Instrumentation For Product Control Vs. Process Control — Which Features Are Relevant For Monitoring High-Purity Pharmaceutical Water Systems?

By Dr. Anthony Bevilacqua, Mettler-Toledo Thornton

Pharmaceutical water systems represent the most critical facility for the most widely used excipient in pharmaceutical manufacturing. Whether used as an in process reactant, solvent, ingredient, or product (e.g. Sterile Water for Injection), water is a necessary material in any pharmaceutical operation, and the majority of required water is purified on-site. There is a direct correlation between the quality of the water system and the quality of the water. While it is the quality of the water that has direct potential for patient impact, it is the quality of the purification process that needs to be controlled. This discussion is not another article about the inherent value of quality by design, rather, focusing solely on the direct relationship between certain instrumental methods of analysis and their purpose.