OSD Equipments

1. M+W Group-India Pharmaceutical Equipment's
Part-1

2. © M+W Group
Safety Moment

3. © 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)

4. © M+W Group
SAMPLING BOOTH

5. © M+W Group

Used to carry out Dispensing of Raw Materials under controll ed 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 m icron)

Exhaust Air Filtration : HEPA Filter (0.3 micron)
DISPENSING BOOTH
LAFRLAF
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.

6. © M+W Group
DISPENSING BOOTH

7. © 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 f or cleaning purpose
SIFTING

8. © 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

9. © 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

10. © M+W Group
COMMUNITING MILL

Used for particle size reduction

System consists of feed chute, Rotor assembly with fixed be ater & screen

Facility available for varying and setting Rotor speed

11. © M+W Group
COLLOID MILL

Used for homogenizing, emulsifying, dispersing of liquid s including high viscous liquids

Product is processed by high shear pressure & friction betwe en Rotor & Stator

12. © 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 contami nation of plant

Economic factors

13. © M+W Group

It is process that attempts to improve the flow of powder ed 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 ingredie nts and excipients
followed by addition of Binder

Types of Granulation
-Wet Granulation
- Dry Granulation

Granulation involves Mixing + Milling + Drying
GRANULATION

14. © 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, im peller speed and Granulation
time.

15. © M+W Group
RMG (RAPID MIXER GRANULATOR)

16. © M+W Group

Used for uniform drying of ingredients by Air fluidiza tion

Hot Air surrounds the material completely which gives hig her heat transfer rate & faster
drying

System consist of
- Inlet Air Handling Unit consisting of coarse, fine foll owed 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 & tro lley filter bag assembly for
removing the powder
- Explosion frame & flap for releasing excessive pressure

Necessary Instruments & Controls
FLUID BED DRYER

17. © M+W Group
FLUID BED DRYER

18. © 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

19. © M+W Group
ROLL COMPACTOR

20. © 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

21. © 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

22. © 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.

23. © 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

24. © M+W Group
COMPRESSION

Process steps involved in compression
- Die fill
- Weight Adjustment
- Compression
- Ejection

25. © M+W Group
COMPRESSION CYCLE OF ROTARY PRESS

26. © M+W Group
TABLET TOOLING; PUNCHES & DIES

27. © M+W Group

Coating performs number of jobs for example
- Prevent tablet cracking or breaking in transit
- Allowing the controlled release of Active ingredients o ver 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

28. © 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

29. © M+W Group

Types of Packing
- Blister Packing
- Strip Packing
PACKING

30. © M+W Group

Used for packing for Capsules & Tablets

Formed by Heat softening sheet of plastic into the moul d followed by cooling and filling into the
moulds.

Blister or Base material can be PVC / PVDC film (may b e 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

31. © M+W Group
BLISTER PACKING

32. © 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 p roduct in continuous strip

Strip is then cut to desired size by cutter assembly
STRIP PACKING

33. © M+W Group
TABLET MANUFACTURING

34. © M+W Group
STAGES OF PHARMA MANUFACURING

35. © M+W Group
DRUG PRODUCT MANUFACTURE

36. © M+W Group
Thank You