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Sum parameter – Total Organic Carbon
TOC –Determination in cleaning
validation - swab method
SCA-130-203
Cleaning validation substantiates the ■ Sampling and analysis
effectiveness of a cleaning process and In COP cleaning, the wiping method (swab) is
ensures that no residues remain on the used for sampling of visible residues. These
surfaces of the production equipment. For the include coatings, crusts, material deposited in
detection of contaminations, validated corners and edges, and especially poorly
analytical methods must be used that are soluble substances. The swab can be
sensitive enough to determine the defined extracted in a solvent and the extracted
acceptable residue level. In general, residue solution is subsequently analyzed. If water is
limits of 10 ppm or 1/1000 of the usual used for extraction, TOC analysis is suitable
therapeutic dose of an active substance are for subsequent analysis. Alternatively, the
used as acceptance criteria. swab can also be measured directly (using a
carbon-free swab) using a TOC solid-sample
module.
■ Measuring system for the swab test
The modular design of Shimadzu’s TOC-L
series now enables the additional
determination of the swabs using the same
instrument. For this purpose, a solid-sample
module (SSM-5000A) was connected to the
main instrument, either a TOC-L series
combustion system or the wet-chemical
model of the TOC-V series.
■ Cleaning methods: Clean out of Place
For COP cleaning, the entire production
system must be disassembled and the
components must be cleaned individually.
This procedure is very time consuming and
labor intensive. Due to the individual For TC determination, the swab is placed in a
cleaning, this procedure cannot be ceramic boat and transferred into the oven,
standardized. Advantages are, however, the which is heated to 900 °C.
low investment costs of the system and the
possibility of visual inspection.
