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, Illinois Radiation Technology Center, USA site has the following characteristics:

Site Details

Gamma

Carrier Type: Dedicated Test Irradiator

 

Process Components:

The Libertyville Radiation Technology Center is home of the Radiation TechTeam® group. Our technical experts offer a variety of services including experimental studies, protocol generation, materials and packaging testing, aging studies, quarterly dose audits, and specialty dose mapping of frozen or unique products. Alanine or PMMA dosimeters are utilized for the most accurate dose measurements.

Radiation Technology Center Facts

  • The Radiation Technology Center is dedicated to the processing of Customer samples and dose audit support.
  • We have the flexibility to handle special projects and/or processing conditions.
  • Hot cell/mini batch irradiators facilitate gamma penetration in tight and/or limited dose ranges.
  • In addition to the Red 4034 dosimetry system, the Gamma Technology Center uses alanine dosimeters for precise dose measurement in the gamma irradiation process. Alanine dosimetry can be used for special applications such as dose mapping, validations, low or high dose processing, and transit and static studies. These technologically advanced dosimeters provide increased precision and lower uncertainty over an expanded dose range
  • 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).

 

Credentials:

  • IEMA licensed
  • FDA registered for the processing of medical devices, drugs, and consumer products

Our processing options include Same Day (in and out the same day), Priority (1-3 business days), and Routine (4-7 business days) from product receipt to outbound shipping. Various storage and handling capabilities are available, including processing and shipping on dry ice, onsite refrigeration and freezer storage, and certification for shipping of hazardous materials (please contact us for details).

We hold the following Site Certificates: