Northborough, Massachusetts, USA

Gamma:

Ethylene Oxide:

Process Components:

Batch Gamma Irradiation Process Components

• Uses Cobalt-60 in a Dwell Type, 9 carrier batch irradiator (for unique or low-volume applications).
• Moves product through the gamma irradiation process using a monorail system.
• Quick turn time within 8 hours door to ship.
• Barriers prevent mixing of processed and unprocessed products.

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 vessel.
• 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/Aeration Cells are individually controlled.
• Facility offers biological indicators and storage services.
• 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 Northborough, MA ISO Certificate FDA Device Registration Number: 1220477 PAL Registration Number: BG30400133 44