The document discusses the scale up of tablet production from the laboratory scale to the pilot plant scale. It describes the various stages involved in tablet production such as material handling, dry blending, granulation, drying, milling, blending, compression, and coating. Scaling up from the lab scale to pilot plant scale requires adjustments to processing equipment, material handling procedures, blending times and speeds, drying methods, and compression equipment to optimize tablet properties such as content uniformity and hardness for production. The goal of the scale up process is to develop a reliable manufacturing process for producing viable tablet products.

1. Presented By: Guided By:
V. D. Lonkar Dr. S. S. Chalikwar
F.Y.M.Pharm Head & Professor
Roll. No – MQA- 24 Quality Assurance.

2.  INTRODUCTION
 PILOT PLANT SCALE UP OF TABLET DESIGN
 STAGES OF PRODUCTION OF TABLETS
 CONCLUSION
 REFERENCES
Scope and Limitations
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3.  Define as a part of the pharmaceutical industry where
is a lab scale formula is transformed into an viable
product by the development of liable practical
procedure for manufacture.
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R & D/ lab
scale
PILOT PLANT
PRODUCTION

4. SCALE UP
Art of designing of prototype using the
data obtained from the pilot plant model.
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PILOT PLANT SCALE UP FOR
TABLET DESIGN

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7.  Material handling
 Dry blending
 Granulation
 Drying
 Reduction of particle size
 Blending
 Special granulation technique
 Wet granulation
 Direct compression
 dry granulation( slugging )
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8.  Compression
 coating
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In lab scale
In pilot plant
scale
Materials are scooped or poured by
hand.
Materials are handled by vacuum
loading, screw feed system &
metering pump.

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drug excipients
Dry blending process uses a binary
cohesive-powder mixture which contains
two different sizes, it is well known that
finer particles adhere preferentially on the
surface of the coarse particles. This type
mixture has been called an interactive
mixture.
Dry blend takes place in vessels.

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Time of
blending
Speed of
blending
Amount of
material
Size of
blender

12. Content
uniformity
Flow
problems
Compression
Inadequate
dose to
patient
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13.  V-Blender
 Double cone Blender
 Ribbon Blender
 Slant cone Blender
 Bin Blender
 Orbiting Screw Blenders vertical and horizontal high
intensity mixers
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Heavy duty planetary
blender

15.  Granulation is defined as a process where by small
particles are gathered into larger, permanent masses
in which the original particles can still be identified
Purpose of granulation :
 To impart good flow properties to the material.
 To increase the apparent density of the powders.
To change the particle size distribution.
Uniform dispersion of active ingredient.
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Wet granulation: in which the use of liquid for the
preparation of granules
• Eg. Sigma blade mixture
Dry granulation: in which the use of dry binder for
granulation.
• Roller compaction mill

17.  There are a number of products currently
manufactured using these low-shear granulators.
 It is employed low-shear mixers or the mixers/blenders
normally used for dry blending such as ribbon mixers
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18.  Dry compaction technique
like roller compaction is
commonly used in the
Pharmaceutical industry.
There are a number of drug
substances which are
moisture sensitive and
cannot be directly
compressed
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chilsonator

19.  Fluid Bed Granulation is a
process by which granules
are produced in single
equipment by spraying a
binder solution onto fluidized
powder bed. The material
processed by fluid bed
granulation are finer, free
flowing and homogenous.
 The system involves the
heating of air and then
directing it through the
material to be processed.
Later the same air exists
through the voids of the
product.
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20. Less space
and
manpower
Less
handling
of
material
since
they are
closed
system
Reduce
danger of
personnel
exposure to
potent
materials
Prevent
from
potentially
hazardous
substances
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21.  Drying is done after the granulation method.
 In control manner of hot air and the temperature.
 Equipments use in granulation techniques.
1. HOT AIR OVEN
2. FBD
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Conventional method.( 8 hrs)
Heated by steam and electricity.
• Hot air oven
Reduction in drying time.(less than 1 hrs).
FBD are more involved in scale up.
• FBD

23. Drying times at specified temperatures and air flow rates.
Monitoring drying process by use of moisture and temperature
probes
Depth of Granulation Trays
Air Temperature
Air Flow
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Optimum
Load
Air flow
rate
Inlet Air
temperature
Humidity
of
incoming
air
Fluidised bed dryer

25.  Particle size are necessary
to the compression
characteristics of a
granules.
 In lab scale small milling
use.
 In pilot plant hammer10/14/2019 4:25 AMRCPIPER SHIRPUR , DIST. DHULE 25

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floability
Content uniformity
Tablet hardness
Filling of die cavity

27.  Type of blending equipment often differs from that
using in laboratory.
 In any blending operation, both segregation and
mixing occur simultaneously are a function of
particle size, shape, hardness, and density, and of the
dynamics of the mixing action.
 Particle abrasion is more likely to occur when high-
shear mixers with spiral screws or blades are used.
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28.  Functions of a tablet press:
 Filling of empty die cavity with
granulation.
 Pre compression of granulation
(optional).
 Compression of granules.
 Ejection of the tablet from the die cavity
and take- off of compressed tablet.
 Potential problems such as sticking to
the punch surface, tablet hardness,
capping, and weight variation detected.
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29.  Tablet coating, which at one time consisted
of sugar coating in conventional coating pans,
has undergone many changes because of new
developments in coating technology and
changes in safety and environmental
regulations.
 There are mainly 3 important techniques
involved in coating .
 They are :
 Sugar Coating
 Film Coating
 Enteric Coating
 Colonic coated .
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30. Single press machine or rotary press with one pair
of punches and dies are used in the small scale
production .
The change from small scale to large scale affects
to
• Powder properties, e.g. segregation and
floability
• Compaction profile.
• Processing speed.
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31.  Lachman, L., Lieberman, H. Kanig, J., Bombay
pub.1991. The Theory and Practice of Industrial
Pharmacy., Forth Indian Edition. Pp. 681-710
 Lippincott Williams and Wilkins, 2005. Remington’s.
The Science and Practice of Pharmacy. Volume-1. 20th
Indian Edition, pp. 858-864
 www. Google.com.
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