Cleanrooms vs. isolators: A healthy debate
06/01/2003
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Ask a drug maker about cleanrooms, and they will quickly and perhaps even defensively point out that they do not operate an aseptic process.
Maybe so, but whether it's Zyrtec for allergies or HeartGard for Rover, most, if not all, pharmaceutical manufacturers have a cleanroom—even if it's just a lowly ISO Class 8. And while the Food and Drug Administration encourages the use of other contamination control technologies, the agency is not going to lift the requirement of a cleanroom anytime soon.
Alas, cleanrooms continue to be a touchy subject in a life science-minded crowd.
Some go out on a limb and say such breakthrough technologies as barrier-systems, isolators and blow-fill-seal systems are continually replacing "conventional manned cleanrooms." Others just come right out and say, "You should change the name of your magazine," suggesting that our 15-year-old moniker will soon be the death of us.
Generating this dialogue (we hope) are the science and theories behind contamination control, which obviously go way beyond the cleanroom. That forum forces meddling journalists to not only keep an ear to the never-ending cleanrooms vs. isolators debate, but a close watch on what the under-funded, silent pioneers are doing in a laboratory on some university campus.
Moving to shelve well-established technologies and pushing an agenda flies in the face of science, and saying one method is better than the other is clearly myopic. Ongoing analysis of all contamination control technologies is essential, whether it is a traditional, manned cleanroom, an isolator or a new filtration technology.
Barrier-systems and isolators could very well be the future of aseptic processing, and for all anyone knows, Intel Corp. could adopt similar methods and scrap plans for its umpteenth cleanroom. As CEO Craig Barrett proclaims, "we should have done this years ago."
If it happens, or whatever happens, you can count on getting the breaking news on www.cleanrooms.com with an in-depth follow-up in CleanRooms, the magazine of contamination control practices, processes and technology.
And what a story it will make.
Mark A. DeSorbo
Associate Editor