PROCESS TESTING AND SCALE-UPFOR A FEST PHARMA ROTARY PRESSURE FILTERAS A REPLACEMENT FOR TWO INVERTING-BASKET CENTRIFUGESAT A BULK PHARMACEUTICAL MANUFACTURING FACILITY

摘要

In the manufacturing of this bulk active pharmaceutical ingredient (Bulk-API), the plant needed to increase production and to improve the washing efficiency of the process. The current process required two (2) inverting-basket centrifuges operating in parallel from one reactor to a downstream pelletizer. Process testing was being conducted simultaneously in the laboratory and in the field to evaluate the FEST? Pharma rotary pressure filter as an alternative to the inverting-basket centrifuges. The lab testing used a BHS pressurized pocket leaf filter with 20 cm2 of filter area while the fieldwork was conducted on a FEST rotary pressure filter with a filter area of 0.12 m2. The paper discusses test procedures, data collection, filter media selection and other process parameters. Equations are presented to scale-up the results to a full-scale production filter. Scale-up data includes process conditions, production rates and filtration, washing, drying and discharge times. The results are then compared to the existing process to determine the cost-effectiveness of a process change to one (1) FEST Pharma rotary pressure filter from two (2) inverting-basket centrifuges. The operating savings from the FEST Pharma in terms of solvent consumption, energy consumption, number of units and maintenance costs as well as the capital costs for the equipment will yield a favorable rate of return on investment and an acceptable payback.