The rise in demand for complex drug products that are not suitable for terminal sterilization has led to an increased need for advanced aseptic fill and finish capabilities.
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 (VH2 O2) 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.
This field guide produced by Mesa Labs, uses current published resources to provide clarity and direction regarding best practices for validating decontamination processes using VH2 O2.
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