Vaporized hydrogen peroxide (vH2O2) is widely used as a surface decontamination tool in the pharmaceutical industry. Vaporized hydrogen peroxide is safe to use, has good material compatibility and low toxicity, and is active at ambient temperatures; it is scientifically proven to have broad, non-specific, and rapid microbial activity. Within the pharmaceutical industry, it is extensively used to support aseptic manufacturing and sterility testing environments as well as a tool for decontamination of cleanrooms. Standard procedures include the preparation of the location to be decontaminated prior to a decontamination cycle being performed. As with any GMP procedure, the process must be understood, verified, and validated.
Demonstration of efficacious decontamination is a critical aspect of aseptic processing and sterility testing. This process currently takes a large data set and the use of biological indicators (BIs). Enzyme indicators provide a mechanism to further understand the process and therefore enhance cycle robustness and sterility assurance. By adopting enzyme indicators in the cycle development phases, greater understanding of efficacy of the gassing process can be achieved by providing quantitative results in a faster time frame. This can lead to efficiency benefits through cycle design being performed with data-driven decisions and by demonstrating a substantial margin quantitatively (rather than a simple pass/fail criteria).
The application of vH2O2 is widely adopted and recognized in the both the European and United States pharmacopoeias for sterilizing primary packaging, equipment, and some pharmaceuticals. Different gases may be used, including ethylene oxide, and the typical process involves exposure to the agent within a leak-proof chamber. In the case of production RABs (restrictive access barrier systems) and isolators, equipment to be sterilized is cleaned prior to the application of the gas cycle. It is essential to monitor any cycle for temperature, humidity, and gas concentration in routine use (as well as throughout cycle optimization and validation).
Cycle efficacy, in line with sterilization techniques, is an assessment of the lethality of the cycle; traditionally, biological indicators are used to demonstrate this. There is an expectation that they are placed at locations where decontamination conditions are most difficult to achieve.
Understanding decontamination and sterilization cycles is a responsibility that industry should take seriously. With the development of overkill cycles, establishing worst-case conditions can be challenging, with biological indicators providing a binary answer on cycle efficacy. Enzyme indicators can provide a quantifiable result, which enables safety margins to be built into cycle design based on data.