A review on importance of cleaning validation protocol for punching machine

Abstract

Pharmaceutical manufacturers must validate their cleaning process to ensure compliance with standard regulato- ry authorities. Manufacturing and cleaning equipment must be designed for effective and consistent cleaning to avoid cross-contamination and the cleaning processes must be verified as effective. A tablet punching machine is a mechanical device that compresses powder into tablets of uniform size and weight. Cleaning Validation of punch- ing machine verify the effectiveness of the cleaning procedure for product residues, degradation products, preser- vatives, excipients and/or cleaning agents so that monitoring may be reduced to a minimum in the routine phase, and to ensure that there is no risk with cross-contamination of active ingredients. It is a prime customer require- ment since it ensures the purity and safety of the product. To achieve these, cleaning procedure need to be vali- dated; sampling and analysis will be carried out for this purpose to assure that the cleaning of complies with speci- fied limits. Cleaning validation will verify the effectiveness of cleaning procedure.