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Cadpress IV - High speed double sided rotary tablet press

 High Speed Double Rotary Machine with Pre-compression
 Available as Standard / PLC-MMI based / Fully Computerized ve
 Conforming to stringent cGMP norms
 Easy accessibility for quick cleaning and product changeover
 Ability to handle difficult products easily due to Pre-compression
 Precise Weight Control
 All Tablet parameters can be fine tuned during operation from out
tabletting zone
 Ensures hygienic production condition and operator safely

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TECHNICAL SPECIFICATIONS:

TYPE CPD IV-45 CPD IV-55 CPD IV-69 CPD

No. of station 45 55 69 75
Type of tooling D B BB BB
Output (Tablets/hour)*
Maximum 324000 396000 496800 540
Minimum 64800 79200 99360 108
Max. operating pressure- 100 65 65 65
Main(kN)
Max. operating pressure-Pre- 10 10 10 10
compression(kN)
Max.tablet diameter (mm) 25 16 11 11
Max. depth of fill(mm) 20 17 17 17
Upper punch entry Penetration - 3 to 6
Main(mm)
Total - Power (kW/hp) 8.75/11.70
Main Electric motor (kW/hp) 7.50/10.00
Force feeder Electric motor 0.19/0.25
(kW/hp)
Power pack Electric motor 0.75/1.00
(kW/hp)
Electrics (a) 415V / 3Phase / 50 Hz
(b) 480V / 3Phase / 60 Hz
(c) 220V / 3Phase / 60 Hz
Overall dimensions L x W x H 146 x 161 x 196
(cm)
Net weight(kg) 3745
Case DimensionL x W x H (cm) 198 x 221 x 229
Gross weight(kg) 4085
 *Depending upon Tooling Size, Shape and also Material Characteristics

ADDITIONAL OPTIONAL FEATURES:

1. Three Piece Turret with Stainless Steel 304/316 die-table

2. Auto tablet rejection during m/c start & stop and random tablet sampling device
3. Powder level monitoring device at feed hoppers
4. Spray lubrication system for effervescent tablet production
5. Gravity feeding system
6. Bi-layer tablet attachment
7. PLC control system with touch screen display
8. Fully computerized CFC system
9. "CE" Marking
10. VAC-U-MAX Conveyor system for Powder loading
11. PLC - Programmable Logic Control

HEAD OFFICE & PLANT

Plot no. 3604 & 3605, GIDC, Phase: IV, Vatva, Ahmedabad 382 445. INDIA
Phone No : + 91-79-2584 1491 / 92 / Fax : + 91-79-2584 E-mail : info@cadmach.com
93 / 53 2602
Copyright @ 2009, CADMACH Machinery Co. Pvt. Ltd.
® All Rights Reserved.

RAPID MIXER GRANULATOR

Description:

Rapid Mixer Granulator is designed to achieve excellent mixing and consistent granules at lower operating cost along
with higher productivity. Better mixing and closed control of granule size leads to faster tableting speeds with improved
quality and least rejections.

Salient Features:
 Homogeneous binder distribution.
 Short batch time and reduce cleaning time.
 Maximize CIP effectiveness.
 Air purge sealing system for main stirrer shaft and granulator shaft.
 All internal contact parts are polished to the mirror finish.
 PLC based operating panel for precise control of process & automation.
 A high-speed granulator is inserted horizontally through wall of bowl to assist blending of powder and to break the
product to the granules of required size.
 The seal housing and drive shaft may be flushed with cleaning water, which is then drained
away from the machine through built in drain tubes.
 Granulator motor is provided with a removable stainless steel shroud which covers the
motor and simplify cleaning.
 All moving parts of the machine are totally enclosed to eliminate accident.
 The machine can not be started unless and until the mixer cover is properly closed.
 All contact parts are made out of SS304. SS316 provided on demand on extra cost.
 Flush wall type discharge valve eliminates pockets at the port of discharge valve

Technical Details: :

Model available from 25 Liters to 250 Liters capacity gross capacity. The gross capacity & working capacity in liters and
working capacity in Kgs. are as below.

Working Capacity In
Model Gross Capacity In Litres
Litres
RMG - 25 25 20 10
RMG - 100 100 80 40
RMG - 150 150 120 60
RMG - 250 250 200 100
Note: Dimensions & Technical Details are subject to change as per customers' requirement without any further notice
Automatic Tablet Counting & Filling Machine Fluid Bed Dryer

Fluidized bed
From Wikipedia, the free encyclopedia
For other uses, see Fluidized bed (disambiguation).

This article needs additional citations for verification. Please help improve this article by adding
citations to reliable sources. Unsourced material may be challenged and removed. (September 2008)

This article needs attention from an expert on the subject. See the talk page for details. WikiProject
Chemical and Bio Engineering may be able to help recruit an expert. (September 2008)

Oldest power station utilizing circular fluidized bed technology, in Lünen, Germany

A fluidized bed is formed when a quantity of a solid particulate substance (usually present in a holding
vessel) is placed under appropriate conditions to cause the solid/fluid mixture to behave as a fluid. This is
usually achieved by the introduction of pressurized fluid through the particulate medium. This results in the
medium then having many properties and characteristics of normal fluids; such as the ability to free-flow
under gravity, or to be pumped using fluid type technologies.

The resulting phenomenon is called fluidization. Fluidized beds are used for several purposes, such
as fluidized bed reactors (types of chemical reactors), fluid catalytic cracking, fluidized bed combustion,
heat or mass transfer or interface modification, such as applying a coating onto solid items.
 Contents
[hide]

 1 Properties of fluidized beds

 2 Application

 3 History

 4 Fluidized bed types

 5 Bed design

o 5.1 Basic model

o 5.2 Geldart Groupings

o 5.3 Distributor

 6 See also

 7 References

 8 External links

[edit]Properties of fluidized beds

A fluidized bed consists of fluid-solid mixture that exhibits fluid-like properties. As such, the upper surface of
the bed is relatively horizontal, which is analogous to hydrostatic behavior. The bed can be considered to
be an inhomogeneous mixture of fluid and solid that can be represented by a single bulk density.

Furthermore, an object with a higher density than the bed will sink, whereas an object with a lower density
than the bed will float, thus the bed can be considered to exhibit the fluid behavior expected ofArchimedes'
principle. As the "density", (actually the solid volume fraction of the suspension), of the bed can be altered
by changing the fluid fraction, objects with different densities comparative to the bed can, by altering either
the fluid or solid fraction, be caused to sink or float.

In fluidized beds, the contact of the solid particles with the fluidization medium (a gas or a liquid) is greatly
enhanced when compared to packed beds. This behavior in fluidized combustion beds enables good
thermal transport inside the system and good heat transfer between the bed and its container. Similarly to
the good heat transfer, which enables thermal uniformity analogous to that of a well mixed gas, the bed can
have a significant heat-capacity whilst maintaining a homogeneous temperature field.

[edit]Application

Fluidized beds are used as a technical process which has the ability to promote high levels of contact
between gases and solids. In a fluidized bed a characteristic set of basic properties can be utilised,
indispensable to modern process and chemical engineering, these properties include:

 Extremely high surface area contact between fluid and solid per unit bed volume

 High relative velocities between the fluid and the dispersed solid phase.
 High levels of intermixing of the particulate phase.

 Frequent particle-particle and particle-wall collisions.

Taking an example from the food processing industry: fluidized beds are used to accelerate freezing in
some IQF tunnel freezers. IQF means Individually Quick Frozen, or freezing unpackaged separate pieces.
These fluidized bed tunnels are typically used on small food products like peas, shrimp or sliced
vegetables, and may use cryogenic or vapor-compression refrigeration. The fluid used in fluidized beds
may also contain a fluid of catalytic type; that's why it is also used to catalyse the chemical reaction and
also to improve the rate of reaction.

[edit]History

In 1922 von Winkler designed a reactor that for the first time utilized a coal gasification process. Further
application of the fluidized bed included the catalytic cracking of mineral oils in the 1940s. During this time
theoretical and experimental research improved the design of the fluidized bed. In the 1960s VAW-
Lippewerk in Lönen implemented the first industrial bed for the combustion of coal and later for the
calcination of aluminium hydroxide.

[edit]Fluidized bed types

Bed types can be coarsely classified by their flow behavior, including:

 Stationary or bubbling beds, where the fluidization of the solids is relatively stationary, with some fine
particles being entrained.

 Circulating beds, where the fluidization suspends the particle bed, due to a larger kinetic energy of the
fluid. As such the surface of the bed is less smooth and larger particles can be entrained from the bed
than for stationary beds. These particles can be classified by a cyclone separator and separated from
or returned to the bed, based upon particle cut size.

 Vibratory Fluidized beds are similar to stationary beds, but add a mechanical vibration to further excite
the particles for increased entrainment.
[edit]Bed design

A diagram of a fluidized bed

[edit]Basic model
When the packed bed has a fluid passed over it, the pressure drop of the fluid is approximately proportional
to the fluid's superficial velocity. In order to transition from a packed bed to a fluidized condition, the gas
velocity is continually raised. For a free-standing bed there will exist a point, known as the minimum or
incipient fluidisation point, whereby the bed's mass is suspended directly by the flow of the fluid stream.
The corresponding fluid velocity, known as the "minimum fluidization velocity", umf.

Beyond the minimum fluidization velocity ( ), the bed material will be suspended by the gas-
stream and further increases in the velocity will have a reduced effect on the pressure, owing to
sufficient percolation of the gas flow. Thus the pressure drop from for u > umf is relatively constant.

At the base of the vessel the apparent pressure drop multiplied by the cross-section area of the bed can be
equated to the force of the weight of the solid particles (less the buoyancy of the solid in the fluid).

Δpw = Hw(1 − εw)(ρs − ρf)g

[edit]Geldart Groupings
In 1973, Professor D. Geldart proposed the grouping of powders in to four so-called "Geldart Groups"[1].
The groups are defined by their locations on a diagram of solid-fluid density difference and particle size.
Design methods for fluidized beds can be tailored based upon the particle's Geldart grouping.

Group A For this group the particle size is between 20 and 100 um, and the particle density is typically less
than 1.4g/cm3. Prior to the initiation of a bubbling bed phase, beds from these particles will expand by a
factor of 2 to 3 at incipient fluidization, due to a decreased bulk density. Most powder-catalyzed beds utilize
this group.

Group B The particle size lies between 40 and 500 um and the particle density between 1.4-4g/cm3.
Bubbling typically forms directly at incipient fluidization.

Group C This group contains extremely fine and consequently the most cohesive particles. With a size of
20 to 30 um, these particles fluidize under very difficult to achieve conditions, and may require the
application of an external force, such as mechanical agitation.

Group D The particles in this region are above 600 um and typically have high particle densities.
Fluidization of this group requires very high fluid energies and is typically associated with high levels of
abrasion. Drying grains and peas, roasting coffee beans, gasifying coals, and some roasting metal ores are
such solids, and they are usually processed in shallow beds or in the spouting mode.

[edit]Distributor

Typically, pressurized gas or liquid enters the fluidized bed vessel through numerous holes via a plate
known as a distributor plate, located at the bottom of the fluidized bed. The fluid flows upward through the
bed, causing the solid particles to be suspended. If the inlet fluid is disabled the bed may settle or pack
onto the plate.
[edit]See also

 Cyclonic separation - A method of separating gases and particulate matter

 Fluidization - Principles and theory of fluidization

 Fluidized bed combustion - Application of fluidized beds to combustion

 Fluidized bed reactor - Application of fluidized beds to reactive chemical processes

 Unit operation - Other Engineering unit operations

 Chemical looping combustion - Dual fluidized bed application

 Heyl & Patterson Inc. - Innovator of fluidized bed technology for industrial dryers, coolers and calciners
[edit]References

Krishnakant Sarvaiya and Stavan Nagori

1. INTRODUCTION
1.1 HISTORY
1.2 COMPARISION OF DIFFERENT GRANULATION TECHNIQUES
(1)
1.1 HISTORY
1892:

(1)
Figure -1 The starting
In 1892, Walloon engineer, Emiel Collette, lost his heart to a girl from
Antwerp. This love story led to the foundation of "Werkhuizen Collette" in the
center of Antwerp. "Werkhuizen Collette" was a mechanical construction
company that produced mainly dough mixer-kneaders for the bakery
industry. During the first decades of the 20th century the company knew a
steady growth and became widely known for the robust and reliable
execution of their equipment.
1920 TO 1930:
After World War I, Mr. Alfred Collette took over the lead of the company from
his father and focussed on the growing industrialization. Collette NV was now
producing machinery for several other industry sectors than the bakery
industry. For example, paint mixers, potato scrapers and almond crushers
were part of the machine range Collette NV had to offer.
 (1)
Figure -2 Expansion
1940 TO 1960: INTERNATIONALIZATION
After World War II, Collette NV knew a revival by expanding the scope of
their equipment to the pharmaceutical industry. Besides industrial mixers
they now also manufactured planetary mixers for both food and
pharmaceutical industry. At the end of the fifties, Alfred Collette's son-in-law,
Ir. Emiel Sanctorum, came in charge of the company and he invested a lot in
research for new machinery and in export activities, especially to France and
the BENELUX. Under his impulse, Collette NV knew a tremendous growth and
the company had to move to a more suitable location then the centre of
Antwerp. In 1963, the factory was moved to Wommelgem, where it is still
located. As for the investment in new technologies, the most important
developments from this time were the high speed kneader (SM-series),
which would later turn out to be the predecessor of the first machine
especially designed for pharmaceutical industry, and the MICO Collette, an
automatic grinding machine originally designed for in-house use, but now still
used by many large companies in the automotive industry.
1970 TO 1980: THE PHARMACEUTICAL INDUSTRY
The definite breakthrough in the pharmaceutical industry came with the
incorporation of Collette NV into the GEI-group in 1972 and with the
introduction of the first High Shear Mixer Granulator (GRAL) in 1975. From
that time on, Collette NV has become an established name in the
pharmaceutical industry. Collette NV stands for innovation, new technologies
and service. In 1980 the one-pot concept was introduced with the TOPO-
design and the GRAL-processor. In 1982, the TOPO-house opened a test lab
for the customers, now better known as the Process development Center
(PDC).
1990: CONTINUING INNOVATIONS
 (1)
Figure -3 Innovations
With the introduction of the Vactron in 1990, Collette NV was one of the first
machine manufacturers to promote microwave drying for pharmaceutical
applications, emphasizing its focus towards this industry. But Collette NV also
remained true to its roots, and still invested a lot in the development of
machinery for the food industry.
In 1993 for example, they introduced the CONVERTICOLL, a continuous
mixer-aerator, and in 1998 the CREAM MASTER has been introduced, a
continuous fat cream aeration system.
In 1992, when Collette celebrated its 100th anniversary, the original TOPO-
house has been expanded, re-planned and re-equipped to become the
Process Development Center. By now it has become a household word in the
industry and many of our customers come there to run tests with their own
products.
2000: LOOKING FORWARD TO THE NEW MILLENIUM
Another major event at the beginning of the 21st century was the
introduction of a new range of high shear mixers and single pot processors,
the ULTIMATM range. This new range is the successor of the GRAL and
VACTRON ranges and answers to the strictest cGMP requirements. Its
introduction signals the continuing focus of Collette on innovation and
customer satisfaction.
Today, Collette NV is still located in Wommelgem, near Antwerp, but its
premises have grown over the years. Under the leadership of Mr. Emiel De
Naeghel, the Managing Director of Collette NV until 2002, the company has
continued to grow and invest in new developments for both food and
pharmaceutical industry.
(4)
1.2 GRANULATION
The term ―granulation‖ regularly refers to processes whereby aggregates
with sizes ranging from about 0.1 to 2.0 mm are produced. The term
―pelletization‖ is used synonymously with granulation, but in pharmacy this
term is usually refers to the manufacture of aggregates, preferably spherical,
with a narrow size distribution in the range of about 0.5 to 1.5 mm. (4)
(4)
1.2.1 DEFINITION

Granulation is a process of size enlargement whereby small particles are

gathered into larger, permanent aggregates in which the original particles
can still be identified.(4)
The major reason for granulating the powdered starting material in the
manufacture of tablets and granules are to:
 To improve the flow properties so that, the mass uniformity of the dose.
 To prevent segregation of ingredients in the mixture.
 To improve the compression characteristics of the mixture.
 To reduce the environmental hazards for the working personnel due to
dust formation from toxic materials.
 To reduce the bulk volume of voluminous powders and make them more
convenient for storage and transport.
 To improve the appearance of the product.(4)
 The granules being heavier do not blow out of the die and do not clog the
lower punch.(12)
(5)
1.2.2 TYPES OF GRANULATION

GENERAL PROCESS SPECIFIC METHODOLOGY

Wet granulation Wet massing

Fluid bed granulation
Spray drying
Pan granulation
Extrusion and palletizing

Dry granulation Roller compaction

Slugging

Other processes Humidification

Melt pelletization

TABLE 1 PROCESS USED FOR PHARMACEUTICAL GRANULATIONS (5)

1.2.3 GRANULATION MECHANISMS
(A) PARTICLE-BONDING MECHANISMS

During granulation, particles adhere and agglomerate due to bond formation.

These bonds should be strong enough to allow granules to withstand
handling without breakdown.(14)(16)
TABLE 2 CLASSIFICATION OF THE BONDING MECHANISMS RELEVANT
TO DRY AND WET GRANULATION PROCESS: - (15)

CLASS MECHANISM

Solid bridges Sintering, heat hardening

Incipient melting due to pressure or friction.
Deposition during drying

Immobile liquids Viscous binders

Adsorption layers

Mobile liquids Liquid bridges

Capillary forces

Intermolecular and long-range forces Van der waals forces

Electrostatic forces

Mechanical interlocking Shape-related bonding

(B) GRANULE GROWTH MECHANISMS

In the dry methods, particle adhesion takes place because of applied

pressure. A compact or sheet is produced which is larger than the granule
size required, and milling and sieving can attain therefore the required
size. (3) The compact masses are called as slugs, and the process is referred
to as ―slugging‖.(13)
In wet granulation methods, liquid added to dry powders has to be
distributed through the powder by the mechanical agitation created in the
granulator(3). The liquid plays a key role in the granulation process. Liquid
bridges developed between particles, and the tensile strength of these
bonds increases as the amount of liquid added is increased. These surface
tension forces and capillary pressure are primarily responsible for initial
granule formation and strength.(13)The particles adhere to each other
because of liquid films, and further agitation and/or liquid addition causes
more particles to adhere. The precise mechanism by which a dry powder is
transformed into a bed of granules varies for each type of granulation
equipment, but the mechanism discussed below serves as a useful broad
generalization of the process. (3)
The proposed granulation mechanism can be divided into three stages.
1.Nucleation:
The granulation starts with adhesion among particles due to liquid bridges
and the formation of agglomerates at capillary state. These structures may
act as nucleus for successive enlargement of granules.(17)(18)(19)
(5)
2. Transition:
Nuclei can grow in two possible ways: either single particles can be added to
the nuclei by pendular bridges, or two or more nuclei may combine. The
combined nuclei will be reshaped by the agitation of the bed. This stage is
characterized by the presence of a large number of small granules with a
fairly wide size distribution. If the size distribution is not excessively large,
this point represents a suitable end point for granules used in capsule and
tablet manufacture.
(5)
3.Ball growth:
Further granule growth produces large, spherical granules and the mean
particle size of the granulating system will increase with time. If agitation is
continued, granule coalescence will continue and produce an unusable,
overmassed system, although this is dependent upon the amount of liquid
added and the properties of the material being granulated.
The four possible mechanisms of ball growth are illustrated in Figure.
(3)
a) Crushing and layering:
Granules break into fragments that adhere to other granules, forming a layer
of material over the surviving granule.
(3)
b) Coalescence:
Two or more granules join to form a larger granule.
(3)
c) Abrasion transfer:
Agitation of the granule bed leads to the attrition of material from granules.
This abraded material adheres to other granules, increasing their size.
(3)
d) Layering:
When a second batch of powder mix is added to a bed of granules the
powder will adhere to the granules, forming a layer over the surface and
increasing the granule size. This mechanism is only relevant to the
production of layered granules using spheronizing equipment.
There is always some degree of overlap between these stages and it is very
difficult to identify a given stage by inspection of the granulating system. For
end-product uniformity it is desirable to finish every batch of a formulation at
the same stage, and this may be a major problem in pharmaceutical
production.
Using the slower processes, such as the planetary mixer, there is usually
sufficient time to stop the process before overmassing occurs. With faster
granulation equipment the duration of granulation can only be used as a
control parameter when the formulation is such that granule growth is slow
and takes place at a fairly uniform rate. In many cases, however, the
transition from a non-granulated to an overmassed system is very rapid, and
monitoring equipment is necessary to stop the granulation at a
predetermined point, known as granulation end-point control.

Figure 4. Mechanism of Ball growth*

(2)
1.2.4 DIFFERENT GRANULATION TECHNIQUES

Granulation is one of the most important unit operations in the production of

pharmaceutical oral dosage forms. However, there are many different
technologies each having different strengths and weaknesses. Most
companies prefer which one to use merely based on their own experience.
(A) SINGLE POT

ØProcessing: -
·A mixer/granulator that dries granules in the same equipment without
discharging is commonly called a single pot (Figure 5).
·The granulation is done in a normal high shear processor; however, care
must be taken to shun the formation of lumps as they cannot be broken
down before drying.
 (2)
Figure - 5 A typical single pot set-up
ØVarious options for drying :-
·For small scale: - The conventional heat source comes from the dryer
walls, which are heated; the boiling temperature and vacuum are used to
reduce and remove vapours. The heat transfer is linked to the surface area of
the dryer walls and the volume of product treated. Therefore, this direct
heating method is only effective for small scale use.
·For large scale: - Introducing stripping gas into the pot allows large scale
operation. A small quantity of gas is introduced in the bottom of the
equipment, which passes through the product bed, improving the heat flow
from the wall into the product. The gas also improves the efficiency of
vapours removal.
ØLimitation:- As the heated wall is the only source of drying energy, linear
scale-up is not possible. This problem is exacerbated if the material to be
processed is heat sensitive (as this limits the wall temperature); if water is
used as a granulation liquid (it has a high boiling temperature under vacuum
and a high heat of evaporation); and if used for larger-scale production (the
surface/volume ratio deteriorates as the volume increases).
ØTo overcome these limitations: - Microwave energy can be used. This
provides a further source of energy and has the additional advantage, with
organic solvents, that only pure organic vapours must be treated on the
exhaust side, and not a mixture of solvent and large volumes of process gas,
as would be required in most other wet granulation technologies.
(B) FLUID BED TOP SPRAY GRANULATION
 (2)
Figure - 6 Bed top spray granulation
ØProcessing:-
·Granulation can be performed using fluid beds fitted with spray nozzles.
·It is possible to have completely closed material handling by a closed linking
with upstream and downstream equipment (Figure 6) Also, fully automatic
cleaning (cleaning- place [CIP] and wash-in-place [WIP]) in fluid beds using
stainless steel filters now compares favorably with what is possible in a single
pot.
(C) HIGH SHEAR GRANULATION/FLUID BED DRYING COMBINATION

Figure -7 A typical set-up installation at an industrial

(2)
scale for the production of pharmaceutical granules
ØThis is the most common pattern used at an industrial scale for the making
of pharmaceutical granules (Figure 7).
ØAdvantages:-
·This system allows full integration with upstream and downstream
equipment, and even includes a wet mill between the granulator and dryer.
·With modern control systems it is easy to load, mix and granulate a second
batch in the high shear granulator whilst drying the previous batch in the
fluid bed prior to discharge.
·All equipment can be CIP in a single automatic process. Whereas a single
shaker might be acceptable for drying applications, a twin shaker or
blowback filter design should be used for granulation processes.
(D) CONTINUOUS FLUID BED GRANULATION

ØProcessing: -
·The equipment is filled with raw material similar to a batch unit.
·After the material has been granulated, the process is switched to the
continuous mode allowing material to be introduced via the rotary inlet valve
and discharged as granules by a second outlet valve.
·Monitoring the pressure drop over the product bed can control the process.
·The inlet air is segmented, which allows the product in different areas to be
treated with different temperatures. Although the process is effectively plug
flow, a significant amount of back mixing occurs during processing.

(2)
Figure -8 Continuous fluid bed granulation
(E) FLUIDIZED SPRAY DRYING (FSD)

ØProcessing
·Fluidized spray drying (FSD) produces granules from a liquid in a one-step
process Figure 9.
·One option is to produce the active in the primary production as granules, so
that it only requires blending with excipients appropriate for direct
compression for secondary processing.
·This can only be done with actives that are tacky (in a wet state), otherwise
the addition of a binder is necessary.
·Another possible use of FSD technology is to mix all the ingredients into a
solution or suspension and to produce granules in a one-step operation.
A principle drawing of an FSD set-up is shown in Figure 9(a). During the FSD
process, the liquid feed is atomized at the top of the tower in a concurrent
mode. After the liquid is evaporated, the particles generated leave the drying
chamber together with the exhaust air. These particles are then separated in
a cyclone or filter and reintroduced into the drying chamber where they come
into contact with wet droplets and form agglomerates. After these
agglomerates have reached a certain weight they cannot leave via the top of
the tower with the exhaust air, but fall down into the integrated fluid bed at
the bottom of the drying chamber. Here they are dried and cooled before
being discharged.
ØLimitation: - this type of equipment is not easy to clean, particularly the
exterior pipework, when changing to another product.
ØTo overcome these limitations: - Systems have, therefore, been
developed where the exterior pipework does not come into contact with the
product (Figure 9(b)).
(2)
1.2.5 COMPARISON OF GRANULATION PROCESSES

Tables 3-5, a brief overview of the implications of particular granulation

methods.
(A) GENERAL ASPECTS $
(2)
TABLE – 3 GENERAL ASPECTS

Option Option Option 3 Option 4 Option 5 Option 6

 1 2 Top spray Continuous Spray Pelleting
granulation top spray drying (3) (4)
Single High
(2) process (2)
pot(1) shear
force
mixer
and
FBD (1)

SCALES LS LS LS (TS) TS (TS)

AVAILABLE TS TS TS PS PS PS
LABORATORY PS PS PS
SCALE (LS)
TECHNICAL
SCALE (TS)
PRODUCTION
SCALE(PS)

DEFINITION OF ++ ++ ++ Material Material Material

BATCH container container container

SCALABILITY + + + ++(down?) ++(down?) ++(down?)

NEED FOR Weight Height Height Integration Height Integration

SPECIAL into building into
BUILDING building

ENERGY/kG(5) >0.25 >0.25 >0.37 kW/kg >0.3 >7.5 >0.5 kW/kg

kW/kg kW/kg 7kW/kg kW/kg

YIELD >99.5% >99% >99% >99% >99% >98%

All information shown assumes ‘normal’ products. Some special products may behave
differently
(1) Granulation with 10% granulation liquid (TS15%)
(2) Granulation with 15% granulation liquid (TS15%)
(3) Mix all components of formulation in liquid form (TS20%); drying step at the end of
primary production can be saved
(4) Granulation with 20% granulation liquid (TS15%)
(5) Only drying energy
++ very good; + good; +- fair; - poor; -- very poor

ØSCALES
·Option 1 is obtainable in a range of 3–1200 L.
·Option 2 can handle up to 1800 L.
·In fluid beds, batches between 30 g and 2 tonnes can be granulated.
·For the continuous granulation technologies offered as options 4–6, the
situation is different. Whereas there exists no upper limit (milk powder
granules are produced by spray drying at a rate of up to 10 tonnes/h), these
technologies are not suitable for very small scale production, even at the
laboratory test level, as some processing time is required to achieve
equilibrium conditions.
ØBATCH DEFINITION
·This is immaterial to batch technologies offered in Options 1–3, but requires
some discussion for the continuous technologies, mainly if the raw materials
are fed in continuously without dispensing and preblending; for example, out
of large tanks or silos.
·The most straightforward approach is to accumulate the dry granulates in
containers and define the load of each container as one batch.
·This method is used when operating a tablet press. Often, the size of such a
container is elected to meet the batch size of a tablet coater.
ØSCALABILITY
·As developments are frequently started in a laboratory, upscaling must be
considered.
·For Options 1-3, users will only face ‗normal‘ up-scaling problems. Often,
processes run better when scaled-up.
·Linear up-scaling for the single pot is only possible if microwaves are used,
otherwise drying time will be increased.
·For continuous processes, up-scaling is easy because operation time is the
only parameter to be changed.
·The situation becomes more complicated if it cannot be done by just running
the final production plant for short periods.
ØBUILDING REQUIREMENTS
·Production scale single pots can weigh up to 10 tonnes. Therefore, a floor of
suitable strength must be prepared and the logistics of getting the equipment
into the building considered, particularly if the equipment is not to be
installed on the ground floor.
·For the high shear granulator/fluid bed dryer combination, both a vertical
and horizontal product flow is possible. Because the transfer of wet granules
is a critical step, the high shear granulator being in an elevated position
makes this easier and safer. Therefore, additional height (a platform or
separate floor) is required.
·Production-scale fluid beds can be some meters high; however, it is not
necessary to install the whole unit in the production room. If it is built as a
‗through the wall design,‘ all necessary technical installations can be
positioned in a technical area.
·The upper part of the fluid bed tower can also be in a technical area above
the production room. Because of the complex material handling requirements
of continuous production (Options 4–6), these systems must be integrated
into the building or, better still, the building must be tailored around the
installation.
ØENERGY
·As energy consumption for drying is significantly higher than that generated
by motors or vents, only the required drying energy amount is discussed.
·To evaporate 1 kg of water, 0.66 kWh of energy are required.
·The total amount of energy is both a function of the amount of liquid to be
evaporated and the grade in which the equipment utilizes the energy
supplied.
·The numbers in Table I assume average cases.
Ø YIELD
·The yield of a process is particularly influenced by the time the process
takes and formulation. Longer processes increase yield.
·The wetter the granulation process, the greater the material loss (as it sticks
to the walls).
·A third important factor is the total surface area in contact with the product.
These factors are not independent from each other. They are also influenced
by product characteristics. It is, therefore, not possible to provide exact
figures; however, the data shown in Table 1 reflect typical scenarios.
(B) FORMULATION ASPECTS
(2)
TABLE – 4 FORMULATION ASPECTS

OPTION OPTIO OPTION OPTION 4.

OPTIO OPTION 6.
1. N 2. 3. CONTINUO N 5. PELLETIN
SINGLE HIGH TOP US TOP SPRAY G
POT SHEAR GRANUL SPRAY DRYIN
FORCE A-TION PROCESS G
MIXER
AND
FBD

CONTAINMEN ++ + ++ + + -
T

HANDLE ++ + + + + +
ORGANIC
SOLVENTS

HEAT ++ + + (+) (+)+(+) (+)

SENSETIVE
MATERIAL

LIMITATION none none PSD of raw PSD and flow fine limited
BY (behaviour materials properties of grades of
DIFFERENT material if raw materials raw
FORMULATIO exposed to materials
NS microwave required
s) if worked
from
suspensio
n

AMOUNT 8-15% 8-15% 15-30% 15-30% >100% 15-50%

GRANULATIO
N LIQUID
REQUIRED

ØCONTAINMENT
·This is necessary if processing toxic or very potent substances. In such case
it is important to know is it possible to achieve a closed material flow into
and out of the equipment; if the equipment is tight; and is it possible
automatically (including upstream and downstream connections).
·Closed material flow is possible for all processes shown. Even the very
sensitive process of transferring wet granules via a wet mill from a high
shear granulator into a fluid bed can be done closed. This is achieved by
using modern split valve technology for contained docking to intermediate
bulk containers.
· Although, the first five process options can be supplied in a gastight design,
this is not possible for the pelletizing line (Option 6).
·There are also automatic cleaning problems. Whereas individual machines
such as fluid beds, high shear granulators, single pots or spray dryers can be
cleaned using very efficient automatic cleaning systems (WIP/CIP depending
on the product), fully automatic cleaning becomes increasingly complicated
as more upstream and downstream equipment are integrated.
·Other important factors affecting containment are how easily exhaust air
filters can be changed without the risk of contamination; whether the
equipment is operated continuously under negative pressure; and to what
extent a sample can be contained.
ØORGANIC SOLVENTS
·If processing with organic solvents, the equipment must be gastight.
·To remove the risk of an explosion it is necessary to either make sure that
the mixture of organic vapours and oxygen is outside the explosion limits
(which can sometimes be achieved in a spray granulation process) or that
nitrogen is used as a process gas. If such processes are to rely entirely on
the elimination of all potential spark sources, they must be carefully checked,
case-by-case.
·In addition, passive measures, such as a pressure shock design, suppression
or venting, are always required except when using a single pot. This is
because the risk of explosion exists only during the drying step, which is
done under vacuum conditions. If the exhaust gas contains organic vapours
it must be cleaned. This can be done in a closed cycle by cooling, adsorption
or catalytic burning. Again, the single pot, particularly if used without
stripping gas, has an advantage: only the pure organic vapours must be
treated.
ØHEAT SENSITIVE MATERIALS
·To treat heat sensitive materials successfully, the temperatures and
exposure time must be carefully controlled, as should the presence of
moisture and oxygen.
·Single pot technology provides safe drying under vacuum, particularly if the
granulation is done with organic solvents because the corresponding
temperature is even lower.
·In a spray dryer, however, relatively high temperatures are involved, but
only for a very short time.
·A batch fluid bed granulator can operate at higher air inlet temperatures
while spraying and during the beginning of drying, reducing the inlet
temperature afterwards to maintain a low product temperature.
ØFORMULATION LIMITATIONS
·High shear granulators are able to granulate all types of formulations.
·For single pot use, the behaviour of all components exposed to microwave
energy must be considered. Although this is not critical for most materials, it
should be tested for new materials because of the small risk of an
unexpected thermal runaway — the (microwave) absorption behaviour relies
on the moisture content or on the actual temperature.
·Fluid beds inherently at as a classifier; that is, the particle size distribution
(PSD) of all raw materials should be similar. Processing very fine powders
can also be problematic because these particles tend to stay in the filter
area. Sometimes this can be solved by introducing the spray liquid.
·If a suspension is used to feed the spray dryer the suspended particles need
to be smaller than 30 μm to allow a proper atomization.
·Tailor made formulations containing, for example, a high amount of
microcrystalline cellulose are needed to run an extrusion process. For
inadequately soluble actives in particular, the maximum drug load that can
be achieved is limited. From a processing point of view, very soluble drugs
can also cause many problems.
ØGRANULATION LIQUID
·For the production of oral dosage forms, high shear granulators have almost
replaced medium and low shear versions because their increased mechanical
energy requires less granulation liquid to produce granules of similar
properties.
·Smaller amounts of liquid added during granulation requires less
evaporation during drying, resulting in a higher throughput and lower
thermal stress for the active.
·The numbers provided in Table I largely depend on the nature of the
formulation; whether the binder is added in a liquid or a solid form; and the
granule characteristic required
(C) COMPARISON OF GRANULE CHARACTERISTICS OBTAINED BY
DIFFERENT MAETHOD
(2)
TABLE – 5 CHARACTERISTICS OF GRANULES

OPTION 1. OPTION OPTION 3. OPTION 4. OPTION 5. OPT

2.
SINGLE TOP CONTINUOUS SPRAY PEL
POT HIGH GRANULA- TOP SPRAY DRYING
SHEAR TION PROCESS
FORCE
MIXER
AND FBD

DUST/ FINE <12% <8% <5% <3% <1% none

PARTICLES

D50;PSD 100-800 m 120-800 m 150-600 m 120-400 m 150-300 m 800-

SPAN (6) 2.5-3 2.5 2 2.5 1.5 <1

HOMOGENEITY + + + (+) ++ +
FLOW PROPERTIES + +(+) + + + ++

BULK DENSITY 0.7g/cm3 0.8g/cm3 0.7g/cm3 0.7g/cm3 0.6g/cm3 near

dens

DISOOLUTION + + ++ ++ ++ -

(6) Span =(D90_D10)/D50

ØAMOUNT OF FINE PARTICLE
·If the percentage of fine particles (63 μm) is too large, flow problems,
segregation and poor tablet formation become common issues.
·The numbers shown in Table III are a reflection of the formulation and
process parameters. If Option 6 is taken, no fine particles in the final product
occur as all material is incorporated into the extrudate. For Options 4 and 5,
fine particles cannot be discharged (because of the way in which the
equipment operates), but are blown back into the operation zone where they
are likely to be bound into granules.
·The relatively high amount of fines for the single pot process is typical of all
types of vacuum drying. If seen as problematic, but adjusting the
formulation can reduce this.
ØMEAN PARTICLE SIZE
·All processes allow the mean particle size to be controlled by varying some
process parameters. The given limits can, in some cases, be extended for
bespoke equipment.
ØSPAN
·The span describes how narrow a PSD is. All results shown are not critical
for tablet compression, but may be of some interest if the granules are sold
as a final product.
ØHOMOGENITY
·All technologies presented generally show no problems with product
homogeneity.
·Mixing all components in a liquid stage followed by granule production in a
one-step operation will give the best homogeneity level.
·The material produced in the continuous fluid bed granulator might, in rare
cases, show some homogeneity problems, mainly if the material produced
just after start-up and just before close down is examined separately and is
not blended with the material produced in between.
ØFLOW PROPERTIES
·Achieving free flowing materials is a major reason for including granulation.
Therefore, only processes able to fulfill this requirement are of interest.
·The slight differences shown in Table III result from the fact that high shear
granulation in general produces more dense and mechanically more stable
granules.
·During vacuum drying, some of these granules are destroyed and a larger
amount of fines is generated.
ØBULK DENSITY
·The bulk density required depends on the physical densities of the materials
used, from the amount and type of binder liquid, the process parameters
selected and the process by which the granulation is done.
·The numbers shown in Table III may, therefore, vary for different materials
or process conditions, but a clear pattern is shown illustrating which process
will drive the bulk density in a particular direction.
ØDISSOLUTION
·How easily granules dissolve (instant properties) depends on their surface
energy and structure.
·Granules produced with lower shear forces, such as in Options 3–5, show a
more open porous structure, therefore, they show fast dissolution profile,
however they are mechanically less stable.
2. RAPID MIXER GRANULATOR (RMG) (6)
2.1 DEFINITION
2.2 VARIABLES
2.3 GENERAL PRODUCTION DESIGN OF RMG
2.4 WORKING PRINCIPLE OF RMG
2.5 INDIAN MANUFACTURED MACHINES
2.6 GLOBALLY AVAILABLE MACHINES
2.7 ADVANTAGES AND DISADVANTAGES
2.1 DEFINITION (21)
High shear mixer Granulator guaranties a homogeneous and foreseeable end
product.
Because with it you obtain:
 Compressibility and fluidity properties in powders
 Mechanical properties to pills
 Bio-disponibility
 Mixture homogeneity in low actives doses
 Doses homogeneity in final product
2.2 VARIABLES
2.2.1 PROCESS VARIABLES

Process variables that affect granulation process are as follow:

ØImpeller rotation speed
ØChopper rotation speed
ØLiquid flow rate
ØLoad of the mixer
ØLiquid addition method
ØWet-massing time (subsequent of liquid addition time)
2.2.2 PRODUCT VARIABLES

Product variables that affect granulation process are as follow:

ØAmount of liquid binder
ØCharacteristics of liquid binder
·Surface tension
·Viscosity
·Adhesiveness
ØCharacteristics of the feed materials
·Particle size and size distribution
·Particle specific surface area
·Solubility in the liquid binder
·Wettability
·Packing properties
2.2.3 APPARATUS VARIABLES

The instrumental variables affecting the granulation characteristics are:

·Size and shape of mixing chamber
·Size and shape of impeller
·Size and shape of chopper
(20)
2.3 GENERAL PRODUCTION DESIGN OF RMG
The High Shear Mixer/Granulator is a multi-purpose processor equally
suitable for high speed dispersion of dry powders, aqueous or solvent
granulations, and effervescent products and melt pelletization.(11)
There should be both simplicity and flexibility in plant design. User-selected
process options, cleaning equipment, control systems and PAT technologies
combine in a system to meet process requirements exactly. This approach
ensures that qualification and validation procedures are kept to a
minimum. (20)
(20)
2.3.1 THROUGH-THE-WALL CONFIGURATION

Through-the-wall offers the best option in terms of cleanliness, maintenance

and ATEX. By keeping the motors out of the process room, you are
preventing risk of contamination coming from these difficult to clean items.
Maintenance is carried out from the technical area, minimizing the need for
the maintenance engineer to work in a GMP area. This makes the job easier
and again reduces the risk of contamination.
For ATEX, the design allows us to classify the technical area as safe. This
avoids the need for costly flameproof motors, making the upgrade The frame
mounting provides a standard format for the machine, allowing it to be
constructed and installed using the same structure. This structure may be
raised using standard modules to achieve the customer‘s desired height. For
some installations it is also possible to mount control panels on the structure,
allowing qualification of the complete system prior to shipping, significantly
reducing the installation time on site.
(20)
2.3.2 IMPELLER & CHOPPER OPTIONS
(A) STANDARD PMA IMPELLER

Standard impeller designed for use with the conical bowl of the PMA high
shear granulator.
(B)U-SHAPED CHOPPER

Standard chopper for use with the conical bowl of the PMA high shear
granulator.
(C) M8 IMPELLER

Innovative swept-back design; for improved mixing characteristics,faster

processing and a more clearly defined end-point.
(D) MULTI-BLADED CHOPPER

Flush mounted, multi-blade design improves binder solution dispersion and

product movement at slow speeds.
2.3.3 FILTRATION (20)
(A) MATERIAL FILTER & SHROUD

Production filtration is achieved using an easily removable material filter that

can be cleaned and re-used. For vacuum and CIP applications stainless steel
may be utilized.
2.3.4 DISCHARGING
(A) THROUGH-THE-WALL MILL
Product can be discharged from the high shear granulator directly into a
receiving container, or via a sizing mill. This breaks down the granules to
produce more even sizing for subsequent processing. through-the-wall hinge-
mounted sizing mill, directly connected to the discharge port, using inflatable
seals. For maintenance, cleaning and product changeovers, the seals are
deflated and the mill hinged away from the port, allowing full access. The
TTW mounting ensures the motor and controls are kept away from the clean
process area. Pressure Shock Resistant options are available, matching the
containment and safety credentials of the main machine.
(B) CONCEALED HINGE MECHANISM

The cover is mounted on a concealed hinge mechanism allowing the cover

tobe lifted with the minimum effort, but keeping the counterweight in the
technical area. This leads to a more GMP design, reducing surfaces, making
cleaning easier. On equipment supplied with the Pressure Shock Resistant
design option the hinge interlocking system is power assisted to provide safe
and comfortable opening to the bowl cover.
2.3.5 LOADING (20)
(A) GRAVITY LOADING

Simple open / close ports may be mounted on the cover and used to
dispense product into the mixing bowl. For potent powders, split-valve
technology provides full containment during loading. The PMA-Advanced™
can also be delivered with a cone loading port, allowing for the removal of
the powder loading ports from the cover, but giving permanent connection to
a Gravity Loading Station, but also continuous access to open the cover.
(B) VACUUM LOADING

Rapid loading can be achieved using vacuum technology. Aeromatic- Fielder‘s

innovative killed-vacuum technique makes for easy operation and
maintenance, and only requires a standard-sized filter.
2.3.6 BINDER SOLUTION ADDITION (20)
(A) NOZZLE

A range of nozzles are available to give the optimum binder liquid droplet
size for an even distribution throughout the powder mass.
(B) PUMP

The binding solution required for granulation may be pumped into the mixing
bowl using a mechanical or peristaltic pump to deliver the binder liquid to the
spray nozzle. Special pumps are available for the dosing of high viscosity
binders.
(C) PRESSURE POT
Alternatively a pressure pot offers fast, high-pressure delivery of the binder
solution, for excellent dispersion of liquid via the binder nozzle spray system.
These systems are chosen typically for small scale, R&D-sized granulators.
2.3.7 STANDARD PLATFORM DESIGNS (OPTIONAL) (20)

Two standard platforms are available to integrate with the PMA-Advanced™.

The "Medium" platform provides room adjacent to the bowl for the operator
to carry out all filling and cleaning operations. The ―XL‖ platform additionally
provides space for other items / operators on the platform and also provides
sufficient space to allow the operator interface to be mounted at the platform
level. Due to the clean lines of this design the bowl/ cover area can be easily
accessed using mobile steps. Additionally we can offer bespoke platform
design and construction services to provide the optimum integration within
the available plant area.

(20)
Figure 10 Standard platform designs
(5)
2.4 WORKING PRINCIPLE OF RMG
The mixers originally designed for mixing of thermoplastics and have later
been adopted and redesigned to meet the good manufacturing practice
(GMP) requirements in the pharmaceutical industry. The high shear mixers
have been further developed as one pot unit, including the drying process, by
use of vacuum assist and microwave or air- stripping systems. The high
shear mixers have been applied to wet granulation, melt granulation and
pelletization, and are set up with process control systems.
Pelletization, i.e., the preparation of granulations with a controlled granule
size and shape, has gained great interest since the 1970s because of its
potential for controlled-release preparations for peroral administration. Wet
processes like extrusion and spheronization and powder or suspension
layering are most commonly used.(4)
Blending and wet massing is accomplished by high mechanical agitation by
an impeller and chopper. Figure shows a vertical high mixer, which is the
most widely used version in the pharmaceutical industry. Mixing,
densification, and agglomeration of wetted materials are achieved through
shearing and compaction forces exerted by the impeller. The impeller rotates
on the vertical shaft at a rotational speed corresponding to a radial blade tip
speed of approximately 5-15 m/s. the chopper rotates at a similar tip speed
which, because of its small diameter, corresponds to a very high rotation
speed in revolutions per minute (rpm)(i.e. 1500-4000 rpm). The primary
function of chopper is to cuts lumps into smaller fragments and aids the bowl
or sprayed onto the powder to achieve a more homogeneous liquid
distribution.
The granulation is conventionally performed in the following process steps:
1. Mixing of dry material at high impeller and chopper speeds for a few
minutes (approx. 2-5 min).
2. Addition of liquid binder by pouring it onto the powder, while both the
impeller and chopper are running at a low speed (approx.1-2min.)
3. Wet massing with both agitators running at high speed (approx.1-5min.)
4. Wet sieving the granules.
5. Drying the granulate.
6. Dry sieving the granulate
2.5 INDIAN MANUFACTURED MACHINES
2.5.1 RAPID MIXER GRANULATOR (CHITRA) (7)

Figure 11 Rapid Mixer Granulator (CHITRA) (7)

ØRapid Mixer Granulator is designed to achieve excellent mixing and
consistent granules at lower operating cost along with higher productivity.
Ø Better mixing and closed control of granule size leads to faster tableting
speeds with improved quality and least rejections.
ØSalient Features :
·Homogeneous binder distribution.
·Short batch time and reduce cleaning time.
·Maximize CIP effectiveness.
·Air purge sealing system for main stirrer shaft and granulator shaft.
·All internal contact parts are polished to the mirror finish.
·PLC based operating panel for precise control of process & automation.
·A high-speed granulator is inserted horizontally through wall of bowl to
assist blending of powder and to break the product to the granules of
required size.
·The seal housing and drive shaft may be flushed with cleaning water, which
is then drained away from the machine through built in drain tubes.
·Granulator motors is provided with a removable stainless steel shroud which
covers the motor and simplify cleaning.
·All moving parts of the machine are totally enclosed to eliminate accident.
·The machine cannot be started unless and until the mixer cover is properly
closed.
·All contact parts are made out of SS304. SS316 provided on demand on
extra cost.
·Flush wall type discharge valve eliminates pockets at the port of discharge
valve.
2.5.2 RAPID MIXER GRANULATOR (SAMS)(8)

Figure 12 Rapid Mixer Granulator (SAMS) (8)

ØThe Sams Rapid Mixer Granulator was developed in close co-operation with
pharmaceutical and chemical industry. With the help of RMG wet sifting is
generally no longer necessary. After the mixing of the dry components,
subsequent wet granulation occurs (without transfer of dry mixture)
producing loose granules in RMG. RMG is specially designed to meet the GMP
requirements of the pharmaceutical industry.
ØWORKING PRINCIPLE

The Sams RMG working principle is based on 2 decisive factors essential for
the mixing systems.
1. Spinning close to the bottom of the mixing bowl.
2. The impeller sets the entire mixture in a whirling-rising tumbling motion
ensuring a quick and even distribution of all dry components, which leads to
an even wetting of every granule. The large lumps occurred during wet
mixing are broken up, by the strategically located chopping tool rotating at
1440/2880 RPM. The mix can be discharged with the impeller running
through the outlet located on the side of the mixing bowl flush to the bottom.
Easy accessibility for cleaning is guaranteed by the low profile. The mixing
tool is easily removed from the drive shaft providing an unobstructed mixing
area which may be cleaned very easily.
Ø CONTROL PANEL

Figure 13Control panel(8)

·Control Panel is made up of S. S. sheet metal.
·It is with special feature DISPLAY SYSTEM and MICROPROCESSOR with
member keys.
·Display system consists of indicator lamps for compressed air supply, main
motor, chopper motor, bowl lid limit switch and for closed / open status of
discharge valve.
·In case of insufficient compressed air supply pressure switch contained in
the panel will prevent the machine from starting.
·Limit switch is provided on main bowl lid, and discharge valve, which will de-
energise the system when the lid is open
ØMIXING BOWL
Figure 14 Mixing Bowl(8)
·Dome shaped processing bowl which directs loose particles into whirling
motion with the help of impeller.
·Impeller consists of 2 full and 2 half solid mixing blades.
·Inclination of the mixing blades accelerates rising and tumbling motion of
the product in the bowl.
·Specially designed chopper blades driven at high speed gives fast and even
granulation, throughout the whole mass in the product bowl.
·For easy accessibility in cleaning the side discharge assembly is provided
with hinges.
ØSPECIAL FEATURES

·Unit is designed to meet requirements of GMP.

·Contact Parts can be SS 304 / 316 quality.
·Specially designed control panel with display system and microprocessor.
·Bowl, lid mixing agitator, discharge housing and all other contact parts will
be stainless steel.
·All M.S. parts of the machine are cladded / covered with stainless steel
·Components of the machine are having easy accessibility for cleaning.
·All electrical & pneumatic parts are pre-wired to simplify installation.
·Limit switch is provided on main lid and discharge valve for safe operation.
·Discharge can be provided on either side to suit client requirement.
2.6 GLOBALLY AVAILABLE MACHINES (7)

Sr. No. MFR Size Description

(liter)

1. COLLETTE 400 ONE (1) Used Collette High Shear Granulating Mixe
400, 400 liter capactiy, stainless steel construction, wi
diameter X 600 MM deep bowl with pneumatically op
valve discharge, with bowl lifter and cart, 3 speed ma
 speed chopper blade, 15/22 KW motor, Serial No. 92G
147, New 1992.

2. DIOSNA 25 ONE (1) Used Diosna high shear granulating mixer, m

liter capacity, stainless steel construction, jacketed bo
bar (43.5 PSI), 2/2.4 KW high speed chopper, 2/2.4 K
drive, 460 volt, manually operated plug valve discharg
design, mounted on stainless steel enclosure with con
no. 241-081.

3. FUJI 10 ONE (1) Used Fuji Powrex High Shear Granulating M

FM-VG-10, 10 liter capacity, sanitary polished stainle
construction, manually operated plug valve discharge
variable speed main drive, .75 KW two speed choppe
portable base with controls, Serial No. 903235, New 1

4. FUKAE 2 ONE (1) Used Fukae Powtec High Shear Granulating

Model LFS-GS-2J, 2 liter capacity, sanitary stainless
construction, jacketed bowl, hinged cover with filter,
variable speed main and chopper drives with control p
No. 662, New 1993.

5. GLATT 50 ONE (1) Used Glatt High Shear Granulating Mixer, M

VG50,50 liter capacity, stainless steel construction, ja
with 1.5 KW 3000 RPM high speed side mounted cho
KW 25-550 RPM main drive, mounted on stainless st
with PLC controller, serial no. 00761, new 1996.

6. GLATT POWREX 25 ONE (1) Used Powrex High Shear Granulating Mixer
VG-25, 25 liter capacity, sanitary polished stainless st
construction, jacketed bowl, manually operated plug v
discharge, 3.7 KW variable speed main drive, 1.5 KW
speed chopper drive, on portable base with controls, s
933306, new 1994.

7. KEY INTERNATIONAL 15 ONE (1) Used 15 liter Key International High Shear G
Mixer/Dryer, Model KG15, 316 stainless steel produc
chamber rated for rull vacuum internal, jacketed bowl
degrees C, 3 H.P. DC main motor with 0-550 RPM sh
top mounted .5 H.P. DC chopper motor, mounted on p
with Mokon Hot Oil Unit, Siemans Vacuum Pump an
Alpha Numeric PLC Controls. Unit New in 1993 and
condition.

8. N/A 60 ONE (1) Used Diosna high shear granulating mixer, m

10/60, stainless steel construction, with 60 liter and 20
interchangeable bowls, high speed chopper and main
mounted on stainless steel enclosure with controls, se
 004, new 2000.

9. NIRO FIELDER 25 ONE (1) Used Niro Fielder High Shear Granulating M
PMA25, 25 L capacity, stainless steel construction, ja
1.3/1.8 KW high speed chopper, 5.5 KW DC maindri
pneumatically operated plug valve discharge, mounte
steel enclosure, with controls, serial no. 8012, new 19

10. T.K. FIELDER 50 ONE (1) Used T.K. Fielder High Shear Granulating M
PMA5026, 50 liter capacity, sanitary stainless steel co
pneumatically operated plug valve, with integrally mo
control panel, 10/7.5 H.P. 220 volt main drive, 2.27/1
volt chopper drive, Serial #2324.

65 ONE (1) Used TK Fielder High Shear Mixer / Granul

Model SP65, stainless steel construction, 65 liter bow
main drive, 0-400 RPM main impeller speed, 1.3-1.8
speed chopper, 1.5 KW microwave heating source, Se
7829.

300 ONE (1) Used T.K. Fielder High Shear Granulating M

PMA3002G, 300 liter capacity, sanitary stainless
steelconstruction, pneumatically operated flush plug v
side entry chopper, operator panel, control cabinet, 44
main drive with SCR Controller, 220 volt controls, Se
2249, Built Feb. 1982, mounted on stainless steel base

400 ONE (1) Used T.K. Fielder High Shear Granulating M

PMA-400, 400 liter capacity, sanitary stainless steel c
jacketed bowl rated 2 bar (29 PSI), 10/7.5 H.P. 1800-
chopper, 25/30 H.P. 0-200 RPM main drive,on base w
speed controllers, with platform, dustcollector, blowe
lock and associated parts and controls, Serial No. 826

1200 ONE (1) Complete 1200 liter TK Fielder/Niro Pharm

Mixer/Granulator/Dryer Installation including: ONE (
SP1200 Mixer, with microwave heat source, bowl jac
PSI, 0-140 RPM rotor speed, chopper blade assembly
includes Vac-U-Max Dust Collector, KEU S/SMill, 2
Lee Tank with agitator, 40 gallon Lee Tank with agita
Plate Exchanger, Toledo Platform Scale, Bal-Trol Pne
Hoist, Acme Package Chiller, Model DDCA-95, Niag
HP Custom Air Handling Unit. System is complete w
connected piping, controlsSerial No. 7865, New 1989

11. ZANCHETTA 400 ONE (1) Unused Zanchetta Roto P Processor,

Mixer/Granulator/Dryer, Model 400P, 400 liters total
sanitary stainless steel construction, plug style dischar
 pneumatically operated, hinged cover, telescopic chop
bowl, hydraulic drive, jacketed bowl and cover.

2000 ONE (1) Used Zanchetta Roto Granulating Mixer, Mo

2000G, 2000 liter capacity, all sanitary stainless steel
variable speed hydraulic drivetelescopic high speed ad
chopper, standard paddle style granulating mixer blad
steel base, cover and control console, vacuum rated, ja
bowl, complete system New in 1992, 1859 total hours

2.7 ADVANTAGES AND DISADVANTAGES OF RAPID MIXING

GRANULATOR(4)
2.7.1 ADVANTAGES:-
 Gravity loaded
 Unit formula maintained
 Forms desired wet granule rapidly
 Less wetting and more rapid drying
 Homogeneously dry mixes quickly: color distribution is excellent; can
eliminate premixes of addition by geometric progression
 Self-discharging
 Improved coefficient of weight variation
 Improved content uniformity
 Sanitary construction
 Relatively easy to clean
 Mixing bowl may be jacketed
 Option to dry granulation with mixer
 Adequate safety devices
 Conforms to good manufacturing practices(GMP)
2.7.2 DISADVANTAGES:-
 Relatively high cost
 High noise level
 Adding material directly is not convenient
 Temperature rise from head of friction
 Non movable
 Must be raised to working height
 Foreign spare part
3 INNOVATIONS
3.1 UltimaGral™(9)
The basic UltimaGral™ design, first introduced in 1972, is a high shear mixer
granulator, in which the processes of dry mixing, wet mixing, and granulation
can be executed. The most important features of this basic design are the
top-driven mixer and chopper, the removable bowl, and the "through-the-
wall" installation of the larger machines.

Figure 15Ultima™ 25(9)

The basic UltimaGral™ design ranges from 10 L to 1200 L machines.The
range of UltimaGral™ processors extends the concept of the basic
UltimaGral™ and allows us to execute the whole cycle of mixing, granulating
and drying in a totally contained environment.
The UltimaGral™ processors are equipped with a vacuum system to allow
drying of the granulate. The Transflo™ system (gas-assisted vacuum drying)
can also be provided on UltimaGral™ processors.
Same design of process bowl, mixer and chopper make sure that process and
validation wise there is no difference to the Collette Gral. This unique design
of process bowl, mixer and chopper makes the UltimaGral™ not only a
perfect wet granulator but also an ideal machine for melt granulation and
pelletizing.
ØSTAND ALONE ULTIMAGRAL™

Any applications of a high-shear mixer-granulator do not require integration

with other equipment. The UltimaGral™ design allows for different ways of
setting up a stand-alone machine in a GMP-compliant way:
·The through-the-wall execution: Space saving, GMP compliant.
·In the freestanding execution, all mechanical parts are completely covered
and sealed, so the machine remains GMP compliant.
Ø CLEAN IN PLACE (CIP)

Contained processing also requires that the equipment can be cleaned in a

contained fashion. The UltimaGral™ can be equipped with a full CIP system
that ensures cleaning-in-place of product feed, product filter, bowl and lid
and discharge valve.Downstream equipment such as a mill can be
incorporated in the CIP system.
Ø PROCESS TECHNOLOGIES

Apart from executing standard wet granulation processes, the UltimaGral™

can be used for many other applications, such as:
·Melt granulation
·Pelletization
The UltimaGral™ can produce a wide variety of products which are as
follows:-
·Effervescents formulation
·Formulations developed for alternative technologies
·Low binder formulations
·Moisture, heat or light sensitive products
·Vitamins
·Highly potent or toxic drugs
Ø CONTROL SYSTEMS

·Basic solution: OP/PLC based (standard)

·Operator panel as user-friendly interface with the machine
·Paperless recorder for historical trending
·High end version: PC/PLC based, batch oriented software with process
visualization.
·Software compliant with ISA S88.01 and NAMUR batch processing
standards, quasi-3D process visualization, and unlimited number of recipes.
·Software designed to be compliant with FDA 21 CFR Part 11.
·Real-time storage of batch information in a relational database.
·Possible integration into higher level business and enterprise planning
systems such as SAP, etc.
·Video camera for easy visual process monitoring.
The basic UltimaGral™ design is a high-shear mixer-granulator without
drying capacities. The features of a basic UltimaGral™ high-shear mixer-
granulator are the following:
Ø STANDARD FEATURES

·Top driven mixer and chopper.

·Vertical chopper shaft.
·No seals in direct contact with the product.
·Free standing machine OR through-the-wall design (only for 75 L or larger).
·Easy to wash-in-place (WIP).
·Built to GMP-standards.
·Easy validation.
·Full stainless steel construction in process room.
·Total containment of the product.
·Twin speed chopper and mixer.
·Full interlocked guarding.
·Operator control panel on the machine.
·Easy access for maintenance.
3.2 VG SERIES (10)
A Glatt VG (Vertical Granulator) allows extremely fast Wet granulation with
high granulate densities and thus very good particle stability. Batch sizes
varies from 100l to 3000l/batch.

Figure 16 Vertical Granulator(10)

Ø IDEAL PROCESS PARTNER
A vertical granulator is the perfect partner for a fluid bed dryer for optimum
economy. Pellets can be manufactured if the vertical granulator is combined
with a spheronizer/pelletizer for subsequent spheronization of the granulate.
Single-Pot systems provide the facility to dry the granulate. For the use of
organic solvents, the vertical granulator can be combined with a special
vacuum system with integral solvent recovery.
Ø UNIQUE TECHNOLOGY

Due to the consistent modular design, the system can be configured

individually and easily matched to the constructional circumstances and
specific requirements. The heart of the Glatt vertical granulator is the
patented "Z"-shaped rotor blade.This and various product-optimized chopper
designs are the result of many years of successful development and
cooperation with the Japanese specialist, Powrex.
Figure 17Patented "Z"-rotor(10)
Ø CYLINDRICAL WORKING VESSEL

It is used for non-sticky products in campaign production.

Figure 18Glatt vertical granulator with cylindrical working vessel(10)

Ø CONICAL WORKING VESSEL

It is used for sticky products and similar processes with identical accessory
configurations.
Figure 19 Glatt vertical granulator with conical working vessel(10)
Ø SIMPLE HANDLING

It can easily be incorporated into horizontal or vertical product flow. The

vertical granulator can be filled manually by means of containers with lift and
transporter devices (or charging stations) or pneumatically by means of
suction conveyor systems. The granulate is discharged from the working
vessel into a fluid bed machine or a container, either gravimetrically or by
means of pneumatic conveyors. A GSF rotor mill is often used downstream in
order to achieve a homogeneous granulate spectrum.
Ø USER-FRIENDLY CONTROL SYSTEM

Glatt offers the customized EcoView and MegaView control systems with
simple, logically designed operator guidances, clear process visualizations as
well as detailed and informative process documentation. Qualification and
validation of the control systems are possible up to GAMP 4.
All control systems are designed in-house by Glatt based on hardware and
software that has become established throughout the world.
Advantages are long-term investment security, superior plant availability,
and immediate and rapid support.

Figure 20Glatt vertical granulator(10)

Ø THE VGPRODESIGN
Figure 21 Underside of VG cover with recessed washing nozzles and
stainless steel CIP filters(10)
The advantage of VGPROdesign includes:-
·Globally unique 12 bar pressure shock resistance.
·Contained design.
·New design and special materials for low weight.
·Pneumatic sealing with Glatt-C flanges.
·No need for explosion protection measures between fluid bed dryer and
vertical granulator.
·Confirms to ATEX standards with CE labels or EC Manufacturer's
Declarations (for partial machines).
·Can be fitted through-the-wall - clean separation of production and
equipment. Maintenance and service work can be carried out on the unit
during production and without bringing maintenance personnel into the GMP
area.
·Suitable for WIP/CIP
* The figure or table represented to express the comparison or concept
which is not available in any of the reference book. It is drawn by our self to
simplify the concept.

Rapid Mixer Granulator

 The Prism Rapid Mixer Granulator Designed
very fast to dry mixing and making wet
granules in the same bowl in only 6 to 20
min. The machine performs mixing
and granulation very precisely and
effectively. All Contact parts made from
Stainless Steel S. S. 304/316 grade and
entire machine designed confirms cGMP
standards. The entire process is fully closed
dust free and automatically discharges the
materials.

Flame Proof Motor and Electricals

PLC based control panel with touch screen
Available model according to batch size from 25 ltrs. To 1000 ltrs

HSMG HSMG HSMG HSMG HSMG

MODEL
50 100 150 250 400
Gross Volume
50L 100L 150L 250L 400L
(Ltrs.)
Working Vol.
40L 80L 120L 320L 500L
(Ltrs.)
Main Motor (HP) 3/5 7.5/10 10/15 20/30 30/40
Chopper Motor
1/2 2/3 3/5 3/5 5/7.5
(HP)

Tableting Toolings - Punch Die

Sets for Tablet Press
Our Tableting Toolings Punch Die Sets for Tablet Press are made from high nickel,
high chrome shock steel. Among the many factors that go into steel selection for us to
manufacture Tableting Toolings Punch Die Sets for Tablet Press are tonnage
required for the tableting, chemical atmosphere, abrasive nature of the product, turret
speed, cup depth, location of embossing, bisect land and physical condition of the press.
We also offer custom punch die sets on demand.

There are many types of coatings and treatments available that can be applied to tool
steel to enhance tableting toolings punch die sets for tablet press.

Types of Coatings and Treatments:

Hard Chrome Plating, Plasma Nitriding, Cryogenic Treatment and Electro less Nickel

We offer tableting toolings punch die sets for most of the tablet presses, few of them are
listed below.
  Manesty  Korsh  Daniel  JCMC
 Cadmach  Killian  Erweka  Kikusi
 ZP  Hata  Fette  Narong
 Colton  Stokes  Hansect  Ronchi
 Courtoy  Clit  Horn

We offer following types of Punch Die Sets :

 Regular Shape Punch Die Sets

 Irregular Shape Punch Die Sets

 Core Rod Toolings Punch Die Sets

 Sealed Grove Punch Die Sets

Regular Shape Punch Die Sets

 [Round, Capsule, Oval, Geometric Shape]

Regular shape tablet punch die sets with round dies, capsule dies, oval dies, and
geometric shape are available.

1 ] Round Shape Punch Die Sets

These punch die sets help you to produce round shape tablets. Normally round shapes
punch die sets used by pharmaceutical and veterinary industry. These punch die sets are
available with different size, concavity, and flat in plain or engraved break line.

By using round shape punch die sets you can also manufacture following types of tablet
:

• Shallow Concave • Concave with Edges

• Ball Shape • Flat with Bevel Edges
• Deep Concave • Normal Concave
• Flat Faced
2 ] Capsule Shape Punch Die Sets

It helps you to produce capsule shape tablets. Capsule shape punch die sets applicable
to pharmaceutical and ayurvedic industries. These punch die sets are available with
different size, concavity, and flat in plain or engraved break line.

By using capsule shape punch die sets, you can manufacture following types of tablet :

• Concave with Edges

• Deep Concave
• Flat Faced
• Normal concave
• Flat with Bevel Edges

3 ] Oval Shape Punch Die Sets

It helps you to produce oval / ellipse shape tablets. Normally oval shape punch die sets
are applicable to pharmaceutical and ayurvedic industries. These punch die sets are
available with different size, concavity, and flat in plain or engraved break line.

By using oval shape punch die sets, you can manufacture following types of tablet :

• Flat Faced
• Flat with bevel edges
• Concave/Deep/Deep
• Concave with bevel edges

4 ] Geometric Shape Punch Die Sets

It helps you to produce tablets with different geometric shapes like square, rectangular,
triangular, benzine, rohmbus etc. Normally shaped (regular) punch die sets are
applicable to pharmaceutical, confectionery, chemical, industrial powder metallurgy
industries. These punch die sets are available with different size, concavity, and flat in
plain or engraved break line.

By using geometric shape punch die sets, you can manufacture following types of tablet
:
• Triangular
• Benzine
• Rohmbus
• Rectangular
• Square

Irregular Shape Punch Die Sets

 [Animal, Diamond, Special Shape]

Irregular shape tablet punch die sets with animal, diamond, and special shape are
available.

Irregular shape punch die sets produce tablets with different shapes like fruit, animals,
part of human body, vehicle etc. Normally irregular shape punch die sets are applicable
to confectionery industries. These punch die sets are available with different size,
concavity, and flat in plain or engraved break line.

Core Rod Toolings Punch Die Sets

We manufacture core rod toolings punch die sets that produce tablets having hole in
center.

Core rod toolings punch die sets produce tablets having hole in center. Normally core rod
toolings punch die sets are applicable in confectionery and ceramic industries. These
punch die sets are available with different size, concavity, and flat in plain or engraved
break line.

By using core rod toolings punch die sets, you can manufacture following types of
tablet:
• Tablet with hole in center & concave rib
• Tablet with hole in center & flat rib

Sealed Grove Punch Die Sets

We also manufacture sealed grove punch die sets.

 Granule contamination during the tabletting process can cause costly manufacturing
problems. 'Black Spots' on tablets resulting in high numbers of rejected tablets,
increased wear of punch guides and tightening of upper punches can result in excessive
machine down time and high maintenance costs.

Sealed grove punch die sets are designed to prevent guide way and tablet contamination
during the tablet compression process, a vast improvement over traditional dust caps
used in the pharmaceutical, confectionery and allied industries.

SA-9 Capsule Filler

The SA-9 is a user-friendly machine with advanced features. It provides a high degree of automation, which,
coupled with sound manufacturing practices, results in higher levels of fill weight accuracy; formulation yields;
maintenance-free operation; and operator ease and safety. Depending on size of capsules the output varies from
22,000 to 28,000 capsules per hour.

 To make it more user-friendly the SA-9 features an automated loading station, eliminating the need for
continuous operator attention. The loading table stops automatically after the completion of each cycle - 60
strokes.

 The machine has an automated filling station. This revolutionary feature reduces operator fatigue by filling the
drug hopper after each filling cycle.

 The machine uses an electronic sensor to activate a pneumatic cylinder to close the station. This makes the
machine easier to use and reduces operator fatigue.

 The filled capsules close vertically. This reduces reject rates and minimizes powder spillage which helps reduce
costs.
 See Also
Irregulare Shape - punches & dies :: Core Rod
Tooling - punches & dies :: Sealedgrove Punch
- punches & dies

Multi Mill Our Products Regula

SALIENT FEATURES Rotary Tablet Press punche

GMP point of
Round S
High Speed Double Rotary Tablet Press
view machine
ACCURA-IV This Dies
is provided with
High Speed Double Rotary Tablet Press produce r
S.S. cladding
ACCURA-II Normally
on base, pillar,
Punches
machine Square GMP Model Double Rotary Tablet Press
Dies & Pu
chamber, S.S. ACCURA-B4 TYPE
different
cover on Square GMP Model Single Rotary Tablet Press - as flat in
motor. No ACCURA-D4 TYPE as per yo
exposed
Square GMP Model Single Rotary Tablet Press - of Round
painted surface
ACCURA-D4 TYPE Punches
on top of the
Single Rotary Tablet Press Machine - ACCURA MINI following
machine.
De-Burring & De-Dusting Machine Flat F
Beaters and
shaft are of Dust Extractor Machine Flat w
stainless steel Communiting Mill Shallo
304 quality and Deep
Multi Mill
beaters are
further Colloid Mill-Plain & Water Jacketted, Vertical &
hardened and Vertical Delux Model Capsule
hard chrome It help yo
plated. Beaters SIFTER MACHINE Shape ta
are fitted on a Shape D
shaft. Sieving Grading Straining Machine (Sifter to Pharm
Direction of Machine Mechanical Type) industrie
beaters can be Sieving Grading Straining Machine (Sifter are Availa
changed by Machine Vibro Type) (length -
reversible as Flat in
Tablet Coating Machine
switch. as per th
Oscillating Granulator requirem
Beaters
Shape Di
assembly is Tablet Punches & Dies produce f
swing type,
dynamically Regular Shape - punches & dies
balanced, Flat F
which reduces Flat w
Irregulare Shape - punches & dies Norm
vibration and
noise level and
increases Core Rod Tooling - punches & dies Oval Sh
bearing life.
12 nos. Beaters are of knife and impact Sealedgrove Punch - punches & dies
edges & 2 nos. beaters are of scrapper
blades types.
All contact parts are of SS 304 quality and
can be easily & quickly dismantled and
cleaned.
 Cylindrical screen for higher output.
It help yo
Flameproof electrical components can be Ellipse S
provided at extra cost. Oval Sha
applicabl
Ayurved
TECHNICAL SPECIFICATIONS & Punche
size & co
Model ACRA- MM - 200 plain/eng
customer
Out put 50 Kgs To 200 Kgs/hour
Oval Sha
produce f
Rotor assembly dia 250 mm (approx)

Rotor speed 750/1500/2300/3000 r.p.m.

Flat F
Conca
Beaters 12 knife & impact edges & 2 scrapper blades

Screen dimensions inner diameter-260 mm, ht-135 mm Geomet

It help yo
TEFC, 3 h.p., 1440 .p.m., 440 v., 50 cs, 3 hp,
Motor different
a.c. supply
square, r
Starter "Dol" with reversible switch benzine,
shaped (r
Material charging are applic
1445 mm (Approx)
height confecti
industria
Overall Dimensions
870 x 965 x 1630 mm Ht. industrie
(mm)
available
Net Weight 275 Kgs. (approx) shapes w
breakline
Gross weight 425 kgs. (approx) requirem
By using
Case dimension Punches
1200 mm x 1550 mm x 1860 mm (ht)
(mm) type of ta

Squa
Benzi
Recta