QUALIFICATION OF EQUIPMENT: BIN BLENDER AND COMPRESSION MACHINE

Abstract

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 performance qualification of the bin blender (200 L) for minimum (20%) and maximum (70%) occupancy capacities and blend uniformity at different blending time intervals and of the compression machine at different compression speeds i.e. 20 RPM to 50 RPM was done. The installation qualification (IQ) and operational qualification (OQ) protocols should be prepared, approved and performed as per the qualification master plan. Bin blenders which are used as dry mixers are used after the initial stages i.e. premixing and granulation. Compression machine is designed for high speed production capability as a modular system in tablet compressing chamber for manufacturing of tablets or press forming preparations. 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 bin blender samples were collected as per sampling plan at different time intervals and the collected samples analyzed for color content in each sample. For the compression machine (26 station), the tablets were checked for physical parameters such as appearance, weight variation, hardness, friability and thickness. The equipment qualification was carried out to demonstrate the efficiency of the equipment’s and ended with satisfactory results.