, Finesse, and Scilog will be exhibiting products and systems in the Vendor exhibit area adjacent to the Life Science Industry Solutions Group exhibits.

Broadley-James Corp. is a source for instruments, sensors, tools, accessories and maintenance supplies for use in microbial fermentation and cell culture bioprocess applications. Special emphasis is given to the areas of measurement and control of the environmental conditions inside fermentation vessels and bioreactors. Key products and supplies are stocked for next day delivery to provide timely backup to your round-the-clock production activities. In addition, the catalog and its personnel strive to be an informed source of application support for the products offered. . For further information visit the Broadley-James website at http://www.broadleyjames.com/.

Finesse was founded to bring digital, plug-and-play solutions to life science customers, so as to improve the management of complex bio-process applications. Our initial focus is on improving sensor, hardware, and software solutions for process control in the biotechnology and pharmaceutical industries. For further information visit the Finesse website at http://finesse.com/

Since its inception in 1990, SciLog has been committed to innovations in automated and single-use purification systems as well as disposable sensor technology. As the Biopharmaceutical industry has matured over the past 18 years, SciLog’s innovative products are used in laboratories, pilot plants and GMP production facilities. Since its inception in 1990, SciLog has been committed to innovations in automated and single-use purification systems as well as disposable sensor technology. For further information visit the SciLog website at http://www.scilog.com/index.php

The entire Life Science Industry Solutions Group is looking forward to meeting you at exchange. Be sure to stop by the exhibit booth and meet the team.

Saroj Patnaik – Director
Alan Babbitt – Manager, Sales Programs
Chris Amstutz – Consultant Group Manager
Michalle Adkins, Mark Coughran, John Piela, David Rehbein – Industry Consultants

Emerson at BioProcess International Conference in Beijing

2009-08-19T08:05:00.010-04:00

Here's a quick update from Shenling Yang, Marketing Manager, based in our Asia Pacific office in Shanghai, China.

"Emerson will be an Exhibitor Sponsor at BioProcess International 2009 at the Westin Beijing Chaoyang Hotel in Beijing China, September 7-8, 2009. We are going to involve Rosemount and Micro Motion divisions to show our PlantWeb® solution for the Life Sciences industry. PlantWeb® is a proven digital plant architecture in Life Sciences that uses the power of predictive intelligence to improve plant performance. PlantWeb® provides greater operational benefits by enabling throughput, availability and quality."

"The main objectives for us attending this conference are as follows:

To reinforce our view of global trends and China Opportunities (How to interpret current reforms of the medical system in China)
To enhance our understanding of China’s 60 billion investment plan in Biopharma sector in 2009 and 2010
To introduce Emerson Life Sciences products/solutions to the China Biopharma sector
Build on our relationships across the industry"

Please let her know if you need more information. You can contact her by clicking here.

IBC's website writes:

“Despite the global economic downturn, economists are still projecting a positive growth rate for China in 2009. Much of this growth will come from China’s biotech sector. China's government initiatives, the SFDA’s tightening of guidelines, the increasing IP, GMP and GLP compliance, the continuing search for lower cost production and the abundance of talent are all contributing factors to the sustained growth in China’s biopharmaceutical sector.”

Here's a link to the conference website:

www.IBCLifeSciences.com/BPIChina

Analytical Accuracy

2009-08-10T16:14:00.009-04:00

Rosemount Analytical Inc., (RAI), a division of Emerson Process Management, provides a comprehensive line of analyzers, sensors and systems for efficiency, quality, and environmental analysis solutions. The instruments and systems are specifically targeted to maximize performance, productivity and profitability in life sciences manufacturing applications. I spoke to Dave Anderson, Industry Marketing Manager, Rosemount Analytical, Liquid Division recently about the value RAI delivers to the life sciences community. His answers were very compelling:

Q. Can you talk a little about your Division? What is its primary emphasis?

A. RAI is the premiere supplier of Liquid Analytical Solutions. Our emphasis is on electrochemical sensing technologies. Our Division’s motto is “Follow the Water,” as there is a significant amount of water requirements in life sciences accounts.

Q. Can you talk about the business drivers in the life sciences industry? What are the basic tactical and consequential pain points you tend to address?

A. Yes, from an Analytical perspective, there are a number of pain points within a biopharmaceutical plant where RAI can improve operations. First and foremost, the Process Analytical Technology (PAT) Initiative has opened the door to take traditional off-line, laboratory measurements and put those methodologies in the process. The benefit to customers is they can now monitor key parameters in real time. By automating the process, customers can capture the data as well as document the calibration logs electronically.

One particular pain point is with pH control in bioreactors. Customers are asking for tighter pH control, some as tight as +/- .01 pH units. One customer mentioned if they can improve pH tolerances by 10% they estimate savings of $250,000 per batch.

Q. What’s the reason for these problems?

A. The problem with maintaining a tight pH measurement is how the sensors are used in the process. Prior to a batch, the pH sensors are calibrated with pH buffers to ensure the sensors will accurately respond to real process changes. After the sensors are calibrated, those chemicals must be cleaned from the sensor. The typical cleaning process is to steam sterilize the vessel at a minimum of 121º C for 30 minutes. The pH sensitive glass will become stressed from the exposure to high temperatures and subsequent cooling. This stress can result in significant offsets in the pH readings or critical failures in the form of cracked glass. Because of these concerns redundant sensors are often utilized.

Q. Who is typically affected at the plant?

A. Plant Operators must properly maintain the sensors and monitor their ability to accurately measure pH. That includes making a determination whether the sensor will survive the next batch.

Q. What capabilities can RAI deliver to the customer?

A. First, the Model 3800 pH sensor with Accuglass® technology is the best in class sensor to withstand the thermal stresses from the cleaning process. Comparison testing with competitive sensors proved the 3800 will withstand more steam in place cycles than any sensor on the market. The RAI XMT-P transmitter delivers real time diagnostics at the operator’s work station. Monitoring one pH loop locally at a transmitter is simple, but when Operators have hundreds to thousands of I/O points with different measuring technologies to manage it can be overwhelming. Diagnostic information such as “glass impedance” and “zero offset” will update the Operators whether a sensor has a critical failure or is beginning to drift. For those Operators with less experience in pH, RAI has Embedded Help Menus that explain in detail what the condition means and appropriate actions to take. This is easy to access in AMS® Suite by clicking a dragging the question mark over the field in question.

Q. What business value does the end user see?

A. Our customers can confidently automate pH measurement, greatly minimizing Operator interface. When an Operator needs to get involved, we supply the tools to allow them to make an informed decision with the assurance of accuracy and stability in the process. For additional information, you can click on this link.

Dave Anderson has over 17 years in the Instrumentation/Process Control field, having several Field Application, Sales and Product Management positions. In 2000, Dave joined Emerson’s Rosemount Analytical Process Analytic Division as Product Manager for the Next Generation Analyzer Line. In 2003 Dave transferred to Rosemount Analytical Liquid Division where he is currently the Industry Marketing Manager. Dave lives in Costa Mesa, California with his wife Megan and two boys Kyle and Matthew.

Earnings Express

2009-08-03T19:40:00.002-04:00

Here's an interesting clip from CNBC with David Brennan, AstraZeneca's Global CEO discussing results. Their numbers are impressive as they topped the "Street's" target, moreover, they are raising guidance. Similar sentiment can be seen as follows:

Roche reports a significant jump in core earnings while "substantially" raising their outlook
Wyeth 2nd quarter earnings per share is up 13% over the prior year and raises guidance
BMS saw a solid jump in profits in the 2nd Quarter vs. the prior year
Mylan posted better than expected performance while upping its full year earnings guidance

This is all good for the industry and hopefully the earnings tailwinds are indicative of healthy signs of things to come. The 2nd Quarter for the broader stock market roared back with a 12% increase in the DOW and a 20% increase at the NASDAQ. Clearly, we can all use some uplifting news!

Precise Control With Baumann Valves

2009-07-27T13:59:00.010-04:00

Fisher Controls International, LLC, Baumann Control Valves is an ISO 9001 certified, PED compliant manufacturer of general utility, precision micro flow, sanitary control valves, and low noise static resistance plates, serving the pharmaceutical and biotechnology industry segments. In a recent conversation with David Gagne, Director of Sales, Baumann Control Valves, I asked; what are the top 3 or 4 things life sciences customers care about regarding Baumann devices? His comments were as follows:

"Fisher Controls Baumann Valves are considered to be the best in the industry and have strong brand recognition. We have the Emerson name that stands behind us. Everything we do adds value to and is an extension of the tightly integrated PlantWeb architecture. The top reasons our customers buy our products include precise control, maintainability, aseptic designs per ASME-BPE, and diagnostics. A key point to appreciate is with the slightest change in the process or signal, our valve will move which means less variability for our customers. We are also dedicated to uncompromised customer service in meeting application requirements and on-site delivery schedules."

Baumann is an integral part of the world's largest global supplier of control valves and instrumentation serving the final control element needs of our customers. The team delivers an unparalleled combination of industry experts, best-in-class technologies, and PlantWeb, the best-in-class systems architecture for next generation digital plants.

There are two segments to the life sciences industry, pharmaceutical (chemical based) and biotechnology (cell culture/bioreactor based). The way in which the drugs are produced differ, however, many of the requirements with respect to processing equipment are similar. In both segments, Baumann sanitary valves meet customer needs for sanitary modulating applications. A major concern for both pharmaceutical and biotechnology applications is that the process will not be interrupted by equipment failure once a batch has begun. One batch in a biotechnology facility can be worth tens of millions of dollars and any failure in the processing equipment will mean that batch's integrity cannot be validated and the batch must be discarded. Therefore, equipment reliability and ease of maintenance are key issues. Inevitably, all mechanical devices wear and need repair. However, PlantWeb digital architecture offers predictive intelligence that indicated any change in valve performance and warns process engineers that a potential issue exists and what is the most likely cause. In this way, engineers can take action and rectify an issue before it becomes a problem and negatively affects production.

As shown in the diagram below, the Baumann family of sanitary valves handles most all modulating applications.

Some of the technical design reasons to consider Baumann valves include:

Valves are available with <30>Self draining designs make them well suited for CIP/SIP applications.

ASME-BPE Class I and III seals have been incorporated, with a Class II seal to be introduced in the near future, satisfying a broad range of a septic applications.

Valves are machined 316L stainless steel with tri-clamp or optional buttweld ends.

Continuous sterile steam applications with temperatures up to 350 degrees F can be accommodated.

Click here for more information or feel free to contact me at 908.364.0996.

Extended Calibration Intervals Initiative at a Pharmaceutical Plant

2009-07-16T10:40:00.000-04:00

Searching for ways to reduce maintenance costs is an important request from all of our customers today. Not long ago, one of our main customers in Puerto Rico requested Emerson Process Management support to help them in the process of achieving a goal of reducing calibration activities by a factor of 50%. Initially, it seemed to be an aggressive goal since results needed to be delivered in what appeared to be a short period of time. Their objective was to prove improvements in operational flexibility by reducing planned downtime and documentation activity. Some areas of concern were the existing standard operational procedures and trained personnel for these tasks since changes also need to be implemented according to the new established calibration frequency and the rationale and supporting documents for these changes. The analysis took place and Emerson was a key part of the overall effort. First, the customer created a database for instruments to be evaluated and re-evaluated criticality of classification. Among the various activities toward reaching their goal, Emerson provided a set of best practices and savings opportunities white paper indicating various recommendations that included how to implement extended calibration intervals initiatives and implementing Certified Factory Calibration when purchasing field devices. Click here for a copy of the document.

For the Extended Calibration Intervals, recommendations were:

Perform an audit of all installed Rosemount field devices to identify current make-up of Rosemount models and their inherent stability specifications

Change SOPs to reflect this new capability

Implement Extended Calibration Intervals on those Rosemount field devices with applicable stability specifications

Perform a replacement-analysis on Rosemount field devices that do not meet the stability specification required for the initiative

Begin replacement of those devices that achieve customer’s ROI hurdle

When implementing Certified Factory Calibration the indicated recommendations were as follows:

Work with Emerson divisions to achieve approval of customer management and quality groups

Change SOPs to reflect this new capability

Implement CFC on all applicable field device purchases and specifically on all purchases associated with the above mentioned Extended Calibration Intervals Initiative.

Rosemount provided all stability specifications for the existing pressure and temperature transmitters at the site. Almost all of the transmitter models were 3051 pressure transmitters and 3144 temperature transmitters. Based on criticality classification, historical data and Rosemount supporting documents for stability specifications, extended calibration frequency intervals were approved, documented and technicians were trained in those new changes. Rosemount contributed along with other actions taken by the customer to achieve the maintenance cost reduction goal requested by upper management.

Many thanks to Vivian Freytes in our Puerto Rico office for the update.

Thoughts About Clean In Place

2009-07-09T12:24:00.003-04:00

Clean-in-place (CIP) is a method of cleaning vessels and lines without disassembling them. It involves delivering solutions of chemical detergents and rinses at specified flow rates and temperatures. Typically, a CIP skid creates the cleaning solutions and routes them to a user skid, such as a bioreactor or chromatography skid, that requires cleaning. At the user skid, the cleaning solutions are routed through different circuits in order to clean the entire skid. Normally, a single CIP skid services several different user skids. Transfer panels or valve arrays transport cleaning solutions from the CIP skid to the different user skids.

CIP operations are a significant portion of the engineering effort for a pharmaceutical or biotech facility. In many cases, CIP can be up to 50% of the automation effort. Some of the challenges include:

automating the CIP skid that needs to communicate with user skids throughout the plant and supply different combinations of solutions to different user skids
automating the user skid cleaning routes which may be slightly different for different cleaning solutions
managing the transfer paths, which are often quite complicated

Although automating CIP may seem at first overwhelming, the problems can be broken down using a modular approach and S88 principles. Emerson has over 25 years of experience automating processes that include CIP operations. If you click on this link, you can view an article provided by one of the contributors, our own Christie Deitz, Senior Principal Engineer in North America. The content describes how Emerson uses class-based programming to simplify design, testing and validation of reusable modules, such as those found in CIP processes.

Thanks for the update Christie!

Christie Deitz is a Senior Principal Engineer with Emerson Process Management’s Life Sciences Industry Center. Christie has 16 years of experience in pharmaceutical automation. She has a BSChE from Texas A&M University and an MSChE from the University of Texas.

Back to Asia Pac with Shenling

2009-06-29T17:25:00.011-04:00

I recently had another conversation with Shenling Yang who shared a few comments around the recent press release on the selection of Emerson Process Management solutions at Lonza in Singapore. She writes the following:

Emerson Process Management has recently been selected by Switzerland-based Lonza Group Ltd. to provide engineering and design services and digital automation architecture and control technologies for a new Lonza biopharmaceutical plant in Singapore. You can read the Press Release by clicking here."

"The win is part of Emerson's growing portfolio of life sciences companies that rely on digital automation with predictive intelligence to reduce overall costs, improve reliability, ensure product quality, meet regulatory requirements, and optimize operations."

Emerson Singapore serves as the life sciences industry center for all of Asia-Pacific. A skilled team of professionals provide a full set of services to Pharmaceutical/Biopharmaceutical customers in Asia-Pacific, ranging from requirement specification to the plant commissioning, including validation assistance.

Shenling further writes:

"Integral to the success of the project is the validation of the control system as a part of the overall process. Pharmaceutical/Biopharmaceutical companies wishing to market a product in either domestic or foreign markets must apply for a license from a regulatory authority, (e.g. FDA). Validation is a key ingredient during this approval process."

The essential elements of validation are:

Decide what you intend to do and document it (PLAN)
Implement what you decided to do, documenting any deviations (PROCEDURES and CHANGE CONTROL)
Test what you implemented to show it does what you intended (VERIFICATION)
Document the results (AUDIT TRAIL).

During an internal Life Sciences session held a short while ago, Shenling picked up a few pointers on the validation process that included the need to establish documented evidence. This provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. She adds the following:

"Other considerations that control system suppliers and customers can do to during the project design phase which increases the successful rate of the validation include:

Customer

Define process requirements detail enough for control system vendor to use
Specifying the normal operation as well as the exception and failure
Involving the end user (operators, maintenance etc.) and process chemist in the early stage of the project

Control System Vendor

Reading the requirements carefully
Don’t underestimate the complexity of a batch project
Develop a requirement specification that defines what is required rather than how it is to be achieved.

Emerson AP knows how important validation is to Life Science customers, and our expertise is continually focused on helping them achieve their business goals."

Process Analytical Technology - Questions & Answers

2009-06-08T10:04:00.011-04:00

Emerson has been taking an increasing interest in the application of Process Analytical Technology (PAT ) within the pharmaceutical industry because if it’s potential to deliver major benefits to the end-user. Central to Emerson’s strategy in this area is a product called ‘synTQ’ which has been developed over the past 8 years by Emerson partner Optimal Industrial Automation, a UK-based company working primarily in the pharmaceutical area. To get an understanding of this solution set and marketplace, I spoke to Gawayne Mahboubian-Jones, Product Development Manager, Optimal and Emerson’s Saroj Patnaik, Director, Life Sciences Global Industry Solutions.

Q. Saroj - What are the business drivers behind PAT?

A. Patient safety is central to the FDA’s Code of Federal Regulations. The FDA’s new paradigm, Quality by Design (QbD) requires that quality cannot be tested into the product and should be built-in or by design. We agree that automation technologies should be aligned to this new paradigm. It requires measurement of critical quality and performance attributes (i.e., during processing, on-line, at-line, in-line) of raw and in-process materials and processes with the goal of ensuring final product quality. Additionally, the global socioeconomic trends such as aging population, patent expiry, and world economies have increased cost pressures on discovery of molecules to manufacturing of medicines. We believe PAT will provide much needed relief to these pressures while maintaining patient safety.

Q. Gawayne - What are the reasons for the problem?

A. The drive in the last quarter of the twentieth century to improve drug quality and consistency led to the development of practices within the pharmaceutical industry which inhibit change and process development. The FDA recognized these practices and their potentially dramatic impact on drug costs and availability. To begin the process of resolving these issues, in the early part of this decade the FDA issued a Guidance document (click here for a copy) encouraging the industry to adopt a new way, PAT, which incorporated risk-based design, full process control, and continuous improvement. It has taken a while to lift-off, but in the current economic climate, and in this highly regulated industry, these ideas are finding fertile ground in which to grow.

Q. Gawayne - Who is affected by PAT?

A. While much of the focus of PAT is currently on manufacturing, in fact it applies just as much to product development. It also draws in experts from all the fields which may have an impact upon product quality and manufacturing efficiency, so the scope is very wide. Applying PAT on a process is very much a multi-disciplinary exercise, but always at the core is the ability to measure the condition of process material, and the ability to apply appropriate controls to drive the process to the desired end-point. It is the development of precisely these capabilities which is at the center of the offering which Emerson and Optimal have developed.

Q. Saroj - What can Emerson and Optimal deliver to the customer?

A. A formal alliance has been in place since the beginning of 2009. The two companies have over the past 2 years developed an offering which provides the ability to apply PAT to any process within the pharmaceutical industry anywhere in the world. We see synTQ as a natural extension of the overall PlantWeb architecture. While Emerson’s existing products, DeltaV and SynCade, are two legs of the PAT ‘stool’, the vital third leg is ‘synTQ’ which provides real-time, on-line data management for complex PAT data sets (they often include spectra, or even 2D arrays of data), and the ability to integrate a wide variety of instruments and third-party analysis packages. The three components link together easily, providing a well integrated system dealing with all aspects of the PAT environment. This, of course, is backed up by Emerson’s worldwide support capability and by the specialist application knowledge within Optimal.

Q. Gawayne - What business value does the end-user see?

A. The value is always seen on the bottom-line, but in different forms. Let me give you three actual examples:

Customer (A) had a process with very high levels of lost product (2 batches in 5). The raw materials cost was over 50% of the end product cost. Applying PAT effectively eliminated the lost batches.
Customer (B) made a wide variety of low volume products. Before the implementation of PAT, testing had to be done after every process, making production scheduling nearly impossible. Applying PAT allowed real-time release at the end of each process, and increased overall effective site capacity by about 20%
Customer (C) had significant variation in incoming raw materials which resulted in significant levels of rework. Applying PAT made the process capable of adapting to this variation in raw material at first pass, almost eliminating rework.

PAT is applicable to improve almost every pharmaceutical manufacturing process, but the benefits customers will see will depend upon the problems in a particular process. The unique global automation offering from Emerson uses synTQ as its core PAT data management product. The architecture of this offering (shown in the diagram above) shows Delta V handling the conventional process data, synTQ collecting and analysing the PAT information, and SynCade providing the high level control and definition of the overall process. The three components create a highly integrated solution that Emerson is fully committed to supply and support globally.

Using WirelessHART Transmitters in Control Applications

2009-06-01T08:26:00.001-04:00

Wireless technology remains a stronghold at Emerson Process Management while offering many promising applications. Terry Blevins, Principal Technologist, based out of Austin, TX, one of Emerson’s legendary technology contributors, offers some insights toward the practical application of this technology in the life sciences industry.

He writes:

"Within the last year, major manufacturers of process instrumentation have introduced WirelessHART transmitters for measurements commonly used in the life sciences industry. Some distributed control systems such as DeltaV have added standard support for WirelessHART transmitters. Even though many wireless transmitter installations have focused on monitoring applications, the WirelessHART technology is specifically designed to also support control applications. Devices that conform to the WirelessHART specification can frequently sense a measurement e.g. 1/sec but will only communicate a measurement value if it has changed significantly since the last communication or if the time since the last communication has exceeded a default reporting time. For example, the latest Rosemount WirelessHART pH transmitter will sense pH as often as 1/sec but will use power to transmit the value only if it has changed significantly. Using this capability it is possible in some cases to reduce the number of transmissions by a factor of 20X while still providing quick response to changes in setpoint or unmeasured load disturbances."

Earlier this year at the Dhirubhai Ambani International symposium on Recent Advances in Biotherapeutics, information was presented on this WirelessHART capability and modifications in the PID that are needed to effectively utilize measurements values reported on an exception basis. Terry further writes:

"Information was presented at the IFPAC and Interphex 2009 conferences on the successful application of WirelessHART pH and temperature transmitters in the control of single-use disposable bioreactor. In this trail installation at Broadley James, batch runs were conducted using mammalian cells to evaluate and compare control performance using WirelessHART transmitters vs. wired transmitters. As illustrated in screen captures below, taken during these batch runs, the observed pH and temperature control using wireless measurements was equivalent to that achieved using wired transmitters."

"Also, this trial installation demonstrated that the ground loops problems that may occur with a wired pH transmitters can in some cases be eliminated by using WirelessHART transmitters since these devices are battery powered."

Terry is a member of Emerson’s DeltaV future architecture team with focus on basic and advanced control technology. He has over 35 years of experience in the process control industry and was a team lead for the development of DeltaV advanced control products from 1998-2005. In 2004, Terry was inducted into Control Magazine’s Process Automation Hall of Fame. He has co-authored the ISA bestseller “Advanced Control Unleashed,” and has over 65 publications and 31 patents on process control and control system technology.

Smart Operations Management in Europe

2009-05-20T12:25:00.002-04:00

The European pharmaceutical market has seen more resilience than other sectors during the current economic crisis. That said, the industry's traditional strategy of placing big bets on a few small molecules and marketing them heavily into primary care with the hope of achieving blockbuster sales will no longer suffice. Along with other broader research strategies, pharmaceutical companies are looking for greater cost and operational efficiences to assist in managing return on shareholder equity expectations.

Emerson’s European Smart Operations Management Suite team is working diligently to support these extensive industry goals and key business requirements. Their aim is to work with Emerson’s extensive prospective and install base in the European market to introduce and develop Smart Operations Management based around Emerson’s Syncade and PlantWeb products. Syncade and PlantWeb solutions are chiefly focused on improving manufacturing operations performance while also advancing quality and compliance. The team is based in Cork, Ireland, a major hub for life sciences manufacturing and development.

Led by Joe Hoare, European Life Science Solution Sales Director, the group brings a wealth of experience to operations management projects gained within Emerson and the broader market. Joe brings many years experience in the industry, including active involvement in some of the largest life sciences projects undertaken by Emerson. Mike Croot, Business Development Director, Europe (picture below) has extensive experience in the MES market as well as being a board member of the Manufacturing Enterprise Solutions Association (MESA) EMEA. Mike is based in the UK. Johan Zebib, Sales Manager based in Emerson’s Lyon, France office has responsibility for sales activities across Europe in support of the team. Johan also has broad based experience in the pharmaceutical and biotechnology industry.

The team is actively engaged with End User customers as well as professional bodies to promote Smart Operations Management. They recently completed a European Road Show geared toward educating and exciting our customer base. The core message was . . . if you are in the life sciences business in today's competitive environment, you need to be talking to Emerson. This is an exciting concept, particularly when companies are striving to increase productivity and reduce costs. The Healthy Horizons video below from CNBC underscores the state of the industry from a European set of eyes. As industry hurdles stay the course, the team will continue with a central focus on business value matched with forward thinking and execution capability.

H1N1 Perspective

2009-05-13T20:17:00.014-04:00

There are a large number of pharmaceutical firms supporting governments and an array of health authorities in response to this new strain. Many companies have developed interventions believed to be effective toward reducing its consequences. Others are quickly revamping plans (see GSK May 16th LA Times Report) and organizing resources to follow course.

For some historical perspective, here's a great two part report issued this month from The Burrill Report. They interview Alexandra Stern, Associate Director of the Center for the History of Medicine at the University of Michigan. Ms. Stern offers insightful viewpoints on lessons learned from the past as well as forward thinking on containing a potential pandemic in our highly globalized world. She has conducted extensive research on this topic including past responses of major U.S. cities. Part one of the report follows:

Part two of The Burrill Report continues to shed light on pharmaceutical and non-pharmaceutical interventions:

Much of this raises questions about manufacturing readiness and how quickly execution and automation system infrastructures can be deployed or adapted to assist in delivering current and future solutions to the marketplace. As this situation develops, we'll continue to see a higher degree of consciousness on maximizing manufacturing output, agility, and time to market.

Cheers

Una Vista a Puerto Rico

2009-05-06T10:31:00.014-04:00

Close to 4 million people live on the "Island of Enchantment," with more than a million in the greater San Juan metropolitan area alone. It is a vibrant, modern, exciting, multicultural society, an area that has been shaped by Spanish, African, Taino Indian and U.S. influences. Residents of Puerto Rico (PR) have a great deal in common with their friends in the continental United States, yet they retain their definitive heritage. Sales Representative, Vivian Freytes is a new member of our Latin America blog team based out of PR. She has been with Emerson for the past 12 years and has seen and heard plenty with regard to life sciences industry trends and development on the island as well as the region.

She writes:

“Major pharmaceutical companies have chosen PR as an investment destination. Abbott Laboratories, Eli Lilly, Pfizer, Bristol-Myers Squibb, Merck, among others have been here for over 40 years. PR continues to lead the way in hosting the next wave of life-sciences development.”

“In 2006, biologics produced in PR sold over $16 billion of product in the U.S. alone, including the top six biologics drugs sold in the U.S. Per the Puerto Rico Development Company, this, along with over $4 billion invested in biotechnology plants since 2002, makes PR one of the fastest growing life sciences and medical device centers in the world. Twenty five percent of the world’s biological manufacturing companies are located in the island. Some of the main reasons for this are; operating in a US jurisdiction while enjoying the benefit of a foreign tax structure and a highly trained, educated and loyal workforce. PR universities graduate over 23,000 bilingual students each year with 9,000 degrees in science, engineering and technology. The island provides for an extensive well developed supplier relationship among other factors providing attractive incentives to the pharmaceutical and biotechnology business.”

Last January, at Puerto Rico Interphex, Emerson Process Management’s PR office introduced a new business model including Process Systems and Solutions direct local resources for products and services into the pharmaceutical industry and other local industries. As part of that team, Vivian and others come with a diversified educational background, professional experience, and deep pharmaceutical industry and business knowledge. Their primary mission is to deliver business value to their current and prospective customer base. The team includes members from Operations, Engineering, and dedicated Sales personnel that are committed to provide support to all identified opportunities striving toward the best level of customer service. Today, the team is engaged in several exciting projects including:

Syncade - Electronic Batch Record and Equipment Tracking at fortune 500 pharmaceutical and biotechnology plants

AMS Device manager and Machinery Manager installations at a large pharmaceutical account

The first DeltaV upgrade to version 10.3 at a biotechnology plant

New DeltaV installation at a University campus site

Additionally, they are collaborating on installing DeltaV at the Bioprocess Development & Training Complex, “a non-profit institution that fosters research interactions between industry and academia in order to strengthen Puerto Rico’s capabilities in bioprocess development and improvement, while providing a venue to conduct training in biotechnology manufacturing and bioprocess engineering”.

Vivian is also keeping busy on a variety of upcoming DeltaV migration projects at many other well recognized pharmaceutical accounts in PR. You will be hearing more from her and the Latin America team in coming articles. We look forward to working closely with her and examining more about the region as well as life sciences perspectives of the remarkable island of Puerto Rico.

Our Friends From Asia Pac

2009-04-28T15:08:00.006-04:00

After 11 years working as a software engineer and life sciences project engineer for Emerson US, Shenling Yang has joined Emerson Asia Pac (AP) as a Marketing Manager. Her mission is to further our cause in developing the life sciences business segment in that region of the world. By being based in Shanghai, China, her location provides a better perspective on up to date market information and industry trends and challenges in AP while helping to build the Emerson brand including PlantWeb, DeltaV and Syncade.

Xu Ning, an AP Sales Engineer, will be working with Shenling in this effort. Together they will be sharing timely industry information and best practice viewpoints in executing life sciences projects from AP.

Shenling offers her initial observations with the following information. She writes:

“Although Chinese GDP, which has been growing at an annual rate of 10–15%, is projected to grow at only 8% or less in 2009, the biotech and pharmaceutical industry, one of the pillar industries counted on by the Chinese government to fuel its sustainable future growth, may come out of the economic crisis as a bigger winner. Most notably, in November of last year, China launched the Mega New Drug Development Program to pour $10 billion over the next 13 years into the field, aiming to stimulate a home-grown innovative drug development industry in China.”

Chinese domestic market demand for healthcare products and services will continue to grow as a result of the government’s strong mandate to provide healthcare to their population of 1.3 billion people. This includes the 70% living in rural areas. The following graphic shows a perspective of CAGR across the different industry segments in China:

Other points of interest Shenling provided include how China’s 2009 regulatory changes will affect makers of drugs, APIs and Devices as noted in a recent article published in API China. According to IMS, the Chinese pharmaceutical sales value will show a Compound Annual Growth Rate (CAGR) of 16.4% for the years 2004 - 2009. These growth trends will see China reach the top 5 pharmaceutical markets in the world by 2010. In 2020, the Chinese pharmaceutical market will reach US$109.5 billion and become the world’s second largest pharmaceutical market.

• Pharmaceutical Ingredients: As the largest Active Pharmaceutical Ingredient (API) producer and exporter in the world, China’s export value of API has risen with a CAGR of 20% since 2000. The Chinese API is predicted to capture 22% of the global API market by 2010.
• Pharmaceutical Machinery: In 2007, profit derived from China’s pharmaceutical equipment grew 50% with a value of RMB 267 million.
• Pharmaceutical Packaging: Today the annual turnover of the China pharmaceutical packaging industry remains constant at US$2 billion but global demands will reach US$300 billion by 2010. So within the next five years China’s pharmaceutical packaging industry will enter an important phase of rapid development.

Much like other global members we will soon introduce from Latin America and Europe, we welcome Shenling to our global team and look forward to sharing some of their thoughts on the Emerson Global Life Sciences Blog.

When Do Equipment Based Recipes Make Sense?

2009-04-21T13:32:00.004-04:00

What if an MES recipe was developed and configured as an equipment-based recipe rather than a product-based recipe? That was the question posed to John Piela, Senior Consultant, Life Sciences Industry Center while recently working on a Manufacturing Execution System (MES) packaging implementation at a fortune 500 pharmaceutical manufacturer. This site was a typical oral solid dosage manufacturing and packaging facility that packages hundreds of different product configurations (sku’s) across multiple packaging lines.

Traditionally each product sku has an approved Bill of Materials (BOM) containing all packaging components necessary to run each product sku. As a result, each standard product sku has a unique BOM associated with that product and a set of validated packaging parameters (equipment settings) to run the equipment. So, if there were 50 different products that are run on a particular line, 50 different recipes would likely be needed, one for each product, even though the recipes are very similar. The result would be a time consuming and expensive process associated with configuring, approving and controlling 50 different products. Enter . . . equipment-based recipes!

Using this approach, one equipment recipe would be configured for each packaging line. At time of order creation, the equipment recipe would be matched with the appropriate product BOM and packaging parameters. If an ERP system downloads the product order specifying the end product sku along with the product BOM then predetermined product specific packaging parameters can be loaded into the equipment recipe at time of order execution. This results in one equipment based recipe per line rather than the required number of product specific recipes per line. By enabling both the product specific BOM and packaging parameters to be “dynamic” and loaded into the recipe at order creation time, 50 recipes can be reduced to one! Further, multiple packaging lines can be leveraged if their packaging line equipment layouts are similar (as they usually are).

John Piela is a Senior Industry Consultant at Emerson Process Management in Royersford, PA. John has more than 30 years of manufacturing and engineering experience in the life sciences and consumer products industries. Throughout his career, John has held a number of positions in Quality, Engineering and Manufacturing within Aventis (and predecessor companies), Schering-Plough, Armour-Dial, and Procter & Gamble. John has extensive experience with manufacturing technology, manufacturing execution systems, new product development, process design and scale-up, validation, and process control systems. John also brings international experience through leadership positions executing assignments within Aventis Industrial Operations in North America, Europe, China and Japan. He has been with Emerson for almost five years helping clients achieve operational excellence with Emerson systems and products. John has a BS in Chemical Engineering from The University of South Florida.

If you would like to know more, feel free to contact us at 908.364.0996.

Syncade From The Summit

2009-04-13T14:30:00.008-04:00

Syncade Smart Operation Management Suite is a group of software modules that provide easy, flexible, integrated solutions for resource management, operations optimization, integrated information, and quality and compliance requirements - improving operations performance. Bob Lenich, Director, Syncade Product Platform, has been one of the visionaries leading the charge in the life sciences industry for this essential growth area for Emerson. I spent some time with Bob last week in Austin, Texas headquarters and he shared his perspective on some of the Syncade fundamentals as well as the business value this powerful suite of products offer. His comments are not only insightful but exhaustively present a view of the breadth and depth of the Syncade platform.

Q. Why implement a manufacturing operations management suite?
A. The function of Manufacturing Operations Management is to deliver the production of quality goods and services while ensuring that business operations are efficient and effective. Once a site has identified what “efficient and effective” operations are (typically through a lean or 6 sigma improvement process or the Emerson OpX AdvantageTM), it normally requires some kind of system to facilitate and enforce the required operational changes. These changes can be in a wide variety of areas. In biotechnology and pharmaceutical manufacturing companies they typically focus on the following:

- Eliminating human mistakes / errors
- Improving throughput / and process yield
- Improving material management, optimizing material use, and reducing work-in-progress inventory
- Reducing product review and release time
- Improving data management and integration between existing systems and users

While addressing some of these issues can be done by changing work practices or additional training, many of them need the kind of assistance provided by technology. Operations management software typically provides the following kind of functionality:

- Order / production management
- Electronic workflow / procedural control
- Material management
- Asset / reliability management
- Sample / lab information management
- Quality management
- Document Management
- Data collection, management and reporting
- Change management
- Performance analysis

These functions help address many of the changes needed for efficient and effective operations.

Q. Why should life sciences customers choose Syncade as their operations management platform?
A. Key aspects of an operations management platform beyond functionality include:

- Real-time / event based activity
- Flexibility while enforcing best practices
- Modular
- Easy to connect / integrate
- Mobile

Syncade Smart Operations Management SuiteTM is built to deliver the operations management functionality and capability described above. You can apply it either as individual modules or as an integrated, comprehensive suite. It seamlessly integrates both with real-time monitoring / control of the process as well as the transactional worlds of the ERP, maintenance management, or CAPA systems. It is built from the ground up on current ISA95 standards for functionality and interoperability. The user interface is Internet Explorer so users can interact in real-time via any device that supports IE (PC’s, mobile devices, PDA’s, etc.). The configuration and set-up are all “point and click” with no requirements for a programming language.

Syncade operations management functionality provides differentiation through the following:

- A single recipe / procedural engineering environment for everything from automation / control through full site recipes
- Integrated ISA88 / ISA95 execution environment for comprehensive workflow with data collection in batch context
- Integrated document management so that access to manufacturing information is easy and in context
- Real-time permissive checks to verify proper materials, equipment or personnel training before doing an activity
- Storage of all information in a relational database in XML format for easy access, user specific rendering, and manipulation

Q. What’s the benefit of running Syncade on a Microsoft.Net platform?
A. Microsoft .NET makes it much easier for mobility, integration, and performance scalability. .NET facilitates use of web services to publish and access information easily. Users of information (people or other applications) can subscribe to information services that provide updates / changes as they occur instead of by polling or request. Security and authorization conflicts across firewalls are minimized as that information travels with the information packet. If performance concerns occur, it is very easy to add additional computing horsepower via network load balancing.

Q. What is the difference between a manufacturing operations management solution like Syncade and some of the large ERP vendor solutions?
A. The big difference is the real-time aspect of Syncade operations management versus transactional ERP operations management. Transactional systems work on a planned schedule. Real-time system have to monitor and respond to events as they occur, so there is much more flexibility with real-time systems. They are also typically focused on smaller scale components and actions. Where an ERP looks at lots and required order volume, real-time systems care about individual containers, where they are, what’s in them, how long have they been out of refrigeration, etc.

Both applications have their place in operations management and require solid integration so that both aspects (transactional and real-time) can leverage their strength to produce products. For instance, the ERP will manage the material master definitions but Syncade will manage using a particular instance of a material.

Q. How long does it take to implement a typical Syncade solution? Does Emerson have a proven implementation approach?
A. There is a wide range of implementation time-lines. If you are starting small with individual modules (such as only doing material dispensing), you can get started in a short time. If you have doing a comprehensive rollout of all the modules it will take longer to design, implement, test, and qualify a completely integrated electronic manufacturing environment. The other big factor is how much optimization of operational work processes has been defined before you start. If you have a solid definition and know what you need, the implementation will go smoothly. If you are working through the definition of how to improve the site, if will take longer to create the definition and implementation.

Emerson has a growing library of starting points for the various functions in different life science unit operations. We also have a comprehensive project implementation methodology that can take you from an initial concept through complete process qualification.

Q. What is the ROI and payback potential for this type of solution?
A. How valuable is one batch? Typical implementation of operations management solutions avoid adding incorrect materials, use of dirty or improper equipment, and improper sequencing. If any of those kinds of problems cause the loss of a batch, the system usually pays for itself through that one event. Typically, though, we see anywhere from 9 to 24 month payback with IRR’s >25% and very positive net present value. Part of our project methodology is to ensure this kind of information is documented as the project starts through our OpX Advantage so everyone knows what to expect.

Mr. Lenich is responsible for planning Emerson Process Systems and Solutions forward direction for Data Management Services across all industries. He is responsible for integrating the new Syncade product platform into PSS' standard support systems, sales and services programs, and forward direction planning. Bob has spent his 28 years in the automation industry at Emerson, working in various project executions, business development, and planning positions. He is an expert in applying technology to solve manufacturing optimization problems. Mr. Lenich has spoken at various trade events and published several articles, most recently in PharmTech titled “Automation Vendor or Partner: Changing Roles.”

The Front Line

2009-04-03T12:21:00.021-04:00

In this changing economy, businesses are utilizing innovative approaches to create value in the life sciences industry. No one knows better than Dean Braithwaite, Vice President; Control Associates, Inc. (CAI) of the Emerson Process Management Local Business Partner network. The Local Business Partner (LBP) organization in the United States and Canada consist of 22 organizations occupying 89 offices. LBP offices are committed to delivering superior value in world class solutions, customer service, and technical support. Since 1933, Control Associates has been providing process management solutions to customers in the Tri-State area. They deliver a broad scope of products along with the engineering, maintenance and asset optimization services required to solve the most challenging process control needs.

We explored the attributes of a world class solution provider in the life sciences industry and how Control Associates has partnered with some of the largest biotechnology and pharmaceutical firms in the industry. Dean provided significant insight on value creation. His answers to questions below are supportive to those seeking to differentiate by maintaining excellence in our demanding marketplace.

Q. Can you talk about the changing nature of the life sciences industry?
A. Pharmaceutical/Biotech Customers are experiencing a major shift in how they discover, qualify and manufacture their products. Because of this shift, the industry is looking at different ways of saving precious capital in their R&D and Manufacturing Sites. Some of the initiatives are Paperless Manufacturing, Reporting by Exception, Simplified Technology Transfer, Reduce Time to Market etc. The challenge for Emerson is to understand what these initiatives are, what products and services we provide, and how do we develop a value message that is meaningful to the customer. In order for this to happen, the Emerson team needs to understand the customer’s business model well enough to create that value message. Projects are no longer justified on speculation but with a concrete and defendable ROI. I think Emerson is well positioned to meet the changing and growing needs of the industry since our solutions include Devices, Control Systems, Asset Management Solutions, MES, Integration Services and Professional Services. No competitor can offer our customer base the breadth and depth of solutions like Emerson.

Q. What are some of the unique business model capabilities CAI delivers to biotechnology and pharmaceutical companies?
A. CAI strongly believes in understanding the industry we serve and more specifically understanding the customer's business before we attempt to create a business plan and coverage strategy. We are also a big proponent of getting entrenched in the R&D Pilot Plant so Technology Transfer is a part of the Account Model. We are able to accomplish this due to the scalability of DeltaV and using products like Bio-Net to get in the door.

Q. How can other companies learn from this model?
A. First of all, each Account Manager calling on strategic accounts should be encouraged to take a refresher Business Acumen Seminar to make sure they understand the business drivers that customers value most in support of capital expenditure. They also need to fully understand the individual customer’s initiative in order to match what Emerson is proposing. Let’s face it, people do business with people they trust and it is important that the customer feels you are understanding the issues most important to them.

Q. Can you give us a specific example?
A. For one of our larger Pharmaceutical/Biotech customers, we have created a working document that identifies various initiatives which are jointly created by the customer and Account Manager. The purpose of this is to have buy-in from the customer as to where the focus of our attention needs to be and what products and services we have to sell that best meet those initiatives. This exercise also allows us to understand where we do not meet the customer’s pain points and what we need to do to resolve the problems. CAI's plan is to have each account manager pick a Most Growable Customer (MGC) and Most Valuable Customer (MVC) and apply this tool to each. The tool will also capture value to the customer and ourselves so we can have future buy-in from the customer’s management team who ultimately justifies working capital for future business.

Q. You have realized significant success with SYNCADE over the last two years. Can you talk about the business value delivered to some of your larger clients?
A. The business value achieved by our customer base is specific to the business drivers established by the customer and how Emerson meets those objectives. Common to all Pharmaceutical/Biotech customers is getting products to market cheaper, faster, and safer all the while protecting intellectual property. The life cycle this follows is complex and requires a clear strategy from compound development to delivery to patient. Emerson provides products and services in most stages of this process. The value starts with establishing a common recipe structure using the S88 standards so movement through the manufacturing process is consistent and traceable. DeltaV fits this model perfect due to its scalability and support of batch standards. The challenge to the customer is to design their processes and train their scientist/operators on using a common recipe structure. This saves the customer a significant amount of time and cost to transfer products from development, kilo lab, scale-up, launch and finally manufacturing. With SYNCADE, Emerson is capable of integrating the DeltaV Control System with Document Control, Integrated Recipes, Electronic Work Instructions, Electronic Batch Record, Material Management, Asset Management, Training, ERP Integration etc. This will allow the customer to transform a Paper Batch Sheet to a true paperless operation. The business value comes from better product quality, faster approval process, less operator errors and quicker time to market therefore prolonging patent protection.

Q. Was there a different approach you took when discussing SYNCADE solutions with your clients? Why?
A. Yes. As stated before, we try to understand where the customer is having issues in the plant and match AO, DeltaV and SYNCADE to those problems. We find most customers have the same problems with getting products to market so it helps to understand the industry and its business drivers. We cannot serve this market without this knowledge.

Q. Finally, what are some of the other solutions you are focusing on to better adapt to the changing industry landscape?
A. The recent downturn in the economy has been a challenge, however we need to try and look at how we can help our customers best meet the challenges with downsizing their staffs. With an aging population, the needs of the industry will only increase and we need to find ways of supplementing their workforce with support staff to engineer, implement and support these complex solutions. CAI is in the process of recreating an engineering group to support local initiatives while using the Emerson Industry Centers to provide large project support and specialized expertise for integration solutions such as ERP, CMMS, LIMS, PAT, Historians, Training and Deviation Logs. Emerson is in the best position of any of our competitors to meet these challenges due to our breadth of products, services and industry expertise.

Dean has over 32 years experience in process control and the life sciences industry, 24 of which have been spent with Northeast Controls (6 years) and Control Associates (18 years) . He has directed Control Associates, Inc in successful BMS, Merck, Schering Plough and Firmenich projects to name a few. Located in Allendale, NJ, Control Associates, Inc. is a leading member of the Emerson Process Management Local Business Partner network.

Discovering Dollars

2009-03-27T15:10:00.010-04:00

With the challenging economic climate in today’s global market, effective and efficient operations are critical. One venue for optimizing operations is an Operational Excellence Program. Michalle Adkins, Senior Consultant, Life Sciences Industry at Emerson Process Management wrote an article published in Chemical Engineering in March 2007 that is even more relevant to today’s economic situation. In this article, Operational Excellence is described predominantly in terms of Lean Six Sigma approaches. The benefits are articulated in both this article and the article that Michalle co-authored with Dawn Marruchella for the March 2007 edition of Chemical Engineering Progress.

For the past four years, Michalle has been working primarily with Life Sciences customers to improve operations business processes. One of the tools, value stream mapping, has been an effective method for capturing the current business process flow and associated costs, identifying opportunities for technology improvements, articulating the benefits, and determining the ROI or other financial indicators for implementing these improvements. Many customers have lamented over the significant amount of non-value added activities on their own current state value stream maps. The result of the value stream mapping exercise is an attention grabbing picture delineating the true benefit of smart operations management solutions.

The picture below depicts Emerson's Operational Excellence process with emphasis on quantifying these benefits and giving reason for change:

So, what are some of the benefits of current, available technology to a Life Science company? Identified tangible benefits include optimizing cumbersome review/approval processes, reducing document errors, minimizing processing errors or deviations, eliminating redundant data entry, and eradicating paper log books and batch records along with their associated challenges. Also significant are the intangible benefits which can include enhanced compliance stature, systematized knowledge to reduce operator to operator variability, and shifting of organizational focus from document traps to operational quality and improvements. For more information, contact the Emerson Global Life Sciences Team at 908.364.0996.

Michalle Adkins, a Senior Consultant, Life Sciences Industry at Emerson Process Management, has 18 years of experience in consulting, project management, planning, manufacturing, automation, and engineering. Her consulting experience has included project justification and definition, system planning, and operations improvements. Prior to joining Emerson, Michalle was with Merck & Co., Inc. for 13 years. Ms. Adkins has a B.S. in Chemical Engineering and an M.E. in Industrial Engineering.

IPA and PAI

2009-03-19T19:03:00.008-04:00

An earlier post mentioned an International Pharmaceutical Academy (IPA) event that occurred March 5th and 6th focused on FDA Pre-Approval Inspections (PAI). The occasion was chock full of good stuff. The International Pharmaceutical Academy is a progressive organization dedicated to broad-based training in the life sciences industry. This training series offered experts from the industry presenting short course formats together with carefully orchestrated workshops.

First on the platform was Mark Elengold, President, FDA Strategies based out of Columbia, MD. Mark was formerly a Consumer Safety Officer and Biologics Deputy Director with the FDA. Mark glided effortlessly through some historical context and then skillfully stepped through who, what, why, when, and how aspects of Pre-Approval Inspections. Some tidbits:

The Code of Federal Regulations (CFRs) has grown exponentially since 1974, as a result, the tolerance for risk has changed, yet, what hasn’t changed is Murphy’s Law. Something will likely go wrong. It can be as innocent as someone looking at a piece of paper noticing a dot and mistaking it for a decimal point. As a consequence, quality is a continuous exercise, starting in Research and Development, continuing in Application Review, applied in Manufacturing, and monitored in Distribution.

FDA personnel typically involved in a PAI include Consumer Safety Officers who develop inspection procedures and techniques and coordinate the review process of New Drug Applications (NDAs). Also part of the team are microbiologists who evaluate the chemical, microbiological and manufacturing data submitted during the NDA. Other members include chemists and engineers as well as the dreaded Special Agent. The latter brings prior experiences using traditional law enforcement methods and investigative techniques. If you see this individual on-site, you have a problem!

It’s important to draw a distinction between an inspection and an investigation. Inspections are not uncommon and can occur during reasonable hours to inspect any company that manufactures and prepares a drug product. Inspection drivers could be the result of pre-approval submissions or routine surveillance by the FDA. An investigation is an information gathering event whose purpose is to document facts concerning a particular issue so the FDA can then make an informed and sound decision. Types of investigations include complaint investigations, health fraud investigations and ones that are the result of product tampering.

Mark’s concluding comments centered on how to prepare for an inspection. The advice seemed to make good common sense; know your business, know the laws and regulations, have a plan, understand their (The FDA) procedures, and practice, practice, practice.

A subsequent section was presented by Dr. Nanda Subbarao, Senior Consultant; Biologics Consulting Group Inc. Nanda provided a great deal of thought leadership on the laboratory portion of PAIs. She reinforced the purpose of the PAI, commented on how the FDA evaluates the state of control of a facility and carefully described the step by step process of the inspection. The process starts with an opening meeting followed by a tour of the facility and review of batch records, stability data, training data, and lab GMP systems among other areas. The FDA is looking to see if the data submitted in the application is authentic and accurate and whether or not the quality control laboratory is in compliance with cGMP regulations. The red flags include missing data to support the application, which is a horrible thing and demonstrates the facility was not running a tight ship. The process is also largely about perceptions and how to defend them, so it’s important not to be defensive.

Interestingly, much time was spent on support systems including, assumed to exist, quality systems. They include competent people, and importantly, integrated data and document control systems among others. This, of course, perks the interest of solution providers such as Emerson, particularly when one of the attendees asked for recommendations on how to keep track of the “massive” amount of documentation. Another asked about the tracking of training required for performing job duties. Emerson has developed a Smart Operations Management platform called SYNCADE that directly supports management of Production and Quality Assurance operational processes using specific types of computer technologies. SYNCADE is an out-of-the-box solution comprised of nine modules that seamlessly integrates plant and lab systems into a cohesive, automated environment. With respect to control of the “massive” amount of documentation, one of the modules, Document Control & Archiving (DCA) features complete document lifecycle functionality including online document storage, document change control, version management, archived records management, and printing. For more information on DCA and other SYNCADE solutions, click here. The bottom line is those sleepless nights need not be so sleepless during inspections due to comprehensive support systems such as SYNCADE.

The last session was covered by Cathy Burgess, Counsel; Crowell & Moring LLP. The other sessions were great but many appeared to enjoy this one the most. Cathy discussed what happens when things go really wrong . . . after the inspection and the facility receives a 483. Responding to a 483 can either be a way of demonstrating how efficient the facility is or if the facts are shaded, additional enforcement action may be warranted. Her approach was firm and attention grabbing. The first rule is to have a plan; the facility needs to fully understand what the FDA is looking for. Second, the facility must address the FDA’s specific concerns and not use stock answers (it happens!). Third, the facility needs to ensure they keep their promises . . . commitments need to be kept, failure to do so will create cause for return visits and raise red flags about misrepresentations. Warning letters are not good. The fun part was breaking the attendees up into groups. There was a role play responding to a made-up Warning Letter. The imaginary letter included all sorts of inspectional observations that had to be parsed and acted upon. Teams had to discuss the root cause analysis, suggest who the response team would include, and delineate understanding of the scope of the problem. It also included, proposing actions such as a complete internal investigation coupled with review of all SOPs and training plans. Fortunately teams did not have to write a narrative for the response but did talk about how it would be comprised. It should be factual, complete, demonstrate understanding of the issues supported by documentation, and easy to read. Cathy really knew her material, was engaging and took control.

Overall, keys to a successful PAI include not falling victim to an array of common mistakes, thinking ahead, and having a unified support system infrastructure. This was a terrific training event and the talk in the halls suggested everyone walked away a little smarter than they walked in.

Trust and Verify

2009-03-12T14:40:00.010-04:00

I recently had the chance to speak with Dawn Ruggiero, Director of Worldwide Operations for Valspec, a Computer Systems Validation company and Emerson partner, specializing in the commissioning, qualification, and validation/verification of computerized systems in the life sciences industry. We discussed a broad range of topics regarding computer validation and issues associated with computer systems in FDA regulated industries. Dawn sheds a great deal of light on the subject matter. Her answers are valuable to those seeking to remain current with industry trends and approaches.

Q. Define commissioning and qualifying Life Science or Pharma/Biopharm manufacturing systems and equipment?
A. The purpose of commissioning and qualification activities is to assure that systems operate safely and effectively. C&Q activities serve as a foundation for successful Process Validation activities, the results of which are intended to provide assurance to regulatory agencies that a product is safe and effective, and consistently manufactured.

Q. What’s the difference between the way validation was done in the past compared to the current model?
A. Historically, validation activities focused on detailed testing of individual system components, with little attention paid to the criticality of those systems with respect to product quality and patient safety. With the FDA support of risk-based and science-based approaches, the industry moved toward assessing the impact of a system with respect to these important criteria. Risk-based approaches then started taking a closer look at items such as technological novelty and application complexity in order to determine during the project planning phase what level of testing and documentation would be required for a system. Risk-based approaches were a way for the industry to drive testing activities to focus on what really mattered, instead of a one-size-fits-all approach. In the current model there is a significant focus on Critical Quality Attributes and Critical Process Parameters in ensuring Product and Patient safety.

Current trends initiated by the issuance ASTM E 2500-07 are pushing most, if not all, of the requirements into Good Engineering Design practices, testing and development activities that are the primary responsibility of a Pharma company's engineering group, which supports other industry practices such as Quality by Design (QbD). The result is that commissioning and qualification activities are changing to a more holistic system-level test of the system functionality against its specified requirements. Reliance on Supplier Quality Management Systems is a must if a Pharma company intends to minimize traditional C&Q activities into verification-level activities.

Q. Why was it changed?
A. The FDA does not set detailed directives on how to test systems. The Code of Federal Regulations defines the laws that are in place, but how compliance is achieved is something that is open to interpretation. The Issuance of the FDA paper Pharmaceutical CGMPs for the 21st Century - A Risk-Based Approach Final Report back in September of 2004 provided a strong impetus for companies to take a fresh look at how they were approaching compliance-related activities.

Q. Is there consistency across the industry?
A. There is an extraordinarily broad range of practices within the industry. Some companies have not adopted the new philosophies that have been introduced in the past few years, and others have determined that there are other non-compliance-related risks that outweigh the benefits of changing.

Q. What is the value? What is the compelling reason for Life Sciences manufacturers?
A. Validation is a requirement. Approval of a manufacturer by the FDA and other worldwide governing agencies hinges on the results of performance and process validation activities. Commissioning, qualification, and validation of the systems that drive the manufacture of the product are a major preliminary step in providing a high degree of assurance that a system is fit for its intended use.

Q. What does a properly validated system look like?
A. A properly implemented validation system is documented and tested at an appropriate level based on its intended use and its impact to patient safety and product quality.

Q. What skills are required to perform system and equipment validation?
A. Subject Matter Expertise in the system as well as an excellent working knowledge of the regulations is a must in order to align with current industry practices.

Q. What methodology is used? What are its parts or types? Can they be separated? Is there a logical order?
A. Yes . . . there is a structured complementary methodology that fits comfortably within the Emerson Quality Project Management Plan framework. Major Deliverables include the following:

Q. Lastly… what would you say about the unique working relationship Valspec has with Emerson? Describe the ideal situation that makes for a successful partnership on an implementation?
A. Valspec's Subject Matter Expertise in the field of validation/verification and experience with client quality groups and their associated testing practices, coupled with Emerson's Automation Systems Subject Matter Expertise, is a powerful partnership in being able to efficiently and cost effectively assess the needs of a client, evaluate what is important to them from a project and a compliance standpoint. This combined knowledge facilitates the development and execution of a project plan that optimizes the complete package of services that Emerson has to offer from the process level through the Manufacturing Execution System and for the entire system life cycle.

Dawn has over 15 years of experience in the life sciences industry, ranging from process design and scale-up for biotechnology processes, through process control systems integration and validation. She has directed the Valspec organization in successful commissioning and qualification projects as well as startup services for over 100 manufacturing, laboratory control, and information system installations. Located in Royersford, PA, Valspec is a valued member of the Emerson Process Management partner network.

http://www.valspec.net/

A Really Smart Guy

2009-03-07T18:57:00.006-05:00

Mark Coughran is a very talented individual! He has optimized the performance of control loops leading to increased production, improved product quality, or reduced energy consumption in the pharmaceutical and biotech industries. Most projects involve onsite loop testing, diagnosis, and controller tuning. Some involve building computer simulations to show how to optimally design or re-design the system.

Not long ago, Mark wrote a white paper outlining the value and importance of controlling reactor temperature which directly ties to product quality, production rate, and operating costs. Mark writes:

"In pharmaceutical and biotech plants, one of the most critical variables to control is reactor temperature. The most obvious effect is on product quality. A batch simply cannot meet quality specifications if the temperature goes too high or too low for too long. However, control of temperature also affects other business drivers: the time to complete a batch, the amount of operator attention required, and the consumption of utilities. Emerson consultants have optimized many reactor control systems for temperature, pH, dissolved oxygen, etc. Our methods of process testing and modeling apply to all controllers, but we have found DeltaV offers particularly great flexibility for optimizing response of the control loop. The article describes successful projects where the temperature initially was oscillating, overshooting, or responding too slowly. The same methods apply to temperature control in centrifuges, dryers, and utility skids."

Mark typifies the value proposition of the Emerson Global Life Sciences team which include, seeking to understand our client’s need, consultative thought leadership, and a results-driven mindset. Please take a moment to read his white paper titled “Improve Batch Reactor Temperature Control.” He has a Ph.D. in Mechanical Engineering from the University of Texas and is also an Emerson instructor. The good news is he is a member of the Emerson Global Life Sciences Team and is committed to solving customer business problems.

Cheers!

Learn to Earn

2009-03-04T20:23:00.008-05:00

“All the world is a laboratory to the inquiring mind.” Martin H. Fischer

I'll be attending a two day International Pharmaceutical Academy (IPA) event tomorrow in Somerset, NJ. It's not far from where I live so that will make for a pleasant travel day.

IPA is a progressive Canadian organization focused on training for the life sciences industry. They will be presenting a number of experts from the industry to bring attendees up to speed on a variety of topics. The agenda looks terrific and includes a perspective on the FDA, Today and Tomorrow, Risk Based Approach for PAI Inspections, FDA Goals of The Laboratory Portion of Pre-Approval Inspections, all followed by a series of workshops.

Inquiring minds want to know more about the history, vision, and mission of the FDA, its goals and principles, and the future of the FDA. The latter being the most interesting to me. It will be attention-grabbing to hear the predictions given the FDA’s main purpose are to protect and serve people from unsafe products and claims of effectiveness. The world continues to become more and more complicated and with the ever growing and vast array of products being produced . . . more and more expertise and controls will be required. Other’s will be interested in the FDA’s Plan on cGMPs for the 21st Century, Application and Approval Processes in the US and Inspection Programs. It’s all good!

By 5:00 PM Friday, I will undoubtedly be ready for the weekend. Something tells me though; I will be a little smarter than when I walk in.

Cheers . . .

Alan

Capital Contraction

2009-03-01T18:07:00.003-05:00

It’s already March 2009 and the choppy waters in the life sciences industry, in part caused by turmoil in the financial marketplace, do not appear to have an end. According to Burrill & Company, a leader in life sciences venture capital, fundamental change is occurring in our industry. They note, over the last 40 years, there has been relatively easy, constant and cheap access to capital which has historically been the engine behind growth and innovation. The life sciences industry wasn’t necessarily built off of sales revenue and instead, built off of access to capital which may have enabled some companies to survive over a decade in hopes they will eventually have the revenue bases to support them. Today, the landscape has shifted on two levels, money is more expensive to borrow and largely inaccessible. Further, the Wall Street buy side and sell side players have dramatically changed. The world is well aware of the departure of bastions such as Bear Stearns and Lehman Brothers . . . Who would have thought that Merrill Lynch would have been absorbed by Bank of America?

Only 1 Biotech firm went public in 2008 and predictions are the Initial Public Offering (IPO) space will continue to be a tough year in 2009. The guess is there will be very few IPOs completed in 2009 and they will be the companies that have proven revenue growth coupled with limited risk. Gone are the IPOs with large technology or regulatory risk. Additionally, venture backed companies looking for more rounds of development capital will be questioning their outlook.

As an investor, you have to wonder about the effect of what is happening. There are many companies now that are below $100M in market capitalization trading at shockingly low prices.

Cash is king and debt is behind the times. Companies in the life sciences space will struggle until financing alternatives become more attractive and less expensive. Technology vendors looking to increase their ability to pursue and win major projects need to be mindful of these sobering trends and be prepared to quantify their value and strategically quote and price solutions. The sky isn’t necessarily falling, but the rain doesn’t appear to want to subside any time soon.

The Emerson Global Life Sciences Team

Works Cited

Burrill & Company. “The Burrill Report: Outlook for the Capital Markets.” Online posting.
31 Dec. 2008. The Journal of Life Sciences < www.tjols.com/rss/podcasts.xml >

Welcome To Our Blog

2009-02-28T18:44:00.000-05:00

We are the Global Life Sciences Team representing Process Systems and Solutions, a division of Emerson Process Management. Our team is a dedicated group of individuals with S95 and S88 expertise committed to broadening the impact of technologies within the Life Sciences Industry.

The purpose of this blog is to provide insight into the Life Sciences Industry from a number of perspectives. We will provide periodic updates on industry trends that include commentary on the state of the Life Sciences marketplace. Of particular interest is the current state of the economy and how we are all affected by change that is in our midst. Our blog will also speak to the value and importance of how the Emerson Team solves business problems at the automation and operations layers of the S95 context model. Readers will benefit from the many years of hands-on experience our team has realized, working with some of the largest pharmaceutical and biotechnology firms in our industry.

We look forward to your participation and importantly, your feedback.

Enjoy!

The Emerson Global Life Sciences Team