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Ethylene Oxide Sterilization Machine
Our ethylene oxide sterilization machine is a state-of-the-art system designed for the reliable and efficient sterilization of heat-sensitive medical devices, pharmaceuticals, and laboratory equipment. Utilizing ethylene oxide gas, this machine ensures complete microbial inactivation while preserving the integrity of delicate materials that cannot withstand high-temperature methods like steam sterilization.
Features
Gentle Yet Effective: Ideal for heat-sensitive instruments (e.g., surgical tools, endoscopes, catheters, implants) without causing thermal or moisture damage.
Deep Penetration :EO gas reaches complex geometries, ensuring thorough sterilization of lumens, porous materials, and tightly packaged items.
Regulatory Compliance:Meets strict international standards (ISO 11135, FDA, EU MDR) for medical and pharmaceutical sterilization.
Customizable Cycles :Adjustable parameters (gas concentration, humidity, temperature, exposure time) for optimal sterilization of different products.
Ethylene oxide sterilization machine operating specifications
Contents
1. Item preparation and packaging requirements
Items to be sterilized must be thoroughly cleaned and saline is prohibited. No obvious water droplets or moisture should remain on the surface of the items to avoid affecting the ethylene oxide sterilization effect.
Selection of packaging materials:
Applicable materials: medical packaging paper, composite dialysis paper, cotton cloth, non-woven fabric, breathable rigid container
Prohibited materials: non-breathable sealing materials
Packaging operation specifications:
Precious instruments should be handled with care to avoid collision
Long instruments (catheters, guide wires, etc.) should be kept in a natural state and folding is prohibited
Sharp instruments (scalpels, scissors, needles, etc.) need to be equipped with protective sleeves to prevent puncture of the package
Air should be excluded as much as possible from the package
Sterilization label:
Place an ethylene oxide chemical indicator card in the package
Paste ethylene oxide chemical indicator tape on the outside of the package
2. Sterilization loading specifications
Loading requirements:
Appropriate space must be maintained in the sterilization cabinet:
Items must not touch the cabinet wall
Gaps must be left above and below
Loading volume shall not exceed 80% of the cabinet volume
Flat items are prohibited from stacking
Validity period description:
The validity period of sterilized items in paper and plastic packaging is 2 years.
Key parameter control:
Temperature, concentration and time should be reasonably proportioned
Increasing temperature or concentration can shorten the sterilization time accordingly
Standard sterilization procedure:
Preheating stage
Pre-wetting treatment
Vacuuming
Injecting vaporized ethylene oxide to the target concentration
Maintaining the set sterilization time
Exhausting the ethylene oxide gas in the sterilizer
Analysis treatment:
After sterilization is completed, you can choose to:
Continue analysis in the sterilizer
Transfer to a dedicated fume hood for analysis
Applications
Medical devices
Surgical instruments, implants (pacemakers, stents), endoscopes and disposables (syringes, catheters).
Pharmaceuticals
Sterilization of drug containers, labware and packaging materials.
Laboratory and biotechnology
Equipment, biosafety materials and research tools requiring contamination-free conditions.
FAQ
Can your ethylene oxide sterilization equipment be customized for special medical devices?
Yes, we can provide customized solutions according to the special needs of customers. For example:
For special devices such as extra-long catheters/endoscopes, extended sterilization chambers can be customized
Design special sterilization brackets for precision implants (such as pacemakers)
Adjust the gas circulation system according to product characteristics to ensure the sterilization effect of complex structure devices
What technical parameters do you need to provide for customized equipment?
It is recommended that customers provide the following key information:
Product characteristics: material, size, thermal sensitivity, etc.
Sterilization requirements: expected sterilization level (such as 10⁻⁶ SAL), residual standard
Production capacity requirements: single batch processing volume, average daily sterilization batches
Site restrictions: equipment installation space, public utility conditions
Compliance standards: regulations to be met (FDA/CE/GB, etc.)
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