The Sulzer Recall: How to Find Manufacturing Process Failures
Medical devices are justifiably highly regulated. Whether the device must comply with FDA regulations or the newer EUMDR requirements, everything from the original design to production must be planned, validated and controlled to ensure that a device that is implanted in the patient is exactly what was designed. In some cases, this thorough regulatory oversight […]
Pyrolysis GCMS of Adhesives
Deformulating low molecular weight and inorganic additives and fillers is relatively routine, but understanding the polymeric composition of a formulation is substantially harder. For composition analysis, more specialized techniques are required, such as Pyrolysis-gas chromatography-mass spectrometry (Py-GC-MS). In this case study, Py-GC-MS was used to examine two silicone adhesives. One adhesive reportedly had good adhesion […]