PDA Technical Report No. 26, (TR 26) Revised 2008, Sterilizing Filtration of Liquids (single user digital version)

Dec 2008
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This Technical Report was prepared by members of the PDA Sterilizing Filtration of Liquids Task Force.

PDA’s original Technical Report No. 26, published in 1998 described the use and validation of sterilizing filtration to a generation of pharmaceutical scientists and engineers. This revision was developed in response to enhancements in filtration technologies and recent additional regulatory requirements within the pharmaceutical industry. References to scientific publications and international regulatory documents are provided where more detail and supportive data may be found. This report underwent an eleven-week global technical peer review that included feedback from the Americas, Asia-Pacific and Europe.

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2008. Volume 62, Issue No. S-5.

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Table of Contents

Table of Contents:

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  1. How Filters Work
  2. Filter Selection and Characterization
  3. Filter Use, Handling and Design Considerations
  4. Sterilizing Filter Validation/Bacterial Retention
  5. Sterilization of Filters
  6. Single-Use Disposable Systems