Kontaktdetails
Adresse:
Isomedix Operations, Inc.,
a STERIS Company
9 Apollo Drive
Whippany, New Jersey 07981
Site Details
Our Whippany, New Jersey, USA site has the following characteristics:
Site Details
Gamma:
| Carrier Type: | BatchIrradiator |
| Carrier Dimensions: | 635 x 940 x 2134 (mm) 25 x 37 x 84 (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 Cobalt-60 in a Dwell Type, 9 carrier batch irradiator (for unique or low-volume applications).
- Moves product through the gamma irradiation process using a monorail system.
- 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 Whippany, NJ ISO Certificate FDA Device Registration Number: 2245304 PAL Registration Number: BG30400473
Whippany, New Jersey, USA FMR Certificate