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THE PHARMA REVIEW (NOVEMBER - DECEMBER 2014)

The Safe and Reliable Testing of Pharmaceutical Samples for Sterility

Dr. Hans Bassler

Introduction: Testing for sterility of a parenteral applicable product of the pharmaceutical industry is according to USP <71> and Ph. EUR. 2.6.1. applied to substances, which according to the Pharmacopeia are required to be sterile (parenterals, ophtalmics,). It is the crucial test for the release of a produced batch to the market1. Sterility testing in an isolator is more and more recommended by the authorities in USA and Europe. So says the FDA Guidance for industry: “A well designed positive pressure isolator, monitoring and control, offers tangible advantage over classical aseptic processing including fewer opportunities for microbial contamination during processing”2, so stated in the FDA Guidance for Industry (2004). In the US Pharmacopeia is a whole chapter referring to sterility testing in isolators. “The isolator for sterility testing need not to be installed in a classified clean room, but it is important to place the isolator in an area that provides limited access to nonessential staff"3. US Pharmacopeia 29 <1208>. 

 

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