Contact Details
Address:
Isomedix Operations, Inc.,
a STERIS Company
43425 Business Park Drive
Temecula, California 92590
United States of America
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
Temecula, California, USA ISO 13485 RvA Certificate