In Defense of Evolution

As beneficial as migrations can be, it sometimes can be burdensome, particularly in heavily regulated industries such as pharmaceuticals.

The Food and Drug Administration, in Silver Spring, Md., requires drug manufacturers to generate new documentation and revalidate their control structures whenever they make any changes to their control strategies. The process is both time consuming and expensive.

To avoid these costs, yet reap the competitive advantages provided by new technology, Bayer Corp.’s research and manufacturing facility in Berkeley, Calif., adopted the evolution strategy of its controls vendor, the Process Automation Division of ABB Inc., in Wickliffe, Ohio. The drug producer needed it to boost the efficiency of its production of Kogenate FS, a drug that enhances clotting in hemophiliacs to let them live relatively normal lives.

ABB prefers the term “evolution” to describe its upgrade philosophy of adding new technology and features to its existing product lines and to new products. These additions can preserve not only installed physical assets such as wiring and terminations but also intellectual assets such as control applications, graphics, historical data, documentation and operating procedures.

According to ABB, the problem with many migration strategies is that they amount to a rip-and-replace that occurs in small increments over several years. Although the strategy usually preserves investments in wiring, terminations and cabinets, it eventually gets around to replacing controllers and, with it, the already proven control strategy.

Because Bayer’s Kogenate production relied on ABB’s MOD 300 controllers to monitor more than 10,000 I/O points in several buildings, it could evolve to the vendor’s System 800xA Extended Automation. “ABB didn’t touch our validated control strategy—how we make our product,” says David Kavanaugh, process control systems engineer. Consequently, Bayer was able to get new tools for boosting efficiency, extracting information for analysis and tracking batches automatically—instead of using manual paperwork—without having to revalidate its process.

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