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Validation of tablet process
- 1. VALIDATION OF TABLETPROCESS PRESENTED BY GUIDED BY PRADNYA SHIRUDE Prof.Dr. M.R. Bhalekar AISSMS COLLEGE OF PHARMACY
- 2. What is validation? Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. The field of validation is divided into a number of subsections Equipment validation Cleaning validation HVAC system validation Process validation Analytical method validation 2
- 3. Process Validation Types ofprocess validation • Retrospective process validation • Prospective process validation • Concurrent process validation
- 4. STAGES OF PROCESSVALIDATION 1.Process design or pre-qualification Stage based on the knowledge gained through development and scale up activities 2.Process qualification Capable of reproducible commercial manufacturing 3.Continued process verification Ongoing assurance is gained during routine production that the process remains in state of control. PHASES OF PROCESS VALIDATION 1.Pre-validation phase Example: formulation, pilot batch studies, scale up studies 2.Process validation phase To verify that all established limits of the critical process parameters are valid 3.Validation maintenance phase Monitoring and improving control and reducing product and process
- 5. PROCESSING STEPS ANDRESPECTIVE IN PROCESS VARIABLES DURING TABLET MANUFACTURING
- 6. 1.MIXING OR BLENDING Directcompression- one blending step Wet granulation- two blending step Prior to granulation to have a uniform drug/excipients After milling the dried granulation to add other excipients, such as the lubricant 2.FACTORS AFFECTING TO THE DRUG/EXCIPIENT AND ITS UNIFORM BLEND Bulk density Particle size distribution Surface area
- 7. MIXING OR BLENDINGOPERATION PARAMETERS Mixing or blending technique Mixing or blending speed/time Drug uniformity Lubrication Distribution of colorant Equipment capacity/load
- 8. WET GRANUATION Low shear-e.g.Hobart Highshear-e.g.Diosna GEI-Collette Fluid bed-e.g.-Glatt,fluid air WET MASSING(FOR UNIFORM WEIGHT MASS) Binder addition Binder concentration Amount of binder solution/granulation solvent Binder solution/solvent addition rate Mixing time Granulation end point
- 9. DRYING Factors Air flow Moisture uniformity Equipmentcapacity DRY MILLING Mill type Screen size Mill speed and feed rate
- 10. TABLET COMPRESSION Tooling Compression speed Compressionejection force PROBLEMS OCCUR DURING COMPRESSION STAGE Appearance Capping, mottling Hardness Mechanical shocks and aberrations Friability Brittleness Disintegration Thickness of the tablet Weight uniformity Batch to batch variation
- 11. TABLET COATING Surface chemistryand solid-liquid interaction is necessary for coating and printing processes. Tablet coating parameters to be considered during development and validation are as follows: Pan coating Inlet/exhaust temperature/humidity Pan speed Spray nozzle size and spray angle Gun to bed distance and Tablets core characteristics
- 12. IN PROCESS TEST TESTPARAMETERS Moisture content o dried granulation Loss on drying- to determine whether or not solvent is removed Granulation particle size distribution Affect compressibility, hardness, thickness-done by sieve analysis Blend uniformity To analysed that drug is uniformly dispersed or not-blend time Individual tablets weight During compression-to ensure the material is flowing properly and consistently Tablet thickness Determined periodically throughout the batch-proper flow and compression Tablets hardness Determined periodically throughout the batch-to ensure that tablets are enough for coating, packing and shipping and not too hard to affect dissolution
- 13. FINISHED PRODUCT TESTS TESTPARAMETRES Appearance Mottling,picking of the monogram, tablets filming and capping of the tablets Assay Determine whether or not the product contains the labelled amount of drug Content uniformity To ensure that the dosage form comply with the standards Tablets hardness Critical parameter to handle dosage form and its performance Tablets friability To check the ability to withstand chipping,cracking or dusting during packing operations Dissolution To ensure proper drug release characteristics and batch to batch uniformity
- 14. ADVANTAGES OF VALIDATION Validation makes good business sense. Reduction in rejections and networks Reduction in utility cost Avoidance of capital expenditure Reduced testing process and finished goods Easier maintenance of process More rapid automation
- 15. REFERANCES Functional overviewof process validation of tablets-A critical review, Manasa S Reddy, Chandramouli R, Journal of pharmaceutical research volume 16, issue 3Jul-sep 2017-268 The theory and practice of industrial pharmacy by Leon Lachamn, H. Liberman, J. Kanig, published by Varghese publishing house, third edition, pg no.293-373 http://www.researchgate.net www.vtu.com/ms&t/biotech
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