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The Challenge:
Ethylene Oxide (EO or ETO) is widely used for sterilizing medical devices, but its residues (EO and ECH) are toxic and carcinogenic. Medical device manufacturers must prove these residues fall below safe limits before products can be used on patients.
Our Approach:
We offer specialized residual testing for Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) in strict accordance with ISO 10993-7. Our validated gas chromatography methods ensure accurate, rapid, and fully compliant residue analysis for all sterilized devices.
Why It Matters
Strict adherence to ISO 10993-7 standards
Accurate quantification of EO and ECH
Rapid turnaround to prevent supply chain bottlenecks
Comprehensive method development for novel devices
Applications
- Sterilized medical devices
- Surgical instruments
- Implants and catheters
- Packaging materials
Regulatory Standards
ISO 10993-7
Instrumentation
LC-MS/MS (Shimadzu LCMS-8045)High Sensitivity LC-MS/MS (Shimadzu LCMS-8060NX)High Sensitivity LC-MS/MS (Shimadzu LCMS-8060RX)ICP-MS (Agilent 7800, SPS 4 Autosampler)GC-MS/MS-FID (Agilent 8890, 7000D GC/TQ)UV Visible Spectrophotometer (Shimadzu)FTIR Spectrophotometer (Shimadzu)
Standards & Compliance
Every test we perform adheres to globally recognized regulatory frameworks.
ICH Q2ICH Q3DICH M7 (R1)USPEPBPJPIPFCCACSISO/IEC 17025ISO 10993-7US FDAEMACDSCO