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PDA Technical Report No. 15, Revised 2009 (TR 15) Validation of Tangential Flow Filtration in Biopharmaceutical Applications

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This Technical Report was prepared by members of the PDA Validation of Tangential Flow Filtration in Biopharmaceutical Applications Task Force.

PDA Technical Report No. 15 (Revised 2009): Validation of Tangential Flow Filtration in Biopharmaceutical Applications, updates the 1992 original version of Technical Report No. 15 in response to the substantial changes that has occurred in industry since then, including improvements to processing equipment, introduction of new technology and materials, and publication of substantial new guidance on validation.

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Table of Contents:

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Introduction
Glossary of Terms
Tangential Flow Filtration in Bioprocessing
Equipment Qualification
Process Development
Process Validation
Cleaning Validation
Membrane Reuse
Post-Validation Activities
Integrity Testing
Extractables and Leachables
References

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