Medical DeviceQualified Supplier Directory

STERIS Isomedix Services

5960 Heisley Rd.
Mentor, 
OH  44060  us
Tel: 877/783-7479
Fax: 440/392-7914


STERIS Isomedix Services has been committed to providing the most comprehensive contract sterilization services to the medical device community for 35 years. Blending industry-advanced technology with a team approach to Customer service, STERIS Isomedix Services offers the industry's most competitive advantage encompassing gamma irradiation and ethylene oxide (EO) sterilization.

Leading Sterilization Technology
Through our network of 18 North American sterilization facilities, we deliver leading technology in Gamma and ethylene oxide sterilization to meet our Customer's needs. State-of-the-art sterilization capabilities are just part of a complete managed program that emphasizes exceptional process quality, efficient turnaround and optimum cost containment.

 

Expedited Gamma and Ethylene Oxide Processing
STERIS Isomedix Services provides contract sterilization with consistent results and fast turnaround, even when your product has unique or custom processing requirements. Our expedited gamma and ethylene oxide processing services provide a cost-effective solution to reducing inventory costs, eliminating backorders, and getting products to your Customers faster.

 

Our GammaExpress® expedited gamma irradiation service uses dosimetric release, enabling products to be shipped immediately after processing. Our two expedited options ensure your product will go from receipt to outbound shipping within either 24 or 48 hours.

By performing preconditioning, sterilization, and aeration within a single vessel, the exclusive EOExpress® expedited ethylene oxide sterilization process allows the sterilization of product and release to market in one day. Combining all-in-one processing and parametric release, EOExpress dramatically reduces total processing time and removes days from the conventional sterilization process.

 

Technical Consultation
Our TechTeam® professionals provide vital technical support in all phases of the sterilization design process including product development, materials testing, protocol generation, and sterility validation. Going beyond contract sterilization, our TechTeam presents insightful alternatives, choices, specialty solutions, and total project management to address complex sterilization issues.

Laboratory Services
STERIS Isomedix Services is pleased to announce the recent acquisition of Biotest Laboratories, Inc. Together, the STERIS Isomedix Services TechTeam® experts and Biotest Laboratories assist our Customers with both ethylene oxide and gamma irradiation services as well as offering the following:

  • Laboratory testing
  • Validation services
  • Contract manufacturing and packaging
  • Steam sterilization
  • Reusable device qualification
  • Tissue testing
  • Cleanroom certification

We are pleased to provide our Customers with a single source for every stage of the sterilization design process, from product development through routine processing.

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 

Supply Chain Visibility
Our dedication to providing cost-effective, quality service extends beyond the scientific reaches of our work. STERIS Isomedix Services is committed to minimizing transportation costs and streamlining response time. With a keen understanding of Supply Chain Management, we work with our Customers to improve turnaround time, reduce inventory and enhance time to market.

Our supply chain focus also includes SteriLink®, the interactive online service providing complete, real-time visibility into STERIS Isomedix processing facilities. SteriLink is designed to shorten time between manufacturing and distribution by allowing Customer to monitor inventory 24/7; send and receive alerts; review and retrieve historical processing documents; check performance metrics and generate reports; and make critical supply chain decisions faster.

 

Customer Satisfaction
STERIS Isomedix Services offers an unmatched combination of technologies, services, and employees with the dedication and passion to help our Customers succeed. Our continual investment in facilities, technology, and our people ensures our Customers have the best possible resources for continued success.

STERIS Isomedix Services 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 Isomedix Services is registered to the ISO 13485:2003 Quality Standard, and adheres to the requirements of ISO 11137-1:2006 (Gamma) and 11135-1:2007 (EO).

STERIS Isomedix Services is a subsidiary of STERIS Corporation (NYSE: STE).