Kontaktdetails
Adresse:
Isomedix Operations, Inc.,
a STERIS Company
2500 Commerce Drive
Libertyville, Illinois 60048
United States of America
Site Details
Our Libertyville II, 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)
| X-ray Irradiator | 7 MeV Electron Beam |
| Pallet Dimensions: | 50 (in) x 50 (in) x 104 (in)
*With 12 (in) transports pallet, max product stackable height is 104 (in). With wood pallet, max product stackable height is 92 (in) 1270 (mm) x 1270 (mm) x 2641 (mm) |
| Pallet Weight Capacity | 2,500lbs (1,000kgs) |
STERIS AST Libertyville II, IL ISO Certificate FDA Device Registration Number: 1424263
Libertyville II, Illinois, USA ISO 13485 RvA Certificate