QUALIFICATION OF EQUIPMENT: SAIZONER MIXER GRANULATOR, COMPRESSION MACHINE AND COATING PAN

Qualification is the action of proving that any equipment works correctly and leads to expected results. The main objective of the present study was to perform the performance qualification of critical tablet manufacturing equipments like Saizoner Mixer Granulator, Compression machine and Coating pan. Saizoner mixers are used for dry and wet mixing of powders. The performance qualification protocols were prepared, approved and studies were performed as per the approved protocols. The performance qualification of Saizoner Mixer Granulator, samples were collected from the bowl with maximum working capacity and then the samples were analyzed for content uniformity, granule appearance and amperage. The performance qualification of compression machine, core tablets of smallest size were compressed and checked for their parameters such as appearance, average weight, hardness, friability, disintegration time, thickness and content uniformity. The performance qualification of coating pan, the coated tablets was checked for their physical parameters such as appearance, weight variation, dimensions and thickness for different tablet sizes and shapes. The results of all performance qualification works were satisfactory and demonstrated the efficiency of the equipments for their intended use.