Topic – ‘Paste mixing’

Submitted by,
Group No. – 02:
Noshin Tanjum Nishi – BPH 066 07402
Showrav roy – BPH 067 07404
Md Muhtamim Hussain – BPH 067 07405
Tahsin mahin – BPH 067 07406
 Content

• Introduction • Sigma blade mixer

• Anchor agitator mixer • Planetary Mixer
• Scrapped surface Agitator • Colloid mill
• Counter rotation agitator • Triple roller mill
• Classification of paste mixing equipment • Conclusion
• Selection of mixing equipment for paste.
• Critical quality attribute – paste mixing
 Introduction
Paste – Paste is a semisolid dosage form. Semi solid dosage forms are the products when applied
to the skin treat a pathological condition and protects from other harmful environment. Semisolid
dosage forms include ointments, pastes, creams & jellies.
Mixing – Mixing is defined as a process that tends to results in a randomization of dissimilar
particles within a system. Mixing is operation in which two or more ingredients in separate or
roughly mixed condition are treated so that each particles of any one ingredient is adjacent to a
particle of each of the other ingredients as nearly as possible.
While mixing such dosage form, the material must be brought to the agitator or the agitator must
move the material throughout the mixer. The mixing action includes combination of low speed
shear, smearing, wiping, folding, stretching & compressing. A large amount of mechanical energy
is applied to the material by moving parts.
 Introduction (Cont.)

Sometimes, a part of the supplied energy appears as heat. The forces required for efficient mixing
are high & consumption of power is also high. Hence, the equipment must be ruggedly constructed
to tolerate these forces. Mixing equipment are also used for preparing tooth – pastes, pill masses &
wet mass for granulation. Some semisolids exhibit dilatant property, i.e. viscosity increases with
increase in shear rates. Therefore, mixing must be done at lower speeds. The speed must be
changed accordingly to thixotropic, plastic & pseudo-plastic materials.
 Anchor Agitator (Mixer)
• Anchor mixer is an agitator (mixing device) which has anchor shape.
• The agitator moves slowly & produces low capability.
• It is useful for dispersion & emulsification without over shearing, aeration & heat transfer
problems.
• The anchor agitator work up to 50 rpm & the sole function is to rotate the contents in a radial
direction without producing any significant shear.
• It functions at variable speeds.
• When the anchor agitator is built very close to the walls of the vessel, they are known as ‘swept-
surface agitator’.
Figure – Anchor agitator
 Scraped-Surface Agitator

• Flexible or movable blades are attached to the anchor, which

is known as scraped-surface agitator.
• The flat blades are made of plastic, nylon & Teflon.
• The blades actually contact the inner walls of the vessel &
scarp the liquid.
• This type has a distinct advantage.
• High viscosity materials do not flow away from the surface
of the mixing vessel, unless the agitator is close proximity to
the wall.
 Scraped-Surface Agitator (Cont.)
The following procedure is adopted for paste mixing –
• Initially heat is supplied to the mixing vessel for maintaining at 40 & 80℃.
• In the heat transfer process, the temperature at the sidewall is higher than the desired temperature in
the batch (bulk). The prolonged higher temperature may have deleterious effects:
• After mixing, the batch of immiscible liquids or semisolids is brought to the lower temperature. This
also has disadvantages.
• The viscosity of the layer on the sidewall becomes high & virtually it is difficult to remove the liquid.
• The layer on the sidewall acts as an insulator, thereby reduces the effective heat transfer. Once this
condition occurs, it is difficult to reverse.
Normally, the layer of liquid residing on the wall for longer periods became too hot or too cold. This
causes the problem of burn on or freeze on. This problem can be avoided by emptying scraped-surface
agitation.
 Scraped-Surface Agitator (Cont.)
Several designs of scraper blades are available –
• Blades are arranged in rows.
• Blades are fixed on both sides of an anchor.
• Blades overlap making the anchor to complete revolution.
• Blades are allowed to revolve in opposite directions. This prevents the buildup of
product on the following edge.
• Springs are included so as to force the blade against the wall.
• Liquid is forced to flow onto the blade to bring it close to the wall by a suitable design.
 Counter – rotation Agitator
The counter-rotating agitator consists of a set of cross-bars that
provide excellent blending.
• Designs use the same motor, but turn on a pinion gears
between two opposing bevel gears to provide rotation in
opposite directions.
• Designs have separate motors & their driving shafts, proving
greater degree of flexibility.
A hallow shaft drive the anchor agitator & an additional shaft
located inside the hallow shaft drives the inner cross bars.
 Classification of Paste Mixing Equipment

There two Agitator mixers – Examples are sigma mixer & planetary
type of paste mixer.
mixer
equipment.
They are –

Shear mixers – Examples are triple roller mill & colloidal mill.
 Selection of Mixing Equipment for paste

• Physical properties of the materials – density, viscosity & miscibility.

• Economic considerations regarding processing – time required for mixing & power
consumption.
• The cost of equipment & its maintenance.
 Critical Quality Attributes – Paste mixing
The Critical Quality Attributes (CQAs), process parameters (PPs) & material attributes (MAs) are recorded
in Figure – 1. The semisolid mixing is considered in the context of production of ointments & pastes. The
un-stream operation must be the solubilization of ingredients into individual phases & the downstream
operation is the packing into a suitable containers. Thus, semisolid mixing is the only step that imparts the
desired quality attributes. The attributes are – assay, viscoelasticity & particle size distribution. Among
these critical quality attributes, a few may be high risk or intermediate or low risk. Accordingly the high
risk attributes are incorporated in the risk management systems & controlled strategy is applied.
The process parameters are several & optimizing is a laborious process. Thus semisolid mixing is a
complex process & always attempted for batch process. The parameters are –
 Rate of shearing
 Temperature program
 Using mixing duration etc.
These are controlled during mixing as standards with limits. The above are normally universal parameters,
though changes are based on possible on the type of mixing system used.
Process Parameters
 Tank type, Tank size,
 Tank jacket temperature,
 Homogenization method, Material attributes
 Product temperature,  Appearance
 Order of addition,  Viscosity
 Impeller & location,  Density
 Heating/ cooling program,  Miscibility
 Feed speed,
 Rate of shearing (speed)
Semisolid Manufacturing
 Mixing duration,
mixing process step
 De-aeration,
 Power consumption, Critical quality attributes of output
 Environment (temp & Rh)  Appearance, pH, density
 Assay (API & preservative, if present),
 Viscosity
 Particle size & its distribution,
 Polymorphic form,
 Impurities,
 Microbial limits.
Figure – 1: CQAs & process parameters for semisolid mixing in the
production.
 Sigma Blade Mixer
Principle – The mechanism of mixing is shearing. The inter-meshing of sigma shaped blades
creates high shear & kneading actions. Convective mixing is achieved by cascading the
material.
Construction –
 The construction of a sigma blade blender is shown in figure.
 It consists of double trough shaped stationary bowl.
 Two sigma (including the shape of the Greek letter) shaped blades are fitted horizontally in
each trough of the bowl.
 These connected to a fixed speed drive.
 The mixer is loaded from the top & unloaded by tilting the entire bowl by means of a rack-
and-pinion drive.
 Figure – Stationary shell &
Figure – Sigma Blade Mixer rotating blades.
 Sigma Blade Mixer (Cont.)
Working –
o Different powders are introduced from the top of the trough.
o The body is covered because considerable dust may be evolved during dry blending &
granulating solution may evaporate during wet granulation.
o Through the fixed speed drive, the sigma blades are allowed to rotate.
o The blades move at different speeds, one usually about twice the speed of other, resulting in
lateral pulling of the material.
o They turn towards each other so that the powders move from the sides to the center of the
bowl.
o The material further moves downwards over the point & then sheared between the blades &
the wall of the trough.
o Thus cascading action (convective) as well as shear action can be achieved.
o The perforated blades help in breaking lumps & aggregates.
 Sigma Blade Mixer (Cont.)
Working (Cont.) –
o Thus high shear forces are set up.
o The final stage of mix represents an equilibrium state.
o The operating conditions of a given mixer can markedly effect the steady state & thus the
quality of the mixing.
o By means of rack-and-pinion drive the bowl is tilted to empty the blend.
 Sigma Blade Mixer (Cont.)
Uses –
 Sigma blade mixer is commonly used for mixing dough ingredients in the baking industry.
 It is used in wet granulation process in the manufacture of tablets, pill masses & ointments.
 It is primarily used for liquid-solid mixing, although it can be used for solid-solid mixing.

Advantages –
 Sigma blade mixer creates a minimum dead space during mixing.
 It has close tolerances between the blades & the side-walls as well as bottom of the mixer
shell.

Disadvantages – Sigma blade mixer works at a fixed speed.

 Planetary mixer
Principle – In a planetary mixer, the blade tears the mass apart & shear is applied between a moving
blade & a stationary wall. The mixing arm moves in two ways, around its own axis & around the central
axis, so that it reaches every spot of the vessel. The plates in the blade are sloped so that the powder
makes an upward movement. Therefore, tumbling (convective) motion is also obtained.
Construction –
 The construction of a planetary mixer is shown in figure.
 It consists of a vertical cylinder shell, which can be removed either by lowering it beneath the
blade or raising the blade above the bowl.
 The mixing blade is mounted from the top of the bowl.
 The mixing shaft is driven by a planetary gear train, as indicated in the figure.
 It rotates around the ring gear, which further rotates round the mixer blade.
 It is normally built with a variable speed drive.
Figure – Planetary mixer
 Planetary mixer (Cont.)
Working –
o In the planetary mixer, the agitator has a planetary motion.
o It rotates on its own & around the central axis so that it reaches all parts of the vessel.
o Beater is shaped to pass with close clearance over the side & bottom of the mixing bowl.
o Therefore, literally there are no dead spaces in the mixing bowl.
o The blades tears the mass apart & shear is applied between the moving blade & the stationary
wall.
o The plates in the blade are sloped so that the powder makes an upward movement.
o Therefore, tumbling (convective) motion is also obtained.
o Since it is a variable speed driven, initially the blade moves slowly for premixing & finally at
increased speed for active mixing.
o Thus high shear can be applied for mixing.
o Emptying the bowl may be done by hand (scooping) or by dumping mechanism.
 Planetary mixer (Cont.)
Uses –
 Planetary mixer produces precise blends in addition to breaking down of agglomerates rapidly.
 Low speeds are used for dry blending & faster speeds for the kneading action required in wet
granulation.
 Steam jacketed bowls are used in the manufacture of sustained release products & ointments.
Advantages –
 Speed of the reaction can be varied at will, so it is advantageous over sigma blade or ribbon
type blenders.
 There are no packing glands in contact with the product.
Disadvantages –
 Mechanical heat is built up within the powder mix.
 It requires high power.
 It has limited size & is useful for batch work only.
 Colloid Mill
Principle – Colloid mill consists of two steel discs (stator & rotor) having very small clearance
between them. One disc is rotating, while the other one is stationary. When the material is passed
through these discs, they get sheared. Thus, course particles are broken down into small particles due
to shear.
Construction –
 The construction of a colloid mill is shown in figure.
 The colloid mill consists of high-speed rotor & stator with conical milling surface.
 The milling surfaces may be smooth surfaced or rough surfaced.
 Rough surfaced mills are used for fibrous material because fibers tend to interlock & clog smooth
surfaced mills.
 The clearance between rotor & stator can be adjusted from 0.05 to 0.75 mm.
 During milling, the heat generated may rise the temperature up to 40℃.
 Hence, cold water circulation is provided to reduce the temperature as much as 20 ℃.
 The discharge pipe is also connected to hopper, so that discharge can be recycled.
Figure – Colloid Mill
 Colloid Mill (Cont.)
Working –
o Materials for the manufacture of suspensions & emulsions are placed in the hopper.
o Usually, the solids are pre-milled to prevent the damage of colloid mill.
o The solids are mixed with the liquid vehicle before introducing into the colloid mill.
o The dispersion flows down & adheres to the rotor.
o During the movement of rotor (3000 to 20000 rotations per minutes), centrifugal force throws a
part of the dispersion on to the stator.
o Depending on the clearance, the dispersion is sheared between rotor & stator.
o Thus, size reduction can be achieved.
o The milled liquid may be recycled.
o After achieving the desired size, the discharge is collected from the outlet in the periphery of
the housing.
 Colloid Mill (Cont.)
Working (Cont.) –
o Normally, the size of milled particles may be smaller than the clearance, because of the force of
the high shear.
o In emulsification, a clearance of 75 µm may produce dispersion with an average particles size
of 3 µm.
o The capacities of colloid mills range from 2 to 3 L/min for small mills to 440 L/min for the
larger mills.
 Colloid Mill (Cont.)
Uses –
 Colloid mill is used for preparing colloidal dispersions, suspensions, emulsions & ointments.
 Particle size as small as 3 µm can be obtained.
 Fibrous material can be milled using rough surfaced rotor & stator.
Advantages –
 Colloid mill can be sterilized.
 So it can be used in production of sterile products.
Disadvantages –
 Colloid mill tends to incorporate air into the finished product. Therefore, the product should be
allowed to rest for some time for deaeration.
 Heat is generated during milling. Hence, water circulation facility around the milling chamber
has to be provided.
 Colloid mill is not useful for dry milling.
 Triple Roller Mill
Principle – The differential speed & the narrow space between the rollers develop high shear over
the material. This shear causes crushing of aggregates, particles & also distributes the drug
uniformly through out the semisolid base.
Construction –
 The construction of a triple roller mill is shown in figure.
 It consists of three parallel rollers of equal diameters.
 These are made up of hard abrasion resistant material, normally stainless steal.
 The rollers are mounted in a rigid framework horizontally.
 The pressure & gap between the rollers are independently adjustable.
 A hopper is arranged between the first two rollers.
 A scrapper is attached to the last roller.
Figure – Triple roller mill
 Triple Roller Mill (Cont.)
Working –
o The gap between the last two rollers is adjusted to be less than the gap between the first two
rollers.
o The rollers are rotated at different speeds.
o In practice, the first roller (receiving-roller) rotates at a slower speed compared to the second
roller.
o Similarly, second roller speed is less than that of third roller (discharge roller).
o The feed is passed through the gap between the first & second rollers.
o The aggregates & particles are crushed & then abraded by the rubbing action of the rollers, which
is developed due to different speeds of rotation.
o A film of appreciable thickness of the feed is produced.
o The material passes from slow rotating to fast rotating roller.
o Between second & third roller, the gap is small & produces a thinner film of feed.
 Triple Roller Mill (Cont.)
Working (Cont.) –
o The speed of the third roller is increased to compensate the reduction of cross sectional area.
o In the thinning film, more crushing & more abrasion are developed.
o Finally the scrapper removes the material completely from the last roller which can be collected
immediately into the receiver or transported through a suitable conveyor.
 Triple Roller Mill (Cont.)
Uses –
 Triple roller mill is often used for mixing of solid ingredients in semisolid base like
ointments.
Advantages –
 Triple roller mill is suitable for continuous processes.
 Extremely uniform dispersion is obtained.
 Conclusion
The manufacture of pastes involves the mixing of solids, liquids & semisolid ingredients. The mass
is highly viscous & mixing is a difficult task & often includes a combination of low speed shear,
smearing, wiping, folding, stretching & compression. In most of the situations, heat is supplied, so
that mixing is facilitated in the molten state. Triple roller mill consists of three rollers, which rotate
in different speeds, different temperatures, at different directions & the clearance between the
rollers is narrow. This arrangement causes shear which crushes the drug uniformity throughout the
semisolid base.
 Reference
• Pharmaceutical engineering by CVS Subramanyam
• Https://www.Slideshare.Net/yagnikankita/mixing-by-ankita-yagnik
• Https://slideplayer.Com/slide/10773164/
• https://en.wikipedia.org/wiki/Mixing_(process_engineering)
THANK YOU