A Risk Based Approach for Pre-Use/Post-Sterilization Integrity Test Simulation During Bacterial Retention Testing as Part of the Process Specific Filter Validation of Sterilizing Grade Filters
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Pre-Use Post Sterilization Integrity Testing is implemented in sterile filtration applications by drug manufacturers using a risk-based approach with consideration of the stipulation in Eudralex volume 4, Annex 1, of the European Union Good Manufacturing Pract... ...
