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Une robe:

Isomedix Operations, Inc.,
a STERIS Company
43425 Business Park Drive
Temecula, California 92590
United States of America

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Site Details

Our Temecula, California, USA site has the following characteristics:

Site Details

Ethylene Oxide:
Number of Chambers: 6 chambers
Pallet Dimensions: 2, 4, & 6: 1016 x 1219 x 2438 (mm) 40 x 48 x 96 (in) *Maximum product height is 96″ with pallet” (2438 mm)

10 Pallet chambers: 1016 x 1219 x 1879 (mm) 40 x 48 x 74 (in) *Maximum product height is 72″ with pallet

Chamber Sizes: 2 pallets 4 pallets 6 pallets 10 pallets


Process Components:
Ethylene Oxide (EO) Sterilization Process Components:
  • Uses 100% EO, a fully automated conveyor system, and a highly flexible computerized vessel control system.
  • 15,000 cfm PCR recirculation system ensures highly efficient temperature and RH distribution.
  • Full load temperature and RH monitoring is available.
  • Facility meets all Clean Air Requirements, including Ethylene Oxide Standards for Sterilization Facilities (CFR-40, part 63, Sub-part O).
  • STERIS ASToperates 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 Temecula, CA ISO Certificate FDA Device Registration Number: 2030624 PAL Registration Number: BG30400453