Measurement of Drug Component Residues (Swab Method)
Since a total organic carbon analyzer (TOC) does not require sample pretreatment, it can rapidly detect the amount of drug residues. Sampling methods for cleaning validation include rinse sampling and swabbing. Both the US FDA and the Japanese Ministry of Health, Labour and Welfare strongly recommend the swabbing method. Swabbing physically samples the adhered residues by wiping a fixed area of the equipment with swab material. It is able to wipe off insoluble substances that are difficult to collect by rinse sampling.
The TOC-V Series Total Organic Carbon Analyzers can be combined with the SSM-5000A Solid Sample Combustion Unit for direct measurement of the swab material without the need for conventional sample extraction from the swab in water. This significantly improves the speed and accuracy of the measurements.
Measurements by swab direct combustion offer highly sensitive detection of water-insoluble contaminants that are difficult to detect by rinse sampling or by swabbing and solvent extraction.