Technical Reports: Print

PDA Technical Report 15, Revised 2009 (TR 15) Validation of Tangential Flow Filtration in Biopharmaceutical Applications (print version)

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.

Click here to order the digital version.


Table of Contents:

Click here to download >>> Table of Contents
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


Date of Publication: June 2009
ISBN Number: 9780939459254
Format:
Number of Pages: 52
Binding: Softcover