Contact Details

Address:

Isomedix Operations, Inc.,
a STERIS Company
9 Apollo Drive
Whippany, New Jersey 07981

+1 973 887 2754

ast_info@steris.com

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