The biopharmaceutical industry has for a long time suffered inconsistent reliability performance of valves and diaphragms. The cost of a single batch failure can run into the millions of dollars while unplanned production stoppage and contamination investigations consume vast amounts of resources. One cause can be poor maintenance practices by the user, but as lessons are learned and practices improved, the spotlight is shifted. End users increasingly expect valve and diaphragms to deliver more consistent reliability performance through better product design, reliability testing, and improved change control. To enable this much needed transition, the time is right for the bio/pharmaceutical industry and valve and diaphragm suppliers to change the way they do business with each other.
A few years after this was published ASME-BPE adopted the recommendations and created a type-test standard