Sterility testing

Contamination of samples during mandatory sterility testing of parenteral and other sterile preparations / devices is a potentially costly problem. With tight controls in a well-managed GMP production area, it is perhaps unlikely that the product and samples are contaminated at source. Logically, it is more likely that sample contamination will occur during handling and transport, or in the testing environment. Such "false positive" results create real and extensive costs of extra investigation and retesting. Moreover, products may not be released for sale until such rework is complete with reliable (i.e. negative) results.

Getinge’s sterility testing isolators and patented DPTE® sterile transfer systems provide a safe and sterile self-contained environment for the most critical steps of the testing process.