Cleaning Validation of a Manufacturing Line using CIP-100 Detergent and a Clean-in-place Skid System

Abstract

Cleaning Validation is a prime element of control to the cross contamination and potential carry over topic at the manufacturing industry. This process must assure the quality, safety and efficiency of cleaning process for residual materials from previous batches manufactured in the same manufacturing line. The cleaning effectiveness will be determined by using critical quality attributes verification methods such as: Visual inspection, Analytical residues determination for total organic carbon (TOC),Microbial testing and Conductivity readings (in-line instruments for CIP100).Indirect method will be used as the only method because all sampling points are rinse samples (liquid).Providing documented evidence that the method employed at the facility consistently controls impurities that can be hazard to the human health. Key Terms⎯ Clean-In-Place (CIP) Skid System, Contamination, Cleaning Validation, Validation.