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Shaban Danish 004 Dated 8th.

May,2020

GRANULATION
MACHINES USED FOR DRY GRANULATION AND WET
GRANULATION

GRANULATION:
Granulation, the process of particle enlargement by agglomeration technique, is one of the most
significant unit operations in the production of pharmaceutical dosage forms, mostly tablets and
capsules. Granulation process transforms fine powders into free-flowing, dust-free granules that
are easy to compress.

TYPES OF GRANULATION:
There are mainly two types of granulations namely:

Dry Granulation

Wet Granulation

Dry Granulation:

Dry granulation is a powder agglomeration process used in the pharmaceutical industry to


improve the flow ability of powders by increasing the particle size (granules).

Wet Granulation:

Wet granulation involves the massing of a mix of dry primary powder particles using
a granulating fluid. The fluid contains a solvent which must be volatile so that it can be removed
by drying, and be non-toxic.
Shaban Danish 004 Dated 8th.May,2020

Machines used for Dry Granulation:

Slugging:
Slugging is a pre-compression process for the formation of extra large tablets (slugs), usually of
variable weight, due to poor flow of the drug powder. The resulting slugs are subsequently
broken down into granules, which are recompressed to obtain the final tablets

Explanation:

In slugging, a large tablet (slug) is produced in a heavy-duty tableting press. This mechanism of
dry granulation leads to variation in the weight of one slug to another. This variation is as a result
of the poor flow rate of powders with small particle size which in turn causes large fluctuation in
the forces applied onto the individual slugs which bring about differences of the slug’s
mechanical strength.  The mechanism of dry granulation is hardly used because the properties of
the granules obtained by milling of the slugs cannot be controlled well either.

Disadvantages of slugging include:

 Single batch processing


 Frequent maintenance change over
 Poor economic of scale
 Low manufacturing throughput per hour
 Excessive air and sound pollution
Shaban Danish 004 Dated 8th.May,2020

 Increased use of storage containers


 Increased need for manufacturing space.
 Increased logistics
 More energy and time is required to produce 1kg of slug than 1kg of roller compact.

Factors affecting slugging process 

 Powder cohesiveness, density and flow characteristics


 Powder particle size distribution
 Machine type
 Feed hopper and feed frame
 Die diameter
 Compression speed
 Slugging pressure
Shaban Danish 004 Dated 8th.May,2020

Slugging Press/ Bolus Tablet Press -Standard

Veterinary Bolus & Slugging Heavy Duty Single Sided Rotary Tablet Press

Working:

Bolus Tablet Press Machine is used for production of simple and precise tablets from powder in
Pharmaceutical and relevant Industries.

PTCM-SH-12 is single sided rotary slugging press with square or painted round body and
suitable for small batch size production of bolus for veterinary and slugging of powder. This is a
single side rotary slugging GMP/ Standard model with rigid design, precise and simple bolus
tablet compression machine. It is heavy duty tablet press to take more press during compression.
The PTCM-SH-12 model machine is designed to enable to maximum cleanliness in operation
and accessibility, thus offering tremendous easy to operate, clean and maintenance

Salient Features :

 Design is cGMP - Current Good Manufacturing Practices compliance.


 All contact parts AISI 316 & non contact parts AISI 304.
 Simple & Convenient Operation, Changeover, Cleanliness, Operator Protection & Ease
to Maintenance.
 Specially designed for pharmaceutical, veterinary, bolus, slugs, pellets, chemicals,
plastic, ceramics, powder metals and other specialized industries.
 A Heavy Duty robust construction with square tubular design.
 Meets the requirements for capacity, precision, control, maintenance, safety and
reliability.
 Maximum resistance to wear and tear.

Safety Features .

Overload pressure release mechanism.


Shaban Danish 004 Dated 8th.May,2020

PTCM-SH-12 Station Slugging - Bolus Tablet Press - Standard Model

Roller Compactors:
Roller Compactors are 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.
Shaban Danish 004 Dated 8th.May,2020

Advantages:

 In general, a major advantage of dry granulation over wet granulation is the


absence of water or any organic solvents. Therefore, this methodology is
especially attractive for drugs, which are moisture or heat sensitive.
 This is suitable for compounds that either have a low melting point or degrade
rapidly during heating, as the method does not involve any drying step.
 Roll compaction results in granules that form porous tablets thus allowing water
to penetrate more easily into the tablet. This leads to improved disintegration
behavior of tablets.
 In addition, this process is environmentally friendly. Also the roll compaction
technique provides an efficient and easily automated process
 Low operational cost.
 Dust problems are minimized or avoided and the die filling during tableting is
improved.
 The capping of tablets might also be reduced.
 Roll compaction/dry granulation can be used, if the drug or the excipient is poorly
flowing or sensitive to heat or moisture.
 It can also be used for densification of powders prior to encapsulation.

Disadvantages:

 One of the disadvantages of roll compaction is a phenomenon called ‘loss of


reworkability.
 Tablets made by roll compaction often show inferior tensile strength compared to
tablets prepared by wet granulation or direct compaction.
 Minimum compaction force should be used, as well as a smaller particle size of
starting powder.
Shaban Danish 004 Dated 8th.May,2020

Roll Compactor - Dry Compaction:

Powder Dry Granulation Process:


Working:

The Roll Compactor machine is used for increased bulk density, making granules, dust free
processing and reducing particle size of pharmaceutical ingredients in pharmaceutical industry.

The material in form of powder passes through the two counter rotating rolls of roller compactor
under very high pressure. As the volume decreases through the region of maximum pressure, the
material is formed into a solid compact sheet or flakes of ingredients. These flakes or compact
sheet of ingredients are reduced in size to obtain the desired grain size. The machine takes extra
care to prevent the generation of fine during this process.

 New Design Features :

 Design is cGMP - Current Good Manufacturing Practices compliance


 All Product contact parts AISI 316 & non-contact parts AISI 304.
 To achieve maximum bulk density and output by various type of rolls.
 Available different type of rolls - 1. Plain 2.Corrugated 3.Knurled.
 Machine fitted with corrugated rolls.

Roll Compactor: Model PRC-200X 100


Shaban Danish 004 Dated 8th.May,2020

Chilsonator Roller Compactor:


Chilsonator roller compactor is a dry granulating equipment that produces a sheet of powder
material by squeezing powder between two rollers. The roller compactor consists of two driver
rollers running in opposite directions from the inside to the outside. The rollers are made of
stainless steel and are equipped with teeth to produce a powerful grinding action by forcing the
material against a series of breaking combs.

Chilsonator roller compactor generally consists of three major units.

 Feeding system: This unit conveys the powder to the compaction area between the rolls.
 A compaction unit: This is where the powder is compacted between two counter-
rotating rolls to a ribbon by applying a force.
 A size-reduction unit: This is for milling the ribbons to the desired particle size.

Advantages of Roller Compactor:

 Simplifies processing
 Facilitates powder flow
 Requires less man-hours to operate
 Reproduces consistent particle density
 Produces good tablet and capsule disintegration
 Eliminates aqueous and solvent granulation
 Improves process circle time
Shaban Danish 004 Dated 8th.May,2020

 Prevents particle segregation


 Facilitates continuous manufacturing
 Improves content uniformity

Wet Granulation:

Wet granulation involves the massing of a mix of dry primary powder particles using
a granulating fluid. The fluid contains a solvent which must be volatile so that it can be removed
by drying, and be non-toxic.

Machines Used For Wet Granulation:

Planetary Mixer:
The planetary mixer is an industrial equipment conceived/made to prepare food, chemical,
ceramic dough or other type of product, replacing manual labour through a mechanical system
that allows to produce, continuously, large quantities of dough. They are composed by:

 Bowl for ingredients placement


 Mixing element (whisk, hook, flat beater, scrapper or other system)
 Motors that start the bowl and whisk movements
 Interconnection of technological process that allows to the operator the control of the
mixing process and other labour process (programming times and speeds; mixing elements)

The name “planetary mixer” comes from the system used in the equipment that mixes the dough
in the planets rotation direction.

Salient Features:

 Stainless steel product contact parts 304 or 316.


 Easy bowl removal without removal of mixing arm.
 Special safety ring prevents injury to hands between bowl & lid.
 Bowl cover incorporates filling aperture & inspection window.
Shaban Danish 004 Dated 8th.May,2020

 Planetary movement provides very intensive, quick, homogeneous & dead-spot-free


mixing.
 Bowl height sufficient for recipient container to be placed underneath.
 Top driven design eliminates contamination through packing & seals.
 Crank case design prevents oil leakage into bowl.
 Removable bowl design and arm interchangeability allow easy cleaning and quick
changeover.

Planetary mixer

Working:

The planetary mixer is so named because the mixing blade (commonly known as the beater)
rotates in a planetary motion inside the mixer bowl. The bowl of the single planetary mixer
consists of an upper cylindrical section and a lower hemispherical section. The mixer bowl is
secured to a semi-circular frame at the time of mixing. The beater profiles are shaped to match
the lower curved surface of the bowl. The beater has two types of movements: it revolves on it
own vertical axis at high speed. At the same time, this vertical axis rotates around the centre of
Shaban Danish 004 Dated 8th.May,2020

the bowl at a relatively lower speed.

Oscilating Granulator:
Oscillating granulator is used for gentle homogenization, size reduction, grading and sieving of
dry, sensitive powders and granules in pharmaceutical, chemical and food industries. Oscillating
Granulator has one rotor with five edges, which oscillate on horizontal axis at about 180 per
minutes.

Working Principle:

The principle of an oscillating granulator is to mechanically pass compacted material through a


wire mesh screen or plate using an oscillating rotor. The rotor speed and rotation time are
variable in the clockwise or counterclockwise directions. Particle size is controlled through mill-
screen size, rotor speed, and the rotor's rotation angle.

Advantages:

Mixing and granulation are all performed within a few minutes in the same piece of equipment

Disadvantages:

The process needs to be controlled with care as the granulation progresses so quickly that a
usable granule can be transformed into an unusable over massed system, Thus it is often
necessary to use suitable monitoring system to indicate the end of the granulation process i.e.
when a granule of the desired properties has been attained.
Shaban Danish 004 Dated 8th.May,2020

OSCILATING GRANULATOR

High Speed Mixers:


A high-shear mixer disperses, or transports, one phase or ingredient (liquid, solid, gas) into a
main continuous phase (liquid), with which it would normally be immiscible.

A rotor or impeller, together with a stationary component known as a stator, or an array of rotors
and stators, is used either in a tank containing the solution to be mixed, or in a pipe through
which the solution passes, to create shear.

Uses:

A high-shear mixer can be used to create emulsions, suspensions, lyosols (gas dispersed in


liquid), and granular products. It is used in the adhesives, chemical, cosmetic, food,
pharmaceutical, and plastics industries for emulsification, homogenization, particle size
reduction, and dispersion.

Working:

Fluid undergoes shear when one area of fluid travels with a different velocity relative to an
adjacent area. A high-shear mixer uses a rotating impeller or high-speed rotor, or a series of such
impellers or inline rotors, usually powered by an electric motor, to "work" the fluid, creating
flow and shear. The tip velocity, or speed of the fluid at the outside diameter of the rotor, will be
higher than the velocity at the center of the rotor, and it is this velocity difference that creates
shear.
Shaban Danish 004 Dated 8th.May,2020

Little Ford Mixer:


Littleford Horizontal Plow Mixers create a mechanical, fluidized bed mixing action. The mixing
tools project and hurl material away from the wall into free space in a crisscross direction, and
inversely back again. The plow separates and lifts the product in a three-dimensional motion,
while the number and arrangement of the tools insure agitation back and forth along the length of
the vessel. The size, number, geometric shape, arrangement, and peripheral speed of the mixing
tools are designed to achieve this mixing action for each specific application. When required, the
mix action is assisted by high shear chopper devices: independent high-speed motors with
customized blades for adding shear to the product mix.

Key Features:

• Material of construction: 304 stainless steel


• Volume: 600 liters
• Speed: 65 rpm (main shaft), 3600 rpm (chopper)
• Max temperature: 200 degrees C

Little Ford Mixer


Shaban Danish 004 Dated 8th.May,2020

Gral Mixer:
Working and Construction:

The angled position of the mixing blades combined with the rounded edges at the bottom of the
vessel guarantee the typical rope-type movement for optimal flow of product during granulation.
Several binder liquid spray systems are available to suit the process. Bowl and mixing blades are
shaped and mounted to minimize clearance for maximum yield, without locally overheating the
product. During a discharge cycle, the centrifugal force created by the rotation of the mixing arm
will push the product in a natural way to a proportionally regulated outlet valve at the side
without compacting the wet granules.

With capacities from 10 to 1200 liter, the Gral range can cover all requirements, from
development over clinical batch production for scale-up trials to large scale production for
marketed products.

Advanatges:

 The equipment is easy to operate.


 Loading the powders can be executed by gravity.
 An inspection window or video is incorporated in the bowl cover for visual process
monitoring.
 The height of the bowl outlet allows for an open discharge in the product vessel of the
dryer or for an inline connection with a calibrating unit and vacuum transfer piece for
closed transport of the wet granules to the Fluid Bed Dryer.
 Process controls and automation are available by means of PLC and operating panel, with
optional recipe control. 
Shaban Danish 004 Dated 8th.May,2020

Gral High Shear Mixer

Fluidized Bed Dryer:


Fluidized bed dryer (also called fluid bed dryer) is a kind of equipment used extensively in the
pharmaceutical industries to reduce the moisture content of pharmaceutical powder and granules.

Working:

The equipment works on a principle of fluidization of the feed materials. In fluidization process,
hot air is introduced at high pressure through a perforated bed of moist solid particulate. The wet
solids are lifted from the bottom and suspended in a stream of air (fluidized state). Heat transfer
is accomplished by direct contact between the wet solid and hot gases. The vaporised liquid is
carried away by the drying gasses. Sometimes to save energy, the exit gas is partially recycled.

Construction:

A typical fluidized bed dryer consists of the following components

 Air preparatory unit.


 Product container.
 Exhaust filter.
 Exhaust blower.
 Control panel.
 Air distribution plate.
Shaban Danish 004 Dated 8th.May,2020

 Spray nozzle.
 Solution deliver.

Types of Fluidized-Bed Dryers:

There are various types of fluidized bed dryer.

Conventional Fluidized Bed Dryers:

Conventional fluidized bed dryers include;

 Batch fluidized bed dryers.


 Semi-continuous fluidized bed dryers.
 Well-mixed, continuous fluidized dryers.
 Plug flow fluidized bed dryer.

Modified Fluidized Bed Dryers:

Various types of modified fluidized bed dryers have been developed and are applied in many
industrial processes to overcome some of the problems encountered while using conventional
fluidized bed dryer and for a drying process.

Advantages of Fluidized bed Dryer


 High rates of moisture removal due to excellent gas-particle constant which results in
high heat and mass transfer rates.
 High thermal efficiency is usually achieved if part of the thermal energy for drying is
supplied by the internal heat exchanger
 Lower capital and maintenance cost
 Reduced contact time for drying.
 Ease of control.

Disadvantages of Fluidized Dryer:


 High pressure drops results as a result of the need to suspend the entire bed in gas which
equally leads to high energy consumption.
 Requires increased gas handling due to extensive recirculation of exhausts gas for high
thermal efficiency operation.
 Poor fluidization and low flexibility especially if the feed is too wet.
 Not the best choice of equipment when organic solvents need to be removed during
drying.
 Non-uniform product quality for certain types of fluidized bed dryer.
 Entertainment of fine particles.
Shaban Danish 004 Dated 8th.May,2020

 High potential for attrition; and in some cases agglomeration of fine particles.
 The conventional hot air fluidized bed dryer is not a good choice of dryer when handling
toxic or flammable solids since there is danger of fire or explosion of flammability limits
are exceeded.

Fluidized Bed Dryer


Shaban Danish 004 Dated 8th.May,2020

Refrences

www.pharmapproach.com

www.gea.com

www,Wikipedia.com

https://mixerworks.com/littleford-day-mixer/

www.slideshare.net

www.pharmaceuticalonline.com

www.ebseos.com

www.bplittleford.com

http://www.pharmtech.com/effect-mill-type-two-dry-granulated-placebo-formulations

https://www.brighthubengineering.com/manufacturing-technology/57871-single-planetary-
mixer/

https://pharmaceuticalmachineriesipec.com/planetary-mixer/

https://www.prismpharmamachinery.com/roll-compactor-300.html

https://www.linkedin.com/pulse/roller-compactor-basic-principles-applications-pharmaceutical-
tareq-/

https://www.saintytec.com/working-principle-pharmaceutical-roller-compactor/

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