Decontamination Cycle with Vaporised Hydrogen Peroxide

This case study focuses on the decontamination cycle utilizing Vaporised Hydrogen Peroxide (VPHP) in isolated filling lines, specifically addressing aspects of development, validation, and criticality. It outlines the necessity of conducting studies to evaluate the compatibility of VPHP with various materials used in isolated filling line machines. The document describes the process of defining the 'LOAD', which includes assessing the quantity and type of materials that will be present during the decontamination process. It emphasizes the importance of validating the decontamination cycle through a structured approach that includes Cycle Development and Performance Qualification phases. The Cycle Development phase involves identifying critical points and monitoring biological and chemical indicators, while the Performance Qualification phase confirms the reproducibility of the decontamination parameters. The study also details the mapping of surfaces within the isolator and the assessment of the distribution of VPHP to ensure effective decontamination. The results of the validation process are documented, demonstrating the effectiveness of the VPHP cycle.