Swab / Direct Combustion Carbon Analysis of Drug Residue by TOC-VCPH

Cleaning validation for production equipment at pharmaceutical facilities is an evaluation examination that is conducted to prevent cross-contamination from previously processed products and contamination due to foreign material.

Cleaning validation for production equipment at pharmaceutical facilities is an evaluation examination that is conducted to prevent cross-contamination from previously processed products and contamination due to foreign material. It is therefore an important process for ensuring quality control and safety. HPLC (high performance liquid chromatography) systems are used to evaluate and test for the presence of drug residues in pharmaceutical production equipment. However, when sample preparation requires the use of solvent extraction or enrichment, etc., this method can become quite complicated and time-consuming. On the other hand, since measurement using a TOC (Total Organic Carbon) analyzer requires no sample preparation, the quantity of drug residues can be quickly and easily detected.
The rinse method and swab method are two major sampling methods used in cleaning validation, however, the United States FDA and Japanese Ministry of Health, Labour and
Welfare evaluate highly and recommend the swab method.

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