ISO 13485 & ISO 10993-7 Compliant
Our laboratory provides highly accurate and fully compliant testing services for Ethylene Oxide (EO), Ethylene Chlorohydrin (ECH), and Ethylene Glycol (EG) residuals in accordance with applicable regulatory standards.
Why Choose Us
- Deep expertise in EO sterilization and residual chemistry
- Reliable, reproducible, and defensible analytical results
- Flexible project support—from development to routine testing
- Fast turnaround without compromising quality
- Dedicated technical support and regulatory guidance
Why Residual Testing Matters
After EO sterilization, trace levels of EO and its byproducts (ECH and EG) may remain in medical devices. These substances can pose toxicological risks if not reduced below acceptable limits.
Residual testing is critical to:
- Ensure patient safety and biocompatibility
- Demonstrate compliance with ISO 10993-7
- Support regulatory submissions (FDA, MDR, etc.)
- Validate sterilization processes and aeration cycles
Our Capabilities
We offer comprehensive analytical services tailored to your device and regulatory requirements:
Residual Analysis
- Quantitative determination of:
- Ethylene Oxide (EO)
- Ethylene Chlorohydrin (ECH)
- Ethylene Glycol (EG)
- Sensitive detection using validated analytical methods (e.g., GC)
Method Development & Validation
- Custom method development for complex materials or geometries
- Full validation in line with ISO 10993-7
- Support for worst-case product testing
Routine & Batch Testing
- Fast turnaround for production release testing
- Scalable solutions for ongoing quality control
- Robust data integrity and traceability
Standards & Compliance
Our testing services are performed within a quality system aligned with:
- ISO 13485 – Medical device quality management
- ISO 10993-7 – EO sterilization residual limits
- Regulatory expectations from FDA, EU MDR, and global authorities
We ensure your data meets the strict documentation and validation requirements necessary for regulatory approval.
Industries We Support
- Medical device manufacturers
- Pharmaceutical packaging providers
- Contract sterilization providers
- OEM suppliers
Your partner in quality, safety, and compliance
The life sciences sector requires specialized knowledge and reliable guidance. Thanks to our extensive expertise, we help organizations comply with laws and regulations, ensure quality, and continue to innovate with confidence.
Related services
Stability studies and sample storage
Analysis of Pharmaceutical Impurities and Contaminants
Method development and validation
Microbiological Testing Services
Cleanroom Validation and Environmental Monitoring
Sterility and Bioburden Testing
Compatibility and stability studies
