Pilot-plant Scale-up Consideration Of Solids by monalisha nayak

Pilot-plant Scale-up Consideration Of Solids by monalisha nayak

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  Pilot-plant Scale-up Consideration OfSolids NAME – MONALISA NAYAK CLASS –B.PHARM 7TH SEM REGD NO – 1803268050 SUBJECT – INDUSTRIAL PHARMACY COLLEGE– JEYPORE COLLEGE OF PHARMACY 1
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  Introduction  Plant :-It is a place were the 5M’s like Money, Material,Man, Method and Machine are brought together for manufacturing of the product.  Pilot-plant :- It is defined as a part of pharmaceutical Industry where a free comercial production system which include new production Technology.  Scale-up :- “The art of designing of protype using the data obtained from the pilot plant material. 2
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  Laboratory scale-up  Oncea formulation scientist develop a laboratory scale product . The first step towards commercialization is to scale it up at a pilot plant level .  Purpose of this Scale-up is to assure that the data , information and finding observed for small scale batches are reproducible during comparatively larger pilot scale manufacturing. 3
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  Stages of productionTablet 1. Material handling 2. Dry blending 3. Granulation 4. Drying 5. Reduction of particle size 6. Slugging 7. Compression 4
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  1. Material handling:- In the laboratory , material are simply poured by hand,but in large scale operation , handling of this material often become necessary. 2. Dry blending :- Powdered to be used for encapsulation are to be granulated and must be well blended to ensure good drug distribution.  Miling of the Ingredients usually makes the process more reliable and reproducible.  Equipment required for blending :- V-blender,Double cone blender 5
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  V-blender Double-Cone blender 6
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  3. Granulation :-In this process in which the primary powder particles are made to adhere to form large, multiparticle entities called granules. Granulation process is a form of particle designing. Types Of Granulation  Wet Granulation Method - Tray dryer  Dry Granulation Method – Slugging mill 7
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  4.Drying :- Mostcommon conventional method of drying a granulation Continuous to be the circulating hot air oven ,which is heated by either steam or electricity.  Drying time at specified temperature and air flow rates must be established for each product ,and for each particular oven load . 5. Reduction of particle size :- Compression factors that may be affected by the particle size distribution are flow ability, compressibility,uniformity of the tablet weight, tablet hardness and colour uniformity.  Equipment:- Oscillating granulator, Screening device 8
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  9 Oscilating Granulator Screening Device
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  6. Slugging :-The process is utilised to produce granules for moisture and and heat –sensitive API and when APIS exhibit sufficient binding.  The method of slugging is also known as dry Granulation. 10 Roll Compactor
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  7. Compression :-The ultimate test of a tablet formulation and granulation Process is weather the granulation can be compressed on a high-speed tablet press . Steps involved during compressed on a high-speed tablet press.  Filling of empty die cavity with granulation  Press compression of granulation  Compress of granulation 11
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