spheronizer and marumerisiers and other special is ed granulation and

8/4/2019 Spheronizer and Marumerisiers and Other Special is Ed Granulation And

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Spheronizer and

Marumerisiers and otherSpecialised granulation and

Drying equipment.Problems

Encountered

Prepared by:Nitu Jha

Guided by:Dharmang Pandya


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y g y

Introduction

Granulation may be defined as a size

enlargement process which converts smallparticles into physically stronger & largeragglomerates.

Granulation method can be broadly classifiedinto two types: Wet granulation, Drygranulation.


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Ideal characteristics of

granules good flow

compactibility.

These are usually accomplished throughcreation of increased density

spherical shape

narrow particle size distribution withsufficient fines to fill void spaces betweengranules, adequate moisture (between 1-2%)


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The effectiveness of granulation depends on thefollowing properties

i) Particle size of the drug and excipients

ii) Type of binder (strong or weak)

iii) Volume of binder (less or more)

iv) Wet massing time ( less or more)

v) Amount of shear applied to distribute drug,binder and moisture.

vi) Drying rate ( Hydrate formation andpolymorphism


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granulating equipments

1) Spray granulator

2) Fluid bed granulator

3) High shear mixture granulator


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Spray granulator


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What is Spray Granulation?

Spray Granulation occurs when a liquid solutionis rapidly dried over an active ingredient.

This newly encapsulated particle structure isharder and denser, yielding particle propertiesthat are desirable in many applications.

The newly formed particle can be sprayed again

and again creating larger and larger sphericalpellets that form in successive onion like layers.


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In the granulation process, the particles areconveyed through the inner partition into theexpansion chamber by the hot fluidizing air.

Gravity overcomes the force of the fluidized airand the particles fall back into the outerpartition.

The pneumatic atomizing nozzle in the bottomcenter of the chamber introduces the coatingsolution. This nozzle sprays upward providingsuccessive applications of coating to the product.


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Mechanism

Stages in Spray Granulation:

1.Atomization of granulation liquid

2.Agglomeration of particles

3.Drying


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Atomization

It is the process by which a liquid is disintegratedinto many fine droplets, thereby yielding a highsurface/mass ratio.

This is achieved by supplying energy to the liquidin the form of kinetic energy, pressure energy,centrifugal energy etc.

The most common form of atomization is

hydraulic pressure nozzle atomization. The differential pressure drop across the orifice

determines the mean droplet diameter.


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Agglomeration

In this stage, the atomized granulating liquid issprayed over the particles to facilitate theagglomeration.

At low moisture contents, particles contact eachother and adhere due to the formation of liquidbridges.

Finally, droplets are formed when the liquidcompletely surrounds the granule.

The strength of the droplet is dependent on thesurface tension of the liquid phase.


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Drying

In this stage, the agglomerated droplets arebrought into contact with heated gas for theevaporation to take place equally from thesurface of all droplets


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Why Spray Granulation?

Advantages Some of the desirable product properties of

the spray granulation process are:

Dust-free granules

Spherical pellets

Free flowing properties

Good solubility

Compact structure Less hygroscopic

Less abrasive


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applications

Spray granulators are widely used for formingmaterials in industries like chemicals, foodproducts and pharmaceuticals.

Its main purpose is to convert light, smallpowders into high-density free-flowinggranulates.


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Fluidized Bed Granulator


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1. Inlet air filter

2. Condenser

3. Humidifier

4. Inlet air Heater

5. HEPA filter

6. Inlet air 7. Inlet air plenum

8. Gas distributor plate

9. Product container

10. Conical expansion zone

11. Filter housing

12. Product filter 13. Outlet air

14. HEPA filter

15. Fan

16. Spray gun


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Introduction

The basic concept in granulation (also known asagglomeration) involves suspending particulates inan air stream and spraying a liquid from the top onto the fluidized bed. Particles in the path of the sprayget slightly wetted and become tacky. The tackyparticles collide with other particles and adhere tothem to form a granule.

There are two different mode of fluid bedgranulation:

1) Dry stage

2) Wet stage


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In the dry stage granulation , the granulatingsolution is applied at a rate less than or equal tothe evaporation rate so that the particles arewetted slightly to become tacky and stick toeach other. Thus the particles remain drythrough the entire process.

In the wet stage granulation , the granulatingsolution is applied at the rate higher than

evaporation rate until the particles build upenough moisture to granulate so that particlesare wetted significantly before they becometacky enough to stick to each other.


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working

A suction fan mounted at the top portion generatesthe airflow necessary for fluidization of powders.

The air used for fluidization is heated to the desiredtemperature by an air heater.

The liquid granulating agent is pumped from itscontainer & sprayed as a fine mist through a sprayhead onto the fluidized powder.

The wetted particles undergo agglomeration

through particle contacts. After appropriateagglomeration is achieved, the spray operation isdiscontinued and the material is dried anddischarged from unit.


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Common Problem In Fluid Bed

Granulation

Excessive fine

Excessive coarse granulation Poor fluidization

Finished product non uniformity

Low yield


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High Shear Granulators


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Construction and working

High Shear Granulators series features a cuttingchamberSound treatment is easily retrofitted whenever

desired. The chamber design uses economicalflat blade knives in a skewed mount for point-contact cutting against the two bed knives.

This, plus an open segmented rotor, yields cooloperation and clean cutting with few fines, whilecontributing to the low overall operating soundlevels. .


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Additional feature

Periodic maintenance has been simplified and quickened.All knife adjustments are accomplished from the top of thechamber after tilting back the hopper.

No dead spots or corners are found in the lower chamber

or screen area, so dust and fines cannot accumulate,making clean out faster and more thorough.

The screen assembly is held in place by two push rods foreasy mounting and dismounting without loose hardware,yet is held firmly with positive seating and sealing.Commonly removed cabinet components clamp in place,and can be removed and replaced in moments, withouttools.


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use

High shear mixture has been widely used inPharmaceutical industries for blending andgranulation.

Blending and wet massing is accompanied byhigh mechanical agitation by an impeller anda chopper.

Mixing, densification and agglomeration areachieved through shear and compactionforce exerted by the impeller.


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Advantages:

i) Short processing time

ii) Less amount of liquid binders required

compared with fluid bed. iii) Highly cohesive material can be

granulated.


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Defect

It cant be used for sticky material

Can not be used for thermolabile substance


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Spheronization

Forming granules with a specific bioconsumableshape

Producing a smooth particle surface suitable for

thin layer coating. Conditioning particles to prevent generation of

dust and fines from usage or shipping..

Increasing flowability by diminution of stickingor bridging points.

Increasing the apparent bulk density up to 25 %compared to extruded material.


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working

The Marumerizer is comprised of three maincomponents: a vertical cylinder with dischargeport, a circular "friction" plate and a variable

speed drive train which turns the plate.

The feed material to the spheronizer can beextruded particles or moist granules from a

mixer/granulator. Since an extruded particle hasat least two dimensions already defined, anarrow final particle size distribution is possible.


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Particles are fed onto the spinning friction plate,which throws them against the inside wall of thecylinder.

Extruded particles are quickly broken intosegments approximately one diameter long.Centrifugal and gravitational forces create amechanically fluidized ring of particles.

Collisions with the wall, friction plate and other

particles result in the plastic deformation of eachgranule, quickly creating a spherical shape.

".


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Drying

Drying is a process that occurs by effectingvaporization of the liquid by supplying heat to thewet feedstock.

Heat may be supplied by convection (direct dryers),by conduction (contact or indirect dryers),radiationor volumetrically by placing the wet material in amicrowave or radio frequency electromagnetic field.Over 85 percent of industrial dryers are of the

convective type with hot air or direct combustion gases as the drying medium.

Over 99 percent of the applications involve removalof water.


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In Drying Process

The following inlet air parameters are critical, andapplicable in all processes of drying, granulation andcoating.

1) Temperature As the inlet air temperature increases the rate of drying

increases and vice versa. This approach to increase the rateof drying can not be used always because some materialsare harmed by high temperature, e.g. Ibuprofen liquefies

above 60C temperature of inlet air should be optimizedwithout any impact on product quality. If temperature ishigh, it leads to blistering. If temperature is low, soft spotcan be formed.


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Cont.

2) Humidity

Humidity in the inlet air should be as low as possible andideally dehumidified air should be used for faster dryingrate because as the humidity of inlet air decreases the rate

of drying increases. 3) Air flow rate

Air flow rate should be controlled properly in order to getefficient use of drying air. As the air flow rate increases, therate of drying increases but the cost of drying also

increases. If drying air is allowed for sufficient time toremain in contact with the drying material, proper heattransfer and mass transfer takes place and thus drying costdecreases. Air flow rate should not be too fast or too slowbut optimized to have efficient drying.


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Fluidised bed dryier


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direct dryingwhere direct contact between aheated gas/air and the product occur to effectheat and mass transfer.

The hot air/gas used for drying can be generatedby either steam coils or a combustion furnace.The holes in the perforated plate are coveredwith caps that prevent material form entering

the plenum when the dryer is not in operation.The fan equipped in the upper part of theapparatus induce fluidizing air stream.

.


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Hot air is fed in the material layer at rest from the bottomof gas straightening valve (e.g. perforated plate).

The velocity of air is adjusted by means of a damper. Whenthe velocity of hot air accelerates a bit, particle groups

gradually come to make active movements graduallyresulting in hot air pressure loss due to the material layerscomes to be in proportion to the weight of materialparticles on the unit area of the straightening vane.

With further accelerating the velocity of hot air, the particlegroups undergo vigorous movement to mix with gas in all

directions, resulting in suspension state


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In indirect fluid bed processing, a tube orseries of plates are incorporated into thedrying chamber.

They are arranged in such a way thatproducts remain in intimately contact withthe heated surface.

The heat energy is transferred by means ofconduction. Here steam is used as a source ofenergy. The cost of operation is low becausesteam is low cost energy source


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Industrial application

Fluid bed dryer is suitable for

powders granules

agglomerates pellets having average particle size normally

between 50 and 5000 micron.


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Pneumatic/Flash Dryer


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working

The pneumatic or flash dryer is used withproducts that dry rapidly owing to the easyremoval of free moisture or where any

required diffusion to the surface occursreadily.

Drying takes place in a matter of seconds.Wet material is mixed with a stream of

heated air (or other gas),which conveys itthrough a drying duct where high heat andmass transfer rates rapidly dry the product.


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Applications include the drying of

filter cakes

crystals Granules

pastes

sludges slurries; in fact almost any material where a

powdered product is required.


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Rotary Dryers


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Direct Rotary Dryers working

Direct Rotary Dryer comprises of a rotatinginclined shell through which a hot stream of air

flows. The wet material present in the rotaryshell is lifted by means of spiral flights andshowered in hot flowing air. Due to this directcontact, the product is dried.

Rotary Dryers are available with co-current orcounter current air flow patterns depending onthe properties of individual products to be dried


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Indirect Rotary Dryers


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INDirect Rotary Dryers

working Indirect Rotary Dryers comprises of a rotating

shell having a concentric inner shell. Hotproducts of combustion passed through the

inner concentric shell not coming in contactwith the product. The product is dried byradiation and conduction.


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Rotary dryers are suitable for a wide varietyof products, from granular, powdered andcrystalline materials, to filter cakes and

sludges


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References

1. The theory and Industrial pharmacyby Leon Lachman, Third edition

2. Pharmaceutical science by Remington,20th edition

3. Pharmaceutical engineering-II By DRGirish k.jani

4. Tutorial pharmacy by cooper andgunns ,edited by S.J Carter

5. Ansels pharmaceutical dosage formand drug delivery system,8 edition,byLoyd v. allen,Howard c.Ansel


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