Non-Polar Extractables Screening by LC-MS/MS
The Non-Polar Extractables Screening using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) is a critical analytical technique employed in the medical device industry to identify and quantify non-polar compounds that may be extracted from materials used during manufacturing. This service ensures regulatory compliance, product safety, and reliability by providing detailed insights into potential contaminants or impurities.
Non-polar compounds are typically present in materials such as polyethylene (PE), ethylene vinyl acetate (EVA), and other hydrocarbon-based polymers. These materials often come into contact with medical devices during various stages of production, including molding, coating, or sterilization processes. Identifying non-polar extractables is crucial to ensure that these compounds do not adversely affect the performance or safety of the final product.
The LC-MS/MS method leverages the high sensitivity and selectivity of tandem mass spectrometry to detect even trace amounts of non-polar substances. This approach allows for precise identification and quantification, which is essential for understanding potential risks associated with these compounds. By screening for known and unknown contaminants, manufacturers can take proactive steps to mitigate any adverse effects on patient safety.
The process begins with thorough sample preparation, where the material in question is immersed in a solvent capable of extracting non-polar compounds. The extracted solution is then analyzed using LC-MS/MS. This method involves several key steps:
- Sample extraction
- Solvent evaporation
- Cleanup and concentration (if necessary)
- Injection into the LC-MS/MS system
The instrumentation used for this service includes a state-of-the-art LC-MS/MS system capable of detecting non-polar compounds down to parts per billion levels. This level of sensitivity ensures that even trace amounts of contaminants can be identified and quantified.
Following analysis, the results are thoroughly reviewed and reported in accordance with relevant international standards such as ISO 10993-18:2017 and USP . The report includes detailed information on the detected compounds, their concentrations, and any potential risks they may pose. This comprehensive approach ensures that all stakeholders have access to accurate and reliable data.
The Non-Polar Extractables Screening by LC-MS/MS is a vital service for medical device manufacturers looking to ensure product safety and compliance with regulatory requirements. By identifying and quantifying non-polar extractables, this service helps to minimize the risk of adverse effects on patients using these devices.
Benefits
- Precise identification and quantification of non-polar extractables down to parts per billion levels
- Compliance with international standards such as ISO 10993-18:2017 and USP
- Proactive risk management by identifying potential contaminants early in the manufacturing process
- Thorough sample preparation and analysis ensuring accurate results
- Detailed reporting with actionable insights for stakeholders
- Expertise and experience in medical device testing, providing reliable and compliant solutions
Eurolab is a leading provider of medical device testing services, offering comprehensive solutions to ensure product safety and compliance. Our team of experts brings years of experience in the industry, ensuring accurate and reliable results.
We provide a range of services tailored to meet the specific needs of our clients, from basic testing to complex multidisciplinary studies. Our advanced equipment and state-of-the-art facilities allow us to offer high-quality services at competitive rates. Eurolab is committed to delivering exceptional service and support, ensuring that every client receives the best possible outcome.
Our commitment to quality and reliability is reflected in our compliance with international standards such as ISO 10993-18:2017 and USP . We are dedicated to helping our clients succeed by providing accurate, reliable data that meets their requirements. Trust Eurolab for all your medical device testing needs.
Competitive Advantage and Market Impact
Eurolab’s Non-Polar Extractables Screening service sets us apart from other laboratories in the market by offering a comprehensive, high-quality analysis that ensures regulatory compliance and product safety. Our expertise in this area allows us to provide accurate results even for complex samples.
We are dedicated to staying at the forefront of medical device testing, continuously investing in advanced equipment and training our staff to ensure we can meet the evolving needs of our clients. By offering reliable and compliant solutions, Eurolab helps manufacturers reduce risks associated with non-polar extractables and enhance product quality.
Our commitment to excellence is reflected in our numerous satisfied clients across various sectors, including healthcare, pharmaceuticals, and medical devices. Trust Eurolab for all your medical device testing needs, ensuring that you can deliver safe, compliant products to the market.
