Swab / Direct Combustion Analysis of Detergent Residue Using SSM-5000A

Introduction

Cleaning validation with respect to production equipment at pharmaceutical facilities refers to the scientific verification that residues of previously processed products and detergent used for equipment cleaning, as well as foreign material from the environment in the production equipment, do not exceed specified permissible limits. HPLC (high performance liquid chromatography) is often used to conduct this evaluation, however, detection with HPLC is often difficult due to the large number of constituents in detergents, and further, measurement is not easy when preparation, such as sample enrichment, is required. On the other hand, if a TOC (Total Organic Carbon) analyzer is used, the residual amount of detergent constituents is easily detected because all of the carbon-containing substances are 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 wiped with the swab material, and he 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” in conjunction with the combination of Shimadzu’s TOC analyzer with the SSM-5000A Solid Sample Combustion Unit allows direct measurement of the carbon in 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 in the case of insoluble residues that are difficult to extract with water, without the need for bothersome pretreatment procedures to extract residues from the swab. (See steps in Fig. 1.) This Application News introduces an example of measurement of detergent using the Total Organic Carbon Analyzer TOC-V_CSH with the Solid Sample Combustion Unit SSM-5000A.

July 16, 2008 GMT