Kontaktdetails
Adresse:
Isomedix Operations, Inc.
a STERIS Company
4405 Marketing Place
Groveport, Ohio 43125
United States of America
Site Details
Our Groveport, Ohio, USA site has the following characteristics:
Site Details
Gamma:
| Carrier Type: | Continuous Irradiator |
| Carrier Dimensions: | Continuous Irradiator: 635x 940 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:
Continuous Gamma Irradiation Process Components:
- Uses a Cobalt-60 continuous irradiator with a source overlap configuration (for high-volume and/or repetitive applications).
- Moves product through the gamma irradiation process using a monorail system and an automatic conveyor system.
- Uses hydraulic elevators to facilitate product loading and unloading.
- Employs barriers to prevent contamination and 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 Groveport, OH ISO Certificate FDA Device Registration Number: 1526711 PAL Registration Number: BG30400321
Groveport, Ohio, USA ISO 13485 RvA Certificate