Transcription of PFR Validation guide - gmpua.com
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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.
Part I. Overview 1. Introduction This report contains validation data applicable to Pall microbially-rated Emflon PFR filter cartridges. Emflon PFR filters contain proprietary PTFE filter membrane and they are designed for sterilizing air
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