Could hydrogen peroxide decontamination affect the results of a sterility test?
A case study of hydrogen peroxide penetration through the load packaging
A case study of hydrogen peroxide penetration through the load packaging: a customer required support for «A Package Integrity Verification» which involved all the samples and consumables inside the Sterility Test Isolator.
USP 39, General Chapter 1208 Sterility testing – Isolators Systems Package Integrity Verification
«Some materials are affected by decontaminating agents which can result in inhibition of microbial growth. Of concern are the penetration of decontaminating agents into product containers or, in general, any material that could come in contact with product, media or dilution fluids used in the sterility test. Its the responsibility of the operator to verify that containers, media and suppliers are unaffected by the decontamination process.»
- author: Bernuzzi Maria Luisa