Development of Vaporized Hydrogen Peroxide (VHP) Decontamination Cycle for a Syringe Isolator

Abstract

Abstract - A parenteral syring filling line inside a closed cabin isolator was installed in an existing manufacturing space. To increase sterility assurance the isolator must be effectively biodecontamined by means of Vapor Hydrogen Peroxide (VHP) to provide a minimum of 6 log-reductions and a residual concentration of VHP of less than 1ppm. During the cycle development phase the operating characteristic and parameters for the decontamination were tested and optimized following the proposed methodology in this article. Final adjustment of the injection quantities was based upon results of the worst case biological indicator tests performed during the study. Based on the results, parameters and validation testing were established to provide for complete destruction of all biological indicators. Key Terms - H2O2 decontamination, cycle development, biological indicator (BI), chemical indicator (CI)