Application Note

Glove Leak Testing In Isolators/RABS - What Regulators Are Saying

Source: Bosch Packaging Technology

By J├╝rgen Metzger and Jamie Schroetter

Bosch

Glove Integrity - A faulty glove or sleeve (gauntlet) assembly represents a route of contamination and a critical breach of isolator integrity. A preventative maintenance program should be established. The choice of durable glove materials, coupled with a well-justified replacement frequency, are key aspects of good manufacturing practice to be addressed. With every use, gloves should be visually evaluated for any macroscopic physical defect. Physical integrity tests should also be performed routinely. A breach in glove integrity can be of serious consequence. The monitoring and maintenance program should identify and eliminate any glove lacking integrity and minimize the possibility of placing a sterile product at risk. Due to the potential for microbial migration through microscopic holes in gloves and the lack of a highly sensitive glove integrity test, we recommend affording attention to the sanitary quality of the inner surface of the installed glove and to integrating the use of a second pair of thin gloves. Routine and frequent leak testing of glove/sleeve system is highly recommended.

The Bosch KHD 3000 is a smart way to handle glove testing and optimizes the time required to perform such testing.

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