435 Whitney Street
Northborough , Massachusetts 01532
Plant Manager: Giovanni Aquino
QS/RC Manager: Angela Forget
STERIS Isomedix Northborough, MA ISO Certificate
FDA Device Registration Number: 1220477
PAL Registration Number: BG30400133
Ethylene Oxide Sterilization
|Gamma Machine Types||Batch irradiator|
|Carrier Dimensions||45 cubic feet
25" x 37" x 84"
Actual dimensions are provided. Usable dimensions may vary depending on product, packaging and/or dose range.
|Number of Chambers||4 chambers|
|Pallet Dimensions||48"W x 40"L x 104" max height|
|Chamber Sizes||13 pallets|
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 and an automatic conveyor 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.
- 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 Isomedix Services 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 Isomedix Services 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).
View our Gamma Irradiation Guidelines for an outline of documentation required for gamma processing.
View our Ethylene Oxide Guidelines for an outline of documentation required for EO processing.
Download the Special Radiation Request form for one-time gamma processing projects.