Extractables Testing After Real-Time Aging
In the medical device industry, ensuring patient safety and regulatory compliance is paramount. Extractables testing plays a critical role in this regard by identifying potential contaminants that could leach out of a device during use or storage conditions. The procedure involves subjecting the material to real-time aging followed by extraction with solvents under controlled conditions. This approach simulates realistic environmental factors such as temperature, humidity, and time, providing more accurate data on what might be released from a medical device over its lifecycle.
Real-time aging helps replicate long-term exposure scenarios, which is essential for understanding the stability of materials used in devices like implants, infusion pumps, or catheters. By performing this test after aging, manufacturers can better predict and mitigate risks associated with extractables leaching into biological systems. Regulatory bodies worldwide emphasize the importance of such testing; it aligns closely with standards like ISO 10993-18, which outlines guidelines for determining potential harmful substances from medical devices.
The process begins by selecting appropriate solvents based on expected contact scenarios between the device and body fluids or tissues. Common solvents include water, ethanol, acetone, methanol among others depending upon the intended use of the product. Specimen preparation involves cutting samples into standard sizes, sterilizing them if necessary, and placing them in containers that mimic actual packaging or storage conditions.
Once prepared, these specimens undergo accelerated aging processes designed to simulate years' worth of real-world usage compressed into weeks or months. These processes typically involve exposure to heat, light, and humidity levels far exceeding those experienced by the end user but within specified limits set forth in industry guidelines such as ISO 10993-25. After completion of the aging phase, samples are extracted using suitable solvents according to predefined methods outlined in relevant standards.
Extracted compounds are then analyzed through various analytical techniques including HPLC (High Performance Liquid Chromatography), GCMS (Gas Chromatography Mass Spectrometry), ICP-MS (Inductively Coupled Plasma Mass Spectrometry), among others. Analytical results provide insights into the types and concentrations of potential extractables present in different parts of the device.
Compliance with regulatory requirements is critical when conducting extractables testing after real-time aging. Laboratories must adhere strictly to recognized international standards such as ISO 10993-25, USP , EU MDR Annex I Section V. Rigorous quality assurance measures ensure accurate and reliable data generation during every step of the process from sample preparation right through to final reporting.
Our laboratory offers comprehensive extractables testing services tailored specifically for medical devices subjected to real-time aging conditions. With state-of-the-art facilities equipped with cutting-edge instrumentation, our team of experienced professionals can handle complex specimens ranging from small implantable components to large infusion systems. Our commitment to precision and accuracy ensures that clients receive precise results necessary for making informed decisions about their products.
Why Choose This Test
- Replicates long-term exposure scenarios for more accurate data on potential contaminants that could leach out of a medical device over its lifecycle.
- Better prediction and mitigation of risks associated with extractables.
- Rigorous quality assurance measures ensure accurate and reliable data generation during every step of the process from sample preparation right through to final reporting.
- Our team of experienced professionals can handle complex specimens ranging from small implantable components to large infusion systems.
Customer Impact and Satisfaction
By providing precise results necessary for making informed decisions about their products, our laboratory ensures that clients receive the information they need to meet regulatory requirements while maintaining high levels of quality assurance. This not only enhances product safety but also builds trust with customers and regulators alike.
We strive to exceed expectations by delivering timely delivery of accurate reports backed by robust evidence. Our commitment to excellence in every aspect of our service has earned us a reputation as one of the leading laboratories in the field. We continuously invest in training our staff, updating our technology, and expanding our capabilities to meet the evolving needs of our clients.
Environmental and Sustainability Contributions
In addition to supporting customer success through reliable testing services, we also contribute positively towards environmental sustainability efforts within our industry. By offering accurate data that helps reduce risk early in the product development cycle, we minimize unnecessary changes later down the line. This reduces waste associated with rework or recalls.
We also prioritize energy efficiency and resource conservation across all operations at our facilities. From optimizing laboratory procedures to sourcing eco-friendly packaging materials, we strive to operate sustainably without compromising on quality standards.
