Abstract

The pharmaceutical cleaning verification can be a challenging process due to the technicality of the analytical process and the hazardous nature of the contaminant on the surface of the manufacturing equipment. There are a number of parameters to be considered before the analytical method is selected for the cleaning verification. The most commonly used methods fall under two main categories: direct and indirect method. The direct method is where the cleanliness is verified directly by visual inspection or any other means where the contaminant is not removed from the surface of the manufacturing equipment. The principle of indirect methods involves the quantitative removal and analysis of the contaminant chemical from the surface of the equipment. This article provides an overview of the current analytical process used by the pharmaceutical industry and the trend of the future pharmaceutical cleaning verification process.

Keywords: Real-time cleaning verification; FTIR for cleaning verification; Cleaning verification; Direct and indirect cleaning; Future of cleaning verification