Kontaktdetails
Ein Kleid:
Isomedix Operations, Inc.
a STERIS Company
1000 South Sarah Place
Ontario, California 91761
United States of America
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 |
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
Ontario, California, USA, FMR Certificate – Drug