Flexible Pharma: Puzzling Out the Plant of the Future

Standardization is a double-edged sword, says Tunnell’s Rogers. It’s cheaper on the front end but if you get the wrong system you’re stuck with it. “I like the idea of modular contained equipment because validation and operation issues are worked out, but you can’t force fit such systems to do everything that you may need them to do,” he says.

Modular Data
This modularization also extends to data. Some advocate the use of modules or templates based on the S-88 concept of breaking any process or procedure down into recipes and developing templates for each part of the recipe that can be duplicated easily. For many, the goal is end-toend integration. “We want to take the recipe concept from late-stage development and move it very quickly,” says Genentech’s Petersen.

For Jacob’s Bader, this approach has made plant design much more efficient. “There’s a trend to modularize design aspects, almost taking an S-88 approach to the design of the valves and piping, so that you always fi lter off the tank in the same way, or you do the jacket recirculation system the same way for all tanks in your facility.” For different pieces of the puzzle, he says, “you modularize and use the pieces over and over again.” Bader recalls the design for Amgen’s landmark Enbrel plant in Rhode Island. “When we looked at doing just the process design for that facility, we had over 300 process and instrumentation diagrams (P&ID’s) and a lot of drawings.” There were nine production bioreactors and six smaller seed bioreactors, and another 18 smaller bioreactors, he says.

His team took a modular approach and created S-88 type modules around piping. They did the production bioreactor as one drawing and the rest of the bioreactors were built off that production bioreactor. “We did the most complex thing fi rst then took diff erent parts of that and put it on the seed and smaller bioreactors,” he explains.

As a result, Bader says, most front-end time was spent on 60 drawings and the rest of the 300 drawings were clones. “When you did the control and automation, you were taking these assemblies that were used on multiple drawings and just reproducing that code—all the valves were tagged the same way . . . so the vent valve off the vessel might be valve 10 and that valve 10 is the vent valve on every vessel on the job so you can reuse the code over again,” he says. Although it took more time to organize the project this way, Bader said it saved thousands of hours throughout the design process. In addition, the people operating the plant found it much easier because they always knew what, say, Valve 10 was.

From Data to Information
The plants of tomorrow will also reflect an increased attention to individual user’s data needs, providing the type of information required in the form needed at the right time. Shaping the overall movement will be the shift from a parametric to an attribute approach to data, in which increased focus is given to critical process attributes, says Suroj Patnaik, life sciences industry leader at Emerson Process Management (Austin, Texas). “Fortunately, tools and approaches for collecting, integrating, and managing data from across the operation are emerging and will become more sophisticated in the next 10 years,” Patnaik predicts. “Managers and others will be able to quickly and easily access correlated data on everything from equipment availability to quality monitoring to lot comparisons and use the information to solve production issues—all in a matter of seconds.”

This easy access to integrated information will enable personnel to be more productive. “Imagine a worker on the plant fl oor being able to instantly correlate increasing vessel-fill times with rising pumpbearing temperatures, then identify the best time to schedule bearing replacement so customer deliveries are unaffected,” Patnaik says. “This type of insight has historically required offl ine analysis by experts from multiple domains—but not in the plant of the future.”

Key to this, Patnaik believes, will be human-centered design. In the past, operator displays were oft en based on P&ID’s, a form useful to the engineer. What plant operators are more concerned about is process flow, so the newer user interfaces are starting to refl ect this fact. Instead of deluging workers with data just because sensors and soft ware make it possible, there will be a return to the spirit of the old days when manually operated panel boards alerted operators about process conditions, says Bryan Jones, product marketing manager for Emerson’s DeltaV Human Centered Design program. Such boards had to be easily visible, so they followed ergonomic principles. “It’s back to the future,” he says. At the same time, the idea of “progressive disclosure” of information will allow operators to drill down to the level of detail they need. [For Patnaik's discussion of Human Centered Design and the future of pharma, click here.]

Leaner Plant Layouts
The impacts of Lean and Toyota Production System are starting to be seen, not only in plant operations but in layouts. Lean principles guide all of Pharmatech Associates’ facility design work, says company principal Bikash Chatterjee. However, on the whole, progress has been spotty, says Tunnell’s Rogers. “Some manufacturing processes such as tableting lend themselves more easily to Lean, but other facets don’t,” he says, recalling a sterile facility startup project. “Some features look Lean, but the paperwork issues and underlying control issues are so difficult that the facility can’t really work Lean. They struggle with inventory, moving product around and keeping track of it,” he says.