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Pilot-plant Scale-up
Consideration Of Solids
NAME – MONALISA NAYAK
CLASS –B.PHARM 7TH SEM
REGD NO – 1803268050
SUBJECT – INDUSTRIAL PHARMACY
COLLEGE– JEYPORE COLLEGE OF PHARMACY
1
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
Laboratory scale-up
 Once a 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
Stages of production Tablet
1. Material handling
2. Dry blending
3. Granulation
4. Drying
5. Reduction of particle size
6. Slugging
7. Compression
4
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
V-blender
Double-Cone blender 6
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
4.Drying :- Most common 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
9
Oscilating Granulator
Screening Device
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
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
12

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

  • 1. Pilot-plant Scale-up Consideration Of Solids NAME – MONALISA NAYAK CLASS –B.PHARM 7TH SEM REGD NO – 1803268050 SUBJECT – INDUSTRIAL PHARMACY COLLEGE– JEYPORE COLLEGE OF PHARMACY 1
  • 2. 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
  • 3. Laboratory scale-up  Once a 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
  • 4. Stages of production Tablet 1. Material handling 2. Dry blending 3. Granulation 4. Drying 5. Reduction of particle size 6. Slugging 7. Compression 4
  • 5. 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
  • 7. 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
  • 8. 4.Drying :- Most common 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
  • 10. 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
  • 11. 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
  • 12.
  • 13. 12