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Say 'hi' to PAT
April 30, 2007

If you've wondered why there hasn't been a posting on this blog in a week, it's because I was at INTERPHEX. The trip was longer than I wanted (more on that to come) but certainly useful. The last time I visited that show was 2001 in Philadelphia. Since then some things have changed.

One that was most visible was PAT proliferation. Process Analytical Technology has been growing in the last few years and was new to me. I was prepared to some extent since Control Engineering ran an article in the April issue about PAT applied to clean in place systems and control. PAT is a big deal and deserves the visibility. However, to someone from a process industry outside of the pharma world, there will be some puzzled looks since the concepts of PAT are really very basic to process analysis, improvement, and optimizing. The larger chemical industry has been practicing PAT for years, even decades. So why is the pharmaceutical industry so far behind?

If your plant is manufacturing organic solvents to be used in paint thinner, you aren't under the same constraints as a company making active ingredients for a cholesterol reducer or a more interesting pharmaceutical product. The US FDA monitors these companies, and when a manufacturing process is finalized, it has to be validated in every respect. A validated process cannot be changed without being re-validated, so changes are not done lightly. PAT offers mechanisms for companies to improve and optimize manufacturing more easily, but adoption has been spotty. While some manufacturers are using it wholeheartedly, the bulk are much slower. This is a very conservative industry, where the "if it ain't broke..." mentality is standard practice. Manufacturers probably find some safety behind the regulations and don't like to risk new things given that so much is at stake. However market forces are driving manufacturing costs down given the long time it takes to make a new drug profitable. PAT will be pushed into the spotlight whether she's ready or not. Control system vendors are ready to help with implementation. Don't be afraid.

Posted by Peter Welander on April 30, 2007 | Comments (0)