Validation Of A Clean In Place System On A Capsule Filling Machine

Cleaning may be defined as the physical or chemical removal of undesirable substances from apparatus surfaces. All substances remaining in the finished product or within processing equipment are contaminants. The current good manufacturing practice (cGMP) regulations emphasize that cleaning is a critical issue to ensure product quality. In response to compliance and other manufacturing and quality-related issues, clean in place systems and technologies have been applied to pharmaceutical processing equipment to facilitate validated cleaning.

The aim of this study was to validate the automated clean in place system installed on a capsule filling machine to determine its ability to adequately eliminate contaminants. The results obtained from the proposed cleaning validation trial showed that all the soluble tracer was removed after the washing procedure. At the end of the CIP procedure, the discharged water had the same pH, phosphate content, and total organic content as the supplied water.