Plan twice; validate once is a prudent variant of the adage. Cleaning validation is a hurdle in many applications, including aerospace, microelectronics, pharmaceuticals, and medical device manufacture.
The term “validation” is often associated with life science applications that are regulated by the FDA or analogous agencies world-wide. We choose to broaden the use of the term to include verification and documentation of cleaning processes in any industry that produces critical product. In this broader context, cleaning validation involves assuring the efficacy for the product being assembled and assuring that the product does not compromise the health and safety of either assembly workers or users of the product. In this context we are discussing cleaning, not sterilization. That is, cleaning validation means demonstrating and documenting that interfering residue, alive or dead, is reduced to an acceptable level.
