Contact Details
Address:
STERIS Isomedix Puerto Rico, LLC
P.O. Box 415
Vega Alta, Puerto Rico 00692
Site Details
Our Vega Alta, Puerto Rico, USA site has the following characteristics:
Site Details
Gamma:
| Carrier Type: | Continuous Irradiator |
| Carrier Dimensions: | 635 x 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 (four pass for high-volume 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& Vega Alta, PR ISO Certificate FDA Device Registration Number: 2648623 PAL Registration Number: BG32400005
Vega Alta, Puerto Rico ISO 13485 RvA Certificate