Line Sterilization Considerations and VHP

Biological drug products are usually filled into the primary packaging container under aseptic conditions. Modern fill–finish plants often employ containment installations like isolators to ensure the highest level of sterility assurance for the product. The industry standard for containment decontamination is the treatment with vapor phase hydrogen peroxide. Although being very efficient in sterilizing the containment, its oxidizing potential makes it a threat to the drug product filled after the decontamination cycle. The following chapter elaborates on the determination of scientifically meaningful product protection measures. It connects the concept of molecule-specific sensitivity assessment to the determination of VPHP residuals in the containment and to the uptake of VPHP from the atmosphere surrounding the drug product during the fill–finish process.