Ethylene Oxide Sterilization of Medical Injection Molded Parts
Ethylene oxide (ETO) sterilization of medical injection molded parts is a common method, especially suitable for medical devices not resistant to high temperatures or humidity. Ethylene oxide (EtO) is a low-temperature gas sterilant with a broad-spectrum bactericidal effect, which can effectively kill microorganisms such as bacteria, viruses, fungi, and spores.
1. Advantages of Ethylene Oxide Sterilization
Low-Temperature Sterilization: Ethylene oxide can be sterilized at a lower temperature, usually between 30-60℃, avoiding damage to medical devices caused by high temperatures.
Strong Penetration: Ethylene oxide gas has strong penetration and can penetrate packaging materials to sterilize medical devices inside the package.
Broad-Spectrum Sterilization: Ethylene oxide can kill various microorganisms, including bacteria, viruses, fungi, and spores.
Wide Range of Applications: Ethylene oxide is suitable for medical devices made of various materials, including plastics, rubber, and metals.
2. Ethylene Oxide Sterilization Process
Preparation: Clean the medical injection molded parts that need to be disinfected and pack them appropriately.
Sterilization: Place the packaged medical injection molded parts into an ethylene oxide sterilizer and sterilize them according to the set temperature, humidity, and time.
Ventilation: After sterilization, ventilate to remove residual ethylene oxide gas.
Inspection: Inspect the sterilized medical injection molded parts to confirm the sterilization effect.
3. Precautions for Ethylene Oxide Sterilization
Safety: Ethylene oxide is a toxic gas and has certain risks. Operators need to undergo professional training and strictly follow operating procedures.
Residue: After ethylene oxide sterilization, there may be residual gas, which needs to be fully ventilated to ensure that the residual amount meets national standards.
Packaging: The packaging material of medical injection molded parts needs to have good air permeability so that ethylene oxide gas can enter, and at the same time, it can effectively block microorganisms.
Monitoring: The sterilization process needs to be monitored to ensure the sterilization effect.
4. Applications of Ethylene Oxide Sterilization
Ethylene oxide sterilization is widely used in the sterilization of various medical injection molded parts, including:
Disposable medical devices: such as syringes, infusion sets, catheters, etc.
Implantable medical devices: such as pacemakers, artificial joints, etc.
Precision medical devices: such as endoscopes, surgical instruments, etc.
