An Ethylene Oxide sterilizer is a specialized device or system used to sterilize medical equipment, devices, and other heat- or moisture-sensitive materials by exposing them to ethylene oxide gas, a highly effective antimicrobial agent. EO gas penetrates packaging and surfaces to destroy microorganisms, including bacteria, viruses, and spores, achieving a sterility assurance level (SAL) of 10⁻⁶. This method is widely used in healthcare, pharmaceuticals, and manufacturing because it operates at low temperatures (typically 37–63°C) and is compatible with a broad range of materials like plastics, electronics, and complex devices such as heart valves, pacemakers, catheters, and endoscopes.
Ethylene Oxide Sterilizer Video
How Does an EO Sterilizer Work?
EO sterilization follows a controlled, multi-stage process to ensure safety and efficacy. The gas works by alkylating microbial DNA, preventing replication. Key parameters include gas concentration (450–1,200 mg/L), temperature, relative humidity (40–80%), and exposure time (1–6 hours). Modern systems use mixtures like 8.5% EO with 91.5% CO₂ to reduce flammability risks.
Regulations and Safety
EO use is tightly regulated by the FDA, EPA, OSHA, and ISO standards to minimize exposure risks. Facilities must monitor emissions, with recent EPA rules requiring reductions to protect nearby communities. The FDA offers transitional enforcement for Class III devices during facility upgrades to avoid supply shortages. Workers handle EO in ventilated chambers with personal protective equipment.
Alternatives to EO Sterilization
Due to health concerns, alternatives are gaining traction:
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Vaporized Hydrogen Peroxide (VHP): Faster cycles (under 1 hour), low toxicity.
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Radiation (Gamma or Electron Beam): Penetrates dense materials but may alter plastics.
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Chlorine Dioxide Gas: Effective oxidizer for heat-sensitive items.
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Steam or Dry Heat: For non-sensitive devices.
Working Principle and Sterilization Process
Let’s take a look at the working principle and several stages involved in the sterilization process. Since, there is no standardized process owing to a vast diversity in exposure periods and gas concentration, the process below is a typical one and must be taken into consideration for reference purposes only.
The machine uses single use EO cartridges of 40, 100 and 170 grams. The chamber is facilitated with a single door and a simple locking system. There is an electronically controlled heating system in place to ensure a uniform heating at 50 degrees centigrade. The machine is designed for optimum durability as it contains venturi of adequate capacity inside a robust cabinet. There are control buttons for heating, gas purging and power supply requirements.
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Product exposed to warm and humid environment
The product is exposed to a warm and humid environment for about 12 hours. 70 percent RH and 55 A Cº is maintained for a uniform temperature and humidity.
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Introduction of ETO gas
Now the vacuum is pulled and ETO gas is introduced at this stage. The exposure is for about 4 to 8 hours at the same RH and temperature as before.
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Removal of ETO gas
Vacuum is continually pulled for the removal of ETO gas and air is introduced into the sterilization chamber to clear out the entire ETO gas. This process lasts for about 8 to 12 hours.
Features of Ethylene Oxide Gas Sterilizer
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Used to sterilize disposable syringes, I.Vs, disposable surgical set, gloves, infusion sets, urine collecting bags, birth control apparatus and plenty of medical devices
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Easy to operate
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Chamber with modular construction
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IQ, OQ and DQ documentation can be provided
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Prevention of micro biological contamination
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Contact parts made of SS 304 and 316
As a leading manufacturer and supplier of cath lab ethylene oxide sterilizer in India, Adinath International offers sterilizers of all sizes, ranging from small ETO sterilizers to room sized sterilizers.
Technical Specification of Ethylene Oxide Sterilizer
| Model | AETOS – 2.6 | AETOS – 4.5 | AETOS – 8 |
| Working Capacity in Cu. Ft. | 2.6 | 4.5 | 8 |
| Working Volume | 70 Liters | 125 Liters | 200 Liters |
| Chamber Size | 12” (W) x 12” (H) x 32”
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12” (W) x 12” (H) x 54” (D) OR
15” (W) x 15” (H) x 36” (D) |
20” (W) x 18” (H) x 38” (D) OR 16” (W) x 16” (H) x 54” (D) |
| Sterilant Gas | 40 grams cartridge | 100 grams cartridge | 170 grams cartridge |
| Sterilization Cycle | Warm & Cold Cycles are possible. | Warm & Cold Cycles are possible. | Warm & Cold Cycles are possible. |
| Aeration | In-built aeration facility provided. | In-built aeration facility provided. | In-built aeration facility provided. |
| Utility | Compressed Air (100 psig) | Compressed Air (100 psig) | Compressed Air (100 psig) |
| Power Supply | 1 K.W. | 2 K.W. | 2.5 K.W. |
| Power Voltage | 220 volts, Single Phase, 50 Hertz | 220 volts, Single Phase, 50 Hertz | 220 volts, Single Phase, 50 Hertz |
* Power voltage can be adjusted as per customer’s domestic power voltage requirements.
* Rights of technical improvements & modification reserved.
* Illustrations & dimensions are shown for information purpose only.
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