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EO Sterilization Chamber For IV Lines
The EO sterilization chamber is designed for safe, low-temperature sterilization of IV lines and heat-sensitive medical devices. Using ethylene oxide gas, it ensures deep penetration and effective microbial elimination. With precise parameter control and reliable aeration, it delivers consistent, compliant sterilization performance for medical manufacturing and healthcare applications.
Features
EO Sterilization Chamber For IV Lines Features & Advantages
High Penetration Sterilization Performance
Ethylene oxide gas can penetrate complex structures, including long and narrow IV tubing, ensuring complete sterilization even in hard-to-reach internal surfaces. This makes it highly suitable for products with intricate geometries and sealed packaging.
Excellent Material Compatibility
Unlike high-temperature sterilization methods, the EO process operates at low temperatures, preventing deformation, discoloration, or degradation of plastic IV lines and polymer-based components.
Modular & Scalable Design
The chamber adopts a modular configuration, allowing integration with preconditioning rooms, aeration systems, and gas treatment units. This flexibility supports both small-scale operations and large-volume industrial production.
High Efficiency & Throughput
Optimized sterilization cycles reduce processing time while maintaining consistent results, improving production efficiency and lowering operational costs.
Technical Details
Sterilization Method: Ethylene Oxide (EtO) Gas
Operating Temperature: 30°C – 55°C
Humidity Control: 40% – 80% RH (adjustable)
Chamber Volume: Customizable (based on production capacity)
Control System: PLC with HMI / SCADA integration
Vacuum System: Multi-stage vacuum for enhanced gas penetration
Gas Concentration Control: Precise and uniform distribution
Aeration System: Integrated degassing to reduce EO residues
Compliance Standards: ISO 11135, GMP, FDA, CE
These technical parameters ensure stable, repeatable sterilization performance and full compliance with global regulatory requirements.
Functional Capabilities
Fully Automated Sterilization Cycles
The system supports automated process control, including preconditioning, vacuuming, gas injection, exposure, and aeration. This minimizes human intervention and ensures consistent results.
Intelligent Monitoring & Data Recording
Equipped with advanced sensors and digital control systems, the chamber enables real-time monitoring of temperature, humidity, pressure, and gas concentration. Data logging functions support traceability and validation requirements.
Safety Protection System
Multiple safety mechanisms are integrated, including gas leakage detection, pressure protection, interlocking doors, and emergency shutdown systems, ensuring safe operation for both personnel and facilities.
Residual Gas Management
The built-in aeration and exhaust treatment system effectively removes residual EO gas from IV lines, ensuring products meet strict safety limits before use or packaging.
FAQ
1. Why is EO sterilization used for IV lines?
EO (ethylene oxide) sterilization is ideal for IV lines because it operates at low temperatures and can penetrate long, narrow tubing. It effectively kills microorganisms without damaging heat-sensitive plastic materials or affecting product performance.
2. How long does an EO sterilization cycle take for IV tubing?
A typical EO sterilization cycle ranges from 8 to 24 hours, depending on load size, product complexity, and aeration requirements. The process includes preconditioning, gas exposure, and degassing to ensure safety and compliance.
3. Is EO sterilization safe for medical devices?
Yes, EO sterilization is widely approved for medical devices when properly controlled. Modern systems include aeration phases to remove residual gas, ensuring products meet ISO 11135 and FDA safety standards before use.
4. What factors affect EO sterilization effectiveness?
Key factors include temperature, humidity, gas concentration, and exposure time. Proper control of these parameters ensures consistent sterilization results and a high sterility assurance level (SAL).
5. Can EO sterilization chambers handle large-scale IV line production?
Yes, EO sterilization chambers are designed for batch processing and can be customized for large-scale manufacturing. Modular systems and automated controls make them suitable for high-volume medical device production.
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