What is an EO sterilizer?
Ethylene oxide sterilizer is the key equipment for disposable sterile medical device manufacturers. It has special requirements for installation, operation and use management. Ethylene oxide is used as a sterilant. Ethylene oxide is a broad-spectrum Sterilizer, which can kill various microorganisms at room temperature, including spores, Mycobacterium tuberculosis, bacteria, viruses, fungi, etc.
Key Parameters for Effective EO Treatment
Ethylene Oxide (EO or ETO) sterilizes the product based on the gas diffusion method, which renders the product free of any viable microorganisms. Sterilization is achieved when EO gas molecules react with and destroy microbial DNA. This process requires the simultaneous control of four variable but interdependent parameters: gas concentration, temperature, relative humidity, and exposure time. The effectiveness of EO sterilization depends on its ability to freely penetrate the product and packaging. All products must be placed in breathable packaging that allows gases to penetrate the sterile barrier and reach all surfaces of the device or product.
Main advantage
The EO sterilization process offers a variety of sterilization advantages, including:
Low temperature sterilization
Ensure product and packaging integrity
product compatibility
Effectively sterilizes polymers, resins, natural materials, metals, and dual-use drug/device combination products that require sterilization of external contact surfaces
Sterility Assurance and Therapeutic Efficacy
Consistently meet product and regulatory requirements
Flexibility and Versatility
Effectively sterilize products with varying dosage requirements, densities and pack/box sizes
Parameter release
The product can be released directly after sterilization, thereby greatly shortening the waiting time of the product and speeding up the speed of the product entering the market
Best Applicable Object
EO is considered the most widely used sterilization method for medical supplies and medical devices due to its effectiveness at low temperatures and its suitability for a wide variety of materials, resins and product types, including:
Polymer Resin Products
Disposable Medical Devices
Surgical Instrument Kit
Surgical tray
Synthetic fiber surgical gown
External terminal sterilization of sealed drug-device combinations (prefilled syringes and drug-coated stents)
