Validation of Sterile Filtration

Pharmaceutical Technology, Pharmaceutical Technology-10-01-2004, Volume 2004 Supplement, Issue 7

This article discusses the basics of sterile filter qualification and validation, with emphasis on bacterial challenge protocol development and testing. Reference is made to Technical Report no. 26 of the Parenteral Drug Association.

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Regulatory/GMP ComplianceAseptic/Sterile ProcessingProcess ValidationManufacturingQuality SystemsPharmaceutical Technology-10-01-2004