This document provides information about a high shear mixer granulator (HSMG) with a capacity of 600 liters. It describes the components, functions, process, and specifications of the HSMG. The key components include a mixing chamber, impellers, chopper, discharge port, cone mill, and control panel. It mixes ingredients to make granules for tablet production and can process up to 240 kg of material in a single batch. Safety features and operating procedures are outlined.

1. High Shear
Mixer
Granulator
CAPACITY 600LITERS

2. HSMG

3. About
High Shear Mixer Granulator is widely used equipment in pharmaceutical manufacturing. It
is used to mix the pharmaceutical ingredients and make the granules before compression
and also called a high shear mixer. Impellers and chopper are mainly responsible for wet
granulation in the rapid mixer granulator.
HSMG Is designed to achieve all requirements of cGMP- Current Good Manufacturing
Practices. The components can be easily dismantled, cleaned thoroughly and assembled in
quick time. The shaft seals are very effective to check any leakages and cross
contamination due to adherents. The bowl and all the components are of highly polished
stainless steel with smooth contours and is crevice less.

4. Components of HSMG
High shear mixture granulator components like Mixing chamber(Bowl), Impeller, Granulator
(Chopper), Discharge port, Cone Mill, Filter, Purging air, and port provided for solution inlet.
Impeller and chopper are responsible for mixing and break granules mass. Discharge
points are connected horizontally at the lower part of HSMG, the discharge point is
operated automatically with the help of a pneumatic pump( required 3-5
kg/cm² compressed air pressure)
The filter is placed with aid of a vent air filter to remove purging air and retained granules
inside. Purging air is supplied below from the impeller to prevent stick the granules to the
impeller and also helps prevents contamination.

5. Mixing Chamber (Bowl)
It is circular with a large diameter of flat base. The top portion of the bowl is conical in
shape to assist mixing of cohesive powders. The bowl is constructed from SS316. A hub
pipe which is on the bottom flat dish surrounds the drive shaft where it enters the base of
the bowl, where the Teflon retainer ring and shaft seal is provided to avoid the cross
contamination. The shaft seal is further provided by air purging.
The impeller blade having three numbers of triangular shape blade is fabricated from
SS316. The blade is fitted on the drive shaft by bolting with a sleeve which is mounted on
the drive shaft. The Blade is used for dry and wet mixing of powders of different products
to prepare the tablet formulation.
Bowl Finish: Inside and Outside surfaces are mirror polished.

6. Impellers
Impellers are fixed at the bottom of the dome-shaped stainless steel bowl. Impeller and
chopper are responsible for mixing and break granules mass. Discharge points are
connected horizontally at the lower part of HSMG, the discharge point is operated
automatically with the help of a pneumatic pump. These impellers break up the wet mass
into small pieces and granules.
Impeller direction - clockwise (both speed slow 10RPM & fast 98RPM)

7. Impeller
Chopper

8. Chopper
A high speed Granulator (Chopper) is inserted horizontally through the wall of the bowl to
assist blending of the powder and to break the product to granules of required size. The
special design chopper blade has two “U” shape blades which are welded 90 degrees apart
from each other. The “U” shape blade is provided with edge to assist breaking of lumps
which forms during the wet mixing. The AC drive is used for varying the speed of the
chopper from 290 to 2900 RPM.
The granulator head is of highly polished stainless steel and is easily removable for
cleaning. The granulator shaft where it enters the bowl incorporates with seal. The motor is
provided with a removable stainless steel shroud which covers it to meet cGMP norms.
Chopper direction - Anti-clockwise (Slow 290RPM & Fast 2900RPM)

9. Lid Lifting
The manual counter weight type lifting arrangement is provided on the bowl lid/ cover for
easy opening and closing of the lid/ cover. A lock in the form of a limit switch is provided at
the top portion of the bowl to prevent the motors to start when top lid is in open position.
In some models pneumatic lid lifting assembly are provides for easy lid lifting.

10. Discharge Port
It is provided on the bowl; located horizontally in the shell. It is operated by a S.S piston
connected to a pneumatic cylinder. Granules are unloaded in the container through the
discharge port. The hinge type cover is provided for easy opening and closing for cleaning
of the inside portion of the discharge port. A safety lock in the form of a limit switch is
provided at the discharge cover to prevent the motors from starting during the operation.
The opening of the discharge port is operated by a compressed air regulated cylinder
known as a pneumatic cylinder that requires 3-5 kg/cm2 pressure of compressed air.

11. Cone-Mill
The inline cone-mill is used for breaking the lumps from during wet mixing of the powder
into HSMG. The cone mill is used to enhance the drying efficiency. The cone mill is in built
with discharge of HSMG. So the final mix material of HSMG directly passed through the
cone mill.
The cone mill blade is triangular in shape and rotates at the speed of 2850 RPM in normal
condition. The cone mill is provided with 10 mm diameter mesh.

12. Control Panel
The NFLP Panel made of M.S Powder coated; Control panel is to be placed on Technical
area which is located just above the machine area. It is mounted on SS frame. PLC, Switch
Gears, A.C Drive, Transformers, Analog and Digital Cards, Chocks and various control and
electrical equipment placed in this control box. In simple words we can say it’s the Brain of
HSMG. All programming and Interlocks done in PLC.

14. Cable Inter-Connection Block Diagram of HSMG

15. Cable Schedule of HSMG

16. HMI
HMI (Human-Machine Interface) as the name indicates, It is a Interface Machine located on
HSMG to operate machine and change input variables ,time according to batch size and
material in HSMG. HMI take inputs from operator send it to PLC in control panel for
processing and receive output from PLC and display it on screen to operator.
A Local Emergency Stop Button also provided to stop HSMG at any time for prevention of
any accident.

17. System Configuration Diagram of HSMG

18. HMI : User Interface

19. A.C Drive
:
The A.C drive is used for varying the speed of the impeller blade to get the uniform
granules and to control feed of the cone-mill at the time of discharge. Three speeds are set
on the A.C drive.
I. High Speed- [50Hz- Variable]
II. Low Speed- [25 Hz- variable]
III. Creep Speed- [10Hz- Factory settable]
The A.C drive is used for varying the speed of the chopper blade. The speed of chopper is
varying from 288 to 2880 RPM. Two speeds are set on the A.C drive.

20. Drive
:
The hollow shaft gear box and motor are coupled with pulley and belts to
rotate the impeller blade. On the gear box M.S lantern is bolted on which
HSMG Bowl is mounted.

21. Frame
:
The HSMG frame is fabricated from M.S Square pipe. The frame legs are cladded with S.S
sheet on the top of the frame S.S chequered plate is welded and safety railing is provided
all around the frame. Inside the frame Gear Box, Motor and Pneumatic panel are mounted.
All side of the frame are covered with S.S panel and a safety lock in the form of limit switch
is provided on the drive side S.S panel to prevent the motors to start if any panel is in open
condition.

22. Instrumentation
I. Pneumatic Limit Switches are installed on discharge nozzle, Top Lid & End Panels for
safety during operation.
II. Proximity Switches is installed at discharge port to locate the position of FBD bowl.
III. Emergency Switch erected near discharge to stop immediate HSMG.
IV. Common pressure Switch also provided for all interlocks.
V. Lid (Top Cover) Opening is provided with Hydraulic Cylinder to smooth opening of
Lid.(Optional)
VI. Hydraulic Powerpack 1.5HP, Single Station ,5 LPM, with flame proof motor & with non
flameproof solenoid coil.
VII. Discharge port equipped with pneumatic operated valve.

23. Electrical System
I. Operating/Control Panel Std IP-55(Protection for the equipment from dust, oils and non-
corrosives, water, including water sprayed from a nozzle ) with HMI for Zone 2 and Flame/Non
flame proof On-Off and Emergency.
II. Control panel is Non-Flame proof placed in Tech. Area.
III. All Electrical are Non-Flameproof, 415V, 50Hz, 3Ph.
IV. Beater Motor-50 HP,1480 RPM,(NOM) N-FLP,FOOT mounted,415V,50Hz,3Ph.
V. Chopper Motor-7.5 HP,2900 RPM,N-FLP , Flange mounted
VI. Cone Mill Motor- 5 Hp,2850 RPM,N-FLP, Flanged mounted,
VII. Main Impeller lifting Motor-0.5 HP,1410 RPM(Normal) 50Hz,415V,N-FLP, Flange mounted
VIII. A.C. Frequency Variable Drives-for Beater(50HP) & Chopper(7.5HP)
IX. PLC - Micrologix 1400, Location: Control Panel
X. HMI - Panel view 700, Touch Screen type, Location: Operating Panel

24. Pneumatic System
This system is used for operating the discharge valve air purging of chopper drive and the
impeller drive to avoid cross contamination. The system also contains air filter pressure
gauge and other pipes and pneumatic fittings.

25. Pneumatic System Diagram of HSMG

26. HSMG
Working

27. In HSMG, the formation of granules occurs by rising, whirling and tumbling
motion of the material. Dry mixing is done by adding all ingredients into the
HSMG by rotation of impeller and chopper at high speed. During the addition
of binder solutions to the powder impeller and chopper are operated at low
speed. After the formation of wet mass impeller and chopper are operated at
high speed to form the granules of the required size.
Dry mixing takes about 3-5 minutes to mix the ingredients, wet mixing takes 5-
10 minutes to make the wet mass of material while the granulation process
takes 5-10 minutes to make 0.5 mm to 1.5 mm sized granules. Mixing time
consumed in processing is depends upon the ingredients quantity and their
particle size.

28. Brief Process Description
I. To start the process, close the discharge valve.
II. Charge the powder (product) into the mixer for dry mixing.
III. Set the time & speed of impeller and chopper blade (variable from product to
product).
IV. Close the bowl with the top lid and lock the top lid with the bowl using clamps.
V. Start impeller blade for dry mixing.
VI. After dry mixing is over, Add Binder into the mixer.
VII. For wet mixing start impeller and chopper blades.
VIII. When wet mixing is over, discharge the material by running the impeller at creep speed

29. Brief Process Description
IX. Before taking the discharge, keep the FBD bowl the cone mill to collect the discharged
Milled material.
X. For taking the discharge, First start the Cone-Mill then start HSMG at pre set discharge
speed.
XI. Then open the discharge gate of the HSMG.
XII. After the discharge is over, stop both machines.
Note:
a) Available impeller speeds are Slow speed, Fast speed and Creep speed (All preset able).
b) The perfect granulation is to be achieved by Validation of each product

30. Automation
To achieve consistency in the product quality it is desirable to minimize/ eliminate the
human elements in monitoring the operational parameters of the machine including the
end point control. It is also desirable to record/ store the critical data which may contribute
to product quality. The operational recipe data can be saved and hard copy(Print Out) can
also be taken out. To incorporate suitable provision in the system of data storage, customer
has to specify parameters which are required to be reproduced. As a standard, following
parameters are recorded:

31. Automation
I. Product Name
II. Operator Name
III. Batch No.
IV. Batch Date
V. Batch cycle Timer
VI. Dry Mixing Time
VII. Wet mixing Time
VIII. Granulation Time
IX. End Point Value (Ampere based)
X. Various faults if any during cycle

32. Calculation For working Capacity of the HSMG
For this first calculate the bulk density of powder to be mixed, then it multiplies by the
capacity in liters (provided by the Client), for e.g.
working capacity in a liter is 600 liter and its working volume is 80% means 480 liters and
bulk density is 0.5 then capacity in kgs is 480 x 0.5= 240 kg. so we can make a batch of 240
kg materials in modal of 600 liters HSMG.

33. Material of Construction

34. Technical Specifications of HSMG
I. Filled volume: 655L
II. Gross capacity: 600L
III. Working Volume: [a] Maximum: 480L(240Kg @0.5BD)
[b]Minimum: 240L (120Kg @0.5 BD)
IV. Weight in Kgs: 3500
V. Impeller Speed: 105RPM +- 10%(Variable from 10 to 105 RPM)
VI. Chopper Speed: 2880 RPM +- 10%(Variable from 288 to 2880 RPM)
VII. Cone-Mill Speed: 2850 RPM +- 10%
VIII. Cone Mill Sieve: 10mm dia. Sieve

35. Technical Specifications of HSMG
IX. Nozzle: [a] Charging Hole-200 dia. with dust free Gasket and Cover
[b] Vent-125 dia. Tri-Cover with 20# Polyester
[c] Discharge- 200dia. pneumatically operated
[d] View Port- 200 dia. With cover
[e] CIP(Clean in Place) Nozzle- 150 dia. Tri Clover with Spray Ball
X. Electrical: Flame Proof.
XI. Drive Specification: Motor and Gear Box are connected with pulley and belts
XII. Connectivity: [a] Discharge- FBD Bowl below the discharge port
[b] Charging - Manual
XII. Power Supply: 415V, 3 Phase, 50Hz

36. Technical Specifications of HSMG
XIII. Operating Panel: Consists of HMI & FLP emergency off, Control ON/OFF switch. All are
enclosed in SS panel Box. The panel is mounted on the machine
frame.
XIV.Control Panel: Non Flame proof with M.S powder coated placed in Technical area.
XV. Material of Construction:[a] Contact Parts- SS316
[b] Non Contact Parts- SS304/M.S Cladded/cover with SS
[c] Gasket- Silicon/neoprene food grade.
XVI. Finish: Bowl- internal & External surface to have a mirror polished.
Frame: External surface to have a dull polished & internal portion are painted
with

37. Process Variables
I. Impeller Rotation Speed
II. Chopper Rotation Speed
III. Liquid Flow Rate
IV. Load of the Mixer
V. Liquid addition Method
VI. Wet-Massing Time
(subsequent of liquid addition time)

38. Product Variables
I. Amount of liquid binder
II. Characteristics of liquid binder
[a] Surface tension
[b] Viscosity
[c] Adhesiveness
III. Characteristics of the feed materials
[a] Particle size and size distribution
[b] Particle specific surface area
[c] Solubility in the liquid binder
[d] Wettability
IV. Packing properties

39. Safety Features
I. SS Railing is provided surround the platform.
II. All the moving parts of the machine are totally enclosed in SS side panel.
III. The drive side panels are interlocked with pressure switch through pneumatic limit
switch.
IV. The pneumatic limit switches provided on discharge cover, lid cover and cone mil
hopper to keep them always in close condition while the process is going on.
V. All corners rounded, to avoid accidental cuts.
VI. Proxy switch is provided near the discharge port for sensing the location of FBD bowl.
VII. The emergency stop button is provided to stop the machine in case of emergency.
VIII. The common pressure switch is provided for incoming air pressure low .

40. FAT Procedure
Factory Acceptance Test procedure shall be as follows:
After the computation of erection work of the machine, client shall be informed to
perform the Factory Acceptance Test [FAT].
Client shall perform the FAT at the manufacturer site and record all the data in the
prescribed FAT document as per the details given below:
I. Test criteria
II. Design Verification Checklist
III. Deficiency and Corrective Action Report
IV. Pre-Installation requirements
V. Final report

41. Advantage of HSMG
I. Easy to operate from PLC panel
II. Required less time for clean and easy to clean
III. Safety is adequate
IV. Standardized according to cGMP
V. Self-discharge
VI. Mixing can be performed at large scale at less time
VII. Can produce Homogenous mass and later on granules in less time.

42. Disadvantage of HSMG
I. High noise level
II. Required large space to install
III. During the process, temperature becomes high because of friction force between
granules.
IV. High in cost
V. Working height is more, so required more effort to add materials.

43. Thank You