Ethylene oxide sterilization for heat-sensitive medical products
Ensure sterility of heat and moisture-sensitive products with precise low-temperature processes that protect their integrity, making it ideal for maintaining quality in sensitive healthcare and pharmaceutical applications.
Sterilizes Heat and Moisture Sensitive Products
The GEE Ethylene Oxide (EO) Sterilizers from Getinge are tailored for healthcare facilities and manufacturers requiring precise sterilization of heat and moisture-sensitive products. This system utilizes a low-temperature EO process capable of sterilizing packed and palletized goods efficiently, preserving packaging integrity and product properties.
Equipped with a PLC automation system (Allen Bradley or Siemens), these sterilizers are designed for seamless integration into your production line with centralized SCADA support for comprehensive monitoring. The flexible data storage and monitoring capabilities cater to specific processing requirements, ensuring compliance with industry standards.
Primarily serving the pharmaceutical, medical device, and healthcare equipment industries, these sterilizers are instrumental in processing surgical sutures, catheters, implantable devices, and electronics like circuit boards. The equipment runs automated and high-speed batch operations suitable for solid and gas product types.
These sterilizers are built with safety in mind, featuring compliance with ATEX regulations and employing redundant safety measures. The chamber design includes a dual gasket for airtight sealing, even in varying pressure conditions, supported by external vaporization of liquid EO.
GEE sterilizers boast components for effective load handling without operator entry into the EO chamber, while also allowing customization to your facility layout and workflow. The system’s robust vacuum pumps facilitate rapid EO removal, and the chamber recirculation system ensures optimal gas and temperature distribution for reliable sterilization results, supporting a safe and efficient sterilization process across various applications.
Benefits
- Enhances product safety and integrity through low-temperature sterilization, preserving sensitive materials.
- Minimizes labor involvement with automated pallet loading and SCADA-managed processes.
- Improves operational safety with ATEX compliance and robust leakage prevention systems.
- Ensures traceability and regulatory compliance with comprehensive batch documentation and 21CFRPart11-compliant SCADA.
- Reduces environmental impact by efficient EO usage and rapid degassing, promoting a safer workplace.
- Applications
- Healthcare equipment,Medical devices,Moisture-sensitive medical products,Surgical instruments,Heat-sensitive medical products,Electronics,Pharmaceuticals
- End products
- Inhalers,Syringes,Catheters,Electronic circuit boards,Patient monitors,Surgical sutures,Infusion pumps,Implantable devices,Hospital beds
- Steps before
- Pre-treatment,Heating,Humidification
- Steps after
- Post-conditioning,Degassing,Packing
- Input ingredients
- heat/moisture sensitive products,products requiring EO sterilization,packaged goods,palletized products,ethylene oxide gas
- Output ingredients
- sterilized products,sterile packaged goods,ready-to-ship products
- Market info
- Getinge is known for providing innovative healthcare and life sciences products, specializing in medical technology, infection control, surgical workflows, and critical care solutions. They maintain a strong reputation for quality and technological advancement in these sectors.
- Automation
- PLC-controlled (Allen Bradley or Siemens)
- Control System
- SCADA 21CFRPart11 compliant
- Batch reporting features
- Detailed and summarized,auto batch release
- Safety Compliance
- ATEX regulations
- Leak test
- Automatic chamber leak rate test
- Temperature Control
- Low-temperature sterilization with EO
- Gas Distribution
- Uniform gas and temperature distribution
- Vacuum System
- Liquid ring vacuum pumps
- Gas vaporization
- Outside building EO vaporization
- Load handling
- Automatic pallet transfer system (APTS)
- Process Monitoring
- PLC with SCADA system
- Automation level
- PLC / SCADA
- Batch vs. continuous operation
- Batch
- CIP/SIP
- CIP
- Cleaning method
- Automatic
- Load handling
- Automatic pallet transfer system
- Process safety
- PLC and SCADA systems
- Temperature control
- Heated water circulation
- Process outline
- Multi-stage (pre-treatment,EO sterilization,post-conditioning)
- Gas dispensing
- Vaporization
- Biological compatibility
- Heat/moisture sensitive materials
- Temperature sensitivity
- Suitable for low-temperature sterilization
- Moisture sensitivity
- Compatible with materials that cannot withstand moisture
- ATEX certification
- Yes
- 21 CFR Part 11 compliance
- Yes
- Chamber size
- Customizable for specific facility layouts
- Control panel type
- HMI interface with full SCADA system
- Door design
- Leak-tight door with dual gasket system
- Pallet handling system
- Automatic Pallet Transfer System (APTS)
- Gas dispensing method
- Vaporization outside building
- Cooling system
- Optional cooling system for rapid temperature transition
- Vacuum system
- Liquid ring vacuum pumps
- Recirculation system
- Ensures uniform gas and temperature distribution
- Material flow direction
- Two linear directions for pallet movement
- Control panel type
- PLC automation (Allen Bradley or Siemens)
- Integration possibilities
- SCADA system integration
- Process monitoring
- SCADA with HMI interface
- Optimization capabilities
- Specific process requirements