Total Organic Carbon (TOC) Analysis of Pharmaceutical Cleaning Validation Samples Application Note

Introduction Total organic carbon (TOC) analysis provides a quick and efficient analytical process for cleaning validation in the pharmaceutical industry. When a single piece of equipment in a pharmaceutical manufacturing facility processes different active pharmaceutical ingredients (APIs), cross-contamination between products must be kept to an absolute minimum. Cleaning validation is the overall process that ensures that equipment cleaning processes and procedures are removing product and cleaning agent residues to predetermined levels of acceptability as required by 21 CFR 211.67, which states that “equipment and utensils shall be cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements”.1