Pharmaceutical Automation Roundtable (PAR) - Part 5 - Automation Reinvestment & Disposable Technology

Pharmaceutical Automation Roundtable (PAR) - Part 5 - Automation Reinvestment & Disposable Technology

 
By Bill Lydon - Editor, January 2011
 
This is the fifth and last in a series of articles that are the result of the annual Pharmaceutical Automation Roundtable (PAR). The individual PAR group members have a wealth of practical knowledge and knowhow to share with other participants, truly learning from each other.
 
I had the privilege of attending the Pharmaceutical Automation Roundtable as an observer this last November at Pfizer's Andover, Massachusetts biotech facility. The PAR was co-hosted by Jim LaBonty and James Galloway, both from Pfizer’s central engineering group. Over 30 automation lead engineers from various parts of the world attended the invitation-only, two-day event. In my opinion, this was likely the most knowledgeable group of automation professionals gathered in one place at any one time focused on discussing automation issues. Life Science companies represented in the PAR include Abbott, Alcon Labs, Allerga, Amgen, Bayer, Biogen Idec, BMS, Boehringer Ingelheim, Centocor, Cook Pharmica, Dow, Genentech, GenMab, Genzyme, GSK, Imclone, J&J, Eli Lilly, Lonza, Merck, NNE Pharmaplan, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi-Aventis, Schering Plough, Talecris, and UniLife.
 
The PAR was founded about 15 years ago by Dave Adler and John Krenzke, both with Eli Lilly and Company at the time, as a means of benchmarking and sharing best practices for automation groups among peer pharmaceutical companies. The group specifically does not discuss confidential or proprietary information, cost or price of products, price or other terms of supply contracts, plans to do business or not do business with specific suppliers, contractors, or other companies.   
 
This year’s PAR topics covered the following items:
 
  • Manufacturing Execution System Projects - Benchmarking
  • Control System Virtualization Approaches
  • Governance Organizational Structures
  • Software Development Environment & Configuration Management
  • Control System – Automation Lifecycle Management and Long Range Planning
  • Electronic Testing Tools & Validation
  • Wireless Networks
  • Disposable Technology and Automation Implications
  • Control Loop Operating Modes – Operator use of Auto & Manual modes relative to Safety
The structure of PAR is to discuss a topic and then attendees respond to 3 - 5 questions.
 
Automation Reinvestment Capital & Long Range Planning
 
A PAR member started the topic discussion by relating their experience noting that automation lifecycle management is important to be in step with lifecycles of systems and system components. They have a program for automation capital reinvestment and long range planning based on existing methods used for facilities and IT. There is now in place a governance group that prioritizes and optimizes capital requests and provides justification in a planned and orderly process. The objectives are to maintain automation assets and desired lifecycle states, provide global governance including oversight, implement automation capital reinvestment, and forecast to reduce the number of individual capital requests. Part of this is reducing the total cost of ownership by maintaining alignment with standards and balancing status quo with the continued acceleration and evolution of technology. Automation systems have different layers so reinvestment does not simply mean complete replacement. Individual parts and pieces of the automation system need to be considered for replacement. The automation program needs to be closely coordinated with other reinvestment programs for process equipment, information system infrastructure, and facility including Building Automation Systems (BAS).   He also outlined what they do NOT consider new investment including expansion in size, scope, and new functionality. 
 
They are now creating 3-5 year automation system roadmaps/strategic plans for their manufacturing sites. Forecasting capital investment requirements allows aggregation of small capital requests and eliminates surprises. This approach is working very well so far.
 
Comments from the PAR group
 
Consider this as part of a lifecycle profit analysis. The corporation will need to invest to stay competitive.
 
Planning allows coordination of plant shutdowns with upgrades.
 
Show at least 3 year capital window and ask for one year investment.
 
Instrumentation has a longer lifecycle but when it is at end of cycle it has a big impact on operations.
 
One plant had a recent example of some engineers who understood the legacy DCS system quit/retired, creating an immediate urgency to replace the system. Planning could have made options available for keeping engineers longer and orderly system replacement.
 
Have a quarterly report for management that shows where the risks are so they can make informed business decisions.
 
Every time you have a recapitalization effort, it is an opportunity to improve and enforce standards. 
 
Learn from IT people, they are really good at this reinvestment model.
 
Identify the most critical systems and define a strategy risk grid. 
 
We need an asset management database so we can better keep track of what equipment each plant has installed. The database should contain purchase date, expected life, maintenance cost incidents, supplier obsolescence, etc.
 
Utilize existing databases such as facilities asset management programs to keep track of automation systems.
 
Asset tracking should be captured and organized into the database at purchase.
 
Lack of tracking can lead to situations like paying for service contracts on equipment that are out of service.
 
Assessing which vendors will continue to supply and support the product in the long run should be part of purchase analysis to avoid being stuck with an orphaned product.
 
Sometimes understanding the “true” obsolescence plan from vendors is really hard and creates a dilemma.  
 
If we had planned based on the vendors first obsolescence policy we would have spent millions of dollars that we did not need to spend.
 
There seems to be a difference between sales obsolescence and technical obsolescence.
 
Planning helps people decide on strategic moves, like buying spare parts on eBay so we have them on hand for aging systems that need to be kept running longer.
 
Lifecycle cost analysis should be done as part of purchase analysis of new automation to avoid simply buying on lowest initial cost solutions.
 
My Observations
 
Planning capital requests for systems migrations, upgrades, and replacement is sound business planning. Anyone with automation systems should be doing this.
 
There is a real sense that vendors have manipulated them with inaccurate obsolescence dates.
 
Disposable Technology and Automation Implications
 
Another PAR member led the topic discussion on disposable equipment for pharmaceutical manufacturing. Rather than using tanks and piping for devices such as bioreactors, these systems use disposable contact materials that eliminate cleaning and validation, thereby reducing costs in operations. A major savings in cost and time is the elimination of CIP. 
 
As an example, a process that had previously been done in a tank is now done in a disposable bag that includes disposable sensors. Benefits cited include less validation required because there is no cleaning process, there is shorter downtime and turnaround time, and there is a lower risk of cross-contamination with use of new bags for each run. The member noted a paper given at ISPE (International Society for Pharmaceutical Engineering) about a new commercial biologics facility built with a mixture of disposable and traditional equipment. The facility reported very positive results of using disposables, including a 35% reduction in building size, 50% energy reduction, 85% water use reduction, and 6 month reduction in construction schedule.
 
There is controversy about the ongoing operating cost and disposal of bags, but these systems are being adopted in the market.
 
Comments from the PAR group
 
Disposable sensors are in widespread use in product development and labs.
 
There was a general feeling among members that disposable sensors need to be calibrated.
 
This creates a heavy reliance on vendor supplied control systems just like skids with the same issues.
 
Disposable systems lock you into a very complicated, dedicated device which is the disposable bag from a sole vendor. We have looked at working with our skid vendors to make the bag holders generic so they could be supplied by multiple bag vendors. 
 
In many cases, we are not familiar with the sensor vendors being used on these systems since they tend to come from the lab environment.
 
One member wondered how this could fit together with wireless technologies, maybe a wireless chip embedded on a disposable sensor.
 
As long as I can get an open PLC platform, then I can have a SCADA system that duplicates my data scanning and send it to a historian.
 
With multiple control platforms, are we going to have multiple software license costs?
 
This is an interesting area since we just made an investment in a large DCS.
 
All disposable components need to be accounted for on process changes.
 
How do you validate the disposable sensors?
 
My Observations
 
Advantages of disposables are quick install and startup time but the long term operating cost tradeoffs are unclear.
 
The controls & automation situation is the same as with skid systems purchased today.
 
The quality and repeatability of disposable sensors is still unclear.
 
Summary
 
The Pharmaceutical Automation Roundtable is a terrific event and I am sure attendees gained a number of ideas. This concludes the series of article on this event.
 
Links to the other articles in this series: