Matt Hofacre, Bruno Aze, Juha Mattila, Mary Van Gaasbeck-Carico
Misconceptions and misleading claims about VH2O2/VHP sterilization and bio-decontamination are increasingly common in today's market. For pharmaceutical and medical device manufacturers, understanding the key differences between the two VH2O2 application methods is essential for successful implementation and regulatory compliance.VH2O2 technologies have been in continuously increasing role for ensuring proper risk assessment and contamination control in pharmaceutical manufacturing processes, especially highlighted by the 2022 revision of EU Annex 1. VHP is specifically important for sensitive drug products manufacturing such as aseptic processing, cleanroom bioburden control and low-temperature terminal surface sterilization of prefilled syringe and other combination products.This presentation will discuss the following topics: Process and technology, applications, pros and cons, implementation, testing and validation of VH2O2 processesRecent regulatory developments for VH2O2 technologiesCommon denominators and differences between VH2O2 sterilization and bio-decontaminationDebunking misconceptions and misleading claimsFuture of VH2O2 technologies in the pharmaceutical and medical device industry.