tailieunhanh - Pharmaceutical Coating Technology (Part 10)

Automation of coating processes Graham SUMMARY Current Good Manufacturing Practice (cGMP) and the demands of the regulatory authorities worldwide requires greater care in the design of manufacturing facilities, the selection of materials used in their construction, their layout, the equipment used in the preparation of tablets to be coated and the coating operation. It is claimed that robotic systems will eventually take over all processing tasks! (Kanig & Rudic, 1986). This chapter will discuss automation concepts and suggestions based on cGMP (DHSS, 1983) in two areas: • the design and layout of the building • the control and transfer. | Page 249 10 Automation of coating processes Graham SUMMARY Current Good Manufacturing Practice cGMP and the demands of the regulatory authorities worldwide requires greater care in the design of manufacturing facilities the selection of materials used in their construction their layout the equipment used in the preparation of tablets to be coated and the coating operation. It is claimed that robotic systems will eventually take over all processing tasks Kanig Rudic 1986 . This chapter will discuss automation concepts and suggestions based on cGMP DHSS 1983 in two areas the design and layout of the building the control and transfer of materials between the various unit operations. An examination of Fig. Chapter 7 shows the general requirement and this chapter will describe how automation of this process can be achieved. INTRODUCTION Since 1970 the explosion in the development of the microprocessor the programmable controller and personal computers has provided tools to make substantial productivity improvements in manufacturing systems. Many of the major pharmaceutical products in the oral solid dosage field are now produced using automated plants. Merck s ALDOMET manufacturing facility is well known and a well-documented example Lumsden 1982 Fig . This process uses fluidized bed coating columns. Figs and show schemes that uses both side-vented and conventional pans. Page 250 Fig. ALDOMET manufacturing and coating process MSD . Fig. Feed system to automated side-vented coating pan. In Figs and IBC Intermediate Bulk Container AHU Air Handling Unit PMCS Process Monitoring Control System ELECT Electricity ph Phase C A Compressed Air DCE Dust Control Equipment . The purpose here is to consider some of the ideas for automated coating systems that are incorporated into these plants and to look at what has been achieved with products that are not produced in large volumes and therefore require a more Page 251 3 PANS JjPMCS