Medical Device Sterilization

STERIS Applied Sterilization Technologies (AST) offers the medical device industry’s most comprehensive array of contract sterilization options using gamma irradiation, electron beam irradiation, X-ray irradiation and ethylene oxide sterilization.

With a wealth of experience providing sterilization for medical devices, STERIS AST has been providing a first class sterilization service for medical device manufacturers for 40 years.

The sterilization of some products can be a complex and delicate process that requires the highest quality standards. Respecting the expense and extensive R&D that our Customers have undertaken in developing these products, STERIS AST continues to place quality as its number one priority.

STERIS AST is also able to sterilize human, animal, and synthetic tissue products.

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

Electron Beam Irradiation

  • Sterilization of medical instruments and single-use medical supplies such as wound dressings, IV administration kits, syringes, dialysis products and catheters
  • Enhanced turnaround times that can improve inventory costs
  • Reduction in denaturing effects such as oxidation.
  • Flexibility to process any dose range and product quantity back to back without lengthy delays for equipment adjustment.

X-ray Irradiation

  • Sterilization of medical instruments and single-use medical supplies such as syringes, catheters, IV sets, surgical gloves, gauze, labware and more
  • Due to reduced processing time, lead times are improved whilst maintaining good penetration capability
  • Adverse effects on products are reduced due to the reduction in processing (exposure) time
  • Flexibility to process different dose ranges and densities within the same process run.

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

STERIS AST 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 medical device sterilization process
  • Dedicated radiation and ethylene oxide technology centers

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 is registered to the ISO 13485 Quality Standards, and adheres to the requirements of ISO 11137 (Radiation) and ISO 11135 (EO).

Why STERIS AST?

As a global leading sterilization and decontamination specialist, STERIS AST has over 40 years experience in providing safe and effective medical device sterilization.

Contact our team of experts to find out more about our Global Contract Sterilization Services