A Cost-Effective Approach To Cleaning Validation And Verification

By Alexander Wellems, Ropack Pharma Solutions

A pharmaceutical contract services organization encounters many compounds at different phases of development and varying customer requirements. From fully developed large-scale manufacturing and packaging to a single development batch, the contract services organization must be prepared to handle multiple compounds in the same facility. One extremely important requirement is ensuring that the established cleaning procedures remove all residual Active Pharmaceutical Ingredients (APIs) from all product‐contact equipment parts utilized during manufacturing so that there is no risk of cross‐contamination.