Medical Device
ETO Sterilization
Generate ISO 11135-compliant validation reports for ethylene oxide sterilization cycles. Meet FDA, EU MDR, and medical device regulatory requirements.
ETO Sterilization Validation
ISO 11135-compliant sterilization validation for medical devices
ISO 11135 Compliant
Meets ISO 11135, FDA 21 CFR Part 820, and EU MDR requirements for ETO sterilization validation.
Cycle Monitoring
Complete temperature, humidity, and gas concentration monitoring throughout the sterilization cycle.
Regulatory Ready
Complete documentation package for FDA submissions and notified body reviews.
Applications
Critical ETO sterilization validation across medical device manufacturing
Single-Use Devices
Syringes, catheters, and disposable medical devices requiring low-temperature sterilization.
Implantable Devices
Heat-sensitive implants and surgical instruments that cannot withstand steam sterilization.
Pharmaceutical Packaging
Primary packaging materials and drug delivery devices requiring sterile validation.
Ready to validate your ETO cycles?
Upload your sterilization data and get ISO 11135-compliant validation reports
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