Détails du contact
Une robe:
Isomedix Operations, Inc.
a STERIS Company
23 Elizabeth Drive
Chester, New York 10918
United States of America
Site Details
Our Chester II, New York, USA site has the following characteristics:
Site Details
Gamma:
| Carrier Type: | Continuous Irradiators Special Tote Batch Irradiator |
| Carrier Dimensions: | Continuous Irradiators 25 x 42 x 72 (in)635 x 1067 x 1829 (mm)Batch Irradiator:37 x 25 x 84 (in) 940 x 635 x 2133 (mm) |
| Notes | Actual dimensions are provided. Usable dimensions may vary depending on product, packaging and/or dose range. |
Process Components:
- Continuous irradiators with a product overlap configuration are utilized for high-volume and/or repetitive applications
- Batch irradiator is utilized for unique or low-volume applications
- Moves product through the gamma irradiation process using a roller conveyor system 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)
Chester, New York, USA ISO 13485 RvA Certificate