Contact Details

Address:

Isomedix Operations, Inc.,
a STERIS Company
2072 Southport Road
Spartanburg, South Carolina 29306
United States of America

+1 864 582 3041

ast_info@steris.com

Site Details

Our Spartanburg, South Carolina, USA site has the following characteristics:

Site Details

Gamma:
Carrier Type: Continuous Irradiator
Carrier Dimensions: 635 x 864 x 3048 (mm) 25 x 34 x 120 (in)
Notes Actual dimensions are provided. Usable dimensions may vary depending on product, packaging and/or dose range.

 

Ethylene Oxide:
Number of Chambers: 3 production chambers 3 small-volume test chambers
Pallet Dimensions: 2642 x 1016 x 1219 (mm) 48 x 40 x 104 (in)
Chamber Sizes: 13 pallets Test chamber

 

Process Components:
Continuous Gamma Irradiation Process Components
  • Uses a Cobalt-60 continuous irradiator with a source overlap configuration (for high-volume applications).
  • Moves product through the gamma irradiation process using a monorail system and an automatic conveyor system.
  • Uses hydraulic elevators to facilitate product loading and unloading.
  • Employs barriers to prevent contamination and mixing of processed and unprocessed products.
  • 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).
Ethylene Oxide (EO) Sterilization Process Components:
  • Uses 100% EO, a fully automated conveyor system, and a highly flexible computerized vessel control system.
  • 60,000 cfm PCR recirculation system ensures highly efficient temperature and RH distribution.
  • Full height chambers eliminate the need to re-stack products between trailer and carrier.
  • 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).
  • Preconditioning rooms and Degas Cells are individually controlled.

STERIS AST Spartanburg, SC ISO Certificate FDA Device Registration Number: 1047843 PAL Registration Number: BG30400076 [/vc_column_text][/vc_column][/vc_row]