- Parametric Release: All sterilizers are equipped to meet the strict requirements of ANSI/AAMI/ISO 11135 and EN 550
- All gamma and EO facilities are in compliance with FDA 21 CFR part 820 requirements, ISO 13485 registered, and AAMI/ANSI/ISO 11135-1:2007, AAMI/ANSI/ISO 11137-1:2006, and EN 550 compliant for product acceptance in U.S. and international markets.
EOExpress® Expedited Processing Service
By combining the advantages of all-in-one processing and parametric release, the EOExpress expedited processing service allows the sterilization of product and its release to market in one day.
All-in-one processing combines the three steps of conventional EO sterilization – preconditioning, exposure, and aeration – into one continuous process performed within the ethylene oxide vessel. Parametric release provides real-time monitoring of ethylene oxide and humidity concentration during processing, and eliminates the time required for biological indicator analysis.
STERIS Isomedix San Diego, CA ISO Certificate
PAL Registration Number: BG30400181