Measuring Potential Leachables in Single-Use Manufacturing Assemblies using Total Organic Carbon (TOC) Analysis

摘要

Regulatory agencies are increasingly requesting a more comprehensive evaluation of the potential contamination of biopharmaceuticals from leachables both from the container closure system used to store the biopharmaceutical and other possible sources such as the manufacturing system. To meet this demand, Total Organic Carbon (TOC) has been investigated as a possible technique that can be used to assess leachables from biopharmaceutical manufacturing equipment and thus provide data to assess the potential risk that biopharmaceutical manufacturing leachables pose to patient safety and product quality.