Cleaning Calidation of Equipments used in Manufacturing of parenteral in pharmaceutical industry

Abstract

The cleaning validations of three different batches were performed in parenteral production line at Karnataka Antibiotics and Pharmaceuticals Limited, Bangalore.The cleaning validations were performed by evaluating parameters with the acceptance limits. Such as,Major parameters like total residual content, TOC analyzing, microbial count etc.Minor parameters like pH, conductivity, clarity of solutions, visual inspectionetc.The result of each parameter indicates the satisfactory completion of cleaning validation. It was concluded that the cleaning procedure followed is appropriate and which can maintain the drug residues in intend level as per company requirements.So the next batches, which manufacture on same equipments will free from all contaminations and cross contaminations like previous materials, detergents,