VHP M100 Biodecontamination System 21 CFR

As a factory-fitted option, a Whitley GMP Workstation can be supplied with a turn-key packaged solution to allow for effective Vaporised Hydrogen Peroxide (VHP) Biodecontamination with a Steris VHP generator.

Steris VHP generators effectively decontaminate and sterilise all surfaces using a specifically designed ‘dry process’, ensuring optimal distribution and high efficacy to achieve automated, validated and controlled 6 log sterility assurance levels (SAL) every cycle.

The VHP package includes:

• Steris VHP generator – an all-in-one unit design providing customer validated Biodecontamination cycles.
• Custom VHP Manifold – a custom manifold designed specifically for each customers isolator configuration. Providing inputs and outputs, pressure control and automated valve control integration with a Steris VHP generator. This provides VHP capabilities for the transfer chambers and processing areas.
• Integrated software control – a tailored software system designed to directly communicate and integrate with the Steris VHP generator, ensuring operators can easily, safely and effectively perform VHP cycles in a controlled, simple, step-by-step data logged procedure.

To suit the requirements of your facility design, the Steris VHP generator can be provided in open-loop and closed-loop configurations.

When operating in an open-loop configuration, exhaust to a local exhaust ventilation (LEV) system facilitates fast and effective aeration of VHP to significantly reduce cycle times.

When operating in a closed-loop configuration, VHP is naturally decomposed into water and oxygen and vented safely to the cleanroom environment during aeration. This provides greater flexibility and reduces facility setup cost as a stand-alone solution.