Millipore Technical Publications |
 | TN- TB1012EN00 | |
The Effect of Peracetic Acid on Steritest Sterility Testing Devices | ||
| Lit No: | TB1012EN00 | |
| Year: | 2001 | |
| Introduction 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. The purpose of this study was to compare the fertility of standard Steritest devices with HA membrane (TLHALV210) after exposure to a peracetic acid atmosphere in an isolator to nonexposed TLHALV210 Steritest units. The study was conducted in two phases: In Phase 1, we compared the fertility of non-exposed Steritest TLHALV210 units to Steritest TLHALV210 units exposed to a peracetic acid atmosphere for 6 hours followed by 12 hours flushing. In Phase 2, we again compared exposed and non-exposed units but pre-rinsed each canister with 50 mL of sterile peptone solution to determine the effect of membrane pre-rinsing on the elimination of peracetic acid residues. Click the PDF above for the full document. | |
| |
| |