Grand Prairie, Texas, USA

Ethylene Oxide:

Process Components:

Ethylene Oxide (EO) Sterilization Process Components:

• Parametric Release: All sterilizers are equipped to meet the strict requirements of ANSI/AAMI/ISO 11135.
• Facility meets all Clean Air Requirements, including Ethylene Oxide Standards for Sterilization Facilities (CFR-40, part 63, Sub-part O).
• STERIS AST operates under a quality system that is in compliance with 21 CFR Part 820 and applicable sections of 21 CFR Part 211. In addition, STERIS AST is registered to the ISO 13485:2003 Quality Standard, and adheres to the requirements of ISO 11137-1:2006 (Gamma) and ISO 11135-1:2007 (EO).

STERIS AST Grand Prairie, TX ISO Certificate FDA Device Registration Number: 1650907 PAL Registration Number: BG30400121