Case Studies - Published by Mass Spec Lab

Removing the Veil from Adhesive Characterization - Does Your Biomedical Device Adhesive Withstand Hydrolysis?


Hydrolytic stability of implantable biomedical devices is often essential to their performance, safety, biocompatibility and thus ultimately to their success in the clinic. In some applications such as drug delivery and scaffold based tissue engineering, controlled hydrolytic processes may be critical to both function and performance. Hydrolytic testing of biomedical devices and their components is not only a key R&D activity necessary for material selection and product development but is also a key element of regulatory submissions.

Hydrolytic testing requires exposure of the biomedical device to aqueous physiological conditions, generally accelerated by elevated temperature. Not only is the effect of exposure on device functionality evaluated but sensitive chemical analysis of the aqueous solvent (hydrolysate) is typically performed to screen for hydrolytic products. Optimally, selected analytical methods should chemically identify hydrolytic products, their source, and provide their quantitation for accurate risk analysis.

Liquid chromatography coupled to UV and mass spectrometry (MS) detectors has been increasingly used for the detection of biomedical device material leachables and extractables and hydrolytic products. This technique affords chromatographic separation, UV and MS detection in a single experiment, and routinely allows detection of analytes at sub part per million (ppm) levels in high sensitivity instruments. LC-MS analysis can be expected to provide rich chemical information on important analytes, e.g. polar aliphatic non-volatiles, otherwise not detectable by more traditional GC-MS and LC-UV techniques.  Click Here to Read Study

Copyright ©2015 - Mass Spec Lab Case Study
Authors:  Marie Dvorak Christ, Ph.D. & Michal Kliman, Ph.D.

Are Raw Material Contaminants Compromising Your Final Product?

Rapid Identification of Unknown Plastics Raw Material Impurities by Accurate Mass Spectrometry and MassFrontier Spectral Interpretation Software

Plastics are fundamental constituents of biomedical devices and of containers and closures (C&Cs) used in packaging of parenteral therapeutics. Leachables and extractables (L&E) residues from these plastics are a common concern of regulated medical industries. Pharmaceutical, biomedical device and therapeutic biologics all require in-depth characterization of residual analytes (ISO 10993-18:2005 and 10993-13:2010) detected in their plastic component leachates and extracts.

Plastic additives such as antioxidants, heat stabilizers, UV absorbers, and mold release agents are common L&E residuals released by plastics. Another obvious, but somewhat neglected source of plastic residuals are plastic contaminants - not prescribed additives –but compounds inadvertently introduced during plastics manufacturing. This case study focuses on the chemical identification and quantification of an acrylic plastic L&E residual compound which was introduced into the plastic as a low level contaminant of one of the monomer raw materials used in the acrylic polymerization manufacturing step.The study highlights how a low level contaminant of a raw material can become a prominent L&E residual, and how mining of analytical data with sophisticated software tools helps to uncover its origin and structure.

In practice, a minimum analytic characterization of plastics extracts for regulatory purposes includes liquid chromatography with UV detection(LC/UV). Low concentration plastic residuals analyzed with LC/UV can yield intense UV signals. However, identification and quantification, which are often needed to support product risk analysis requirements codified in numerous international regulatory guidances (ISO 14971:2007, USP<1663> and USP<1664>), are limited with LC/UV. Often, LC/MS provides the only practical analytical avenue for chemical identification of ppm level L&E analytes.

This case study highlights the analytical power of “accurate mass” mass spectrometry in the chemical identification of an unknown, ppm-level analyte extracted from a long-term implantable (Class III) acrylic ophthalmic device. The LC/UV-PDA/QTof-MS instrument used in this study proved to be an effective “qual/quant” tool for this application.    Click Here to Read Study

Copyright ©2015 - Mass Spec Lab
Authors:  Marie Dvorak Christ, Ph.D. & Michal Kliman, Ph.D.