Qualification of equipment: Saizoner mixer granulator and automatic coating machine (Neocota)

Qualification is the planning, carrying out and recording of tests on equipment and systems, which will form a part of the validated process, to demonstrate that it will perform as intended. The objective is to do the performance qualification of the Saizoner Mixer Granulator (SMG) (150 L) for minimum (20%) and maximum (70%) occupancy capacities and content uniformity at different mixing intervals and of the Automatic coating machine(ACM) for minimum and maximum capacity with aqueous coating operation for 6-10 Kg Pan and 24-40 Kg Pan. The installation qualification (IQ) and operational qualification (OQ) protocols should be prepared, approved and performed as per the qualification master plan. Saizoner mixers are used for dry and wet mixing of powders of different products to prepare the tablet formulations. The machine is used in the initial stages i.e. premixing & granulation. The automatic coating system is used for automatic film coating of tablets of various shapes and sizes by batch process. The prerequisites required before starting the performance qualification of equipment is that OQ should be successfully completed, all the necessary materials, procedures and testing arrangements should be made. For the SMG samples were collected as per sampling plan at different time intervals and the collected samples analyzed for color content, content uniformity, granule appearance, amperage and water content in each sample. For the ACM, the coated tablets were checked for physical parameters such as appearance, weight variation, weight build up and thickness for different batch sizes. The equipment qualification was carried out to demonstrate the efficiency of the equipment’s and ended with satisfactory results.

Author(s): Shaik Nasreen, Mamatha T and Husna Kanwal Qureshi

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