Ontario, California, USA

SITE DETAILS

Our Ontario, California, USA site has the following characteristics:

Electron Beam:

Operational Energy Level:

Dual 10 MeV Accelerators

Beam Types:

Vertical Beam Delivery

Gamma:

Carrier Type:

Continuous Irradiator Incremental Irradiator

Carrier Dimensions:

635 x 1041 x 1829 (mm) 25 x 41 x 72 (in)

Notes:

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

Process Components:

Electron Beam Process Components

• Dual 10 MeV, 30 kW vertical beams
• Conveyor system allows for single-side, box by box treatment

Continuous Gamma Irradiation Process Components:

• Uses a Cobalt-60 continuous irradiator with a product overlap configuration (8 pass for high-volume and/or repetitive applications)
• Moves product through the gamma irradiation process using a roller conveyor and an automatic conveyor system
• Uses hydraulic elevators to facilitate product loading and unloading
• Employs barriers to prevent 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 Ontario, CA ISO Certificate FDA Device Registration Number: 2032098 PAL Registration Number: BG30400479