Product/Service

Contract Sterilization Services For Microbial Control

Source: STERIS Corporation

STERIS Isomedix Services provides contract sterilization and microbial control services for single-use bioprocess systems used in the production of biopharmaceuticals and vaccines.

STERIS Isomedix Services provides contract sterilization and microbial control services for single-use bioprocess systems used in the production of biopharmaceuticals and vaccines. Our gamma irradiation services are utilized for a range of disposable bioprocess components including:

  • Flexible containers/bags
  • Tubing, hoses and connectors
  • Filtration
  • Membrane chromatography units
  • Sensors

Our Radiation TechTeam provides technical support for the unique requirements of disposable bioprocess systems including protocol generation, sterilization validation and dose setting.

The Radiation TechTeam group's skilled technical staff is ready to guide you through the gamma sterilization process. From validation support to dose audit reminders, the Radiation TechTeam professionals are committed to being a vital part of your sterilization process. We are completely dedicated to processing Customer samples, handling special projects and processing under specific conditions with superior flexibility.

Radiation TechTeam Services
Our team offers a variety of services to our Customers, including:

  • Gamma irradiation and project guidance for dose setting qualifications, verifications and audits
  • Specialty dose mapping of frozen or extremely dense products performed for single boxes or routine production quantities at a STERIS Isomedix facility
  • Small volume test market processing
  • Irradiation for material compatibility and maximum dose evaluations
  • Refrigerated storage
  • 24-hour turnaround time
  • Product tracking at all stages, from receiving to shipping

STERIS Isomedix Services offers the medical device industry’s most comprehensive array of contract sterilization options.

Gamma Irradiation

  • Sterilization of medical instruments and single-use medical supplies such as syringes, catheters, IV sets, surgical gloves, gauze, labware and more
  • Superior material penetration of complex device sets
  • Sterilization of tissue/biological based products
  • Just-in-time inventory
  • Pressure-sensitive packaging
  • Pre-treatment and microbial reduction of raw materials

Ethylene Oxide Sterilization

  • Sterilization of medical devices manufactured from materials whose physical properties degrade with irradiation or heat
  • Cellulose and plastic products that may exhibit discoloration with irradiation
  • Custom procedure kits
  • Various materials not compatible with other medical device sterilization methods

Isomedix Services Advantages:

  • High quality, cost-effective processing
  • Widespread network of sterilization facilities
  • Multi-disciplinary technical staff and on-site quality assurance personnel
  • Detailed certification of your sterilization process
  • Dedicated radiation and ethylene oxide technology centers

 

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 ISO 11135-1:2007 (EO).