Contact Details
Address:
Isomedix Operations, Inc.,
a STERIS Company
2500 Commerce Drive
Libertyville, Illinois 60048
United States of America
Site Details
Our Libertyville South, Illinois, USA site has the following characteristics:
Site Details
Gamma:
| Carrier Type: | Continuous Irradiator Incremental Irradiator |
| Carrier Dimensions: | 635 x 1067 x 1829 (mm) 25 x 42 x 72 (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 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 Libertyville South, IL ISO Certificate FDA Device Registration Number: 1424263
Libertyville South, Illinois, USA ISO 13485 RvA Certificate