Isomedix Operations, Inc.
a STERIS Company
3459 South Clinton Avenue
South Plainfield, New Jersey 07080
United States of America

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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