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PILOT PLANT - TABLETS & CAPSULES.pptx
- 1. PILOT PLANT DESIGN FOR TABLETS AND CAPSULES
- 2. Research pharmacist responsible for initial scale-up and initial production runs Department of pharmaceutical research Technical director of production Manager of solid dosage form research Manager of tablet and capsule production Pharmaceutical research staff Section head operators
- 3. Technical director of production Director of pharmaceutical research and development Manager of solid dosage form research Manager of pilot development Manager of tablet and capsule production Pharmaceutical research staff Pharmacists and engineers Section head in charge of tablet production Operators Pilot plant controlled by pharmaceutical plant controlled by pharmaceutical research
- 4. Pharmaceutical pilot plant controlled by production division Director of Pharmaceutical research Technical director of production Manager of solid dosage form research Manager of tablet and capsule production Pharmaceutical Research staff Section head of pilot department operators operators Section head in charge of tablet production
- 6. Dry Blending The equipment used for blending are: V- blender Double cone blender Ribbon blender Slant cone blender Bin blender Orbiting screw blenders vertical and horizontal high intensity mixers. SCALE UP CONSIDERATIONS Time of blending . Blender loading. Size of blender
- 7. V – CONE BLENDER DOUBLE CONE BLENDER
- 9. Granulation The most common reasons given to justify granulating are: 1. To impart good flow properties to the material, 2. To increase the apparent density of the powders, 3. To change the particle size distribution, 4. Uniform dispersion of active ingredient. Traditionally, wet granulation has been carried out using, Sigma blade mixer, Heavy-duty planetary mixer.
- 11. Wet granulation can also be prepared using tumble blenders equipped with high-speed chopper blades.
- 12. DRYING Fluidized bed dryers are an attractive alternative to the circulating hot air ovens. The important factor considered as part of scale up fluidized bed dryer are optimum loads, rate of airflow, inlet air temperature and humidity.
- 13. Reduction of Particle size Compression factors that may be affected by the particle size distribution are flowability, compressibility, uniformity of tablet weight, content uniformity, tablet hardness, and tablet color uniformity. First step in this process is to determine the particle size distribution of granulation using a series of “stacked” sieves of decreasing mesh openings. Particle size reduction of the dried granulation of production size batches can be carried out by passing all the material through an oscillating granulator, a hammer mill, a mechanical sieving device, or in some cases, a screening device. OSCILLATING TYPE GRANULATOR HAMMER MILL
- 14. Slugging (Dry Granulation) A dry powder blend that cannot be directly compressed because of poor flow or compression properties. This is done on a tablet press designed for slugging, which operates at pressures of about 15 tons, compared with a normal tablet press, which operates at pressure of 4 tons or less. Slugs range in diameter from 1 inch, for the more easily slugged material, to ¾ inch in diameter for materials that are more difficult to compress and require more pressure per unit area to yield satisfactory compacts. If an excessive amount of fine powder is generated during the milling operation the material must be screened & fines recycled through the slugging operation.
- 15. Dry Compaction Granulation by dry compaction can also be achieved by passing powders between two rollers that compact the material at pressure of up to 10 tons per linear inch. Materials of very low density require roller compaction to achieve a bulk density sufficient to allow encapsulation or compression. One of the best examples of this process is the densification of aluminum hydroxide. Pilot plant personnel should determine whether the final drug blend or the active ingredient could be more efficiently processed in this manner than by conventional processing in order to produce a granulation with the required tabletting or encapsulation properties.
- 16. Compression The ultimate test of a tablet formulation and granulation process is whether the granulation can be compressed on a high-speed tablet press. During compression, the tablet press performs the following functions: 1. Filling of empty die cavity with granulation. 2. Precompression of granulation (optional). 3. Compression of granules. 4. Ejection of the tablet from the die cavity and take-off of compressed tablet.
- 18. HIGH SPEED ROTARY MACHINE MULTI ROTARY MACHINE
- 19. DOUBLE ROTARY MACHINE UPPER PUNCH AND LOWER PUNCH
- 21. Tablet Coating Sugar coating is carried out in conventional coating pans, has undergone many changes because of new developments in coating technology and changes in safety and environmental regulations. The conventional sugar coating pan has given way to perforated pans or fluidized-bed coating columns. The development of new polymeric materials has resulted in a change from aqueous sugar coating and more recently, to aqueous film coating. The tablets must be sufficiently hard to withstand the tumbling to which they are subjected in either the coating pan or the coating column.
- 22. Pilot Plant scale-up techniques for Capsule Capsules are solid dosage forms in which the drug substance is enclosed in either a hard or soft soluble container or shell of a suitable form of gelatin. Steps in capsule production 1. Mixing of ingredient 2. Granulation and lubrication 3. Making of capsules 4. Filling of capsules 5. Uniformity testing 6. Packing and labeling
- 24. Size Volume Fill weight(g) at 0.8 g/cm3 powder density 000 1.37 1.096 00 0.95 0.760 0 0.68 0.544 1 0.50 0.400 2 0.37 0.296 3 0.30 0.240 4 0.21 0.168 5 0.15 0.104 Sizes and shapes For human use, empty gelatin capsules are manufactured in eight sizes, ranging from 000 to 5.
- 25. 25 HOFLIGER KARG AUTOMATIC CAPSULE FILLING MACHINE ZANASI AUTOMATIC CAPSULE FILLING MACHINE
- 26. 26 OSAKA MODEL R-180 SEMI AUTOMATIC CAPSULE FILLING MACHINE
- 28. Operational Aspects Validation Training Engineering support Maintenance and calibration Material control Inventory, Orders, Labeling Process & Manufacturing Activities QA & QC
- 29. Process improvement and implementation
- 30. A good design is essential for Qualification approach Key Definitions : DQ - Design Qualification IQ - Installation Qualification OQ - Operational Qualification PQ - Performance Qualification VMP- Validation Master Plan GEP- Good Engineering Practice FAT- Factory Acceptance Test SAT- Site Acceptance Test UAT- User acceptance test
- 31. Product development process and milestones Candidate Selection Form Selection Process Development Scale up Technology Transfer Composition & Process Discovery Development Manufacturing Post Approval changes Properties: •Potency •Selectivity •In vivo efficacy Form selection: •Salt form •Polymorph •Hydrate…. Excipients: •Physical effects •Chemical effects Process selection: •Granulation •Direct compression Characterize: •Raw materials •Unit operations •Process flow Establish criteria: •Tech transfer •Validation •Process monitoring Equipment: •Qualify Process: •Engineering run •Validation •Process monitoring
- 32. SU: scale-up during original dossier assessment: ► Components and composition ► Manufacturing (equipment, process) ► Batch size ► Manufacturing changes PAC: post-approval changes: i.e. Variations - approved product to a changed product Two key areas: ► Changes to components and composition ► Changes to manufacturing (equipment, process)
- 33. Production Planning Control involves three phases: 1. Pre-planning phase 2. planning phase 3. control phase functions/activities of Production Planning Control ? 1. Materials planning 2. Facility planning 3. Methods planning 4. Estimating 5. Process planning(routing) 6. Scheduling and loading 7. Dispatching 8. Expediting (or follow up) 9. Inspection and testing, 10. Evaluation