VH₂O₂ Field Guide

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 these 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 a contaminated product.    

In our modern-day field guide, we outline an established isolator decontamination validation process with Vapor Hydrogen Peroxide (VH₂O₂) biological indicators containing a monolayer of spores. Download our free guide by filling out the form.