Large-Scale ETO Sterilizer

• High-Efficiency Mass Production Capacity: A single chamber can process 2,000-5,000 pieces of standardized packaging (e.g., a 6,000L system can sterilize 500,000 gloves in a single run), increasing daily production capacity by eight times compared to smaller ETO sterilizers. It supports parallel operation of multiple chambers, enabling integration into production lines and shortening product inventory cycles awaiting sterilization.
• Gradient Low-Temperature Protection: Through a "preheating - constant temperature - slow cooling" temperature control process, the sterilization temperature remains stable at 35-55°C, preventing stress cracking in materials like plastics and rubber. Electronic components can also utilize an additional low-temperature desorption module to prevent shrinkage and deformation of the encapsulated colloid.
• Pulsed Gas Penetration: ETO gas is injected in 3-5 pulses to a set concentration of 500-1300 mg/L. Combined with multi-point airflow disturbances within the chamber, gas penetration reaches 1.5 times the depth of traditional equipment, covering difficult-to-sterilize areas and maintaining a stable sterility pass rate of over 99%. Full-chain compliance traceability: Equipped with an industrial-grade PLC control system and an FDA-certified data storage module, it records 12 key sterilization parameters in real time, with data storage for ≥2 years. It supports audit tracking and electronic signatures, meeting compliance requirements such as medical GMP and EU CE MDR.
• Safe and environmentally friendly design: A laser-based ETO leak detector ensures that the working environment leak concentration is ≤0.3ppm (better than the national standard of 0.5ppm). Exhaust gas is treated through "catalytic combustion + activated carbon adsorption," achieving an EO decomposition efficiency of ≥99.95% and final emissions of ≤0.1mg/m³, complying with GB 16297-1996.

 

Notes

Packaging Material and Pore Size Control: Items to be sterilized must be packaged in specialized, breathable packaging (e.g., 70g/m² medical dialysis paper, 0.3μm pore size Tyvek film). Seams must be sealed with a width of ≥5mm to prevent ETO gas leakage and external contamination.

Item Loading Specifications: The chamber should contain no more than 40%-80% of the chamber volume, with a gap of ≥3cm between items. The stacking height of pallets should be ≤70% of the chamber height to ensure uniform airflow and avoid incomplete sterilization.

Storage and Replacement of ETO Cylinders: ETO cylinders must be stored in an explosion-proof warehouse (temperature ≤30°C, away from oxidants). When replacing cylinders, close the main gas supply valve of the equipment and purge the delivery pipeline with nitrogen before disassembly to prevent residual gas leakage. Equipment Calibration and Verification: The chamber temperature sensor must be calibrated quarterly using a standard thermometer (accuracy ±0.1°C). Sterilization effectiveness must be verified semi-annually using a biological indicator (Bacillus subtilis var. niger spore disc) to ensure the sterility rate meets the required standards.

Emergency Response Procedure: If the equipment alarm indicates an ETO leak, the ETO supply must be immediately stopped, the workshop's explosion-proof exhaust fan must be turned on, and operators wearing positive-pressure respirators must enter the site to investigate the leak (prioritizing the chamber gasket and pipe joints). After repairs, the system must pass a leak test (≤0.3ppm) before restarting.

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FAQ

What are the workshop environment requirements for equipment operation? Is a separate sterilization room necessary?

It is recommended to construct a separate explosion-proof sterilization room (area ≥ 3 times the equipment footprint). This room should be equipped with explosion-proof lighting (Ex d IIB T4), explosion-proof exhaust fans (air volume ≥ 10 air changes/hour), anti-static epoxy resin coating on the floor, and an ETO concentration alarm (alarm threshold 0.3ppm) installed on the wall. A separate sterile room is not necessary, as sterilized items are removed and sealed in a sterile state after sterilization.

What are the advantages of Large-Scale ETO Sterilizer compared to other low-temperature sterilization technologies (such as low-temperature plasma sterilization)?

Compared to low-temperature plasma sterilization, ETO sterilization's core advantages include a higher processing capacity (a single-pass processing capacity is 20-50 times that of plasma equipment), greater penetration (it can penetrate packaging with a pore size of 0.3μm, while plasma cannot penetrate sealed packaging), and a wider range of material compatibility (plasma has the risk of corrosive effects on metals, while ETO has no material restrictions), making it more suitable for industrial mass production scenarios.

What are the energy consumption and operating costs of the equipment? Are there any energy-saving features?

Take a 6000L system as an example. A single sterilization cycle (including pretreatment, sterilization, and aeration) consumes approximately 80-100 kWh of energy, and ETO gas consumption is approximately 0.8-1.2 kg. Large-Scale ETO Sterilizer is equipped with energy-saving features, such as a waste heat recovery system during the aeration phase (which recovers 30% of the heat for preheating) and a low-temperature insulation mode during standby (which reduces energy consumption by 60%). These features can reduce energy costs by 15%-20% over long-term operation.

After installing new equipment, what verifications are required before it can be officially put into production?

Three core validations are required: Installation Qualification (IQ), which confirms that the equipment dimensions, power supply, and air supply meet design requirements; Operational Qualification (OQ), which tests the functioning of the equipment's various modules (vacuum system, ETO injection, and exhaust gas treatment); and Performance Qualification (PQ), which tests the sterilization effectiveness of three consecutive batches using biological indicators to ensure a 100% sterility acceptance rate. All parameters must be recorded to meet industry standards, and validation reports must be retained for future reference.

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