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.
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