120W Filter Integrity Tester 100-8000 Mbar 115psi Filter Integrity Test Apparatus

Introduction

SHUOBODA Filter Integrity Testers are special instruments of integrity testing for sterile filtration membrane and filter system, where the testing method and instrument design fully meet the requirements for relevant laws and regulations in GMP, EP, FDA and USP.

◎ Regulatory requirements

1. Chinese GMP and EU EP have made specific provision for the integrity testing of sterile filter on the test method, where the commonly used methods include bubble point test, diffusion flow test or pressure holding test. GMP regulates that the test is required after the use of sterile filtration. EP regulates that the test is required before and after the use, and at the same time EP regulates that the critical gas and air filter must be confirmed after use, while other filters must be tested on a regular basis.

2. According to Drug Manufacturing Quality Management Standard (revised in 2010) Article 310, two appendices of Computerized System and Confirmation and Validation are now issued, as the supportive documents for Drug Manufacturing Quality Management Standard (revised in 2010), effective as of December 1, 2015.

3. The requirements for electronic records and electronic signatures as specified in 21 CFR Part 11.

◎ Solutions

Connection diagram of online test

◎ Applied range

1. Disc Membrane:Φ25mm-Φ300mm;            2. Standard Cartridge:2.5″- 40″

3. Capsule & Mini Cartridge                     4. Air filter test :2.5″- 40″

5. Ultrafiltration membrane

Model Selection Guide

FT-4.0 Filter Integrity Tester

FT Serials Integrity Tester are designed for testing integrity of filters and filter systems. The test meets to verify the sterilizing filter in the FDA, the State Pharmacopoeia and GMP specification requirements. FT series Integrity Tester is compact, handy to use, and fully automated integrity test instrument, which performs bubble point, diffusion flow, enhanced bubble point, and water-based test for hydrophobic filters. The first domestic launch of integrity test for water-based test for hydrophobic filters to meet different customer needs.

Main features

 The scientific electronic signature and classification to distinguish the responsibility easily, and to prevent false operation.

 Display of test data and curves in real time, monitoring the whole process of testing.

 Provides automatic printing set function, the user can operate simpler and more convenient.

 Water Based test (WH) for Hydrophobic Filter: using purified water as test liquid instead of IPA and Ethanol, thus it can avoid trace quantity of ethanol or IPA contamination when testing filters.

 The instrument can store 500 history record and curve.

 Advanced "water intrusion method” has solved the disadvantage that the hydrophobic filter can only be tested immersed in organic solvent.

 Advanced automatic control system, no need of manual adjusting pressure, to ensure the accuracy and precision.

 Real-time displaying test data and curve, monitoring the whole testing process.

 Dual-core operation, with PC software.

 Covers all of the functions of foreign similar instruments.

 More perfect user extension management, users can change the password according to need.

 Add the automatic protection function for tested filters, to avoid doing harm to the filter because of overvoltage testing.

 Provide automatic printing setting, and make the operation easier and more convenient.

 5.7 " backlight digital LCD, display clearly.

 Testing the Diffusion flux of the disc membrane is of important significance for judging the characteristics of the membrane.

Specifications