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This technical report (tr) is intended to provide a systematic approach to selecting and validating the most appropriate filter for liquid sterilizing filtration applications. 26 published in 1998 described the use and validation of sterilizing filtration to a generation of pharmaceutical scientists and engineers. By comparing the earlier and revised versions of pda tr 26, this article outlines the key developments in sterile filtration validation and provides practical guidance to help pharmaceutical manufacturers.
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26 (sterilizing filtration of liquids) specifically addresses steps to take in troubleshooting. Pda’s original technical report no A flow chart based on an understanding of integrity testing principles and applies clear logic is a central component to a good integrity test troubleshooting sop.
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