Validating a manufacturing process for a pacemaker

With all types of manufacturing operations facing increasingly stringent industrial safety regulations and fines, today’s best practices include testing 100% of critical materials as part of a QA/QC program.

And when it comes to medical implants, lives may depend on the correct identification.

Patients who have metal allergies can even suffer from chronic fatigue syndrome as a result of titanium in their body. One article published on behalf of the European Society of Cardiology reported that after a patient had an allergic reaction to the metal components in their standard pacemaker, a gold-plated generator and polyurethane leads were implanted.

This replacement is considered effective in selected cases and did indeed work for this patient.

As most of us know, gold is one of the top ten most precious metals, but in the case of cardiac pacemakers, titanium is a pretty precious metal as well.

Process Validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard.

Process validation is an ongoing process that must be frequently adapted as manufacturing feedback is gathered.

Pacemakers are medical implant devices that can stimulate the human heart muscle and regulate the heartbeat.Portable X-ray fluorescent analyzers are ideal for ensuring material chemistry specifications are met.XRF is a nondestructive technique that can determine the elemental composition of a sample within seconds, helping to ensure that no incorrect or out-of-specification metal alloys caused by material mix-ups, lost traceability, incorrect weld chemistry and dilution, or even counterfeit materials enter the manufacturing process.Process Analytical Technology is used to measure critical process parameters (CPP) and critical quality attributes (CQA).PAT facilitates measurement of quantitative production variables in real time and allows access to relevant manufacturing feedback.

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