What is Medical Device Sterilization?
Medical device sterilization is the process of eliminating microbial life from medical devices to ensure they are safe for use.
Why Sterilize Medical Devices?
Sterilizing medical devices is essential to prevent infections and ensure patient safety by eliminating harmful microorganisms.
How are Medical Devices Sterilized?
Medical devices can be sterilized using either radiation or gas technologies, depending on the device’s material and design. 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, ethylene oxide, vaporized hydrogen peroxide (VHP), and moist heat (steam) technologies.
To learn more about medical device sterilization, visit our contract sterilization video library here.
Gamma Irradiation Sterilization for Medical Devices
- 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
To learn more about gamma irradiation sterilization, click here.
Electron Beam Irradiation Sterilization for Medical Devices
- 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
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Flexibility to process any dose range and product quantity back to back without lengthy delays for equipment adjustment
To learn more about electron beam irradiation sterilization, click here.
X-ray Irradiation Sterilization for Medical Devices
- 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
To learn more about X-ray irradiation sterilization, click here.
Ethylene Oxide Sterilization of Medical Devices
- 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
To learn more about ethylene oxide sterilization, click here.
Vaporized Hydrogen Peroxide Sterilization of Medical Devices
- Sterilization of medical products such as implants and devices with electronics, pharmaceutical containers, parental drug delivery devices (such as pre-filled syringes) and temperature sensitive devices
- Low-temperature vapor process that has traditionally been used for sterilization of reusable medical devices
- Compatible with a wide range of polymeric materials, making it an effective sterilization method for single-use healthcare and pharmaceutical products
To learn more about VHP sterilization, click here.
Moist Heat (Steam) Sterilization of Medical Devices
- Sterilization of single-use medical products such as retinal and ocular devices, wound care products, liquid products in sealed rigid or soft containers, and reusable manufacturing components (such as labware and equipment change parts)
- Commonly used to sterilize heat-stable, non-porous dry goods as well as liquid products in sealed containers, such as vials, syringes, bottles, and bags, that cannot be processed using alternate or radiation technologies
To learn more about moist heat (steam) sterilization, click here.
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).