Ethylene Oxide Sterilisation

Best for medical products and medical devices

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What is Ethylene Oxide Sterilisation

Ethylene oxide (EtO) sterilization is a chemical process used to sterilize medical devices and other heat and moisture-sensitive products. Ethylene oxide is a gas that can penetrate complex structures and reach hard-to-access areas, making it highly effective for sterilizing medical equipment, especially those with intricate designs or sensitive materials.

Our Ethylene Oxide Processing Standards

The Provision of Ethylene Oxide Sterlization Services For Medical Devices

Applied Standard(s): ISO 13485:2016Sterilization of Health Care Products (Ethylene Oxide) Requirements for development, validation and routine control of a sterilization process for medical devices

Applied Standard(s): ISO 11135:2014

US FDA Certified
Registration Number: 3010280660

 

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Based on a gas diffusion process, Ethylene Oxide (EO or ETO) is capable of sterilising and rendering products free of viable microorganisms. Sterility occurs when an EO gas molecule reacts with and destroys the microbial DNA. The process requires the simultaneous control of four variables, but interdependent parameters: gas concentration, temperature, relative humidity, and time of exposure. ETO sterilization effectiveness depends on its ability to freely diffuse through a product and packaging All products must be placed in breathable packaging that allows gas to penetrate the sterile barrier and reach all surfaces of the device or product.

EtO best suited for what products?

  • Anesthesia masks
  • Artificial joints (e.g., hip, knee)
  • Biological materials, like collagen and other tissue grafts
  • Blood collection bags
  • Catheters
  • Cochlear implants
  • Dental implants
  • Dialysis filters
  • Dressings and bandages in sealed packaging
  • Electronic circuit boards used in medical devices
  • 11. Endoscopes
  • 12. Heart valves
  • 13. IV sets and tubing
  • 14. Medical-grade batteries
  • 15. Nebulizer tubing
  • 16. Optical instruments
  • 17. Pacemakers
  • 18. Pipette tips and petri dishes
  • 19. Scissors and forceps with plastic handles
  • 20. Sterile gloves
  • 21. Stents
  • 22. Surgical trays and containers
  • 23. Sutures
  • 24. Syringes

Sina-SterilGamma EtO Plant

Lot 88077, Jalan Perigi Nenas 7/1, Taman Perindustrian Pulau Indah, 42907 Pelabuhan Klang, Selangor, Malaysia

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