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-1.2 Filter Integrity Tester

Features

Online testing, does not interfere the downstream aseptic conditions

It has system self-check function, with an error report function for the system tightness and wrong operation;

It is microcomputer control of automatic detection, with many kinds of test functions such as bubble point scanning, fast bubble point test and pressure holding method;

Real-time print of test results;

It can be used to test the single core filter and multi-core filter.

Performance Parameter