Cleaning Validation | Measurement of Drug Component Residues (Swab Method)

Cleaning Validation

Measurement of Drug Component Residues (Swab Method)

Cleaning validation is performed in the pharmaceuticals industry to confirm that manufacturing equipment has been properly cleaned. This testing, aimed at preventing the ingress of foreign matter and cross-contamination by drug products previously handled by the manufacturing equipment, is essential for quality control and to maintain safety. The high-performance liquid chromatograph (HPLC) can be used to evaluate drug residues in manufacturing equipment. However, this method is lengthy due to the pretreatment required, including solvent extraction and, in some cases, concentration.

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.

Swab Sampling for Cleaning Validation

Swab/Direct Combustion Carbon Analysis System

Combining the SSM-5000A Solid Sample Combustion Unit (right) with a TOC-V Series Total Organic Carbon Analyzer (left) enables the analysis of TOC in both liquid and solid samples, including soil, sludge, and sediment.
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.

For Research Use Only. Not for use in diagnostic procedures.

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