Total Organic Carbon Analysis

Introduction

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. In the swab method, a fixed area of the equipment surface is iped with the swab material, and the residues adhering to the material are physically collected and analyzed. This allows sampling by just wiping up adhering substances, which are often difficult to sample by the rinse method if any of the adhering substances are insoluble. Using the "swab / direct combustion carbon analysis method" with the combination of Shimadzu's TOC analyzer with the SSM-5000A Solid Sample Combustion Unit allows direct measurement of the carbon with the SSM-5000A. This is contingent on the use of a swab that consists only of inorganic material. Thus, quick, accurate measurement can be conducted even when there are insoluble residues, which are difficult to extract with water. Furthermore, no special pretreatment procedures are required to extract residues from the swab. This Application News introduces an example of measurement of a drug substance using the TOC-V_CPH Total Organic Carbon Analyzer with the SSM-5000A Solid Sample Combustion Unit.

November 13, 2009 GMT