White Paper: Glove Integrity Testing — Pressure Decay Method: Performance Qualification

In recent years, Glove Integrity Testing has been profoundly discussed and numerous articles have been written on this topic. However, many doubts still remain within the industry due to the lack of norms and clear guidance available. In 2008 Annex 1 to EU Guidelines to Good Manufacturing Practice reiterated the importance of having glove integrity testing:

"25. Monitoring should be carried out routinely and should include frequent leak testing of the isolator and glove/sleeve system."

Over the course of the past few years different industry specific associations have conducted statistical studies about the frequency in which this type of testing is performed in the pharma industry and the results indicated that the test is executed normally prior to each batch of a production run. However as far as performance requirements the question is still open: