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Un abito:

Isomedix Operations, Inc.
a STERIS Company
1000 South Sarah Place
Ontario, California 91761
United States of America

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Site Details

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

Site Details

Electron Beam:
Operational Energy Level: Dual 10 MeV Accelerators
Beam Types: Vertical Beam Delivery
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