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We thank CleanRroom Technology for the permission granted to use this article printed on the January/February 2010 issue.
Cleanroom Technology is the European Journal of Contamination Control.
Comercer, of Italy, is marketing an automatic glove tester designed to meet the latest GMP Annex 1 needs.
Annex 1 of the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use came into operation in March 2009 and details requirements for the manufacture of sterile products in order to minimise the risks of microbiological, particulate and pyrogen contamination. Within these guidelines, the document dedicated to isolator technology states:
«Monitoring should be carried out routinely and should include frequent leak testing of the isolator and glove/sleeve system».
The AGT automatic glove tester has all the features that make testing a simple and complete operation. It can be used to test glove integrity in conformity with the pressure decay method ISO 14644-7 Annex E.5 (test in positive pressure).
It can also perform the leak test of an isolator chamber/glove box through a flange (or cover) equipped with a differential pressure transmitter and a temperature sensor, supplied with the equipment. Standard features also include an integrated thermal printer and touch-panel. The system can be equipped with one to three glove test modules. Each module can test four gloves, enabling a maximum 12 of gloves to be tested simultaneously.