As more manufacturers in all industrial sectors embrace the techniques of the Toyota Production System, terms like Kanban, Poka Yoke and Jidoka are becoming part of the fabric of more drug manufacturing facilities. Jidoka, also called autonomation, gives equipment and operators the ability to see when an abnormal condition has occurred and to stop work immediately, building quality into each step of the process.
A key part of Jidoka is error proofing, or systems that either prevent operator error or allow prompt response. It is a process where people are asked to identify every instance where the situation doesn’t match the expectation. More equipment is being designed to eliminate operator error and improve root cause analysis, while radio frequency identification (RFID) is playing a part in more systems throughout the plant.
Source: The Five Steps to Building Jidoka Equipment, J. Miller, Panta Rei, www.gembapantarei.com, May 4, 2006.
Editor-in-Chief Agnes Shanley interviewed three experts in automation for life sciences — Bob Lenich of Emerson Process Management, Bob Honor of Rockwell Automation, and Bengt Stom of ABB — to elicit their perspectives on the current state of, and future prospects for, automation and process control solutions in pharmaceutical and biopharmaceutical operations. Their respective Q&As follow.
A 30,000-foot-view from Emerson’s Bob Lenich
PM — Looking broadly at the automation and process control solutions now available to pharma and biopharma manufacturers, would you say that today's life sciences solutions fully reflect this principle in their designs, or that they are evolving to that point? If they haven't reached that point yet, what is still needed?
BL — The principle of Jidoka is seen today in the many responses life sciences producers are making to the FDA PAT initiative. The evolution includes expansion with more reliance on in-line analyzers to provide accurate real-time feedback, applied modeling and simulation and optimization techniques to permit decision making and more “closed-loop” processes.
PM — Are end users in pharma/biopharma demanding these features in their solutions? What differences do you see in this regard between customers in pharma vs. those in automotive or discrete manufacturing?
BL — The leaders of the pharma industry are demanding and using new responses to the PAT initiative to improve their operations. There are some leaders in this field including in our experience — Pfizer, AstraZeneca and Wyeth, among others. These advances are currently being seen most commonly in the fill/finish portions of the pharmaceutical manufacturers with the goal of increasing product throughput and decreasing the cost of quality by enabling parametric release of products. In our current view and experience, biological manufacturers are not as invested in this technology primarily due to the more difficult nature of their measurements and corresponding lack of accurate instruments to rely upon.
We don’t deal with automotive industry in the main so direct comparisons are more difficult to make. It is clear that the ability of piece-parts manufacturers to measure their works-in-progress against their specifications (size, weight, roundness, etc.) is, in the main, easier than determining the exact chemical nature of a complicated pharmaceutical intermediate. It is logical that the Jidoka practices and principles that apply more broadly there would be more entrenched at this time. In a similar fashion, once an active pharmacological ingredient or biologic product has been produced and now need to be packaged. The processes are very much aligned and the Jidoka principles apply very well.
PM — Which products and platforms has Emerson introduced within the past year that best embody the principle of Jidoka?
BL — There are three main areas in which Emerson Process Management is responding to the life sciences demands for Jidoka practices.
- Abnormal Situation Prevention: This permits pharmaceutical manufacturers to avoid disruptions in their process due to predictable failure analysis of capital equipment. While not exactly tied to in-line measurement, a failure of a key piece of hardware in the middle of a batch can clearly disrupt production and waste valuable time and raw materials. Emerson has techniques that help end users minimize disruptions due to predictable equipment failure.
- Recipe Authoring and Electronic Work Flow Management: A key part of life science management is the ability to control precisely the process necessary to make product and to record accurately for reporting purposes what was done and how. This tool set provides life sciences manufacturers the tools needed to produce product repeatably and prove that they have done so.
- Bioprocess Modeling: Emerson Process Management has developed and is in the process of testing and releasing tools that permit the modeling of complicated bioprocesses. This will provide the biopharmaceutical industry with a valuable new tool that will permit more accurate and repeatable cell manufacture and active ingredient manufacture. It is another tool that moves beyond the current wait-and-test approach that is so antithetical to the Jidoka philosophy.
Perspectives from Rockwell’s Bob Honor
PM — Looking broadly at the automation and process control solutions now available to pharma and biopharma manufacturers, would you say that today's solutions fully reflect the principle of Jidoka in their designs, or that they are evolving to that point? If they haven't reached that point yet, what is still needed?