Active air sampling in isolators with SAS successfully monitors isolator performance in preparation of sterile bulk drugs, sterility testing and containment of potent materials.
The proficiency of SAS in isolators stems from the SAS ruggedness during vaporous hydrogen peroxide (VHP) treatment and its use with triple-wrapped contact plates especially designed for isolators.
After experience with other samplers which deteriorated under VHP, Bryan Topolewski, Associate Microbiologist in the production of demineralized bone products at Osteotech, found “The SAS Air Sampler held up well under VHP with no ill effects at all.” At Abbott Laboratories, Lisa Thimmisch, Senior Microbiologist who operates a closed isolator for sterility testing of intravenous drugs, said “The ability of the SAS to stand up to our two-hour VHP process is a major benefit to our isolator procedure.” Valerie Ostrander, Senior Microbiologist for Aseptic Quality in the production of titanium implants at Alza, said “an additional advantage to using the SAS in an isolator is that contact plates, unlike proprietary media, can be triple-wrapped, which most isolators require.” The SAS Air Sampler integrates well into isolator protocol. At Abbott Laboratories, Thimmisch stocks one of her two transfer isolators with a sleeve of contact plates and an autoclavable stainless steel SAS sampling head. After docking the transfer isolator to the workstation, she transfers the head and one plate to the work-station attaching them to the SAS.
After sampling a cubic meter of air, she transfers the head and plate to a sterile bag and transfers them to the transfer isolator. She then undocks the transfer isolator and incubates the plate, unbags and autoclaves the head and returns it to the bag. She returns the bagged head to the transfer isolator and sterilizes the exterior of the bag. The SAS is removed from the isolator as needed for routine battery charging. Abbott has SAS units with the new standard seven-hour NiMH batteries, which have a 45,000 liter sampling capability per charge.
From Bioscience World, Autumn 2001
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