Director, Sterilization Technologies at STERIS Life Sciences
Juha Mattila is Director, Sterilization Technologies, responsible for the STERIS Life Sciences Finland portfolio, including GMP steam and VHP sterilization and biodecontamination technologies, and WFI and Pure Steam generation systems. He has B. Sc. in HVAC and Process Engineering, and Master of Engineering in Business Informatics. He has over 22 years of experience with pharmaceutical and research technologies, including R&D, engineering, and product management. He is an active member of PDA, ISPE and Finnish Biosafety Network and subject matter expert in relative international standard work groups, representing Finland.
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Fri. February 24 | 09:30am – Vaporized hydrogen peroxide (VHP) sterilization and biodecontamination technologies – implications from new regulatory and standards developments (EU Annex 1:2022 and ISO 22441:2022).
Low temperature terminal sterilization and biodecontamination technologies serve a wide range of applications within the Pharma/Biotech and Medical Device Industry, including many Cell and Gene Therapies applications.
Recently published VH2O2 / VHP specific standard for process characterization, validation and routine monitoring (ISO 22441:2022) and the revised EU Annex 1:2022 shape the future of VHP in these industry segments. The ISO 22441 standard brings new clarity through standardized requirements for VHP sterilization applications and the new revision of EU Annex 1 provides an update to cleanroom manufacturing requirements. Highlights of these related to VHP sterilization and biodecontamination are presented as well as for basis of this topic, examples of VHP applications and technology are provided from room and isolator decontamination through material transfer VHP decontamination to VHP terminal sterilization.