PFR Validation guide - gmpua.com

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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.

3 Part III. Validation of Physical Characteristics 34 1. Resistance to Steam Sterilization 34 1.1 Introduction 34 1.2 Summary of methods 34 1.3 Results 35

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