Technical Report No. 26 (Revised 2025): Sterilizing Filtration of Liquids

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Sterilizing filtration is the process of removing microorganisms from a fluid stream without adversely affecting product quality (1-4). This technical report (TR) is intended to provide a systematic approach to selecting and validating the most appropriate filter for liquid sterilizing filtration applications.

PDA's original Technical Report No. 26: Sterilizing Filtration of Liquids, (TR-26) published in 1998 described the use and validation of sterilizing filtration to a generation of pharmaceutical scientists and engineers. A revision of the original report was developed in 2008 in response to enhancements in filtration technologies and recent additional regulatory requirements within the pharmaceutical industry at that time. This current revision has been implemented to reflect current best practices and regulatory expectations, as well as clarify the roles of filter suppliers and end-users. References are provided for scientific publications and international regulatory documents where more detail and supportive data may be found.