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PDA TR 51-2010

Biological Indicators for Gas and Vapor-Phase Decontamination Processes: Specification, Manufacture, Control and Use

This Technical Report provides a comprehensive review of an area not adequately addressed in current guidance documents: recommended specifications for BIs to be used with sporicidal gas and vapor-phase decontamination cycles together with guidance regarding their manufacture, quality control, and use. The principles described in this report are based upon the manufacture and use of BIs prepared from spore suspensions; however, they can be equally applied to the preparation of BIs from other sources.

Content Provider
Parenteral Drug Association [pda]

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