TOC Analysis in Cleaning Validation
The validation process is applied to ensure the safety and purity of a product, the quality and suitability of the process. The importance of cleanliness is an indisputable issue, especially in the pharmaceutical industry. Cleaning validation is the most important work in order to ensure the suitability of cleaning procedures applied in pharmaceutical production areas, reducing risk and ensuring quality assurance.The main purpose of cleaning validation studies is to determine appropriate residue limits. A risk-oriented approach has been developed to determine acceptable residue levels, and it is preferred to calculate residue levels based on toxicological data. With cleaning validation, it is aimed to develop more efficient and cost-effective cleaning processes.
In short, cleaning validation is the proper removal of product residues, degradation products, preservatives – cleaning agents from equipment, verifying the effectiveness of the cleaning procedure to prevent potential microbiological contamination.
Many different methods such as TOC, HPLC, UV/Vis, pH, conductivity can be used in cleaning validation systems. The TOC system is also one of the most preferred. The reasons for choosing TOC include reducing the number of methods in the laboratory and optimizing the cleaning process.
Currently, the TOC method is preferred as the most effective and efficient method. With the TOC method, the worst case scenario is taken into account, the process is carried out considering the factors that may cause many pollution, the maximum acceptable residue limit is reduced.
