Puhastusvalideerimine

Puhastusvalideerimine refers to the documented evidence that a cleaning procedure consistently removes and/or removes residual contamination to a predetermined acceptable level. This process is critical in industries where product integrity and patient safety are paramount, such as pharmaceuticals, medical devices, and food processing. The goal is to ensure that manufacturing equipment is free from residues of previous products, cleaning agents, or microbial contamination before the next manufacturing run.

The validation process typically involves developing a cleaning protocol that outlines the specific steps, cleaning agents, and equipment used. Subsequently, samples are taken from the cleaned equipment and analyzed using validated analytical methods. These methods are designed to detect and quantify trace amounts of residues. Common analytical techniques include High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and Total Organic Carbon (TOC) analysis. Swab samples or rinse samples are collected and analyzed.

Acceptance criteria are established beforehand, defining the maximum allowable levels of residues. These criteria are based on factors such as the toxicity of the previous product, the solubility of residues, and regulatory guidelines. Successful validation demonstrates that the cleaning process is effective and reproducible, minimizing the risk of cross-contamination. Revalidation is often required periodically or when significant changes are made to the cleaning procedure, equipment, or products.