Articles
Safe Access Using Glove Ports – Facts and Fiction
April 4, 2007
•Case Study: Safe Access Using Glove Ports – Facts and Fiction
By Johannes Rauschnabel, Albrecht Kühnle, and Kuno Lemke
Barrier systems, such as aseptic isolators, RABs and glove boxes, are continually being used more often in pharmaceutical production, research, and laboratories. The purpose of these barrier systems is to separate a process area from a surrounding environment – either to shield the process from contaminants coming from outside, or to shield the environment from hazardous products inside. If manual operator access is needed either during processing for maintenance reasons or for environmental monitoring inside the barrier, glove ports are needed.
The integrity of these glove ports is crucial for maintaining sterility of the barrier system. Therefore, frequent inspection of the glove ports has to take place. FDA guidance for industry on aseptic processing asks that "With every use, gloves should be visually evaluated for any macroscopic physical defect. Physical integrity tests should also be performed routinely", while EC GMP requires that "Monitoring should be carried out routinely and should include frequent leak testing of the isolator and glove/sleeve system." Thus, some kind of leak testing has to take place in addition to visual inspection.
•Case Study: Safe Access Using Glove Ports – Facts and Fiction
