Cleaning Validation

Hi, can anyone please assist/ comment on the following:

What is your opinion about the procedure for cleaning validation of a dedicated transportation/ tranfer pipe or hose made of e.g. PVC? The PVC pipe is dedicated to a specific product. Does one have to show cleaning studies on this piping?



In my opinion there is no need for a cleaning validation for dedicated pipes or hoses, as long as they are cleaned and visibly clean (we use clear PVC hoses to allow for inspection). The issue with dedicated equipment usually comes from degradation products from product residues potentially left in the equipment, so if you keep visual cleanliness there is a reasonable assurance that there is not sufficient product left to generate critical degradation product levels.

Best regards


if pipes are too long to be verified by a visibly procedure, you probably need to rinse your pipes with purified water and then to measure rinsed water conductivity or TOC.