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PDA Technical Report No.41  Revised 2022 (TR 41)  Virus Filtration (Single user digital version)

PDA Technical Report No.41 Revised 2022 (TR 41) Virus Filtration (Single user digital version)

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  • Table of Contents

Technical Report No. 41 (Revised): Virus Retentive Filtration, provides a summary of best practices for utilization of virus filtration in process development and manufacturing. The document explains what virus filters are and where they can be used in current and emerging bioprocesses. Recommendations for selection of a suitable virus filter are presented that include information on their physical and biological/safety characterization and guidance on how to incorporate quality by design (QbD) principles into virus filtration applications. Strategies for evaluating and validating virus retention by virus filtration, including defining the worst-case test parameters, are also discussed. Finally, considerations that reflect best practices and current thinking for implementing virus filtration into novel manufacturing technologies, such as barrier filters, continuous bioprocessing modes for filtration, or production of ATMPs, are also included.

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Table of Contents:

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  1. Introduction
  2. Glossary of Terms
  3. Virus-Retentive Filters
  4. Considerations For Virus Filter Selection
  5. Virus filter Integrity Tests
  6. Virus Filtration Validation/Qualification Studies
  7. Types and Uses of Virus Filtration
  8. Physical and Mechanical Characterization
  9. Sterilization
  10. Areas for Further Consideration
  11. References
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