Pharmsteri™ II PES 0.22 Buffer Capsule Filters
Validation Guide
Pharmsteri™ II PES 0.22 buffer capsule filters (Pharmsteri II filters) are made of high-grade, gamma stable polypropylene shell and a hydrophilic polyethersulfone (PES) membrane with nominal pore rating at 0.22 μm. The asymmetric PES membrane is sterilizing grade and meets bacterial retentiveness per ASTM F838. Entegris has a long history of compliance in countries of operation/distribution. Entegris actively reviews products for compliance and conformance with government and customer requirements affecting raw materials/substances that may be used in manufacturing processes. This guide contains compliance information that can support validation in regulated applications.
Table of Contents
| Introduction............................................................................................................................................ | 2 |
| Scope........................................................................................................................................................ | 2 |
| Compliance Overview........................................................................................................................... | 2 |
| Certificate of Quality............................................................................................................................. | 3 |
| Manufacturing Environment............................................................................................................... | 4 |
| Materials of Construction.................................................................................................................... | 4 |
| Country of Origin................................................................................................................................... | 4 |
| Animal Derivative Content and TSE/BSE Risk................................................................................. | 4 |
| Water Flow Characteristics................................................................................................................. | 4 |
| Integrity Correlation Between Diffusive Flow Cutoff and Bacterial Challenge Test............... | 5 |
| Post-Gamma Filter Integrity Test (Bacterial Challenge Test)....................................................... | 6 |
| Filter Integrity Post-Gamma Sterilization (Diffusive Flow Test)................................................... | 8 |
| Operating Temperature And Pressure Range............................................................................... | 9 |
| Shelf Life (Post-Gamma Sterilized Filter).......................................................................................... | 9 |
| Gamma Sterilization.............................................................................................................................. | 19 |
| Filter Cleanliness – TOC, Conductivity, Particulates, Fiber Release........................................... | 20 |
| USP <87> Biological Reactivity Tests, In Vitro................................................................................. | 22 |
| USP <88> Biological Reactivity Tests, In Vivo, Class VI Test......................................................... | 23 |
| USP <85> Bacterial Endotoxin Tests, EP 2.6.14, JP........................................................................ | 23 |
| Extractables............................................................................................................................................ | 23 |
| Capsule Burst Test................................................................................................................................ | 24 |
| Manufacturing Process Validation..................................................................................................... | 24 |
| Packaging Validation............................................................................................................................. | 24 |
| References.............................................................................................................................................. | 27 |
| Technical Information........................................................................................................................... | 27 |
| Limited Warranty................................................................................................................................... | 27 |
| For More Information........................................................................................................................... | 27 |
| Terms and Conditions of Sale............................................................................................................ | 27 |
