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.
