Ethylene Oxide Cylindrical Sterilizer

EO gas penetrates packaging and complex geometries, destroying microorganisms by alkylating their DNA and proteins to achieve a Sterility Assurance Level (SAL) of 10⁻⁶. The process typically includes preconditioning (controlled humidity and temperature), vacuum purging, EO gas injection and exposure, aeration/de-gassing to remove residuals, and exhaust with monitoring.

A standard cycle generally involves:

• Pre-conditioning (e.g., ~70% relative humidity and ~55°C for around 12 hours).
• Sterilant injection/exposure (4–8 hours under controlled temperature and humidity after chamber evacuation).
• Aeration and exhaust (8–12 hours of vacuum draws and clean air flushing to remove residual gas). Warm and cold cycles are supported depending on the model.

It is ideal for disposable syringes, intravenous administration kits, single-use surgical packages, medical gloves, infusion assemblies, urine collection bags, contraceptive instruments, and a wide range of other heat- or moisture-sensitive clinical and medical devices.

Product-contact components are made from premium stainless steel (SS 304 and SS 316). The cylindrical design offers high structural integrity under vacuum and pressure cycles. Models feature modular chamber architecture for scalable configurations, single-entry doors with simple closures, and heavy-duty outer chassis construction.

Models include AETOS–2.6 (≈70 liters / 2.6 cu. ft.), AETOS–4.5 (≈125 liters / 4.5 cu. ft.), and AETOS–8 (≈200 liters / 8 cu. ft.). They use disposable EO cartridges (40 g, 100 g, or 170 g), offer in-built aeration, require compressed air (100 psig), and operate on single-phase power (typically 1–2.5 kW at 220 V / 50 Hz, adjustable as needed). Chamber dimensions vary by model.

Comprehensive Installation Qualification (IQ), Operational Qualification (OQ), and Design Qualification (DQ) documentation packages are available to support validation and regulatory compliance.

They are applied in the pharmaceutical, nutraceutical, herbal, Ayurvedic, biotech, cosmetic, and chemical industries, as well as in hospitals and medical device manufacturing for sterilizing heat-sensitive items.

Systems incorporate engineering controls (ventilation, enclosed loading), PPE requirements, and monitoring. They comply with standards such as ISO 11135, ISO 10993-7 (residual limits), OSHA 29 CFR 1910.1047, and NIOSH guidelines. EO is flammable, explosive, and a potential carcinogen, so proper aeration, residual control, training, and signage are essential. Modern designs often include features to reduce emissions.

The cylindrical vessel distributes stress evenly under vacuum and pressure cycles, providing exceptional structural integrity, superior gas distribution, efficient vacuum performance, and enhanced overall safety compared with alternative shapes. It is commonly engineered to meet rigorous standards such as ASME-PVHO and ISO 11135.