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Une robe:
Isomedix Operations, Inc.
a STERIS Company
380 90th Avenue NW
Minneapolis, Minnesota 55433
United States of America
Site Details
Our Minneapolis, Minnesota, USA site has the following characteristics:
Site Details
Ethylene Oxide:
| Number of Chambers: | 12 chambers of various sizes |
| Pallet Dimensions: | 48 x 40 x 76 (in) 1219 x 1016 x 1930 (mm) or 48 x 40 x 72 (in) 1219 x 1016 x 1828 (mm) |
| Chamber Sizes: | 11 pallets 9 pallets 7 pallets 4 pallets 3 pallets 2 pallets |
Process Components:
Ethylene Oxide (EO) Sterilization Process Components:
- Uses 100% EO and a highly flexible computerized vessel control system.
- 24,000 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 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 Minneapolis, MN ISO Certificate FDA Device Registration Number: 2183744 PAL Registration Number: BG30400163 EO Engineering Run Request Form
Minneapolis, Minnesota, USA ISO 13485 RvA Certificate