Cleaning Validation And Verification In A High Potent Granulation Suite

As seen in Manufacturing Chemist, January 2023 issue

When manufacturing highly potent solid oral dosage forms, taking an effective approach to cleaning the equipment used is paramount. Process experts at PCI Pharma Services share more about cleaning validation and verification, the differences between the two … and why they’re so important.

Ben Potter, Validation Manager at PCI Tredegar, describes cleaning validation as “a documented process which proves that a cleaning procedure can effectively remove drug product, agents and microbial contamination from a specific piece of equipment to below the scientifically set maximum allowable carryover limit. Importantly, the procedure must be reproducible.”

“At PCI Tredegar,” adds Amala Alex (AA), Cleaning Validation Specialist, “cleaning validation is in place for any shared equipment that’s used to manufacture and package drug products. When cleaning validation is not set up — or prior to completion — we adopt a standard approach for all products and equipment by performing cleaning verification.”