A Review on Pharmaceutical Cleaning Validation

Abstract

The goal of this review is to establish the significance of cleaning validation in the pharmaceutical industry. Pharmaceutical product and active pharmaceutical ingredients (APIs) can be contaminated by other pharmaceutical products or APIs, by cleaning agents, by microorganisms or by other materials e.g. air borne particles, dust, lubricants, raw materials, intermediates, etc. Cleaning procedure is the process of assuring that cleaning procedures effectively remove the potentially dangerous substances from equipments. This can be minimized by proper cleaning of equipment, apparatus as well as the processing area. So it is necessary to validate the cleaning procedures to ensure safety, efficacy, quality of the subsequent batches of drug product and regulatory requirements in Pharmaceutical product manufacture. It briefly provides an overview on mechanism of contamination, cleaning mechanisms, cleaning agents, procedure of cleaning, and sampling techniques.