Cleaning Validation of Equipments in Bulk Drug Manufacturing Facility for Lignocaine Hydrochloride by using HPLC

Abstract

In most pharmaceutical manufacturing facilities, the effectiveness of a cleaning process is determined by monitoring the residues of only one compound (active ingredient). But in an API facility unlike in pharmaceutical production, during which is stable and unchanged throughout the entire process. API manufacturing may involve different chemical entities. Therefore, it is very important to choose which chemical entities will be monitored to determine the effectiveness of the cleaning process. A short lived and highly reactive intermediates would not be a good compound to monitor. The choice of the chemical entity also depends on the accuracy and limit of detection and method of analysis of the particular depend i.e. it should be suitable according the acceptance criteria's. In API manufacturing facility another area of concern is that most of the equipment comes in contact with intermediates for which no medical response levels are known and toxicity data is not available, hence it's well advised to consider the potential levels of precursors and intermediates remaining on equipment. It recommended to identity precursors and intermediates and begins to study their levels carefully during the manufacturing process. Later, purification steps in manufacturing process remove many of these materials and hence they may not cause any problem.