Industry news

Quickly understand the latest developments in the industry and Canada

Changsha Pharmaceutical Machinery Exhibition
2019-04-20

From April 17 to April 19, 2019, CIPM Pharmaceutical Machinery Exhibition was grandly opened at Changsha International Convention and Exhibition Center. With the validation of isolation system for sterility test in Pharmacopoeia 9206, 2020.

With the upgrading of the requirements for the integrity verification of the isolation system in the Guideline for the Validation and Application of the Isolation System for Sterile Examination (Revised) of the Pharmacopoeia 9206, the integrity test of gloves has attracted more and more attention.

The guiding principles point out that:

1. The isolation system shall be able to maintain good integrity under normal operation conditions. The integrity test usually includes:; High efficiency air filter leak test, hull integrity, and glove and half-jacket integrity have been installed.

2. For the integrity leakage test of gloves and half-clothes, gloves shall be physically tested with glove leak detector based on visual inspection. For the test method, please refer to the current national standard Appendix E5 of Clean Room and Related Controlled Environment Part 7: Isolation Device; Half-body clothing can be tested by chemical method filled with tracer gas (such as ammonia) or other appropriate methods.

The integrity test system of the wireless group control glove of Kashuo is designed and developed in accordance with the guiding principles, and conforms to the current customer and market needs of computer verification, audit tracking, electronic signature, RF scanning, and the test data cannot be modified, which has become a highlight of this exhibition!

 


 

News
Jiashuo official account

Get our updated information as soon as possible