Kontaktdetails
Adresse:
Isomedix Operations, Inc.
a STERIS Company
3459 South Clinton Avenue
South Plainfield, New Jersey 07080
United States of America
Site Details
Our South Plainfield, New Jersey, USA site has the following characteristics:
Site Details
Ethylene Oxide:
| Number of Chambers: | 7 chambers of various sizes |
| Pallet Dimensions: | 48 x 40 x 72 (in) 1219 x 1016 x 1829 (mm) |
| Chamber Sizes: | 24 pallets 12 pallets 8 pallets 6 pallets 1 pallet |
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 South Plainfield, NJ ISO Certificate FDA Device Registration Number: 2246552 PAL Registration Number: BG30400253
South Plainfield, New Jersey USA ISO 13485 RvA Certificate