Whitby, Ontario, Canada

Our Whitby, Ontario, Canada site has the following characteristics:

Gamma:

Carrier Type:

Continuous Irradiator

Carrier Dimensions:

635 x 940 x 3048 (mm) 25 x 37 x 120 (in)

Notes:

Actual dimensions are provided. Usable dimensions may vary depending on product, packaging and/or dose range.

Process Components:

Continuous Gamma Irradiation Process Components:

• Uses a Cobalt-60 continuous irradiator with a source overlap configuration (four pass 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).

STERIS AST Whitby, ON, CAN ISO Certificate FDA Device Registration Number: 9680143 PAL Registration Number: BG30200029 Health Canada Drug Establishment License 2013