Jordi Labs is one of the world’s leading authorities in the field of medical device analytical chemistry and laboratory testing. It is a deceptively broad field of analysis, comprising routine physical testing and complex product deformulation, alongside contamination and failure investigations. Each of these analytical requirements can be subdivided into varying technological branches and areas of application. At Jordi Labs, we must work closely with clients to understand the unique manufacturing, storage, and operating conditions of distinct products to provide a reliable medical device analytical chemistry service with both quantitative and qualitative results.
Our holistic approach to medical device analytical chemistry is best exemplified by our approach to extractables and leachables (E&L) testing. This is a multi-step process in which our chemists design a bespoke study from the ground up. Background information regarding the composition and usage conditions of the device informs the E&L study’s pathway. This includes determining the sample selection and extraction conditions, alongside the necessary analytical techniques.
An arrangement of multiple analytical technologies is typically used to detect, identify, and quantify E&L contaminants in medical devices. This ensures medical device analytical chemistry is carried out to the most rigorous quality control (QC) measures.
The technological capabilities of any medical device analytical chemistry laboratory must be matched by the experience of chemists running the study. Gas Chromatography Mass Spectrometry (GCMS), Liquid Chromatography Mass Spectrometry (LCMS), Nuclear Magnetic Resonance Spectroscopy (NMR), Fourier Transform Infrared Spectroscopy (FTIR), and many more techniques can be applied to acquire and qualify results, but successful and rapid analysis must be handled by chemists with a working knowledge of identifying unknown elements.
Our chemists have been providing support for medical device manufacturing, research, and QC practices for years. This has instilled us with confidence and credibility when it comes to identifying unknowns and tracing them back to the origin of contamination. Our medical device analytical chemistry service is subsequently one of the most rounded available worldwide.
Medical Device Analytical Chemistry with Jordi Labs
Jordi Labs has been providing medical device analytical chemistry services for manufacturers and researchers for decades. Our facilities are equipped with an array of techniques to ensure that our service is as reliable as possible. Feel free to contact a member of our team to find out more or explore some of our pharmaceutical lab testing technical notes below.
E&L testing is conducted on the small molecules present in a polymer system including antioxidants, surfactants, slip agents, plasticizers, acid scavengers, crosslinking agents, lubricants, residual monomers and oligomers.
Jordi Labs offers different methods to assist in the determination of the physical properties of your materials. We routinely work with our customers to assist in studying stability, stiffness, impact resistance, melt flow index, tensile strength and more.
Jordi Labs has provided support for 510(k) premarket notifications of surgical instruments and medical devices and has extensive experience in determining extractables and leachables.