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2023 Aseptic Conference

SES203c - Not Your Legacy H2O2-Innovations in Biodecon Automation

‐ Mar 7, 2023 12:30pm

This presentation discusses how cleanrooms can address the call for improved biosafety in the newly revised EU GMP Annex I by implementing automated, efficacious, and lower-consequence gaseous hydrogen peroxide biodecontamination technology. Legacy high-concentration hydrogen peroxides containing 35-59% solutions have been the norm for gaseous biodecontamination, based on the assumption higher concentrations are more effective antimicrobials. However, higher concentration peroxides are responsible for lengthy periods of off gassing following treatment and leaching from materials which may require residue cleanup or interact with pharmaceutical products. New systems employing lower percentages of peroxide combine vapor and micro-aerosols which revolutionize how we understand and apply gaseous hydrogen peroxide. Proven through the trifecta of verification, Regulatory approval, Real-World implementation, and Scholarly publications, these new systems shorten downtime and are technologically advanced. In support of the latest Annex I revision, innovations in gaseous hydrogen peroxide, such as hybrid hydrogen peroxide, may support risk management with safer, low concentrations, improved material compatibilities, reduced downtimes, and sporicidal efficacy. All of this, coupled with lower residues compared to legacy methods traditionally employed, makes it possible to support Annex I revision goals for faster automated processes without sacrificing safety.


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