Re-Thinking PAT For Cleanability

Practical and Achievable Perspectives for Changing How You Think About Cleaning Validation

By Jon Yourkin, GE Analytical Instruments

The Food and Drug Administration (FDA) released a document in 1993 that was intended to transform how the pharmaceutical manufacturing industry was cleaning or not cleaning. The FDA repeated history in 2006 and tried to transform how this same industry could have better quality and cost effective manufacturing systems comparable to very efficient potato-chip and laundry-soap manufacturers.¹ The document that is called Guidance for Industry: PAT (Process Analytical Technology) – A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance intrigued the interest of many analytical instrument vendors-but received a lukewarm response from the majority of pharmaceutical manufacturers. And after almost ten years of this document being alive and supporting cGMPs for the 21^st Century – the industry continues to refuse the call to adventure to adopt PAT or the valuable concepts within the PAT Framework. In addition, pharmaceutical manufacturers have been jumping over hurdles for twenty years with the concepts of cleaning validation and the question of “how clean is clean?” Why is this the case and is there a connection between the two?