Kontaktdetails

Adresse:

Isomedix Operations, Inc.,
a STERIS Company
2500 Commerce Drive
Libertyville, Illinois 60048
United States of America

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ast_info@steris.com

Site Details

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

Site Details

Gamma:

Carrier Type: Continuous Irradiator Incremental Irradiator
Carrier Dimensions: 635 x 1067 x 1829 (mm) 25 x 42 x 72 (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 product overlap configuration (8 pass for high-volume and/or repetitive applications)
  • Moves product through the gamma irradiation process using a roller conveyor and an automatic conveyor system
  • Uses hydraulic elevators 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 South, IL ISO Certificate FDA Device Registration Number: 1424263