The rise in demand for complex drug products that are not suitable for terminal sterilization has led to an increasing need for advanced aseptic fill and finish capabilities. There are many challenges facing biopharmaceutical manufacturers as they implement aseptic fill processes and technologies. One particularly difficult aspect is the development and validation of the decontamination and/or sterilization methodologies, as these processes are subject to high risk of contamination. Proper decontamination and/or sterilization protocols are critical for manufacturing safe biopharmaceuticals and reducing the risks and associated costs that may result from contaminated product.
Vapor-phase hydrogen peroxide (VH2O2) is the primary agent utilized by biopharmaceutical manufacturing to decontaminate isolators and restricted access barrier systems (RABS) as it has significant advantages over other modalities. Organizations such as the United States Pharmacopeia (USP) and the Pharmaceutical Inspection Convention Co-Operation Scheme (PIC/S) publish guidance, but unfortunately there are no widely recognized consensus standards on the methods and acceptance criteria that are affirmed by the regulatory bodies. Complicating matters further, VH2O2 exists as both a gas and a liquid during decontamination activities resulting in challenges in controlling and understanding the process. In addition, biological indicators (BIs), which are the most important lethality measurement tool for these processes, are not controlled by standards regarding their manufacturing and performance. Inconsistent and poor quality BI’s makes qualification, validation, and revalidation very difficult to perform accurately, consistently, and reliably.
This field guide uses current published resources to provide clarity and direction regarding best practices for validating decontamination processes using VH2O2.