Meeting the challenges of Annex 1 with innovation in rapid H2O2 validation.
Processes that utilize Hydrogen Peroxide (H2O2) for decontamination (e.g. Isolators, pass-through chambers, room decontamination, etc.) have traditionally relied on initial validation and periodic revalidation to check the efficacy of the process with biological indicators (BIs).
Enzyme Indicators (EIs) are an innovative rapid tool for providing instant and quantitative feedback, of H202 efficacy by providing real time quantifiable data when applied to cycle optimization, qualification and trouble-shooting.
With the revision of EU guidelines for GMP manufacture of Sterile Medicinal product, Annex 1 now complete, learn how the EIs ability to aid, clarify and provide additional confidence in the process of bio decontamination leads to an increased confidence in Quality Assurance and compliance to requirements.