Cleaning Validation by TOC Analyzer with Easy Wiper

Introduction

In the pharmaceutical industry, "cleaning validation" where residues on manufacturing equipment are quantitated to verify whether the amount is within tolerance, has been a valuable criterion for quality control and safety. To perform cleaning validation by Shimadzu TOC analyzer, the following three methods are available depending on selected sampling and analysis methods. * Swab Sampling - Direct Combustion Method * Swab Sampling - Water Extraction-TOC Analysis Method * Rinse Sampling - TOC Analysis Method For sampling methods, there are the swab method and the rinse method, and the swab method is suitable for accurately evaluating the amount of residues. For analysis method, the direct combustion method can achieve an effective, rapid, and easy-to-perform analysis since it does not require any pretreatment process, such as sample extraction from swab materials. With these reasons, the swab sampling-direct combustion method using Shimadzu TOC analyzer is significantly effective as a method for cleaning validation. In past Application News which introduced the swab sampling - direct combustion method, a piece of quartz glass filter paper was used as the swab sampling material. When using this material, however, the method sometimes required re-cleaning of the equipment since fragments of the filter paper were left on surfaces. To avoid this difficulty, the method here uses Easy wiper, made of quartz glass fibers which leaves no fragments on swabbed surfaces. Here, we introduce the method using Easy wiper as the swab sampling material in the analysis of residual pharmaceutical products and their constituent substances.

January 19, 2017 GMT