osd equipments

M+W Group-India

Pharmaceutical Equipment'sPart-1

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Safety Moment

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SAMPLING BOOTH

� Used to carry out sampling of Raw Materials under controlled environment

� Can be Laminar Air Flow Type or Reverse Laminar Air Flow type

� Air Flow Rate of 90 fpm ± 20% is maintained inside the booth

� Class 100 and Lux level of 750 is maintained inside the booth

� Inlet level Air Filtration : 10 micron + 3 micron + HEPA Filter (0.3 micron)

� Exhaust level Air Filtration : HEPA (0.3 micron)

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SAMPLING BOOTH

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� Used to carry out Dispensing of Raw Materials under controlled environment

� Can be Laminar Air Flow Type or Reverse Laminar Air Flow type

� Air Flow Rate of 90 fpm ± 20% is maintained inside the booth

� Class 100 and Lux level of 750 is maintained inside the booth

� Inlet Air Filtration : 10 micron + 3 micron + HEPA Filter (0.3 micron)

� Exhaust Air Filtration : HEPA Filter (0.3 micron)

DISPENSING BOOTH

LAF RLAF

Air flow parallel

Flow once through

Air flow turbulent

Re circulated flow

Protect the product only

Not recommended for raw material dispensing.

Protect the product and area

Recommended for product/raw material dispensing.

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DISPENSING BOOTH

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�Used to carry out Sifting (sieving) of ingredients

�Particle size is controlled by passing the material through vibrating screen

�Material fed manually to feed hopper

�Provision variable for easy dismantling of screen for cleaning purpose

SIFTING

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�Used for Particle size reduction

�Types of Mills available

�Multi Mill

�Communiting Mill

�Colloid Mill

�All Mills consist of three basic parts

�Feed chute

�Grinding Mechanism (usually consisting of rotor and stator)

�Discharge chute

MILLING

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MULTILL MILL

� Used for mixing & chopping of ingredients

� Has hammer blades

� Screen present for particle size selection

� Material fed in charging hopper, travels to

chamber where it gets chopped, then

if finally passes through the screen

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COMMUNITING MILL

� Used for particle size reduction

� System consists of feed chute, Rotor assembly with fixed beater & screen

� Facility available for varying and setting Rotor speed

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COLLOID MILL

� Used for homogenizing, emulsifying, dispersing of liquids including high viscous liquids

� Product is processed by high shear pressure & friction between Rotor & Stator

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SELECTION OF A MILL

� Product specifications (size range, particle size distribution shape, moisture content,

physical & chemical properties of the material

� Capacity of the mill & production rate requirements.

� Dust control (loss of costing drugs, health hazardous contamination of plant

� Economic factors

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� It is process that attempts to improve the flow of powdered material by forming sphere

like or regularly shaped aggregates called granules.

� Need of Granulation

- For flowability

- For Compressibility

� The process involves mixing of Active pharmaceuticals ingredients and excipients

followed by addition of Binder

� Types of Granulation

- Wet Granulation

- Dry Granulation

� Granulation involves Mixing + Milling + Drying

GRANULATION

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WET GRANULATION

� The Process involves binding the powder together with an adhesive (binder)

� Equipment used for Wet Granulation

- RMG (Rapid Mixer Granulator) – used for Mixing & Milling

- Fluid Bed Dryer – used for Drying

� Alternatively instead of above two equipments both the operations can be performed

together in a FBP (Fluid Bed Processor)

� RMG (RAPID MIXER GRANULATOR)

� Used for Mixing of ingredients & for Wet Granulation by addition of binder

� Equipment consists of

- Mixing Bowl, Impeller (for Mixing), Chopper (lump breaker)

� Provision available for monitoring & setting chopper, impeller speed and Granulation time.

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RMG (RAPID MIXER GRANULATOR)

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� Used for uniform drying of ingredients by Air fluidization

� Hot Air surrounds the material completely which gives higher heat transfer rate & faster

drying

� System consist of

- Inlet Air Handling Unit consisting of coarse, fine followed by HEPA filter, Chilled

water & Steam Coils.

- Outlet Air Exhaust blower to create an induced draft of hot air

- Main machine tower consisting of Product container & trolley filter bag assembly for

removing the powder

- Explosion frame & flap for releasing excessive pressure

� Necessary Instruments & Controls

FLUID BED DRYER

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FLUID BED DRYER

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� Granulation process carried out without any addition of binder

� Done with the help of Roll Compactor

� Roll Compactor

- Utilizes Rollers for carrying out compaction

- Compaction means improving the bulk density and giving equal quality to granules

Feed

Hopper

Rolls

DRY GRANULATION

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ROLL COMPACTOR

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� Used for mixing of Dry powder & homogenous lubrication of Granules

� Equipment's of Blending

- Octagonal Blender

- Due to octagonal shape it is designed to process large volume of material

- Occupies less space

- Well balanced in high capacities and has removable baffles

BLENDING

OCTAGONAL BLENDER

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DOUBLE CONE BLENDER

� Double Cone Blender

- Conical shape at both ends enables uniform mixing & easy discharge

- Baffles can be provided for better

mixing

� Important parameters during Blending operation

- Blending time

- Rotational speed of Bin

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CONTA BLENDER

� Conta Blender

- It has completely replaced conventional blenders

- Can accept varying

sizes of containers or bins

- Mixing efficiency better

than other types of blender

as it Rotates in diagonal &

in a eccentric plane.

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� Tablets are made by compressing a formulation containing a drug with excipients on

stamping machines called presses

� Compression machines is made of following

- Dies for defining shape & size of tablets

- Punches for compressing the ingredients within the dies

- A feeding mechanism for moving ingredients into the dies

� Tablet machine is categorized by

- No. of compression station (like 20,32,37,55 etc.)

- Rotational speed of press (like 480,1640 etc.)

- Type of tooling set (like ‘B’, ‘BB’, ‘DD’)

COMPRESSION

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COMPRESSION

� Process steps involved in compression

- Die fill

- Weight Adjustment

- Compression

- Ejection

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COMPRESSION CYCLE OF ROTARY PRESS

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TABLET TOOLING; PUNCHES & DIES

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� Coating performs number of jobs for example

- Prevent tablet cracking or breaking in transit

- Allowing the controlled release of Active ingredients over a longer time

- Mask the taste

- Make the tablet easier to swallow

� Coating can be with water based or non-aqueous solvents

� Coating equipment

- Auto coater

COATING

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AUTOCOATER

� System consists of

• Solution tank with stirrer on platform scale

• Peristaltic feed pump

• Perforated coating pan with baffles

• Compressed Air atomized spray system

including spray gun

• Conditioned Supply & Exhaust Air System

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� Types of Packing

- Blister Packing

- Strip Packing

PACKING

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� Used for packing for Capsules & Tablets

� Formed by Heat softening sheet of plastic into the mould followed by cooling and filling into the moulds.

� Blister or Base material can be PVC / PVDC film (may be transparent)

� Lidding material can be aluminum foil (Alu-Alu)

� Process steps involved

- Feeding of tablets

- Sheet forming

- Tablet filling

Batch code printing

- Punching to cut Blister as per layout

� Miss fill detectors present to detect empty Blisters

� Line perforation tool provided

� For checking the printing on lidding material edge to edge print registration control system

BLISTER PACKING

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BLISTER PACKING

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� Used for packing of tablets & capsule

� Consist of set of rollers with heaters

� Laminated foils drawn from two rollers packs & seals the product in continuous strip

� Strip is then cut to desired size by cutter assembly

STRIP PACKING

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TABLET MANUFACTURING

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STAGES OF PHARMA MANUFACURING

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DRUG PRODUCT MANUFACTURE

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