The document discusses the layout, equipment, and processes required for the production of solid oral dosage forms like tablets in a pharmaceutical manufacturing facility. It provides details on the building facilities, various production areas and equipment for activities such as granulation, drying, milling, blending, compression, coating, packaging and quality control tests. The layout is designed for proper material and air flow following cGMP guidelines. Commonly used equipment for different processes are also outlined.

1. Preparation of qualitative & quantitative department with equipments for Presented by Patel Jignesh. P. Guided by Mrs Anita Patel Department of pharmaceutics Nootan pharmacy college, visnagar layout SOLID DOSAGE FORM

6. CROSS OVER TRAFFIC Area : 60+20 sq.meter Deduster 30+10 sq.meter 30 Pascal 10 Pascal 20 Pascal 15 Pascal 15 Pascal Temp. 25+/-5 Humidity : 55+/-10%RH

7. Circular flow Area : 60+20 sq.meter Temp. 25+/-5 Humidity : 55+/-10%RH 30+10 sq.meter

8. Parallel flow

9. For Uncoated Tablet For Coating Section For Basic Installation Sq.mtrs . For Ancillary Area Sq.mtrs . 60 30 20 10 AREA REQUIREMENT ENVIRONMENT REQUIREMENT Temperature : 25 ± 5 C Humidity : 55 ± 10 %RH Pressure in Ware House Area: 10 Pascal Pressure in Weighing Area : 20 Pascal Pressure in Tableting Area : 15 Pascal Pressure in Central Corridor : 30 Pascal

11. WET GRANULATION: some equipment High Shear Granulator Diosna Granulator Gral Mixer/Granulator Granulator with Drying Facility Fluidized Bed Granulator Day Nauta Mixer Processor Double cone/Twin Shell Processor Topo Granulator Special Granulator Roto Granulator Marumerizer

14. Rapid mixing granulator: (RMG )

18. Drying:

19. Fluidised bed Dryer:

21. Milling: Multi mill

22. Blending

23. Tabletting :

25. Punch& Die Hopper Cam tracks

28. Coating :

30. Standard coating pan INLET AIR Exhaust Air

35. Hardness test: Monsanto hardness tester: Advantage :- convenient low priced Drawback: - Hardness obtained is lesser by 1.5-1.7% compared to later developed instrument. -Instrument use spring which has no standard of compression

36. Pfizer hardness tester: - Use mechanical principle of plier (instrument for holding things tightly) - Reading are recorded on a dial. Strong cobb tester: - Disadvantage: - Air pump get damaged. Need frequent services -Calibration process is difficult

41. Packaging

45. Packaging label: Printed packaging material Includes formula, Dosage, storage condition, instruction, mfg lic. Number Not changed from batch to batch. Stereo part includes batch no, Mfg. date, Exp date, MRP Changed depends on batch & production date.

47. THANKS