You say potato…

I just read the January 2003 issue of CleanRooms and, as usual, was impressed with both the content and presentation. I have an issue to present in line with the articles on minienvironments and their testing.

As an NSF-accredited certifier, I have a concern about the testing and certification of minienvironments for the issues brought to light in the articles from this issue of CleanRooms magazine. Once in a facility to certify the biosafety cabinets and laminar flow hoods and cleanrooms, a client will say, “While you're here, certify my 'glovebox.'” This term is often used as a catchall phrase for a small, totally enclosed minienvironment, laminar flow or otherwise.

Not knowing what was used in the “box,” or what methodologies are appropriate, certifiers often find themselves calling manufacturers.

Sometimes you get an answer, sometimes you don't.

I'd like to see the industry propose testing and certification guidelines for the different types of gear available, as well as for the different agents used. It can be classed by high-toxics, chemical, bio, high-potency or whatever. We can do a pressure test with SF-6, but not if there's a potentially lethal agent inside that would blow out under positive pressure.

Does the industry believe that there will ever be a “neutralizing” protocol for chemical/toxic/potent compounds that could be followed? I don't believe this should fall on the shoulders of the certifiers out there.

We do biohazard decontaminations per industry standards, but this is a different ballpark. Only the end users know what's inside these things, they should be responsible for both doing the procedure to make it safe to certify and to provide documentation to the certifier that it's clear to test to a certain protocol/methodology.

I sense a real education issue/opportunity here. It's great to come up with all sorts of recommendations to use the right gear for the right application in a particular facility, but I think we need to address the issue of maintaining the minienvironments in the best possible operating condition safely and effectively.

The biggest challenge will be seeing to it that all parties are communicating on the same wavelength and reaching the same conclusions.

Richard Gastner
ENV Services (Colmar, Pa.)


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