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Summary of Contents for entegris Pharmsteri II GSV UPE
- Page 1 MICROCONTAMINATION CONTROL MANUAL Pharmsteri II GSV UPE ™ Vent Capsule Filters User manual...
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Page 2: Table Of Contents
PHARMSTERI II GSV UPE VENT CAPSULE FILTERS TABLE OF CONTENTS — Introduction ................ 3 Acceptance ................3 Installation ................4 Background: Non-Destructive Integrity Testing..4 Bubble Point ..............4 Diffusional Flow..............4 Water Intrusion Test ............5 Integrity Testing – Wetting Procedure ......5 Wetting Methods ............. -
Page 3: Introduction
SAP lot number 1: 2021 A: January Last 6 numbers of Figure 1. Pharmsteri II GSV UPE 0.22 um vent capsule filter examples. Hangzhou the work order Flow direction arrows shown moving from top to bottom. Capsule vent 2: 2022 B: February 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 GSV UPE vent capsule filter integrity test specifications. User Guide | Entegris, Inc. -
Page 5: Water Intrusion Test
Entegris Pharmsteri II GSV UPE vent capsule filters. For WIT, representative for additional technical and trouble- no pre-wetting is required to perform the integrity shooting support. -
Page 6: Wetting Methods
PHARMSTERI II GSV UPE VENT CAPSULE FILTERS WETTING METHODS 7. Gradually open the outlet valve (V3) and ensure the target flux rate of 50 LMH is maintain across Tubing the filter. The differential pressure (P2 – P3) across Gas source Valve the filter should be ≤... - Page 7 PHARMSTERI II GSV UPE VENT CAPSULE FILTERS 6. Open the outlet valve (V3) and flush the filter for 1 Peristaltic pump minute. The differential pressure (P2 – P3) across the filter should be ≤ 2 psid. 7. Partially close the outlet valve (V3) to allow for backpressure during flushing for approximately 1 –...
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Page 8: Integrity Test Guide
70 psig. 3. Input the integrity test parameters into automated integrity tester. For the minimum bubble point test specification, refer to Pharmsteri II GSV UPE vent datasheet or validation guide. 4. A filter can be considered integral if the measured... -
Page 9: Water Intrusion Test
70 psig. 3. Input the integrity test parameters into automated integrity tester. For the max water intrusion pressure, refer to Pharmsteri II GSV UPE vent datasheet or validation guide. 4. A filter can be considered integral if the measured... -
Page 10: Troubleshooting Guide
PHARMSTERI II GSV UPE VENT 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 11: Sterilization
2. To keep disposable filters in good condition do not store them with toxic, corrosive, volatile, or This is designed as a single-use product and Entegris pungent materials. recommends replacing a capsule filter after each 3. -
Page 12: 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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