Hydrogen Peroxide Biodecontamination – Cycle Development
The subject of biodecontamination using both vapour phase and aerosol form hydrogen peroxide has been the subject of much discussion, and is regarded by some as complex.
We have experience with a number of different VPHP and aerosol generators dating back over 30 years, and we have a very clear understanding of the VPHP process, which we prefer to refer to as the micro-condensed hydrogen peroxide process (MCHP). Pharminox Technical Director Tim Coles has published a number of recent papers on the technology.
The MHRA does not regard the MCHP process as a true sterilising process and this is a view we share at Pharminox. However, given a clear view of the mechanisms of the process, it is none-the-less a very useful biodecontaminating agent, particularly in the context of aseptic isolators.
We can advise on most aspects of hydrogen peroxide biodecontamination, from conceptual design through to gassing cycle development and PQ. We currently have some limited experience with the validation of biodecontamination using enzyme indicators.
On the practical side, we can draft the gassing cycle development (GCD) protocol, and then we can carry out the GCD work using our own incubator if required. We normally expect to work with the client microbiology department during GCD and PQ.