Cleaning Validation by TOC Analyzer

Introduction

To ensure quality control and safety in manufacturing facilities within the pharmaceutical industry, it is important that cleaning validation be conducted following the c leaning of production-related equipment. Cleaning validation ensures that the quantity of residual substances collected from the surfaces of the equipment is within permissible limit. Depending on the sampling method and measurement method used for this cleaning validation using a TOC analyzer, the following 3 types of methods are available. (1) Rinse sampling - TOC measurement method (2) Swab sampling - aqueous extraction - measurement method (3) Swab sampling - direct combustion carbon measurement method Here we introduce the features of each of these methods, using the TOC-L_CPH total organic carbon analyzer in the measurement of residual pharmaceutical products and their constituent substances.

November 22, 2011 GMT