Spartanburg, South Carolina, USA

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

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