Our Extractables and Leachables Testing services ensure that materials used in packaging and medical devices do not release harmful substances into their contents, safeguarding consumer health and compliance with regulatory standards.
Extractables and Leachables Testing
Extractables and Leachables (E&L) Testing is a critical component in evaluating the safety of materials used in food and pharmaceutical packaging, as well as medical devices. Our comprehensive E&L testing services assess the potential release of harmful substances, ensuring compliance with safety regulations and protecting consumer health.
Understanding Extractables and Leachables
Extractables are substances that can be extracted from a material under exaggerated conditions, while leachables are those that migrate into the product during normal use. Testing for both is essential for:
- Material Safety: Identifying harmful compounds that could compromise the safety of the product.
- Regulatory Compliance: Meeting stringent regulations set by bodies such as the FDA, EMA, and ISO.
- Product Integrity: Ensuring that the functionality and effectiveness of the product are not compromised.
Our E&L Testing Services
We provide a variety of testing services tailored to your needs:
- Method Development: Customizing analytical methods to detect specific extractables and leachables in your materials.
- Testing Protocols: Conducting rigorous testing under controlled conditions to simulate real-world usage.
- Analytical Testing: Utilizing advanced techniques such as GC-MS, LC-MS, and FTIR to accurately identify and quantify extractables and leachables.
- Risk Assessment: Evaluating the potential health risks associated with detected substances.
- Reporting and Documentation: Providing detailed reports that meet regulatory submission requirements, including recommendations for risk mitigation.
Benefits of Our E&L Testing Services
Engaging our E&L testing services offers several advantages:
- Expertise in Compliance: Our team understands the complexities of E&L regulations and can guide you through the testing process.
- Customized Solutions: We tailor our testing approaches based on the specific materials and applications of your products.
- Enhanced Consumer Safety: Identifying and mitigating risks associated with harmful substances reinforces consumer trust.
- Market Readiness: Ensure that your products are compliant and ready for market introduction.
Contact Us for Extractables and Leachables Testing
Ensure the safety and compliance of your products with our expert Extractables and Leachables Testing services. Contact us today to discuss your requirements and learn how we can assist you in maintaining the highest standards in product safety.
