PHARMACEUTICAL

MILLS

[Author name] [Date] [Course title]

S.NO GROUP MEMBERS: ROLL TOPIC DONE
NO
1 ABDUL HADI 02 Spiral jet mill and end runner
mills
2 AMMAR HASNAIN 05 Selection of Pharmaceutical
SHAKIR mills based on dosage form,
Factors for selecting the
pharmaceutical mills,
Guidelines for pharmaceutical
mills, Safety consideration,
Environmental considerations
and Additional considerations
3 ATIF ALI 12 Types of mills, hammer mills
and pin mills
4 MOIN YAMEEN 46 Colloidal mills, roller mills
KHAN and cutter mills
5 SYED SUBHAN ALI 50 Ball mills, vibratory mills and
fluid energy mills
6 SYED YOUSUF BIN 37 Pharmaceutical mills
ISHTEYAQ introduction and importance.

CLASS: 9THSEM MORNING

COURSE CODE: PHT-713
BATCH: PHARM D(2020-24)

SUBMITED TO MADAM GHAZALA

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 CONTENTS

PHARMACEUTICAL MILLS
S.NO CONTENT PAGE
NO
1 Pharmaceutical mills 3
2 Importance of pharmaceutical mills 4

3 Types of Pharmaceutical mills 5

4 Selection of Pharmaceutical mills based 19
on dosage form
5 Factors for selecting the pharmaceutical 19
mills
6 Guidelines for pharmaceutical mills 20

7 Safety considerations 20
8 Environmental considerations 21
9 Additional considerations 21
10 Glossary 22
11 References 23

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 PHARMACEUTICAL MILLS
Pharmaceutical mills are a crucial component in the manufacturing process of
pharmaceutical products. These mills are specifically designed to process active
pharmaceutical ingredients, excipients, and other materials used in the production of various
medicinal products, such as tablets, capsules, powders, and ointments.

The primary function of pharmaceutical mills is to reduce the size of particles or grind
materials into smaller particles or powder. This process is essential to achieve the desired
consistency, uniformity, and bioavailability of the final product. Pharmaceutical mills are
engineered to meet strict specifications and regulations, ensuring the quality and safety of the
processed materials.

There are various types of pharmaceutical mills, each designed for specific
applications and processes. Hammer mills, pin mills, ball mills, jet mills, cone mills, and
colloid mills are some of the commonly used mills in the pharmaceutical industry. Each mill
has its unique features, advantages, and limitations, making them suitable for specific
processing requirements.

Pharmaceutical mills are constructed from materials that meet strict regulatory
guidelines, such as stainless steel, titanium, and other corrosion-resistant materials. These
mills are designed to facilitate easy cleaning, maintenance, and sanitation to prevent cross-
contamination and ensure compliance with good manufacturing practices (GMPs).

The processing parameters of pharmaceutical mills, such as speed, temperature, and

pressure, can be precisely controlled to ensure optimal performance and product quality.
Some mills are also equipped with advanced features, such as temperature control systems,
vacuum operation, and inert gas purging, to handle sensitive materials and prevent
degradation.
In addition to size reduction, pharmaceutical mills can also perform other functions,
such as mixing, blending, and homogenization. These mills play a vital role in ensuring the
uniformity and consistency of pharmaceutical products, which is critical for their efficacy and
safety.

The use of pharmaceutical mills has numerous benefits, including improved product
quality, increased efficiency, reduced processing time, and enhanced safety. These mills are
also designed to minimize waste, reduce energy consumption, and optimize resource
utilization.

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 IMPORTANCE OF PHARMACEUTICAL MILLS

Pharmaceutical mills play a vital role in the manufacturing process of pharmaceutical

products, and their importance cannot be overstated. Here are some key reasons why
pharmaceutical mills are crucial:

1. Uniform particle size: Mills ensure uniform particle size, which is critical for
consistent drug delivery, bioavailability, and efficacy.
2. Improved solubility: Milling enhances solubility, making it easier to formulate drugs
into various dosage forms.
3. Increased surface area: Reduced particle size increases the surface area, allowing
better mixing, blending, and dissolution.
4. Enhanced bioavailability: Optimized particle size and distribution improve drug
absorption and bioavailability.
5. Consistent product quality: Mills ensure consistent product quality, reducing batch-
to-batch variations.
6. Efficient processing: Mills streamline processing, reducing processing time and
increasing productivity.
7. Safety and containment: Mills are designed for containment, minimizing exposure
to hazardous or potent compounds.
8. Compliance with regulations: Mills meet strict regulatory guidelines, ensuring
compliance with cGMP, FDA, and other global regulatory requirements.
9. Flexibility and versatility: Various mill types and configurations allow for
adaptability to different processing needs.
10. Scalability: Mills can be scaled up or down depending on production requirements,
making them suitable for both small-scale development and large-scale commercial
manufacturing.
11. Cost Efficiency: Efficient milling processes reduce wastage of expensive
pharmaceutical ingredients. They also contribute to overall cost efficiency by
improving production rates and reducing processing times.

Versatility: Pharmaceutical mills are versatile and can handle a wide

range of materials, from powders to granules, and different types of
formulations. This versatility makes them indispensable in
pharmaceutical manufacturing.

TYPES OF PHARMACEUTICAL MILLS

It’s important to understand the crucial role of mills in the pharmaceutical

manufacturing process. These specialized machines are designed to handle various dosage

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forms, from solid tablets to liquid formulations, and play a vital role in particle size reduction,
blending, granulation, and formulation homogenization. Each type of mill is tailored to
specific requirements, ensuring precision and consistency in the production of pharmaceutical
products. Understanding these machines is essential for optimizing manufacturing processes
and maintaining product quality and efficacy.

1. HAMMER MILLS

The hammer mill typifies a group of machines operating at very high speeds and
acting primarily by impact on a freely suspended particle. The term “dis-Integrator” is also
used. High efficiency, which would be expected from the operation of a free-crushing
mechanism, is reduced because the blows delivered are in excess of the minimum required
for breakage.

Construction

A typical machine is shown in Figure . It consists of a disk rotating at Speeds up to

8000 rpm. The higher speeds are used for fine grinding in relatively small machines. A
balanced number of hammers are fitted to the disk. These may be fixed or pivoted, presenting
flat, knife, or file edges to the material. The material is fed to the top or the center of the mill
and is broken by direct impact until it is fine enough to pass through the screen, which forms
the lower part of the mill casing. A range of screens are normally provided. Because of
tangential exit, the product size is considerably smaller than the screen apertures. The disk
and hammers act as a centrifugal fan, drawing large volumes of air through the mill.
Entrained dust must be separated with a bag filter or a cyclone separator.

Working
The material is fed at the top or center, thrown out centrifugally, and ground by
impact of the hammers or against the plates around the periphery of the casing. The clearance
between the housing and the hammers contributes to size reduction. The material is retained
until it is small enough to fall through the screen that forms the lower portion of the casing.
Particles fine enough to pass through the screen are discharged almost as fast as they are
formed. A Universal mill employs a variety of rotating milling elements such as a pin disk,
wing or blade beater, turbine rotor, or hammer-type rotor, in combination with either a
matched pin disk (that may or may not rotate), or perforated screen or stator. Some internal

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classification can be achieved by appropriate
selection of milling tools. The particle size
that can be achieved will depend on the type
of milling tool selected, rotor speed
(calculated as tip speed at the outermost
rotating part), and solid density in the mill or
solid feed rate. Applications. The hammer
mill can be used for almost any type of Size
reduction. Its versatility makes it popular in
the pharmaceutical industry, Where it is used
to mill dry materials, wet filter-press cakes,
ointments, and Slurries. Comminution is
effected by impact at peripheral hammer
speeds of up to 7,600 meters per minute, at
which speed most materials behave as if
they were brittle. Brittle material is best
fractured by impact from a blunt hammer
and fibrous material is best reduced in size
by cutting edges. Some models of hammer
mills have a rotor that may be turned 180
degrees to allow use of either the blunt edge
for fine grinding or the knife edge for cutting or granulating.

Advantages and disadvantages

Hammer mills are compact with a high capacity. Size reduction of 20 to 40 μm may
be achieved, however, a hammer mill must be operated with internal or external classification
to produce ultrafine particles. Because the inertial forces vary with mass as the inverse cube
of the diameter, small particles with a constant velocity impact with much less kinetic energy
than larger ones, and the probability that particles less than a certain size will fracture
decreases rapidly. In addition, small particles pass through the screen almost as fast as they
are formed. Thus, a hammer mill tends to yield a relatively narrow size distribution. Hammer
mills are simple to install and operate. The speed and screen can be rapidly changed. They are
easy to clean and may be operated as a closed system to reduce dust and explosion hazards.

2. PIN MILLS

Pin mills are industrial grinding machines that are used to reduce the size of particles
(powders) by impacting them with a series of pins or needles. These machines are typically

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used in food, pharmaceutical, and chemical industries for grinding substances into fine
powders. The pins or needles are mounted on a rotor that rotates at high speeds within a
stationary casing. As the material enters the mill, it is impacted by the pins, resulting in size
reduction through particle breakage and attrition. Pin mills are valued for their ability to
achieve fine particle sizes efficiently and for their versatility in processing various materials.

Construction:
Pin mills consist of two
horizontal steel plates with vertical
projections arranged in concentric
circles on opposing faces, and
becoming more closely spaced
towards the periphery. The
projections of the two faces
intermesh.

Working:
The feed is introduced at a controlled rate to the milling chamber through the center
of the stator and is propelled through intermeshing rings of rotor and stator pins by
centrifugal motion. The Passage between the pins leads to size reduction by impact and
attrition. The material is collected in the annular space surrounding the disks and passes to a
separator. The large volumes of air drawn through the mill are discharged through the
separator. The final particle size achieved in a pin mill is governed by the rotor speed, solids
feed rate, and air flow rate through the mill. Smaller particles can be generated by
maximizing the rotor tip speed and minimizing both product feed and air flow rate.
Advantages and disadvantages:

Absence of screens and gratings provides a clog-free action. This type of milling is
typically able to achieve smaller average particle size than wet rotor-stator milling. The
machine is suitable for grinding soft, non-abrasive powders, and low milling temperatures
permit heat-sensitive materials to be processed. The fineness of the grind may be varied by
the use of disks with different dispositions of pins. As equipment scale is increased,
maintaining rotor tip speed is one reliable way to achieve milled particle sizes comparable to
small-scale results.

3. BALL MILLS

The ball mill is widely used for fine grinding. Extremely fine powders may be
produced, although milling times are often protracted. Despite simple construction, the mill is
extremely versatile. It can be used for wet or dry grinding in continuous or batch processes.
The latter are usually imposed by the scale of pharmaceutical operations. The mill is closed.

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Sterility can therefore be maintained or an operation can be conducted in an inert atmosphere
if the process demands such conditions. Materials of widely differing mechanical properties
can be ground by the combined effects of impact and attrition characteristic of the mill.

Construction:

The ball mill consists of a horizontally rotating hollow vessel of cylindrical shape
with the length slightly greater than its diameter. The mill is partially filled with balls of steel
or pebbles, which act as the grinding medium. If pebbles are used, it is known as a pebble
mill, and if rods or bars are used, it is known as a rod mill. The rod mill is particularly useful
with sticky material that would hold the balls together, because the greater weight of the rods
causes them to pull apart. The tube mill is a modified ball mill in which the length is about
four times that of the diameter and in which the balls are somewhat smaller than in a ball
mill. Because the material remains in the longer tube mill for a greater length of time, the
tube mill grinds more finely than the ball mill. The ball mill may be modified to a conical
shape and tapered at the discharge end. If balls of different size are used in a conical ball mill,
they segregate according to size and provide progressively finer grinding as the material
flows axially through the mill.

Working:

In a ball mill rotating at a slow speed, the balls roll and cascade over one another,
providing an attrition action. As the speed is increased, the balls are carried up the sides of the
mill and fall freely onto the material with an impact action, which is responsible for most size
reduction. Ball milling is a combination of impact and attrition. If the speed is increased
sufficiently, the balls are held against the mill casing by centrifugal force and revolve with the
mill. The critical speed of a ball mill is the speed at which the balls just begin to centrifuge
with the mill. Thus, at the critical speed, the centrifugal force is equal to the weight of the
ball, and the critical angular velocity, ωc may be expressed as:

Where, r is the radius of the ball mill.

Advantages and disadvantages:

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 In addition to being used for
either wet or dry milling, the ball
mill has the advantage of being used
for batch or continuous operation.
In a batch operation, unstable or
explosive materials may be sealed
Within an inert atmosphere and
satisfactorily ground. Ball mills may
be sterilized and sealed for sterile
milling in the production of
ophthalmic and parenteral products.
The installation, operation, and
labor costs involved in ball milling
are low. Finally, the ball mill is
unsurpassed for fine grinding of
hard and abrasive materials.

4. VIBRATORY MILLS

In the ball mill, the energy for grinding is derived from the acceleration of the Balls in
a gravitational field. Under normal conditions, the latter limits the speed at which a mill of a
given diameter can be run and therefore limits the rate at which energy can be applied to the
process. Long milling times are characteristic of the ball mill. The advantage of vibratory
milling is centered mainly on this limitation since it is possible, by this method, to develop
accelerations much greater than those induced by the earth’s gravitational field. Grinding can
be more energetic, and milling times can be greatly reduced.

Construction:

A simple form of a vibratory mill consists of an annular grinding chamber

accommodating cylinders, which align coaxially in a three- dimensional vibratory field to
give close packing and line contact between the moving surfaces. The mill body is supported
on springs which permit an oscillatory movement. This vibration is usually, but not
necessarily, in a vertical plane. The resultant chattering of the mill gives comminution by
attrition.
Working:

Chattering of the mill gives comminution by attrition. In additional attrition is induced

by porcelain or stainless steel balls used as grinding media. The more efficient use of the
energy applied and the shorter grinding times usually result in lower milling temperatures and

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products with narrow particle size distributions than are found in a ball mill. Furthermore, the
vibratory mill is usually more flexible than the ball mill. Construction, however, is more
complex and the mill is not suitable for grinding resilient materials which cannot be ground
by impact since the shear forces developed are less than those found in a ball mill.

Advantages and disadvantages:

Vibratory energy mills offer several advantages and disadvantages in particle size
reduction applications. On the positive side, these mills are highly efficient, capable of
rapidly reducing materials to fine powders due to their high-frequency vibrations and
accelerated grinding media motion. They excel in minimizing contamination, making them
suitable for sensitive materials, and they can handle a wide range of substances and sizes in
both dry and wet conditions. Their ability to operate continuously is advantageous for large-
scale production. Moreover, vibratory mills generate less heat during operation, beneficial for
temperature-sensitive materials. However, they come with drawbacks such as higher initial
costs compared to other mills, complex design requirements needing careful engineering, and
potential issues with noise and vibrations during operation. Achieving very coarse particle
size reduction may also be limited, and their intricate design may necessitate more frequent
maintenance. Despite these challenges, vibratory energy mills remain highly effective tools
for industries requiring precise and efficient particle size reduction.

5. FLUID ENERGY MILLS

The fluid energy mill offers an alternative method of producing very fine powders.
The term “micronizer” is in general use and is a trade name coined by a company that
originated a particular type of fluid energy mill. In all fluid energy mills, the grinding results

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mainly from attrition between the particles being ground, the energy inducing movement of
the particles being supplied in the form of compressed fluids. Air and steam are widely used.

Construction:

Fluid energy mills, integral to fine powder grinding, feature a robust construction
designed for high-efficiency particle size reduction. The main components include a
cylindrical grinding chamber where the grinding occurs, typically fed by mechanisms such as
gravity or pneumatic feeds. Surrounding the chamber are nozzles or jets that inject high-
velocity gas (often air), creating a fluidized bed of particles that collide and break apart. A
critical aspect is the fluidizing gas system, powered by compressors or blowers, ensuring
consistent operation and purity of the gas stream. Materials used in construction prioritize
wear resistance and corrosion resistance, commonly employing stainless steel or ceramics.
Safety measures like pressure relief valves and interlocks are integrated due to the high
speeds and pressures involved. These mills incorporate sophisticated control systems to
monitor parameters such as gas flow and temperature, optimizing grinding performance and
maintaining product quality across diverse applications in pharmaceuticals, chemicals, and
food processing industries.

Working:

In the fluid-energy mill or micronizer, the material is suspended and conveyed at high
velocity by air or steam, which is passed through nozzles at pressures of 100 to 150 pounds
per square inch(psi). The violent turbulence of the air and steam reduces the particle size
chiefly by interparticular attrition. Air is usually used because most pharmaceuticals have a
low melting point or are thermolabile. As the compressed air expands at the orifice, the
cooling effect counteracts the heat generated by milling.

As shown in , the material is fed near the bottom of the mill through a venturi
injector (A). As the compressed air passes through the nozzles (B), the material is thrown
outward against the wall of the grinding chamber (impact) and other particles (attrition). The
air moves at high speed in an elliptical path carrying with it the fine particles that pass out of
the discharge outlet (D) into a cyclone separator and a bag collector. The large particles are
carried by centrifugal force to the periphery, where they are further exposed to the attrition
action. The design of the fluid-energy mill Provides internal classification, which permits the
finer and lighter particles To be discharged and the heavier oversized particles, under the
effect of Centrifugal force, to be retained until reduced to a small size.

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Advantages and disadvantages:

Powders with all particles below a few micrometers may be quickly produced by this
method. The disadvantage of high capital and running costs may not be so serious in the
pharmaceutical industry because of the high value of the materials which are often processed.
One drawback of this type of mill is the potential for build-up of compressed producr in the
mill or on the classifier. This can affect milled particle size by changing the open volume in
the mill or open area in the classifier, especially if classifier vanes or gas nozzles become
plugged or blocked.

6. SPIRAL JET MILLS

Spiral jet mills are specialized machines used in the pharmaceutical, food processing,
and chemical industries for fine particle size reduction. They operate on the principle of
creating a spiral gas vortex within a cylindrical milling chamber. This vortex accelerates
particles to high velocities, causing them to collide and break into smaller sizes upon impact
with each other or the chamber walls. Spiral jet mills are valued for their ability to produce
very fine powders with a narrow particle size distribution, making them crucial in
applications requiring precise particle size control and uniformity.

Construction:

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 The laboratory spiral jet mill (Fig. 2.15) comprises a flat, cylindrical milling chamber.
The milling gas (air, vapor or nitrogen) with a pressure between 1–16 bars expands through
8–10 milling nozzles, tangential in the milling chamber, thus creating a spiral vortex.

Working:

The feed material enters the milling chamber accelerated by an injector gas stream.
The milling takes place by autogeneous impact grinding between the particles. Those
particles milled fine enough leave the mill with the gas stream through the vortex finder.
Spiral jet mills are used for dry fine comminution and deagglomeration of materials to
particle sizes below 10 μm.

Advantages and disadvantages:

Compared with grinding media mills, the spiral jet mill offers the advantage of (i)
high fineness with narrow particle size distribution, (ii) low milling chamber temperatures,
(iii) being insusceptible to dust explosions and contamination due to absence of any moving
part and (iv) high mass and heat transfer rates.

7. EDGE AND END RUNNER MILLS

Edge runner mills and end runner mills are two types of pharmaceutical mills used for
size reduction and grinding of materials. These mills have been employed for centuries, with
edge runner mills dating back to ancient civilizations, and end runner mills evolving from
traditional mortar and pestle designs. Both types of mills have been adapted and modified to

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meet the stringent demands of the pharmaceutical industry, offering reliable and efficient
processing solutions for a wide range of applications.

Construction:

The edge runner mill consists of one or two heavy granite or cast iron wheels or
mullers mounted on a horizontal shaft and standing in a heavy pan. Either the muller or the
pan is driven.

The end runner mill is similar in principle and consists of a rotating pan or
mortar made of cast iron or porcelain. A heavy pestle is mounted vertically within the pan in
an off-center position.
Working:

In edge runner mills the material is fed

into the center of the pan and is worked outward by
the action of the muller. While in the zone traversed
by the muller, comminution will occur by
compression, due to the weight of the muller, and by
shear. The origin of the shear forces is indicated in
Figure. The linear velocity of the pan surface will
vary over the line of contact between muller and
pan. For efficient grinding, this dimension is large
compared with the diameter of the pan. Muller and
pan speeds may only coincide on one hypothetical
circle, and at other positions, a varying amount of
slip must occur. A scraper continually moves
material from the perimeter of the pan to the
grinding zone.
In end runner mills the he mechanism of size reduction is compression due to the
weight of the pestle, and shear. The latter is developed by the relative movement of muller
and pan, which varies over the face of the muller. The muller is friction driven by the pan
through the ground material. A scraper is used to redirect the material into the grinding zone.

Advantages and disadvantages:

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 Edge runner mills and
end runner mills have both
advantages and disadvantages.
Edge runner mills are easy to use,
produce fine particles, and are easy
to clean and maintain. However,
they occupy more space, may
contaminate products with roller
material, require long milling
times, and are not suitable for
sticky materials. Additionally, they
have high energy consumption and
noise levels.

End runner mills, on the other hand, have a simple design that makes cleaning
and maintenance easy, consume less electricity, and produce fine particles. They also require
less supervision during milling and do not clog or choke. However, they are only suitable for
batch processing, not suitable for sticky materials, and require scrapper adjustment
intermittently. Moreover, they are not suitable for hard and unbroken or slightly broken drugs
and generate a lot of noise.

8. COLLOID MILLS

Colloid mills are a group of machines used for wet grinding and dispersion. They
operate by shearing relatively thin layers of material between two surfaces, one of which is
moving at a high angular velocity relative to the other. Although very fine dispersions can be
produced, they are not, as the name implies, of colloidal dimensions. Colloid mills are also
widely used in the preparation of emulsions

Construction:

A typical colloid mill consists of a stator and a rotor with flat working surfaces. These
are often made of stainless steel or carborundum. The clearance is adjustable from virtually
zero upward.

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Working:

The rotor is rotated at several

thousand revolutions per minute, and the
slurry of already fine material passes
through the clearance under the action of
centrifugal forces. Surface-active agents
fulfill the same function in colloid mills
as in ball milling.

Advantages and disadvantages:

Colloidal mills have several advantages, including their ability to produce

extremely fine particles, typically in the range of 1-10 microns, making them ideal for
applications where high surface areas are required. They also offer high throughput rates,
ease of operation, and low maintenance costs. Additionally, colloidal mills can handle a wide
range of materials, including liquids, suspensions, and slurries, and are suitable for both batch
and continuous processing.

However, colloidal mills also have some disadvantages. They can be expensive
to purchase and install, and require specialized training to operate effectively. The high shear
forces generated during processing can also lead to overheating, which can damage sensitive
materials. Furthermore, colloidal mills can be prone to wear and tear, particularly on the rotor
and stator, which can lead to costly repairs and downtime. Finally, the fine particles produced
by colloidal mills can be difficult to handle and process further, requiring specialized
equipment and techniques.

9. ROLLER MILLS

Consists of two to give rollers operating at different speeds.

Construction :

Roller mills are constructed with a sturdy frame that houses multiple rollers, typically
between 2-6, which are mounted on a shaft and rotate at high speeds. The rollers are typically
made of hardened steel or other wear-resistant materials and are designed with a specific
surface texture to optimize grinding efficiency. The frame also includes a feed hopper, a
grinding chamber, and a discharge chute, which are designed to facilitate smooth material
flow and minimize dust generation. The rollers are adjustable, allowing for precise control
over the gap between them, which determines the final particle size. Additionally, roller mills
often feature cooling systems, such as air or water cooling, to prevent overheating and

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maintain optimal operating temperatures. The entire assembly is typically mounted on a
vibration-isolation system to minimize vibration and ensure smooth operation.

Working:

Roller mills may be used to grind

pastes and other plastic dispersions. They
operate by inducing crushing and
shearing forces in a thin layer of the paste
as it passes through the narrow clearance
between two rollers. Commonly, shear
forces are intensified by the differing
peripheral velocity of the rolls. The
clearance between the rolls is variable
and depends on the plasticity of the mass,
the gap increasing as the stiffness of the
material increases. With thin pastes, the
milling action is similar to the colloid mill.

Advantages and disadvantages

Roller mills offer several advantages, including high grinding efficiency, precise
control over particle size, and low energy consumption. They also have a large capacity, are
relatively quiet, and produce minimal dust. Additionally, roller mills are easy to maintain,
have a long lifespan, and can be used for a wide range of materials. However, roller mills also
have some disadvantages. They can be expensive to purchase and install, and require
specialized training to operate effectively. The rollers can also wear out quickly, especially
when processing abrasive materials, and require frequent replacement. Furthermore, roller
mills can generate heat, which can damage certain materials, and may not be suitable for
materials that require very fine grinding. Overall, roller mills are a popular choice for many
industries, but it’s important to carefully consider their advantages and disadvantages before
selecting a grinding solution.

10.CUTTER MILLS

Pharmaceutical cutter mills are a type of pharmaceutical mill used for the size
reduction of soft to medium-hard materials. They are commonly used in the pharmaceutical
industry for grinding, sizing, and milling of various materials, including herbs, roots, leaves,
and other plant materials. These mills are designed to provide efficient and precise size
reduction, making them an essential equipment in the pharmaceutical industry.
Construction :

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 A pharmaceutical cutter mill typically consists of a sturdy frame or body, a rotating
shaft or blade, a stationary blade or screen, a feed hopper, and a discharge chute. The blades
are typically made of stainless steel or other corrosion-resistant materials, and are designed to
rotate at high speeds to ensure efficient cutting and grinding. The blades are also adjustable,
allowing for precise control over the final particle size.

Working:

The working principle of a pharmaceutical

cutter mill is straightforward. Material is fed
into the feed hopper and falls onto the
rotating blades, which cut and grind the
material into smaller pieces. The ground
material then passes through the stationary
blade or screen, which further reduces the
particle size. The final product is discharged
through the discharge chute. With their
efficient and precise size reduction
capabilities, pharmaceutical cutter mills are
widely used for various applications,
including grinding of herbs and roots, milling of pharmaceutical powders, size reduction of
food ingredients, and processing of chemicals and cosmetics.

Advantages and disadvantages:

Pharmaceutical cutter mills offer several advantages, including precise control

over particle size, high efficiency, and versatility in processing a wide range of materials.
They are also easy to clean and maintain, making them a practical choice for pharmaceutical
applications. Additionally, cutter mills are relatively quiet and produce minimal dust, creating
a safer working environment. Their ability to process materials without generating heat is
another significant advantage, as it prevents damage to heat-sensitive materials.

Despite their advantages, pharmaceutical cutter mills have some limitations.

They can be expensive to purchase and maintain, and their blades may require frequent
replacement, depending on usage. Additionally, cutter mills may not be suitable for
processing very hard or abrasive materials, as this can lead to blade damage. Furthermore, the
high speed of the blades can generate heat, potentially affecting temperature-sensitive
materials. Finally, cutter mills may require specialized training to operate effectively, which
can be a disadvantage for some users.

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 SELECTION OF PHARMACEUTICAL MILLS BASED ON
DOSAGE FORM

• Tablets and capsules: Hammer mills, pin mills, and universal mills for powder
preparation.
• Ointments and creams: Colloid mills and roller compactors for mixing and
homogenizing.
• Solutions and suspensions: Fluid energy mills and colloid mills for size reduction and
mixing.
• Powders and granules: Hammer mills, pin mills, and universal mills for size reduction
and processing.
• Nanoparticles: Fluid energy mills and colloid mills for producing nanoparticles.

FACTORS FOR SELECTING PHARMACEUTICAL

MILLS:

• Material properties: Hardness, brittleness, moisture content, and particle size

distribution.
• Desired particle size: Coarse, fine, ultra-fine, or nano-particles.
• Capacity: Small batches, pilot scale, or large-scale production.
• Energy efficiency: Low energy consumption, high efficiency, and cost-effectiveness.
• Cleanability: Easy cleaning, sanitation, and maintenance to prevent cross-
contamination.
• Regulatory compliance: Meeting FDA, cGMP, and other regulatory requirements.
• Cost: Purchase price, operating costs, and maintenance expenses.
• Versatility: Ability to process various materials and particle size ranges.
• Noise level: Low noise levels for operator comfort and safety.
• Heat generation: Minimal heat generation to prevent material degradation.
• Operator safety: Safety features to prevent accidents and ensure operator well-being.

These factors help pharmaceutical manufacturers select the most suitable mill for their
specific processing needs, ensuring efficient, effective, and compliant production.

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 GUIDELINES FOR PHARMACEUTICAL MILLS

Here are some guidelines for pharmaceutical mills:

• Good Manufacturing Practice (GMP): Pharmaceutical mills must comply with GMP
guidelines to ensure the quality and safety of pharmaceutical products.
• Cleanliness and Sanitation: Mills should be designed for easy cleaning and sanitation
to prevent cross-contamination and contamination.
• Material Selection: Mills should be constructed from materials that are compatible
with the Here are some guidelines for pharmaceutical mills:
• Design and Construction: Mills should be designed and constructed to ensure optimal
performance, safety, and ease of maintenance.
• Validation and Qualification: Mills should be validated and qualified to ensure they
meet the required specifications and perform consistently.
• Operator Training: Operators should be trained on the proper use, maintenance, and
cleaning of the mills.
• Regular Maintenance: Regular maintenance should be performed to ensure the mills
are in good working condition.
• Documentation: Accurate documentation of mill operations, maintenance, and
cleaning should be kept.
• Compliance with Regulations: Mills should comply with relevant regulatory
requirements, such as FDA and EU guidelines.
• Quality Control: Mills should be equipped with quality control measures to ensure the
processed material meets the required specifications.

SAFETY CONSIDERATIONS:

• Explosion-proof design: Mills should be designed to prevent explosions and fires.

• Operator safety: Mills should be designed with operator safety in mind, including
easy access, ergonomic design, and minimal vibration.
• Lockout/tagout procedures: Procedures should be in place to ensure the mill is
properly shut off and locked out during maintenance.
• Personal protective equipment (PPE): Operators should wear appropriate PPE, such as
gloves, safety glasses, and dust masks.
• Regular maintenance: Regular maintenance should be performed to prevent accidents
and ensure the mill is in good working condition.

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 ENVIRONMENTAL CONSIDERATIONS:

• Dust containment: Mills should be designed to minimize dust emissions and prevent
environmental contamination.
• Waste disposal: Proper disposal of waste materials and cleaning solvents should be
ensured.
• Energy efficiency: Mills should be designed to optimize energy efficiency and reduce
carbon footprint.
• Noise reduction: Mills should be designed to minimize noise pollution.
• Compliance with regulations: Mills should comply with relevant environmental
regulations, such as OSHA and EPA guidelines.

ADDITIONAL CONSIDERATIONS:

• Containment systems: Mills should be designed with containment systems to prevent

material spillage and environmental contamination.
• Ventilation systems: Proper ventilation systems should be in place to remove dust and
vapors.
• Spill response plan: A spill response plan should be in place in case of accidents.
• Training and education: Operators should be trained on safety and environmental
procedures.
• Regular inspections: Regular inspections should be performed to ensure compliance
with safety and environmental regulations.

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GLOSSARY
• Explosion-proof Design: Equipment
Active Pharmaceutical Ingredients
design preventing ignition of hazardous
(APIs): Chemical compounds that produce
materials, critical for pharmaceutical safety.
the intended effects of a pharmaceutical
drug.
• Good Manufacturing Practice (GMP):
Guidelines ensuring pharmaceutical
• Bioavailability: The proportion of a drug
products are consistently produced and
that enters the bloodstream and is able to
controlled according to quality standards.
have an active effect. Milling processes
optimize particle size to improve
bioavailability. • Granulation: Process of forming grains
or granules from a powdery substance,
improving flow and compaction properties
• Cleanability: Ease of cleaning equipment
to prevent cross-contamination in in tablet production.
pharmaceutical manufacturing.
• Homogenization: Process of making a
mixture uniform in composition, ensuring
• Colloid Mill: Used for particle size
consistency in medicinal products through
reduction by a rotor-stator assembly, ideal
pharmaceutical milling.
for emulsification.
• Lockout/Tagout: Safety procedure
• Compliance: Adherence to regulatory
ensuring equipment is properly shut off
standards such as cGMP and FDA
during maintenance.
requirements to ensure product safety and
quality.
• Nanoparticles: Extremely small particles
typically ranging from 1 to 100 nanometers,
• Comminution: Process of reducing the
produced using specialized mills for
size of solid materials.
pharmaceutical applications.
• Compression: Compacting powder into
• Particle Size Reduction: Primary
solid form, like tablets.
function of pharmaceutical mills, grinding
materials into smaller particles or powders
• Containment System: Prevent material
to improve consistency and bioavailability.
spillage and environmental contamination.
• Personal Protective Equipment (PPE):
• Cyclone Separator: Device separating
Gear worn to minimize exposure to hazards
particles from gas or liquid streams.
in the workplace.
• Disintegration: Solid dosage form breaks
• Quality Control: Procedures ensuring
into smaller particles.
products meet specifications.
• Excipients: Inactive substances used in
• Regulatory Compliance: Adherence to
drug formulation to provide bulk,
regulations set by authorities like FDA and
consistency, and stability. Processed in
EU for pharmaceutical manufacturing.
pharmaceutical mills.

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• Regulatory Guidelines: Standards • Spill Response Plan: Protocol for
governing pharmaceutical manufacturing handling accidental spills or leaks of
processes to ensure quality and safety. hazardous materials.

• Roller Compactor: Equipment for dry • Uniformity: Consistency in particle size

granulation of powders into granules.
• Safety Data Sheet (SDS): Document on
substance safety and hazards.
• Scalability: Ability of pharmaceutical
mills to adjust for different production
scales, from small-scale development to
large-scale manufacturing.
and distribution crucial for efficacy and
safety of pharmaceutical products.
• Validation: Process ensuring consistent
product quality.
• Ventilation Systems: Control air quality,
temperature, humidity, and circulation in
pharmaceutical manufacturing
environments.

References
• Sud Sushant, Kamath Archana methods of size reduction and factors affecting size
reduction in pharmaceutics
• Dr Ibtihal O Alkarim: Milling of pharmaceutical ingredient
• Anthony J. Hickey David Ganderton: Pharmaceutical Process Engineering( pg 143 -150)
• Leon lachman and lieberman: The theory and practice of industrial pharmacy (pg 21-46)
• Pharmaceutical Mills” by Dr. J. B. Sharma (Chapter 5: Hammer Mills, Chapter 6: Pin
Mills, Chapter 7: Jet Mills)
• Pharmaceutical Engineering” by Dr. R. K. Sharma (Chapter 12: Size Reduction, Chapter
13: Pharmaceutical Mills)
• Size Reduction and Pharmaceutical Applications” by Dr. A. K. Singh (Chapter 3: Hammer
Mills, Chapter 4: Pin Mills, Chapter 5: Jet Mills, Chapter 6: Ball Mills)
• Pharmaceutical Processing and Technology” by Dr. D. M. Parikh (Chapter 10: Milling and
Size Reduction, Chapter 11: Pharmaceutical Mills)
• Handbook of Pharmaceutical Manufacturing” by Dr. S. K. Singh (Chapter 15:
Pharmaceutical Mills, Chapter 16: Size Reduction)

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