Cath Lab Ethylene Oxide Gas Sterilizer

Description

A Cath Lab Ethylene Oxide Gas Sterilizer (also known as ETO Sterilizer) is a specialized medical-grade system designed for safe, low-temperature sterilization of highly sensitive instruments used in cardiac catheterization laboratories. Unlike high-heat steam autoclaves, this technology employs ethylene oxide (ETO/EO) gas — a powerful, colorless alkylating agent — to penetrate complex devices and eliminate bacteria, viruses, fungi, and resistant spores without compromising delicate materials.

 

Operating at low temperatures (typically 30–60°C), ETO sterilization is the preferred method for heat- and moisture-sensitive equipment that cannot withstand traditional autoclaving. This makes it indispensable in modern Cath Labs where precision instruments are critical for life-saving procedures.

Working Principle of Cath Lab Ethylene Oxide Gas Sterilizer

The sterilization cycle follows a general sequence, though exact timings and gas concentrations can vary widely depending on the load and requirements. The outline below is provided only as a typical reference.

 

The unit operates with disposable EO cartridges available in 40 g, 100 g, and 170 g sizes. It features a single-door chamber equipped with a straightforward locking mechanism. An electronic heating system maintains a consistent chamber temperature of 50 °C. Built for long-term reliability, the machine incorporates a suitably sized venturi housed within a sturdy cabinet. Dedicated control switches manage heating, gas injection, and power supply.

 

Preconditioning – Warm Humid Exposure Items are held in a controlled warm and humid atmosphere for approximately 12 hours. Conditions of about 70 % relative humidity and 55 °C are maintained to achieve uniform temperature and moisture throughout the load.

 

Gas Injection and Exposure A vacuum is drawn, after which EO gas is introduced into the chamber. The load remains under these conditions (same temperature and humidity) for roughly 4 to 8 hours.

 

Gas Removal and Aeration Vacuum is repeatedly applied while fresh air is admitted to purge residual EO from the chamber. This flushing and aeration phase typically continues for 8 to 12 hours until the sterilant is fully cleared.

Technical Specification of Cath Lab Ethylene Oxide Gas 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”

 

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.

Types of Sterilization Equipment

Applications of Sterilization Equipment

Benefits of Cath Lab Ethylene Oxide Gas Sterilizer

Safe for plastics, rubbers, electronics, and heat-labile polymers.

Effectively sterilizes sealed packages and long, narrow lumens common in interventional tools.

Proven destruction of even the most resistant microorganisms.

Meets stringent standards including ISO 11135, FDA guidelines, and AAMI recommendations for medical device sterilization.

Safety and Regulatory Considerations of Cath Lab Ethylene Oxide Gas Sterilizer

  • Hazards: ETO is flammable, explosive, and a potential carcinogen. Proper aeration prevents operator exposure; OSHA limits are 1 ppm over 8 hours.

 

  • Compliance: Units meet ISO 11135, EN 1422, and FDA standards. Eco-friendly models use 100% ETO cartridges or mixtures to minimize environmental impact.

 

  • Maintenance: Requires regular calibration, cleaning, and validation; chambers are double-walled with insulation for energy efficiency.

FAQ for Cath Lab Ethylene Oxide Gas Sterilizer

It is suitable for disposable syringes, IV sets, single-use surgical kits, gloves, infusion sets, urine collection bags, contraceptive devices, and other medical products—especially those with complex geometries, sealed packaging, or long narrow lumens common in interventional tools.

A general cycle includes:

  • Preconditioning (warm humid exposure for ~12 hours at ~70% RH and 55°C)
  • Gas injection and exposure (vacuum drawn, EO gas introduced, held 4–8 hours)
  • Gas removal and aeration (repeated vacuum and air flushing for 8–12 hours) Exact timings and concentrations vary by load.

Models include AETOS-2.6 (2.6 cu. ft. / 70 L, 40 g cartridge), AETOS-4.5 (4.5 cu. ft. / 125 L, 100 g cartridge), and AETOS-8 (8 cu. ft. / 200 L, 170 g cartridge). All support warm and cold cycles with built-in aeration.

Power ranges from 1 kW to 2.5 kW depending on model, typically 220 V single-phase 50 Hz (adjustable to local voltage). It requires compressed air at 100 psig.

It features in-built aeration, repeated vacuum/air washes, and an exhaust/abatement system (scrubbers or similar) to remove residual ethylene oxide. This protects operators and meets environmental compliance.

Product-contact surfaces are Stainless Steel 304 and 316. The chamber has a modular design. Installation Qualification (IQ), Operational Qualification (OQ), and Design Qualification (DQ) documents are available on request.

It safely handles plastics, rubbers, electronics, and heat-labile polymers; penetrates sealed packages and narrow lumens; destroys resistant microorganisms (bacteria, viruses, fungi, spores); and complies with standards such as ISO 11135, FDA guidelines, and AAMI recommendations.

Core components include the pressure/vacuum-rated sterilization chamber, vacuum system, heating/temperature control, humidification system, EO gas delivery (cartridges or cylinders), recirculation, nitrogen/air inbleed, exhaust/abatement, control/monitoring (PLC/HMI with sensors), and aeration features.

Beyond Cath Labs and hospitals, it serves pharmaceutical, nutraceutical, herbal, Ayurvedic, biotech, cosmetic, and chemical industries, as well as medical device manufacturing for heat- and moisture-sensitive products.

Countries We Export to

United States | Canada | Mexico | Brazil | Argentina | Chile | Colombia | Peru | Germany | United Kingdom | France | Italy | Spain | Netherlands | Belgium | Switzerland | Sweden | Austria | Denmark | Norway | Poland | Finland | Czech Republic | Hungary | Portugal | Ireland | Greece | Slovakia | Romania | Bulgaria | China | Japan | India | South Korea | Indonesia | Vietnam | Thailand | Malaysia | Philippines | Singapore | Bangladesh | Pakistan | Saudi Arabia | United Arab Emirates | Israel | Turkey | Iran | Qatar | Kuwait | South Africa | Nigeria | Egypt | Algeria | Morocco | Kenya | Ghana | Tunisia | Australia | New Zealand | Russia | Ukraine | Belarus | Kazakhstan | Taiwan | Hong Kong | South Sudan | Uzbekistan | Oman | Jordan | Bahrain | Sri Lanka | Myanmar | Lebanon | Mongolia | Ethiopia | Libya | Angola | Zambia | Zimbabwe | Mozambique | Ivory Coast | Senegal | Uganda | Tanzania | Botswana | Ecuador | Venezuela | Bolivia | Paraguay | Uruguay | Trinidad and Tobago | Panama | Guatemala | Costa Rica | Honduras | El Salvador | Nicaragua | Dominican Republic | Haiti | Cuba

Partner with Industry Experts

Connect with our engineering team to discuss your specific production requirements. We provide customized, cGMP-compliant machinery solutions designed to optimize your manufacturing facility and maximize output.

Countries We Export to

United States | Canada | Mexico | Brazil | Argentina | Chile | Colombia | Peru | Germany | United Kingdom | France | Italy | Spain | Netherlands | Belgium | Switzerland | Sweden | Austria | Denmark | Norway | Poland | Finland | Czech Republic | Hungary | Portugal | Ireland | Greece | Slovakia | Romania | Bulgaria | China | Japan | India | South Korea | Indonesia | Vietnam | Thailand | Malaysia | Philippines | Singapore | Bangladesh | Pakistan | Saudi Arabia | United Arab Emirates | Israel | Turkey | Iran | Qatar | Kuwait | South Africa | Nigeria | Egypt | Algeria | Morocco | Kenya | Ghana | Tunisia | Australia | New Zealand | Russia | Ukraine | Belarus | Kazakhstan | Taiwan | Hong Kong | South Sudan | Uzbekistan | Oman | Jordan | Bahrain | Sri Lanka | Myanmar | Lebanon | Mongolia | Ethiopia | Libya | Angola | Zambia | Zimbabwe | Mozambique | Ivory Coast | Senegal | Uganda | Tanzania | Botswana | Ecuador | Venezuela | Bolivia | Paraguay | Uruguay | Trinidad and Tobago | Panama | Guatemala | Costa Rica | Honduras | El Salvador | Nicaragua | Dominican Republic | Haiti | Cuba

Partner with Industry Experts

Connect with our engineering team to discuss your specific production requirements. We provide customized, cGMP-compliant machinery solutions designed to optimize your manufacturing facility and maximize output.

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