Millipore Technical Publications |
 | TN- TB1002EN00 | |
The Effect of Vaporous Hydrogen Peroxide on Steritest Sterility Testing DevicesA Joint Study Conducted By Millipore and a BioPharmaceutical Customer | ||
| Lit No: | TB1002EN00 | |
| Year: | 2001 | |
| Closed, disposable Steritest sterility test devices reduce the risk of false positives during the sterility testing of pharmaceuticals. To further reduce the risk of false positives, some manufacturers use the devices inside an isolator. Typically, the filtration devices are placed in the isolator while the isolator is decontaminated using sterilization gases. In this study, pre-sterilized Steritest devices were exposed to two 90-minute vaporous hydrogen peroxide (VHP) cycles. This design simulates one particular sterilization scenario in which filtration devices are placed inside an isolator prior to a sterility test and are treated with VHP. The devices are not used during the sterility testing and remain in the isolator until the next test day. Prior to the second sterility test, the isolator (and the Steritest devices) is treated with VHP again. The purpose of this study is to answer the following questions:
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