Cath Lab ETO Sterilizer
The Cath Lab ETO Sterilizer enables validated, low-temperature sterilization of temperature-sensitive cardiology products such as catheters, guidewires, sheaths and EP accessories. EO gas penetrates complex lumens and breathable packaging to achieve the required sterility assurance while maintaining device functionality and shelf life.
Working Principle and Process Flow
After preconditioning for temperature and humidity, the chamber is evacuated and EO gas is introduced to a validated concentration. Controlled exposure time allows complete microbial inactivation across long, narrow lumens. Post-exposure aeration removes residual EO to meet safety limits before release to the cath lab sterile store.
Types of EO Systems for Cath Labs
- Tabletop/Compact EO Units :- For small daily batches of catheters and accessories.
- Cartridge-Based Systems :- Single-use EO cartridges with automated dosing for clinics.
- Mid-Size Hospital CSSD EO Sterilizers :- Higher capacity cycles for cath labs and cardiac OT.
- Integrated Aeration Cabinets :- Dedicated forced-air aeration to expedite EO off-gassing.
Key Features and Specifications
- Lumen Sterilization :- Validated cycles for long, narrow lumens using appropriate humidity and exposure.
- Packaging Compatibility :- Works with Tyvek and medical-grade paper pouches and trays.
- Safety Architecture :- Gas monitoring, alarms, interlocks and leak checks protect staff.
- Documentation & Traceability :- Cycle records, BI/CI tracking and electronic logs for QA.
Applications
- Cardiac catheters, PTCA guidewires, diagnostic/therapeutic sheaths and EP tools.
- Sterilization of kits prepacked in breathable pouches or trays.
- Reprocessing compatible single-use accessories per local policy.
- Support for cardiac OT and hybrid lab workflows.
Benefits
- Low-temperature process preserves polymer integrity and device performance.
- Deep penetration into complex geometries and long lumens.
- Terminal sterilization inside final packaging for protected shelf life.
- Regulatory-aligned validation and routine monitoring.
Maintenance and Safety Tips
- Use manufacturer-approved packaging and lumen adapters for validation.
- Observe aeration times strictly to ensure residual EO is within limits.
- Calibrate sensors and leak-test the chamber routinely.
- Record BI/CI results and retain batch documentation for traceability.
- Train staff on EO handling, emergency response and PPE use.
FAQs – Cath Lab ETO Sterilizer
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