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Sterility Testing Cycle Hydrogen Peroxide Change

Date of event 12th August 2014

At Wickham Laboratories we operate several flexible film isolators in our sterility testing suite.

These are routinely decontaminated using hydrogen peroxide vapour to ensure we can work aseptically. By performing routine decontamination we minimise the likelihood of false positive results and the associated time and financial implications these bring to our customers. Our hydrogen peroxide supplier has recently changed the concentration of their peroxide from 30% to 35%. Following risk assessment it was felt necessary to perform a validation study to ensure there were no detrimental effects on the fertility of media and packaging integrity of Steritestâ„¢ canisters which have been exposed to the hydrogen peroxide for short periods of time. We are pleased to announce that the validation study has been completed and we have noted no detrimental effects of moving from 30% to 35% hydrogen peroxide. Please contact us if you require any supporting documentation.

Sterility - Wickham Laboratories

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