Process Validation

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Biological Validation With Spores

The treatment and high level disinfection of a space by Altapure can be validated for regulatory compliance using Altapure’s “Validation Culture Kit”.

This kit includes one (1) hermetically sealed pouch that contains one (1) “Validation Spore Strip”, and one (1) “Validation Culture Tube”.

One or more of Altapure’s “Validation Spore Strips” are placed in various locations within the targeted room(s) or area(s) before they are treated. These strips are inoculated with Geobacillus stearothermophilus spores.

After the room(s) are treated, this test media is aseptically transferred into a proprietary “Validation Culture Tube” that is specifically tailored to show at least a (Log 6) spore reduction after decontamination with Altapure’s PAA (Peroxyacetic Acid) aerosol fog. Successful treatment of the area is indicated by the lack of a color change after a 48 hour incubation time and means that there was 100% kill and no spore growth on the test strips.