Application Note: Vapor Phase Hydrogen Peroxide

By STERIS Corporation

Sterile products which are not terminally sterlized, and therefore are aseptically produced, need to be tested to assure their sterility prior to release for shipment. This sterlity testing occurs in a controled environment where the product is removed from its container and tested through various methods for microbial contamination. If the aseptic process has not been compromised, the product should yield no growth for microbes, and the product may be released for shipment. If, however, the test shows a positive growth, then release of the product may be delayed while additional testing takes place or, worse, the entire lot may be scrapped. For this reason it is important that the environment where the testing is being done does not contaminate the testing process.

Benefits

• Reduction Of Potential False Positives
  Typically, 0.25% of lots tested result in false positives. That's 1 out of every 400 lots tested. Isolators can almost eliminate the false positives.
• Improved Biodecontamination
  Using the VHP 1000 to decontaminate an isolator can result in reductions of 10^-6 in microbial content.
• Improved Throughput
  By reducing false positive occurrences, product is available for shipment immediately after successful testing.