Analysis of ethylene oxide residues in medical products validated under ISO 10993-7 precise and fast
With MCI analysis you will get guaranteed safety and efficiency. At MCI we have achieved internal validation of our analysis service for ethylene oxide and 2-chloroethanol (ECH) residues in medical devices. This allows us to offer a highly reliable service, complying with international standards of safety and precision. Our analysis is validated under the ISO 10993-7 standard, guaranteeing that medical devices comply with the permitted limits of these residues before being marketed and used.
Why is ethylene oxide residue analysis important?
Ethylene oxide is a widely used agent in the sterilization of medical devices, but its correct disposal is essential to avoid risks to patients’ health. The presence of uncontrolled residues can generate adverse effects, so the analysis of ethylene oxide residues is key to ensuring the safety of medical devices. 2-chloroethanol (ECH) is a byproduct of ethylene oxide degradation and must also be measured, as it can represent a potential risk if not within acceptable levels.
Advanced technology for analysis
At MCI we use state-of-the-art equipment to ensure ethylene oxide residue analysis with maximum precision. Our advanced technology enables the detection and quantification of EO and ECH residues in medical devices, ensuring regulatory compliance with high quality standards.
Our specialized services
We perform specific tests for medical devices that require water as an extraction solvent, applying methods of:
- Simulated extraction, replicating real conditions of product use.
- Thorough extraction, such as immersion and fluid flow, ensuring proper waste assessment.
Thanks to these methods, our residue analysis provides highly reliable results to ensure the safety of medical devices.
Save time and costs with MCI
With our ethylene oxide residue analysis service, there is no longer a need to send samples overseas, eliminating high costs and logistical complications. Advantages of working with MCI:
- Fast and reliable results.
- Strategic location near sterilization companies.
- Efficient and simplified logistics for shipping samples.
How to send your samples for ethylene oxide residue analysis?
To ensure sample integrity, samples must be shipped on dry ice. There are two shipping options:
- Send them directly to our facilities.
- Coordinate with us the collection of samples from your sterilization provider, after prior coordination.
For more information about our services, please contact our team. Ensure the safety of your medical devices and healthcare products with our ethylene oxide residue analysis.
