Industrial Ethylene Oxide Sterilizer

Ethylene Oxide Sterilizers are designed to perform low temperature, chemical sterilization treatment of medical, food and pharmaceutical products sensitive to temperature/ humidity. LODHA ETO gas Sterilizers kill the toughest of microbes but are gentle enough to protect the integrity of the product and packaging. A wide range of program options, installation arrangements and loading options increases the versatility. Whether you use external preconditioning and aeration or our unique Combined Process Systems, LODHA can offer customized solutions for your most exacting needs.
ETO Gas Sterilizers operate with a sterilant which is potentially explosive. Hence these Sterilizers incorporate design features, devices & additional means of protection in order to operate in potentially explosive atmosphere in conformity with the established parameters ensuring a very high level of protection against explosions.

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Applications:

Health Care Industry: Syringes, Catheters, Cartridges & Dialysis, Sutures, IV Sets, Plastic Articles, Heat Sensitive Rubber Products, Surgical Gloves.
Pharmaceutical Industry: Thermo stable basic pharmaceutical products and chemical compounds.
Food Industry: Spices and Herbs

Salient Features:

Double gasket for improved & fails proof door sealing.
Screw Vacuum Pumps & Roots Blowers for applications which require ultra-high vacuum.
Flame Proof design for your maximum safety.
Gas station with manifold fitted with air regulators, pressure switches, safety release valves and load cell for controlled injection of sterilant.
Energy efficient, jacket and door heating system for uniform temperature distribution.
Gas Circulation Blower for uniform concentration of sterilant & temperature distribution
HI/LO temperature & pressure alarms.
Gas detection system with audio-visual alarm to prevent gas leakages. Flame proof.
Evacuation hoods to evacuate any residual traces of Ethylene Oxide.
Emergency evacuation system for rapid evacuation of the gas in case of emergency.

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Industrial Ethylene Oxide (ETO) Sterilizer FAQs

It is a large-capacity, high-throughput low-temperature sterilization system designed for bulk industrial production, unlike smaller hospital ETO units used for limited loads.

ETO operates at 37°C–63°C, preserving APIs, herbal extracts, and polymer packaging that would degrade under steam or dry heat sterilization.

Prefilled syringes, sutures, wound dressings, implants, transdermal patches, medical devices, and heat-sensitive powders.

Yes — for bulk herbal powders and packaged health products requiring validated bioburden reduction without affecting potency.

It sterilizes heat-sensitive packaging, applicators, and finished cosmetic products to ensure safety and export compliance.

ETO concentration 450–1200 mg/L, temperature 37°C–63°C, RH 40%–80%, exposure 2–6 hours to achieve SAL 10⁻⁶.

ISO 11135, ISO 10993-7, USP 1229.1, WHO-GMP, Schedule M, and applicable USFDA/EU-GMP requirements.

Gas-tight chambers, leak detectors, safety interlocks, negative pressure design, and catalytic abatement systems ensure operator and environmental safety.

Post-sterilization aeration removes residual ETO and byproducts to safe ISO 10993-7 limits before product release.

Typically 24–72 hours including conditioning, exposure, evacuation, and aeration.

From 1 m³ to 30+ m³, processing 500 kg to several tonnes per cycle.

Using validated gas chromatography (GC) methods to ensure compliance with ISO residual limits.

IQ, OQ, PQ, biological indicator testing, half-cycle studies, and residual ETO verification.

Validated ISO-compliant sterilization supports USFDA, EU-GMP, and international market submissions.

100% ETO offers superior penetration; ETO-CO2 blends reduce flammability risk.

Yes — PLC systems support 21 CFR Part 11 compliance and full electronic batch documentation.

Compliance with CPCB guidelines, Hazardous Chemical Rules 1989, and Fire Safety regulations.

It converts exhaust ETO gas into non-toxic byproducts using catalytic oxidizers or scrubbers.

Installation, IQ/OQ/PQ support, training, spare parts, calibration, and annual maintenance services.

Selection depends on sterilization volume, product type, utilities, regulatory targets, and long-term production planning.

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Industrial Ethylene Oxide Sterilizer