This document discusses process automation in the pharmaceutical industry, specifically related to tablet manufacturing. It covers various unit operations involved in tablet production like size reduction, mixing, granulation, drying, tableting, coating, and packaging. It describes the equipment used for each unit operation, including mills, blenders, granulators, dryers, tablet presses, coating pans, and packaging machines. The goals of process automation are outlined as increased productivity, quality, accuracy, and reduced costs and waste. Overall, the document provides an overview of the tablet manufacturing process and how automation has improved production.

1. Process Automation in
Pharmaceutical Industry with
specific reference to Manufacturing
of Tablets
Prepared By:
Shah Vaidehi Dipesh
Department of pharmaceutical chemistry and quality assurance
L.M. College of Pharmacy, Ahmedabad

2. CONTENTS
Advance Non-sterile Solid Product Manufacturing Technology
Process Automation In Pharmaceutical Industry:
Improved Tablet Production
Tablet Manufacturing Equipment/ Machines
Size Reduction Equipment
Mixing Equipment
Granulation Equipments
Drying Equipment
Tableting Machine
Tablet Coating Equipment
Tablet Packing Machines

3. ADVANCE NON-STERILE SOLID PRODUCT
MANUFACTURING TECHNOLOGY
Recent trends in tablet
manufacturing
technology reduce the
manual input and
performing the process
validation of each unit
operation thus
ensuring enhance
product quality and
process reliability.
In the recent trend,
much advancement
has taken place such as
advancement in
granulation
technology.
Disadvantages of
Traditional manual
handling the materials
is it is expensive and
causes delay in
production
Advancement in the
material Handling
Technology is needed
as the loss of material
which takes place
ultimately affects
product output.

4. PROCESS AUTOMATION IN PHARMACEUTICAL INDUSTRY :
It means the use of machines and equipments for performing physical and mental
operations in a production process in place of human being.
 It can be done at various levels of manufacturing system, handling of raw materials, semi-
finished goods or finished goods during production process (efficient 2 machines are used) in
Inspection and quality control operations.
The pharmaceutical industry is increasingly making use of robotics to automate specific
procees in drug development, including drug screening, anti-counterfeiting, and
manufacturing tasks.
The pharmaceutical industry produces millions of tablets each week, all of which must be
carefully scrutinized before being packed and shipped to distributors.
During this inspection, drug manufacturers must ensure that the correct amount of
medication, with the exact chemical composition and weight are precisely packed into the
appropriate containers.
Most pharmaceutical packaging systems use automation to manage bottle orientation,
capping, labeling and collation systems.

5. Basic purpose of automation in manufacturing industry is:
To increase
Productivity.
The quality of
product
improves as
human input is
minimized.
It causes
reduction in
direct labor
costs.
There is greater
accuracy, more
output and
greater speed.
Minimization
of wastage.

6. IMPROVED TABLET PRODUCTION
 It is the result of
industrialization, driven
by the need to increase
productivity and to
archive consisting quality
product.
 It is a system of doing
work where material
handling, production
process and product
design are integrated
through mechanism of
thoughts and effort to
achieve a set regulating
and control system.
Strong and hard to withstand mechanical shock
encountered during manufacturing, packing, shipping,
dispensing and use.
Uniform in weight and in drug content.
Bioavailable according to indication requirements.
Chemically and physically stable over a long period of time.
Have elegant product identity which is free from any tablet
defects.
Primary goals of tablet manufacturing process:
To formulate tablets that are/is:

7. Area required for manufacture of tablets:
A controlled (classified) area is an enclosed environment or room with a flawless control over
particulate contamination. For tablet manufacturing, minimum of 30 sq. meter area is
required for basic installation.
1. Raw material
warehouse
2. Receiving
quarantine
3. Approved raw
material section
4. Dispensary
5. Production
room
6. Mixing,
Granulation and
Drying Section
7. Tablet
Punching Section
8. Coating Section
9. Quality section
& Packaging
Section

8. Techniques/methods used in
tablet formulation:
Tablets are commonly manufactured by
following techniques :
1) Wet granulation
2) Dry granulation
3) Direct compression.

9. TABLET MANUFACTURING EQUIPMENT/ MACHINES:
Common equipment used in pharmaceutical tablet manufacturing include:
1] Size reduction equipment/ communition equipment:
e.g., hammer mill, vibrational mill, roller mill, pin mill, fluidized energy mill, end-runner
mill, edge-runner mill, cutter mill and ball mill.
2] Weighing balance/ balances:
e.g., bulk weighing balance (weighs in kilogram), electro weighing balance (weighs in grams
and milligrams).
3] Mixing equipment:
e.g., pneumatic mixers (air-mix mixer or air-driven mixer), diffusion/ tumbling mixers (e.g.,
v-blender, double cone blender, cubic mixer, drum blender), convective mixers (e.g., ribbon
blenders, orbiting screw mixers, horizontal high-intensity blenders, planetary blenders,
diffusion mixer with intensifier bar/agitator, horizontal double arm mixers, vertical high-
intensity mixer).
4] Granulators:
e.g., rotating shape granulators, mechanical agitator granulators (e.g., ribbon paddle
blender, sigma blade mixer, planetary mixer, orbiting screw mixers), high-shear granulator,
fluidized bed granulator, dry granulator etc.

10. 5] Drying equipment:
e.g., spray dryer, rotary dryer, fluidized bed dryer etc.
6] Tableting machine:
single punch tablet press and multi-station/ rotary tablet
(e.g., high-speed rotary tablet machines and multi-layer rotary tablet machines).
7] Quality control equipment:
e.g., disintegration equipment (manesty single unit apparatus or erweka multiple unit
disintegrating apparatus), USP dissolution tester, tablet hardness tester, tablet thickness
tester, tablet friability testers etc.
8] Coating and polishing machines for coated tablets:
e.g., standard coating pan, perforated pan, fluidized bed/ air suspension coating system etc.
9] Packaging machines:
e.g., blister packaging machines, strip packing machine, aluminium foil packaging machine,
etc.
-Tablet equipment continues to improve in both production speed and uniformity of the
tablets compressed.

11. SIZE REDUCTION EQUIPMENT:
 Size reduction equipment
refers to machines that crush
and grind materials to reduce
their size.
 Pulverizers are a type of size
equipment, the names are
used interchangeably.
 Size reduction is an essential
component of a wide range of
industrial processes.

12. Principle: attrition & impact
Uses: for moderately hard & friable material
Principle : impact
Uses: almost all drugs
Fluid Energy Mill Hammer Mill
The high-velocity air stream passed and the
milling takes place because of the high-
velocity collision between the suspended
particles.
The hammer mill has a rotor that is fitted
with hammers, which repeatedly strike the
particles and cause them to be broken down
into smaller pieces.

13. Principle : cutting
Uses: for fibrous , crude drug
Principle : crushing & shearing
Uses: almost all drugs
Cutter Mill Edge Runner Mill
A rotor inside the mill revolves at high
speed. The rotor is equipped with special
cutting plates which comminute the sample
material.
The size reduction is done by crushing
(compression) due to the heavy weight of
stones. The stones revolve on their axes, and
crush sample.

14. MIXING EQUIPMENT:
• In batch operation, all ingredients are loaded into the mixer
together or in a pre-defined sequence, and mixed until a
homogenous material is produced and discharged from the
mixer in a single lot.
Batch Mixing :
• Ingredients are continuously charged into the mixer in
accordance with the formulation. The mixing takes place as
the material travels from the charging port to the discharge
nozzle, from where it is continuously discharged.
Continuous mixing :
ADVANTAGES OF CONTINUOUS MIXING OVER BATCH MIXING
•Consistent finished product weight, size and texture
•Eliminates variables due to batch process
•Even hydration of dough
•High production rates with one mixer
•Self-monitoring and self-correcting system
•Eliminates chance of contamination

15. Batch Mixing :
Steps to Batch Mixing Ingredients:
 Loading of the components to be mixed
Mixing the ingredients
Discharging the mixed material
Equipment Needed in Batch Mixing:
The different equipment used in batch mixing include:
1] Convective mixers: Planetary mixer, sigma mixer, vertical screw blender, paddle blender,
Ribbon blender.
2] Fluidization mixers: Double paddle mixer, plow mixer.
3] Tumbler blenders: Rotary drum Blender, V-blenders, double cone blender, octagonal
blender.

16. 1] Convective mixers : It consist of a vertical or horizontal static shell or container (cylindrical,
conical, U- or W- shaped trough) in which powders are circulated around by a rotating blade,
paddle or screw. The choice of mixer within the convective group is much wider. Mixing consists
of convection, diffusive and shear mechanism.
Planetary mixer Sigma mixer
Vertical screw blender Ribbon blender

17. 2] Fluidization mixers:
 Plow Mixer’s insightful design incorporates high-intensity wedge-shaped plows to deliver a
fluidized mixing zone. The slurry mixer shaft operates at higher speeds than a traditional batch
mixer, and when incorporated with the cylindrical vessel design, delivers excellent mixing results.
 High accuracy double shaft paddle blender for solids and powders, suitable for all kinds of mixing
products, especially for those with a fragile morphology that need to be respected. provided
with two shafts with counter-rotating blades, which produce two intense upward flows of
product, generating a zone of weightlessness with an intense mixing effect.
Plow Mixer Double shaft paddle blender

18. 3] Tumbler blenders:
Rely upon the action of gravity to cause the powder to cascade within the rotating vessel.
Blender movements increase the mobility of the individual particles and in the absence of
segregating effects, result in high degree of homogeneity. Mixing homogeneity of upto 98
percent and higher can be achieved using tumbler blenders.
Blending efficiency is affected by the volume of the material loaded into the blender and
the speed of blender rotation. Tumbler blenders are also available with blender containers
in octagonal, cubical or cylindrical shapes.
Double Cone Blender Octagonal Blender V Cone Blender

19. Granulation:
Granulation is a technique of particle
enlargement by agglomeration in the
production of tablets.
 During the granulation process, small fine or
coarse particles are converted into larger
agglomerates called granules.
Granules enhance the uniformity of the API,
increase the density of the blend, facilitate
metering or volumetric dispensing, reduce
dust, and improve the appearance of
product.
Granules are formed from the powder
particles by wetting and nucleation,
coalescence or growth, consolidation, and
attrition or breakage.
GRANULATION EQUIPMENTS:

20. Granulation technologies:
1. Conventional methods
• Dry granulation
• Wet granulation
2. Novel/advanced methods
• Moisture activated dry granulation
• Thermal adhesion granulation
• Pneumatic dry granulation
• Melt/thermoplastic granulation
• Fluidized bed granulation
• Extrusion-spheronization granulation
• Spray drying granulation
• Freeze granulation
• Foam binder granulation
• Steam granulation

21. Oscillating granulator Gral mixer processer
Fluidized Bed Granulator Double cone granulator
Diosna mixer granulator Day Nauta mixer processer
Topo vacuum granulator Chilsonator (Roller compacter)
Modern equipments used in granulation technology:
Fluidized Bed Granulator:
• The powder particles are fluidized in a stream of air.
• Granulation fluid is pumped from a reservoir and sprayed
from a nozzle on to the bed of powders.
• Heated and filtered air is blown through the bed of unmixed
powders to fluidize the particles admix the powders.
• The fluid causes the primary powder particles to adhere the
droplets and powders collide.

22. The oscillating granulator :
• Materials to be granulated and binders (if
required) are loaded into the feed hopper at
the top of the granulator machine.
• These substances fall onto the oscillating
rotor—the rotor rotation alternates between
clockwise and counterclockwise.
• The rotor arms with sharp edges work to
crush the large agglomerates into smaller
particles in an oscillating and rotating manner.
• The crushed particles are then forced through
the oscillating granulator sieve to form the
desired, uniform granule sizes.
• Used for moist and sensitive powder
materials.

23. Diosna mixer granulator
The machine have a stainless steel mixing bowl
containing three bladed impeller and auxiliary
chopper blade.
The high-shear wet granulation process using
high- shear granulator can be divided into 5
stages and they included;
1. Powder mixing
2. Binder addition or addition of granulating liquid.
3. Wetting of powder and nucleation
4. Growth of granules and densification of the
powder.
5. Granule attrition and breakage.

24. Topo vacuum granulator :
 It was developed in Austria for the
preparation of granules and coated particles
under high vacuum.
 The material placed in chamber which must
be dust free suction.
 Then compartment is loaded by vacuum,
granulating fluid or addition products.
 Under vacuum, granulation force are
increased greatly increase to produce the
the necessary compaction.
 Resulted agglomerated particles dried under
vacuum in chamber.
 Advantage is low requirement of granulating
fluid.
 Used for preparing effervescent products.

25. Roller Compactors:
It is used to force fine powders between two counter rotating rolls and presses the raw materials into a
solid compact (flakes, sheets, strips). Roll Compacters are also called dry granulators.
Principle:
A roller compactor generally consists of three major units:
1.A feeding system, which converts the powder to the compaction area between the rolls.
2.A compaction unit, where powder is compacted between two counter rotating rolls to a ribbon by
applying a force.
3.A size reduction unit, for milling the ribbons to the desired particle size.

26. DRYING EQUIPMENT:
Dryers are used to remove liquids or moisture from bulk solids, powders, parts, continuous
sheets or other liquids by evaporation or sublimation.
Dryers can be broken up into two main types: direct and indirect.
1] Direct dryers convectively heat a product through direct contact with heated air.
2] Indirect dryers conductively heat a product through contact with a heated wall.
There are various types of Dryer used in Pharmaceutical Industries:
Fluid Bed Dryers
Tray Dryer
Belt Dryer
Vacuum Tray Dryer
Spray Dryer
Rotary Dryer

27. Fluid Bed Dryers Tray Dryer

28. Vacuum Tray Dryer Spray Dryer

29. TABLETING MACHINE
A tablet compression machine is a mechanical equipment which is used to compress powder
and convert it into tablets which are of uniform size and weight. The rotary tablet press
machine are also known as multi station machine. They have multiple tooling stations which
rotate in order to compress granules into a tablet of uniform size, shape (depending on the
punch design) and uniform weight.

30. TABLET COATING EQUIPMENT:
 Tablet coating is the process where coating material is applied to the surface of the tablet
to achieve the desired properties of dosage form over the uncoated variety.
 The advantages of coating are:
Improving taste,
odor, and color of
the drug
Improving ease of
swallowing by the
patient
Improving product
stability
To protect against
the gastric
environment
To improve
mechanical
resistance of the
dosage form
Modifying release
properties
Coating Process:
 Rotating coating pans are commonly used for coating purpose. Uncoated tablets are
placed inside the pan and the liquid coating material is brought into the pan during the
tumbling of tablets. Air is passed over the tumbling tablets so that liquid part of coating
material gets evaporated leaving the layer of solid coating material.

31. The coating method have following subsequent steps:
• There are three main processes for tablet coating: sugar coating, film coating, and
enteric coating.
Batch identification
and selection of
type of coating.
(film or sugar
coating)
Dispensing (accurate
dosing of all
required raw
materials)
Loading of tablets
into pan
Warming of tablet
Spraying (application of
coating material and
rolling of tablet are
carried out
simultaneously)
Drying
Cooling
Unloading

32. Tablet coating equipment:
A] Conventional
Pan Systems :
• a) Pellegrini system
b) Immersion-sword
system
c) Immersion –tube
system
B] Perforated
Pans Systems:
• a) Accela-coata
b) Hi-coater systems
c) Dria coater
d) Glatt coater
C] Fluid Bed
Systems:
• a) Top spray
• b) Bottom Spray
• c) Tangential spray
A] Conventional pan systems:
The standard coating pan system consists of a circular metal pan
mounted somewhat angularly on a stand. The pan is 8-60 inches
diameter and is rotated on its horizontal axis by a motor. Heated air is
directed into the pan and onto the tablet bed surface, and is
exhausted by means of ducts positioned through the front of the pan.

33. a) Pellegrini pan: • Has a baffled pan and diffuser for uniform distribution of drying air. • It is
enclosed and automated.
b) Immersion-sword system: • Drying air is introduced through a perforated metal sword
immersed in the tablet bed. • The drying air flows upward through bed. • Coating solutions
are applied by an atomized spray system directed onto the tablet bed surface.
c) Immersion-tube system: • The tube immersed delivers heated air and • Coating solution
is applied through spray nozzle built in the tip of tube • The drying air flows upward through
the tablet bed and is exhausted by a conventional duct.

34. B] Perforated pan system:
It consists of a Perforated or partially perforated drum that rotates on its horizontal axis in
an enclosed housing.
a) Accela-Coater and Hi-coater system: Drying air is directed in to drum, is passed through
bed, and is exhausted through perforations in to drum.
Accela-Coater Hi-coater

35. b) Driacoater: • Introduces drying air through hollow perforated ribs located inside
periphery of the drum. • As the coating pan rotates, ribs dip into tablet bed • Drying air
passes up through and fluidizes the tablet bed • Exhaust is from the back of the pan.
c) Glatt coater : • Drying air is directed from inside the drum through the tablet bed and out
an exhaust duct • It consists of an optional split chambered, drying air can be directed in the
reverse manner up through the drum perforations for partial fluidization of the tablet bed.
• Several air flow configurations are possible.
Driacoater

36. C] Fluidized bed (Air suspension system):
• These are highly efficient drying systems • Fluidization of tablet bed is achieved in a
columnar chamber by the upward flow of drying air. • The airflow is controlled so that more
air enters the center of the column, causing the tablets to rise in the center. • The
movement of tablets is upward through the center of the chamber. They then fall towards
the chamber wall and move downward to re-enter the air stream at the bottom of the
chamber. • Coating solutions are continuously applied from a spray nozzle located at the
bottom of the chamber or are sprayed onto the top of the cascading tablet bed by nozzles
located in the upper region of the chamber.

37. TABLET PACKING MACHINES
 A wide variety of tablet packaging machines are available from different manufacturers.
The main types, categorized as follows:
 Strip Packing Machine:
• High Speed Tablet Strip Packing Machine
• Automatic/Soft Double Al Strip Packing Machine
• Automatic Al/Al packing machine and foil strip packing machine
• High Quality Tablet Strip Packing Machine
• Rotary Type Tablet Strip Packing Machine
 Blister Packaging Machines:
• Automatic Strip Blister Packing Machine
• PVC Blister Packaging of Tablets
• Self-checking Moulding Aluminum Blister Packing Machine
• LFA High Quality Blister Strip Packing Machine

38. Strip Packaging Machine
Machines are robust and well constructed and generally
provide high quality by using accurate temperature
control, and the ability to exert variable pressure on the
sealing rollers.
A strip packaging machine is ideal for coating heat sealable
films such as polymer-coated aluminum foil, cellophone
and polymer-coated paper.
 Important features of the machine are:
Availability of Standard interchangeable parts
Cutting arrangement are adjustable
Quick and easy change of parts for application with
different product types
Smooth, silent operation
Compact – minimal floor space
Robust and corrosion resistant coating

39. Blister Packaging Machine
• This machine is ideal for packaging pharmaceutical
materials in blister packs that use materials such as
polyvinyl chloride, polystyrene and polypropylene.
• The primary component of a blister pack is a cavity or
pocket made from a formable web, usually
a thermoformed plastic. This usually has a backing
of paperboard or a lidding seal of aluminum foil or plastic.
A blister that folds onto itself is often called a clamshell.
• Blister packs are useful for protecting products against
external factors, such as humidity and contamination for
extended periods of time. Opaque blisters also protect
light-sensitive products against UV rays.
• Many blister packaging machines use heat and pressure
via a die to form the cavity or pocket from a roll or sheet
of plastic.

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