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:
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.
