Northborough, Massachusetts

Batch Gamma 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

GammaExpress^® Expedited Processing Service
Our GammaExpress processing option uses dosimetric release, enabling products to be shipped immediately after processing. Our two expedited options ensure your product will go from receipt to outbound shipping in either 24 or 48 hours, or less.

Ethylene Oxide

• 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 and the proposed EO 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
• All gamma and EO facilities are in compliance with FDA 21 CFR part 820 requirements, ISO 13485 registered, and AAMI/ANSI/ISO 11135-1:2007, AAMI/ANSI/ISO 11137-1:2006, and EN 550 compliant for product acceptance in U.S. and international markets.

STERIS Isomedix Northborough, MA ISO Certificate
PAL Registration Number: BG30400133