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

2. List of content...... Introduction Plant layout Equipments References

3. BUILDING & FACILITIES Designed according to GMP practices which ensures ……. Prevention of cross contamination Proper air handling systems. Proper cleaning & sanitary facilities. Proper Lighting Proper Plumbing Proper washing etc.

4. Layout : It is the organized properly planned INTERDEPARTMENT and INTRADEPARTMENT arrangements. PROPER LAYOUT: Increases productivity Helps in proper utilization of - MAN - MATERIAL - MONEY - MACHINES

5. TYPES OF LAYOUT layout With 1) crossover traffic 2) circular flow 3) Parallel flow

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

10. Granulation: Wet Granulation Direct Compression Dry Granulation – Slugging – Roll Compaction

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

12. Rapid mixer granulator Fluidised bed granulator Most commonly used granulator:

13. Typical Time Sequence Mixing – 2 minutes Granulation – 8 minutes Discharge – 1 minutes Rapid Mixer Granulator (RMG)

14. Rapid mixing granulator: (RMG )

15. Advantage Mixing, Massing ,Granulation in a single equipment within few minutes End point monitor needed Disadvantage:

16. Designs of FB granulators Top spray Bottom spray Rotating disc granulator Suction Fan Fabric Filter Bag Granulating solution Product Bed Spray Nozzle Air Filter Air Heater

17. Fluidized bed granulator: Advantage One unit so saving labour cost, transfer loses and time 2-6 time greater heat transfer than tray dryer Uniform drying….prevent mottling. Process can be automated once parameters optimized Disadvantage Expensive Multiple process variable Filter clocking, demixing, electrostatic charge, solvent explosion

18. Drying:

19. Fluidised bed Dryer:

20. Tray dryer No. of trays in one close cabinet into which heated air is circulated. Drying time depends on Temperature of heated air Depth of bed Circulation of heated air Distance between trays

21. Milling: Multi mill

22. Blending

23. Tabletting :

24. Tablet machine is regulated by.. Number of tooling sets Number of compression station Rotational speed of the press

25. Punch& Die Hopper Cam tracks

26. Auxillary equipment: Mechanised feeder Tablet Deduster Granule level sensor

27. FETTE PREFECTA 2000 COOLTEX Enables the compression of the substance at low temp This cooling unit allows for the preparation by compression of suppositories, enzyme preparations or thermo sensitive active ingredients. -6 0 C temp is attainable by the press. Recent addition in tablet press system:

28. Coating :

29. TABLET COATING : OBJECTIVES OF COATING:- To mask taste ,odor, colour , of the drug. To provide physical & chemical protection to the drug. To control release of the drug from the tablet. To protect drug from gastric environment. To avoid chemical incompatibilities. To provide physical elegance.

30. Standard coating pan INLET AIR Exhaust Air

31. modification in standard coating pans : A) pellegrini pan :-it has a baffled pan & a diffuser that distributes the drying air uniformly over the tablet bed surface. B ) Immersion tube system :-A tube is immersed in the tablet bed. the tube delivers the heated air & a spray nozzle is built in the tip of the tube. C) Immersion sword system:- Drying air is introduced through a perforated metal sword device that is immersed in the tablet bed.

32. Perforated coating pan: Accela cota & Hi coater system Driacoater: Glatt coater: Fluidised bed coater

33. Innovation…. GLATT COATER: Latest Perforated pan with airflow facility both from inside to outside & alternatively from outside to inside. Drying air can be directed from inside the drum through the tablet bed & out an Exhaust duct.

34. Evaluation of tablets: ( I.P.Q.C Tests) Hardness test Friability test Disintegration test Dissolution tests Weight variation Content uniformity

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

37. Fribility test Tablets are subjected to combine effect of shock and abrasion.

38. Loss in weight after de dusting should less than 0.5-1.0% Limit : Rotation Speed : 25 RPM No. of Rotations : 100 Dropping Height : 6 inch

39. - Basket assembly with 6 glass tubes, 3 inches long, open at top & 10 # screen at bottom end. - Moves up and down through distance of 5-6 cm at frequency of 28-32 cycles per minute Disintegration tester:

40. WEIGHT VARIATION TEST: WEIGHT VARIATION TOLERANCES FOR UNCOATED TABLETS (USP): Avg. weight of tablets (mg) Maximum % difference allowed 130 or less 10 130-324 7.5 > 324 5

41. Packaging

43. Leak test: Packed final product is placed in to close jar containing water. Vacuum is applied for 30 min. and observe for bubble formation. Instead of vacuum, pressure may be applied and after test strip or blister was opened to observe wetting of tablets.

44. LABELLING REQUIREMENTS FOR TABLETS: The label states that: The quantity of active ingredient Batch number, Date of manufacturing Date of expiry. Storage condition Information about type of dosage form Such as SR , IR , Mouth dissolving. Enteric coated etc.

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.

46. The Theory and Practice of Industrial Pharmacy by Leon Lachman Pharmaceutical Dosage Forms : TABLETS Vol. 3 Encyclopedia of Pharmaceutical Technology, Marcel Dekker, Volume-6 Pharmaceutical Sciences by Remington Pharmaceutical dosage form by Aulton How to Practice GMPs by P.P.Sharma The eastern pharmacist 2001 The Indian pharmacist Pharma times-Aug-2006 Manufacturing chemist Tabmach tools pvt limited. Indian pharmaceutical congress-2007, Expo. www.wikipedia.com www.pharmatech.com www.bioprocess.com www.sotex.com www.pharmamachine.com www.stablemicrosystem.com www.celisinstrument.com www.tablettesting.com www.mocoa.com www.rpc-marketrasen.co.uk REFERENCES :

47. THANKS