Understanding the Cleaning Validation Processes

“Know and understand the cleaning processes you must validate” Dawn Tavalsky orated in the finale of her workshop at 17th Annual Validation Week. According to Tavalsky, the FDA process validation stages can apply to cleaning validation. Stage 1 are the phases that precede the purification steps; Stage 2 involves the steps regarding product purification and conjugation; Stage 3 is the final formulation and filling. 

Tavalsky continued to emphasize the importance of understanding cleaning equipment and equipment flow. Explaining an example of equipment flow, Tavalsky said “Equipment can come in to the central cleaning services area…and any of that equipment can go back out to any one of those buildings again…everything is shared, nothing is dedicated…from a validation perspective, that’s hugely difficult.” 

Tavalsky also discusses different cleaning systems; namely clean-in-place (CIP), clean-out-of-place (COP), cabinet washer, and manual cleaning. Focusing on first CIP, Tavalsky explained the intricacies of CIP flow.

Moving next to manual cleaning, she asks “can you validate manual cleaning?” Tavalsky argues that you can; procedures just need to be specific. “There is a difference between a 200-pound, six-foot-two man and a 140-pound woman. They’re going to scrub differently; they are going to have different pressures they apply.” “You have to make the cleaning prescriptive enough that it works for the worst-case situation,” Tavalsky says with a smile, “I don’t want to call a woman the worst-case situation, but when it comes to force, she might be!”  “The other problem we have with manual cleaning,” Tavalsky continues, “is that the equipment can come at you in different soil levels.” For example, when manually cleaning a tank, a tank can be a quarter-full of material or almost none at all. “We got to do what we call ‘gross debris removal.’” This is a process that precedes cleaning validation wherein the equipment is cleaned to a visually clean baseline.

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