How Medical Device Manufacturers Can Improve Quality by Applying the Principles of Process Analytical Technologies (PAT)

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چکیده

This white paper reviews how the Process Analytical Technologies (PAT) originally developed by the FDA for the pharmaceutical industry can also improve quality and efficiency in medical device manufacturing. The underlying principle of the PAT approach is that quality should be designed into the product based on a fundamental understanding of the critical manufacturing processes. This understanding is derived from the wealth of data collected by real-time process analyzers, which is then analyzed, organized and stored using multivariate tools and highly integrated information management systems. These tools provide the basis for a process control methodology that manages product quality in real-time, instead of the traditional batch-based approach. This leads to the implementation of a Real-Time Release strategy, where product quality is evaluated in real-time, on a part-by-part basis, based on the process data. This ensures not only a higher level of product quality, but also improves throughput and efficiency. To demonstrate how the principles of PAT can be applied to medical device manufacturing, a simplified example consisting of a single resistance weld process is explored. From developing the process using a series of DOE trials, to volume manufacturing using the real-time release strategy, and the collection of detailed device history records, we show how the PAT process can be applied to a medical device, and how much the manufacturer stands to gain. Applying the Principles of PAT ii

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تاریخ انتشار 2010