Aseptic manufacturing processes are inherently lengthy and time consuming due to the many process steps that are required, not only for the manufacturing processes themselves, but also the preparation of facilities, consumables and equipment for use. Manufacturing process 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). The BIs require incubation that determines a binary pass/fail (no growth/growth of the BI ) result which effects the speed at which the process can be deemed as fit for use but also potentially, as a result of a BI failure lead to investigations into product quality of any batches manufactured between qualification.
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. This collaborative presentation will provide an overview of the technology and showcase case studies from various pharmaceutical companies and their collective suggestions on applications and future usage of EIs.