Apparatus capable of carrying out on-line detection on glove integrity in isolator system

Abstract

The invention relates to the sealing detection apparatus and discloses an apparatus capable of carrying out on-line detection on glove integrity in an isolator system. The apparatus comprises a hollow sealing cover and a hollow square sealing ring. The sealing cover is formed through superposing a first sealing cover plate and a second sealing cover plate. The first sealing cover plate and the second sealing cover plate are fixedly connected. The sealing ring is sleeved on a periphery of a sidewall of the sealing cover. The first sealing cover plate is provided with a hollow L-shape handle. A short arm of the L-shape handle is fixedly connected with the first sealing cover plate. An oversleeve gas filling tube, a sleeve pressure detection tube and a cover plate gas filling tube are also comprised. The oversleeve gas filling tube and the sleeve pressure detection tube successively pass through the L-shape handle and the first sealing cover plate and then are connected with an oversleeve gas filling port and a sleeve pressure detection port respectively. The oversleeve gas filling port and the sleeve pressure detection port are through holes arranged on the second sealing cover plate. The cover plate gas filling tube passes through the L-shape handle and the first sealing cover plate and then is connected with the square sealing ring. The apparatus of the invention has the advantages that usage is convenient; the on-line detection can be performed.

Description

technical field [0001] The invention relates to a leak detection device, in particular to a device for online detection of glove integrity in an isolator system. Background technique [0002] Ministry of Health Order No. 79 "Good Manufacturing Practice for Drugs (Revised in 2010)" Appendix 1 Sterile Drugs Chapter 4 Isolation Operation Technique Article 16 The isolation operator and isolation sleeve or glove system should be routinely monitored, including frequent Necessary leak test. The pharmaceutical industry standard of the People's Republic of China YY / T 0567.6-2011 / ISO 13408-6:2005 "Aseptic processing of medical and health care products Part 6: Isolator system" clearly requires that isolation gloves / sleeves should be used according to The frequency is checked regularly to ensure its integrity. In addition, it is clarified in 9.2.2 that the integrity of gloves, etc. should be demonstrated periodically. Integrity can be tested by microbiological and / or physical methods...

AI Technical Summary

Problems solved by technology

[0004] The present invention aims at the shortcomings in the prior art that the glove needs to be separately installed on the detection equipment and cannot be detected online, and provides a new type of device for the online detection of glove integrity in the isolator system which can perform online detection of the glove

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