ISO 11135 Ethylene Oxide Sterilization Residuals Support Testing
The ISO 11135 standard is widely recognized as a critical guideline for ensuring the safety and effectiveness of medical devices, pharmaceutical products, and other sterilized items processed through ethylene oxide (EO) sterilization. This service provides comprehensive support to clients who are seeking to comply with the stringent requirements set forth in this international standard.
Our laboratory specializes in providing expert analysis for residual EO concentrations in ophthalmic products post-sterilization, ensuring that all trace amounts meet regulatory and client-specified thresholds. Our team of highly qualified professionals uses state-of-the-art equipment to perform precise testing, offering reliable data that contributes significantly to the quality assurance process.
The process begins with meticulous sample preparation, which involves extracting residual EO from the product using advanced methods such as gas chromatography or similar techniques compliant with ISO 11135. Once prepared, these samples are analyzed according to internationally recognized protocols ensuring accurate measurement of ethylene oxide residues. Our laboratory adheres strictly to ISO 11135 guidelines throughout this process.
Upon completion of the analysis, detailed reports are generated summarizing findings including concentrations detected in parts per million (ppm). These reports not only meet but often exceed regulatory expectations by providing comprehensive insights into any potential risks associated with EO exposure. Compliance documentation is also provided to assist clients in meeting necessary certifications and approvals.
Our services extend beyond mere compliance; they aim at enhancing overall product safety through rigorous scrutiny of every aspect related to EO sterilization. By leveraging our expertise, you can ensure that your products not only comply with current standards but also maintain high levels of reliability and performance throughout their lifecycle.
Applied Standards
The ISO 11135 standard is specifically designed for the determination of ethylene oxide residues following sterilization by this method. It specifies procedures for sampling, extraction, and analysis aimed at ensuring that residual levels do not exceed acceptable limits set forth in various regulatory frameworks.
- ISO 11135:2017 - Sterilization of Medical Devices - Ethylene Oxide
- ASTM E2684-19 - Standard Practice for Sampling and Analysis of Residual Ethylene Oxide in Sterilized Products
The application of these standards ensures consistency across different laboratories, thereby facilitating accurate comparisons between results obtained from various sources. This is particularly important given the variability inherent in EO sterilization processes.
Industry Applications
- Medical device manufacturers ensuring compliance with regulatory requirements.
- Ophthalmic product companies validating the safety and efficacy of their products post-sterilization.
- Pharmaceutical firms guaranteeing the integrity of sterile medications during production.
In addition to these core industries, our expertise in EO sterilization residual testing can also benefit suppliers dealing with highly sensitive materials requiring stringent contamination control measures. By adhering strictly to ISO 11135 guidelines, we help maintain consistent quality standards across all sectors.
Use Cases and Application Examples
- Ophthalmic lens manufacturers conducting routine post-sterilization testing to ensure product integrity.
- Pharmacy chains verifying the safety of compounded sterile preparations before distribution.
- Medical device distributors ensuring that all items meet stringent quality assurance criteria prior to sale.
Our service has been instrumental in helping clients navigate complex regulatory landscapes, providing them with robust evidence demonstrating compliance. For instance, one leading ophthalmic company used our ISO 11135 testing services to successfully demonstrate that their lenses maintained optimal clarity even after rigorous sterilization processes.
