DQ RMG
DQ RMG
DQ RMG
:
DESIGN QUALIFICATION DQ/RG001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA RAPID MIXER GRANULATOR (RMG) SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 1 of 23
DESIGN QUALIFICATION
PROTOCOL CUM REPORT
FOR
RAPID MIXER GRANULATOR (RMG)
OF
GRANULATION-I,
GENERAL BLOCK
2. OBJECTIVE 4
3. SCOPE 4
4. RESPONSIBILITY 4
6. PROJECT REQUIREMENT 9
7. EQUIPMENT DETAILS 9
9. EQUIPMENT PARAMETERS 11
13. SAFETY 20
18. RECOMMENDATION 22
19. ABBREVIATIONS 22
PREPARED BY:
DESIGNATION NAME SIGNATURE DATE
OFFICER/EXECUTIVE
(QUALITY ASSURANCE)
REVIEWED BY:
DESIGNATION NAME SIGNATURE DATE
OPERATING MANAGER
(ENGINEERING)
HEAD
(ENGINEERING)
HEAD
(PRODUCTION)
APPROVED BY:
DESIGNATION NAME SIGNATURE DATE
HEAD
(QUALITY ASSURANCE)
AUTHORISED BY:
DESIGNATION NAME SIGNATURE DATE
PLANT HEAD
2. OBJECTIVE:
3. SCOPE:
The Scope of this design qualification document is limited to design of Rapid Mixer Granulator (RMG)
as per functional requirements and as well as design specification, including its all accessories for preset
acceptance criteria at Granulation-I, General Block, Shangrila Industries (P) Ltd., Sikkim. The
equipment shall be intended in mixing and granulation of the product.
4. RESPONSIBILITY:
The validation group, comprising of a representative from each of the following department shall be
responsible for the overall compliance of this protocol cum report;
Departments Responsibilities
The RMG 600 is a machine developed for mixing as well as granulation of the desired product
(pharmaceutical bulk powders). The multi-bladed impeller is fitted close to the base of the mixing bowl
whereas the chopper is mounted on the wall of the mixing bowl. The Impeller and Chopper are of a
Dual speed motors. The RMG is designed to meet special needs of pharmaceutical granulation. This is
achieved by reducing processing time, more homogeneous mixing, uniformity of granule size and
above all maintaining improved hygiene compliant to cGMP norms.
This RMG is designed to achieve all the 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 an 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.
Bowl:
It is circular with a large diameter and flat base. The top portion of the bowl is conical in shape to
assist mixing of cohesive powders. The bowl is constructed from SS 316 material. A hub pipe which is
on bottom flat dish surrounds the drive shaft where it enters the base of the bowl, where the mechanical
seal is provided for sealing & holding the partial vacuum inside the bowl. The air cooling is provided to
mechanical seal. The beater blade which having three numbers blade of triangular shape which is
fabricated from SS 316 material. The blade is fitted on drive shaft by bolting with sleeve which is
mounted on the drive shaft. The blade is used for dry & wet mixing of powders of different products, to
prepare the tablet formulations.
Bowl Finish: Inside and outside surfaces is mirror polished.
Mechanical Seal: The single dry mechanical seal at impeller end is provided to withstand the bowl for
partial vacuum.
Lid Lifting:
The hydraulic lid lifting arrangement is given on bowl for ease of opening & closing of lid. The
telescopic hydraulic cylinder is mounted on bowl & connected with lid. The cylinder is operated by
hydraulic power pack unit. The hydraulic unit is placed inside the drive frame.
Granulator:
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” shaped blades which is welded 90 degree apart from each other. The “U”
shape blade is provided with knife edge to assist breaking of lumps which forms during the wet mixing.
The granulator rotates at single speeds- 2840 RPM. The AC drive is used for varying the speed of
chopper from 284 to 2840 RPM.
The granulator head is of highly polished stainless steel and is easily removable for cleaning. The
granulator shaft where it enters the bowl is provided with mechanical seal. The air flushing/cooling is
provide to mechanical seal. The motor is provided with a removable stainless steel shroud which covers
it to meet cGMP norms.
Discharge Valve:
It is provided on the bowl bottom side of the shell. It is operated by a SS Piston connected to a
pneumatic cylinder. The hinge type cover is provided for easy opening & closing for cleaning of the
inside portion of the discharge. A safety lock in the form of a limit switch is provided at the discharge
cover to prevent the motors to start during the operation. The pneumatic cylinder is covered by a
stainless steel shroud.
Cone Mill:
The in-line cone mill is used for breaking the lump formed during wet mixing of powder into the RMG.
The cone mill is used to enhance the drying efficiency. The cone mill is in built with discharge of
RMG. So final mix material of RMG directly passed through cone mill. The cone mill blade is
triangular in shape and rotates at a speed of 2850 RPM (nom) the cone mill is provide with 10 mm dia.
Mesh.
The discharge of the cone mill is provided with a vacuum transfer chute which has a 20
Micron sintered filter for easy transfer of product into FBD. A flexible hose is provided to connect in
between FBD nd cone mill for the transfer of product.
Saizoner improved processing:
Uniform distribution of all formulation ingredients.
Short mixing and granulation time.
Useful working capacity of upto 80 % to 40% of bowl volume.
FORMAT No: F03-00/QAD 046
PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/RG001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA RAPID MIXER GRANULATOR (RMG) SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 7 of 23
AC Drive:
(A) The AC drive is used for varying the speed of the beater blade to get the uniform granules and to
control feed of the cone mill at time of discharge. Three speeds are set on the AC drive.
1. High Speed (50 Hz- Variable)
2. Low Speed (25 Hz- Variable)
3. Creep Speed (10 Hz- Factory Settable)
(B) The AC 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 AC drive.
Drive:
The gear box and motor are coupled with pulleys and belts to rotate the beater blade. On the gear box
MS Lantern is bolted on which RMG Bowl is mounted.
Frame:
The RMG Frame is fabricated from MS Square pipe. The frame legs are cladded with SS sheet on the
top of the frame SS Dimple plate is welded and safety railing is provided all around the frame. Inside
the frame Gear box, motor and pneumatic panel are mounted. All sides of the frames are coverd with
SS Panel and a safety lock in the form of a limit switch is provided on the drive side SS Panel to
prevent the motors to start if any panel is in open condition.
Blade Removing Arrangement:
The blade lifting arrangement is given to remove the blade from the bowl for cleaning or other
maintenance work. The blade lifting arrangement consists of the SS pipe, wire rope & gear motor. The
SS swivel pipe is mounted on the machine frame and wire rope is passed through the pipe for lifting the
blade. On one end of the rope, lifting hook if fitted & other end of the rope is fitted with rope drum
which is fitted with gear box shaft. To rotate the drum Gear box is coupled with motor by which blade
is lifted up & down for removing or placing it into the bowl.
Separator with Vacuum Pump:
The vacuum pump with separator is provided for creating the vacuum into the RMG bowl for charging
the material by vacuum from existing drum. The separator is fabricated from SS 304 plate. The outside
& inside portion of the separator is dull polished. The vacuum pump & separator are mounted on skid
and placed in the technical area.
6. PROJECT REQUIREMENT:
The project for set up of Rapid Mixer Granulator based on product, safety, regulatory and cGMP
requirements and to prevent cross contamination in product. The Rapid Mixer Granulator is equipment
used for mixing and granulation of the product.
7. EQUIPMENT DETAILS:
Equipment Name Rapid Mixer Granulator (RMG)-600 Ltr.
Equipment ID SP/PRD/17/RG001
Manufacturer’s Name Tapasya Engineering Works Pvt. Ltd., Thane
Supplier’s Name Tapasya Engineering Works Pvt. Ltd., Thane
Location of Installation Granulation-I, First Floor, General Block
12. Direction of Rotation for Chopper clockwise (from chopper blade side)
13. Main Motor 50 HP, 415 V, 50 HZ, NFLP
14. Drive Gearbox Ratio - 10:1, Type – Upward shaft
15. Chopper Motor 7.5 HP, 415 V, 50 HZ, NFLP
16. Cone mill motor 5 HP, 415 V, 50 HZ, NFLP
17. Nozzles a. Charging hole-200 dia
b. Vent- 200 dia. Tri-clover with 10# sintered filter
with valve
c. Discharge- 200 dia. Pneumatically Operated
d. View Port- 200 dia. With cover
e. WIP nozzle-150 dia. Tri-clover with spray ball &
spray nozzle
f. Vacuum charging port-100 dia. TC with pipe &
elbow & pneumatic valve.
18. Electrical Non flame proof
19. Drive Specification Motor and gear box are connected with pulley and belts
20. Connectivity Discharge- FBD bowl below the discharge port or
direct transfer into FBD by connecting flexible pipe
between RMG discharge and FBD charge port
charging- by vacuum
21. Mechanical seal For beater & chopper, make-eagle burgmann/SEAL
WELL or equivalent
22. Operating Panel Consist of MMI & emergency off, control ON/OFF
switch. All are enclosed in SS panel Box. The panel is
mounted on the machine frame.
23. Control Panel Non Flameproof placed in Technical area.
24. Separator Placed in the technical area along with the vacuum
pump assemble
Design pressure – Full vacuum
Operating pressure – 300 mm of Hg.
25. Machine Dimensions (in mm) - 3506 (L)×2060 (W)×3395 (H)
Approx
9. EQUIPMENT PARAMETERS:
Sl. No. Description Details
1. Name Rapid Mixer Granulator (RMG)-600 Ltr.
2. Make Tapasya Engineering Works Pvt. Ltd., Thane
3. Model TAP- HSMG 600 - NFLP
4. Filled Volume 655 Ltr.
5. Capacity 600 Ltr.
6. Net Weight (in kg.) – Approx. 4500 kg Approx.
7. Impeller Speed 105 RPM ±10% Variable from 10 to 105 RPM
8. Chopper Speed 2880 RPM ±10%Variable from 288 to 2880 RPM
9. Cone Mill Speed 2850 RPM ± 10%
10. Lid Lifting Mechanism Automatic
11. Cone Mill Sieve 10 mm dia. Sieve is supplied with machine
Power Consumption
1. Electricity 3 Phase, 415 Volts, 50 Hz. Cycles, Earth + Neutral
Control Volts: 110 V, 3 Phases, 50 Cycles
Control: PLC based
AC Drive: Yes (Main & Chopper Motor)
Make Festo
Model PEV-1/4-B
Location On Pneumatic plate
Purpose For main air supply
19. Vacuum Pump
Make Rotovac
Model RSVP-160
Location In technical area
Purpose For crating vacuum inside the bowl
20. Peristaltic Pump
Make Flow Tech
Model FP-05
Flow Rate 22LPM (For Water)
Location Near the machine
Purpose For supply binder solution into the bowl
21. A.C. Drive
Make Allen Bradley/ Siemens
Model 7.5 HP
Location Control Panel
Purpose Chopper motor VFD
22. A.C. Drive
Make Allen Bradley/ Siemens
Model 50 HP
Type Power Flex 753
Location Control Panel
13. SAFETY:
Sl. No. Safety feature Specified function
1. Bowl Top Lid Interlock For Operator Safety
2. Discharge Port Interlock For Safety of the operator, batch & the process
3. Hardware Emergency switch at Operator For Operator Safety.
Console
4. Password protection at operator To assign specific controls to the operator,
interface supervisor and Manager.
5. The drive side panels are interlocked For Safety of the operator, batch & the process
with pressure switch through pneumatic
limit switch
6. The common pressure switch is For Equipment safety
provided for incoming air pressure low.
7. All moving Parts of the machine are For operator safety & Batch Safety
totally enclosed
8. Emergency Stop Button For Operator Safety & Batch Safety
9. All corners rounded For Operator Safety
10. SS Railing provided surround the For Operator Safety
plateform
18. RECOMMENDATION:
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19. ABBREVIATIONS:
SS : Stainless Steel
QA : Quality Assurance
GA : General Arrangement
FORMAT No: F03-00/QAD 046
PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/RG001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA RAPID MIXER GRANULATOR (RMG) SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 22 of 23
PREPARED BY:
DESIGNATION NAME SIGNATURE DATE
OFFICER/EXECUTIVE
(QUALITY ASSURANCE)
REVIEWED BY:
DESIGNATION NAME SIGNATURE DATE
OPERATING MANAGER
(ENGINEERING)
HEAD
(ENGINEERING)
HEAD
(PRODUCTION)
APPROVED BY:
DESIGNATION NAME SIGNATURE DATE
HEAD
(QUALITY ASSURANCE)
AUTHORISED BY:
DESIGNATION NAME SIGNATURE DATE
PLANT HEAD