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EQUIPMENT QUALIFICATION AND VALIDATION OF TABLET COMPRESSION MACHINE
P.Ramasubramaniyan*, N.Sharanya, Palanichamy.S, T.Srinag, P.Pavani, Solairaj.P
ABSTRACT Qualification an ideal step for equipment validation is the action undertaken to demonstrate the intended use and performance of the utilities and equipment. The individual steps of qualification such as design, installation, operational and performance qualification were done in order to qualify the equipment. Blue print of equipment validation was also included. In this article the compression parameters such as compression force, turret rpm and feeder rpm were studied. The process capability of the equipment was studied by observing the weight of 20 tablets, disintegration time, friability, individual weight variation, thickness and hardness. These parameters were studied at three different speeds and the best results were obtained at the optimum speed (40 rpm). Keywords: Qualification, validation, design, installation, operational, performance, compression. [Download Article] [Download Certifiate] |