Total Organic Carbon Analysis (TOC) for Cleaning Validation

Total Organic Carbon Analysis (TOC) for Cleaning Validation

In order to ensure cleaning validation, safety and quality control in production facilities, all equipment used in the production process must be cleaned effectively with appropriate methods. The main purpose of cleaning validation is to eliminate any residues or residues that may occur in the production equipment and area. At the same time, after cleaning equipment, Cleaning Validation is carried out to determine the effectiveness of cleaning.

At the end of the Cleaning Validation, the amount of residual material in the equipment or the production area is above the limits, which is the main reason for the contamination of products such as pharmaceuticals, cosmetics and medical products. In Cleaning Validation, total organic carbon analysis (TOC) is performed. All organic carbon in the products is measured by TOC Analysis, which is carried out with three different methods, namely the Rinse Water Method, the Direct Swap Extraction Method, and the Direct Swap Incineration Method. Thus, the entire residual amount can be determined at the ppb level.

TOC Analysis in Brief: It is a method that is carbon specific, based on the worst scenario, measures all existing organic carbon, is cost-effective and measures all existing potential residues at a sensitive level such as ppb level in a short time. .