Productive cleaning validation relies upon knowing medical device requirements and clearly defining processes

By Barbara Kanegsberg and Ed Kanegsberg, BFK Solutions LLC

C leaning process validation is essential for the manufacture of many high-value products. The important steps in a cleaning validation program vary depending on the type of manufacturing as well as on the specific product under consideration. This article emphasizes considerations and principles that are important in medical device and other life-science area manufacturing processes; however, the approaches and principles can be used for many applications.

Why validate critical cleaning processes for medical devices?

In many cases, the initial response to this question is something akin to “well, we are required to.” The correct, critical cleaning processes are essential to achieving the appropriate surface quality, attributes, and levels of contamination for the particular needs of the product and application. Validating the critical cleaning processes used in fabricating implantable medical devices is an important factor in successful interaction with regulators and in achieving a high-quality, high-performing product.

It is important to define internal customers and external customers, as well as current and future customers. Who is your “audience”? Manufacturers have to demonstrate and document quality and consistency in terms of product performance and product safety. Increasingly they also must demonstrate environmental acceptability.

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