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Validation of a Sporicidal Bio-Decontamination Process

3rd Feb, 2023

This recently published paper by the Quality Assurance Pharmacist Brian McBride from Western Health and Social Care Trust uses our Devea Environment Phileas Genius hydrogen peroxide bio-decontamination system. It highlights the recently published EU GMP Annex 1 section on Manufacture of Sterile Medicinal Products, the requirement for pharmaceutical isolators to undergo a bio-decontamination process of the interior which should be automated, validated and controlled within defined cycle parameters and including a sporicidal agent.

The technology to do this has been around for years and can be validated to give a high level of assurance of surface bio-decontamination comparable with sterilisation when used on surfaces in the isolator critical work zone.

For information on our bio-decontamination range contact: info@abscientific.com

 

Click here to read the full validation

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