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

BACKGROUND:

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

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