Application note: Online cleaning validation for real-time equipment release using total organic carbon, inorganic carbon and conductivity data
Cleaning validation is an important element to current good manufacturing practice (cGMP) manufacturing to ensure purity, quality and potency of drug product. Above all, patient safety is the primary concern.
Demonstrating a validated cleaning process has been a regulatory requirement for many years. Today, many manufacturing facilities still follow the historical practice of capturing grab samples and swabs for laboratory analysis for total organic carbon (TOC) and conductivity to satisfy this requirement.