In late July, the European Pharmacopeia (PhEur) has made available for comment a revised draft monograph on biological indicators in the preparation of sterile products, which replaces a draft published in 2011 that received extensive comments. Changes from the 2011 draft include: clarification that the monograph does not apply for biological indicators used to validate the sterility of pipework and other non-terminal units a description of a four acceptable indicators along with their quality and user requirements removal of the requirement to use biological indicators for ionizing radiation sterilization, and a list of characteristics of the lipopolysaccharide preparation acceptable for use as indicators for depyrogenation processes. Comments are due by September 30.
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