Kontaktdetails
Adresse:
1880 Industrial Drive
Libertyville
IL 60048
United States of America
Site Details
Our Libertyville I, Illinois, USA site has the following characteristics:
Site Details
Gamma:
| Carrier Type: | JS 8900 batch Irradiator (11 Carriers) |
| Carrier Dimensions: | 635 x 939 x 3048 (mm) 25 x 37 x 120 (in) |
| Notes: | Actual dimensions are provided. Usable dimensions may vary depending on product, packaging and/or dose range. |
Process Components:
Batch Gamma Irradiation Process Components:
- Uses a Cobalt-60 continuous irradiator with a source overlap configuration – single pass process
- Moves product through the gamma irradiation process using an overhead monorail system and pneumatic cylinders to advance the carriers
- Uses electric scissor lifts 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)
Libertyville I, Illinois, USA ISO 13485 RvA Certificate