PFR Validation guide - gmpua.com

Validation guide USTR 2114(2). Validation guide for Pall Emflon PFR. Filter Cartridges CONTENTS. Part I. overview 4. 1. Introduction 4. 2. Summary of Conclusions 4. Part II. Studies on Removal Efficiency 6. 1. Microbial Validation using Brevundimonas diminuta Liquid Challenge Tests 6. Introduction 6. Summary of methods 8. Results 10. Conclusions 13. Microbial Validation of other styles of Emflon PFR filters 15. 2. Aerosol Bacterial Retention Tests using Brevundimonas diminuta 22. Introduction 22. Summary of methods 22. Results 23. Conclusions 24. 3. Long-Term Aerosol Microbial Challenge Tests 25. Introduction 25. Summary of methods 25. Results 27. Conclusions 28. 4. Bacteriophage and Spore Aerosol Challenge Tests 29. Introduction 29. Summary of methods 29. Results 30. Conclusions 31. 5. Sodium Chloride Aerosol Challenge Testing 32.

CONTENTS Part I. Overview 4 1. Introduction 4 2. Summary of Conclusions 4 Part II. Studies on Removal Efficiency 6 1. Microbial Validation using Brevundimonas diminutaLiquid Challenge Tests 6 1.1 Introduction 6

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