The Quest For Sterility Assurance: A New Approach To Isolator Decontamination

How can you address the decontamination challenges associated with isolated fill-finish operations? Meeting the sterility and regulatory thresholds in pharmaceutical manufacturing is a critical process. Conventional decontamination methods, predominantly utilizing high concentrations of hydrogen peroxide, present challenges regarding efficacy, residue, and operational downtime. A new innovation being explored, involves the implementation of low-concentration Vapor Phase Hydrogen Peroxide (VPHP) with patented Pulse™ technology, ensuring superior sporicidal reduction and operational safety. Here we explore this forward-looking approach to sterile parenteral drug manufacturing and solutions being used to reduce decontamination cycle time while maintaining sterility assurance and meeting industry demands effectively.