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    VHP Sterilisation – Environmental Monitoring & Process Validation (SAS)

    Hydrogen Peroxide Vapour Sterilisation

    Environmental MonitoringProcess Validation

    Ambient pressure hydrogen peroxide vapour is used as a surface sanitising agent in many different situations from closed hospital wards to glass houses. In the pharmaceutical, medical device and healthcare industries, it is used to protect critical processes by surface sterilising components and consumable packaging in isolators and Restricted Access Barrier Systems (RABS). These RABS are used to enclose, for example, automated filling lines, whilst isolators are used for small batch aseptic processing and sterility testing. Processes and systems are designed to minimise the number of interventions into the protected sterile space.  However, some materials must move in and out and Hydrogen Peroxide gassed ports can be used to surface sterilise these. It is still an essential requirement for Good Manufacturing Practice (GMP) that the disinfection process is validated and that the enclosed environment is monitored for microbiological contamination.

    Environmental Monitoring

    Cherwell Laboratories has been supplying active air samplers and Redipor® culture media, gamma irradiated settle plates and contact plates, for environmental monitoring for over 20 years. Both have been successfully adapted to use with hydrogen peroxide vapour systems. The SAS air sampler range includes the SAS Super Isolator, a model that can remain permanently in the isolator and sanitised in place with hydrogen peroxide. Redipor Barrier Pack agar plates are presented in packs where the inner layer is impermeable to the vapour to protect the agar medium during gassing, yet easy to tear open for use. The packaging is transparent so the quality and identity of the medium can be read before it is opened.

    Process Validation

    Validation of the VHP sterilisation process requires the demonstration of a 6 log spore reduction. This is the same requirement as for an autoclave validation but presents a very different challenge. Hydrogen peroxide vapour, at ambient pressure, does not penetrate well and is active only on surfaces. Therefore, the biological indicators must present a sufficient population, greater than 1 x 106, as a monolayer on a clean, smooth, stainless steel surface. The envelope in which they are presented must protect the biological indicator and be penetrated by the hydrogen peroxide. The culture medium for the incubation of the BIs must also be presented so that the aseptic transfer can, in most cases, be managed in the isolator.

     

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