M+W Group-India Pharmaceutical Equipment's Part-1
M+W Group-India
Pharmaceutical Equipment'sPart-1
© M+W Group
Safety Moment
© M+W Group
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)
© M+W Group
SAMPLING BOOTH
© M+W Group
� 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.
© M+W Group
DISPENSING BOOTH
© M+W Group
�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
© M+W Group
�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
© M+W Group
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
© M+W Group
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
© M+W Group
COLLOID MILL
� Used for homogenizing, emulsifying, dispersing of liquids including high viscous liquids
� Product is processed by high shear pressure & friction between Rotor & Stator
© M+W Group
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
© M+W Group
� 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
© M+W Group
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.
© M+W Group
RMG (RAPID MIXER GRANULATOR)
© M+W Group
� 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
© M+W Group
FLUID BED DRYER
© M+W Group
� 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
© M+W Group
ROLL COMPACTOR
© M+W Group
� 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
© M+W Group
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
© M+W Group
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.
© M+W Group
� 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
© M+W Group
COMPRESSION
� Process steps involved in compression
- Die fill
- Weight Adjustment
- Compression
- Ejection
© M+W Group
COMPRESSION CYCLE OF ROTARY PRESS
© M+W Group
TABLET TOOLING; PUNCHES & DIES
© M+W Group
� 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
© M+W Group
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
© M+W Group
� Types of Packing
- Blister Packing
- Strip Packing
PACKING
© M+W Group
� 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
© M+W Group
BLISTER PACKING
© M+W Group
� 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
© M+W Group
TABLET MANUFACTURING
© M+W Group
STAGES OF PHARMA MANUFACURING
© M+W Group
DRUG PRODUCT MANUFACTURE
© M+W Group
Thank You