Related Manuals for entegris Pharmsteri II
Summary of Contents for entegris Pharmsteri II
- Page 1 MICROCONTAMINATION CONTROL MANUAL Pharmsteri II PES ™ Liquid Capsule Filters User manual...
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Page 2: Table Of Contents
PHARMSTERI II PES LIQUID CAPSULE FILTERS TABLE OF CONTENTS — Introduction ................ 3 Acceptance ................3 Installation ................4 Background: Non-Destructive Integrity Testing..4 Bubble Point ..............4 Diffusional Flow..............4 Integrity Testing – Wetting Procedure ......4 Wetting Methods ............. 6 Integrity Test Guide ............ -
Page 3: Introduction
2: 2022 B: February 3: 2023 C: March Figure 1. Pharmsteri II 0.22 um GHF and GHC capsule filter examples. 4: 2024 D: April Flow direction arrows shown moving from top to bottom. Capsule vent ports are shown twisted in the fully open position. -
Page 4: Installation
The overview below describes each integrity test in detail and related to the Pharmsteri II 0.22 µm capsule filter integrity test specifications. User Manual | Entegris, Inc. - Page 5 Constant Pressure System Constant Flow System Manual System Gas source Peristaltic pump Venting Wetting Water source Pressure vessel Figure 3. Example schematic of wetting systems for Pharmsteri II PES liquid capsule filters. User Manual | Entegris, Inc.
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Page 6: Wetting Methods
PHARMSTERI II PES LIQUID CAPSULE FILTERS WETTING METHODS 7. Gradually open the outlet valve (V3) and ensure the target flux rate of 420 LMH is maintain across Tubing the filter. The differential pressure (P2 – P3) across Gas source Valve the filter should be ≤... - Page 7 PHARMSTERI II PES LIQUID CAPSULE FILTERS 6. Open the outlet valve (V3) and flush the filter for Peristaltic pump 1 – 2 minutes. The differential pressure (P2 – P3) across the filter should be ≤ 2 psid. 7. During the flush period, pulse the outlet valve (V3) by opening and closing.
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Page 8: Integrity Test Guide
DIFFUSIONAL FLOW TEST — 1. Ensure the filter has been wetted using one of A BP or DF test can be performed on the Pharmsteri II wetting methods in previous section before PES liquid capsule filters with appropriate wetting connecting the filter to integrity test system. -
Page 9: Troubleshooting Guide
PHARMSTERI II PES LIQUID CAPSULE FILTERS TROUBLESHOOTING GUIDE — Entegris Integrity Troubleshooting Guide to Diffusive Flow Measurements Saturate membrane following Entegris wetting procedure Does the Pass Fail Record di usive Record di usive filter pass flow value flow value dii usive flow? -
Page 10: Sterilization
2. To keep disposable filters in good condition do This is designed as a single-use product and Entegris not store them with toxic, corrosive, volatile, or recommends replacing a capsule filter after each pungent materials. -
Page 11: Epa Information
Contact us or visit our website www.entegris.com to learn more. LIMITED WARRANTY Entegris' products are subject to the Entegris, Inc. General Limited Warranty. To view and print this information, visit entegris.com and select the Legal & Trademark Notices link in the footer.
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