Contact Details

Address:

Isomedix Operations, Inc.
a STERIS Company
1880 Industrial Drive
Libertyville, Illinois 60048
United States of America


ast_info@steris.com

Site Details

Our Libertyville North, Illinois, USA site has the following characteristics:

Site Details

Gamma:
Carrier Type: Batch Irradiator
Carrier Dimensions: Batch 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 Cobalt-60 in a Dwell Type, 11 carrier batch irradiator (for unique or low-volume applications)
  • Moves product through the gamma irradiation process using a monorail system
  • Uses hydraulic 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)

STERIS AST Libertyville North, IL ISO Certificate FDA Device Registration Number: 1450662 PAL Registration Number: BG30400152