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