PDA技术报告第41号修订版2022（TR 41）病毒过滤（单用户数字版）

Technical Report No. 41 (Revised): Virus Retentive Filtration, provides a summary of best practices for utilization of virus filtration in process development and manufacturing. It 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, and strategies for evaluating and validating virus retention by virus filtration are discussed. TR 41 also includes considerations that reflect best practices and current thinking for implementing virus filtration into novel manufacturing technologies. \n

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

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Table of Contents:

\nClick here to download >>> Detailed Table of Contents

Introduction \n
Glossary of Terms\n
Virus-Retentive Filters\n
Considerations For Virus Filter Selection\n
Virus filter Integrity Tests\n
Virus Filtration Validation/Qualification Studies\n
Types and Uses of Virus Filtration\n
Physical and Mechanical Characterization\n
Sterilization\n
Areas for Further Consideration\n
References

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