Iq RMG001

PHARM PROTOCOL NO.
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INSTALLATION QUALIFICATION IQ/RG001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
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HANGRILA RAPID MIXER GRANULATOR (RMG) SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 1 of 30
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
RAPID MIXER GRANULATOR (RMG)
OF
GRANULATION
EQUIPMENT/INSTRUMENT ID. NO. CUC/PD/RMG/01

LOCATION GRANULATION
DATE OF QUALIFICATION
SUPERSEDES PROTOCOL NO. NIL
PROTOCOL CUM REPORT CONTENT
SL. TITLE PAGE NO.

NO.
FORMAT No: F04-00/QAD 046
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01 PROTOCOL CUM REPORT PRE APPROVAL 3
02 OBJECTIVE 4
03 SCOPE 4
04 RESPONSIBILITY 4
05 VALIDATION TEAM SIGNATURE 5
06 EQUIPMENT DETAILS 5
07 SYSTEM DESCRIPTION 6
08 PRE-QUALIFICATION REQUIREMENT 10
09 CRITICAL VARIABLES TO BE MET 10
10 REFERENCES 27
11 DOCUMENT TO BE ATTACHED 27
12 DEVIATION FROM PRE DEFINED SPECIFICATION, IF ANY 27
13 CHANGE CONTROL, IF ANY 27
14 REVIEW (INCLUSIVE OF FOLLOW UP ACTION, IF ANY) 27
15 CONCLUSION 28
16 RECOMMENDATION 28
17 ABBREVIATIONS 28
18 PROTOCOL CUM REPORT POST APPROVAL 30
1. PROTOCOL CUM REPORT PRE APPROVAL:
PREPARED BY:
DESIGNATION NAME SIGNATURE DATE

OFFICER/EXECUTIVE
(QUALITY ASSURANCE)

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REVIEWED BY:

OPERATING MANAGER
(ENGINEERING)
HEAD
(ENGINEERING)
HEAD
(PRODUCTION)
APPROVED BY:

HEAD
(QUALITY ASSURANCE)
AUTHORISED BY:

PLANT HEAD
2. OBJECTIVE:
The objectives of this Installation qualification protocol are as follows;
 To verify that the equipment installed in accordance with the design and user requirements as defined
by set acceptance criteria and complies with relevant cGMP requirements.
 To confirm the suitability of the Standard Operating Procedures for all routine activities associated
with the system.

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 Following execution of the protocol cum report will be written and approved. All results, conclusions
and variances will be addressed and final disposition of the equipment will be stated. Successful
completion of this protocol cum report and approval of the same will verify that the Rapid Mixer
Granulator (RMG) System meets all the acceptance criteria and is ready for OQ.
3. SCOPE:
The Scope of this Installation qualification document is limited to verify Installation of Rapid Mixer
Granulator (RMG) (ID No.: CUC/PD/RMG/01) as per preset acceptance criteria at Granulation,
Cuckos Pharmaceutical Pvt. Ltd., Sampla. 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
Manufacturer  To provide the complete technical details & installed the equipment
pertaining to its operational functions.
 To perform the IQ
Quality Assurance  Preparation, review and approval of the installation qualification protocol
cum report.
 To verify the installation and document all the critical aspects of
Process/Product, cGMP and Regulatory guidelines with the help of party.
Production  Review of protocol cum report and verify the installation.
Engineering  Reviewof protocol cum report and verify the installation.
 Co-ordination and technical support in qualification activity.
5. VALIDATION TEAM SIGNATURE:
Sl. Participants Name Designation Employee Code Dept. Participants
No. Signature

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6. EQUIPMENT DETAILS:
Equipment Name Rapid Mixer Granulator (RMG)-250Ltr.
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
7. SYSTEM DESCRIPTION:
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.
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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.
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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 thedischarge
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.
 Uniform granules by gentle processing.
 Wide range of applications.
 Easy scale up & scale down between machine sizes.
 Bowl shape design to have no dead spaces.
Electricals:

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Saizoner Mixer Granulator is offered in Non-flame Proof constructions. The machine has two panels.
Main Panel: made out of MS Powder coated casing, housing the main contactors, overload relays,
MCB'S and the various other control instrumentations. The main panel is located in technical area.
Operating Panel: the panel is air purged and made in SS 304. The machine is programmable logic
control base. The panel is consists of MMI & emergency button, control ON/OFF switch. The PLC is
has a printer port to connect the printer.
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 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.
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
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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.
8. PRE-QUALIFICATION REQUIREMENT:
8.1. Pre requisite:
Sl. No. Document Name Yes / No Checked By Verified By QA
1. Availability of DQ
2. All drawings are available
3.Location of the equipment &
installation is as per design
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4. Purchase order is available
5. User Manual is available
6. Master Instrument
Calibration Certificate
Inferences:
……………………………………………………………………………………………………………
…………………………………………………………………….……………………………
Reviewed By:
(QA)
Sign & Date………………
9. CRITICAL VARIABLES TO BE MET:

9.1. Pre-Installation Checks:
Sl. Check Point Observation
No.
1. Check for the availability of required power supply for the
machine
2. Check for all the utilities are connected or made available
up to the machine location
3. Check for any foundation / Bolting requirement with
respect of machine
4. There should be enough space around the components for
operation & Maintenance.
5. The connection shall be in such a way that there should
not be any leaks and the drain end to be connected to a
main line.
6. Check the wiring of control panel & operating panel as
per wiring diagram before starting the machine
7. Check all respective wires for ferrules of their
identification & proper looping.
8. Check for body earthing connectivity arrangement
9. Check for the motor directional connectivity required

Clockwise / Anti clockwise
10. Check for any abnormal Noise while machine run on trial
Checked By: Verified By:

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(Engineering) (QA)
Sign & Date…………………. Sign & Date……………
9.2. Preliminary Check List – Overall Condition:
Sl. Checks to be performed Observation Remarks

No.
1. Check for actual Dimensions with the
site conditions for installation
2. Check for the receipt of the
consignment with reference to the
packing list
3. Unpack the equipment as per the
instructions given in IOM
4. Check for the horizontal leveling and
proper positioning of the equipment
5. Check for scratches or any physical
damage on the machine body
6. Check for the Control Panel and
Operating Panel for any scratches on
the body.

(Engineering) (QA)
9.3. Component Location List& Condition:

Sl. Component Location Observation Remarks
No.
Mechanical
1. Working platform Top of the Main Stand
2. Bowl with top lid Fitted on Working
platform, on the RHS
3. Charging lid Bowl top lid
4. Staircase with safety Fitted on Main stand,
railing on the LHS
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5. Impeller Assembled with Main

Drive, enclosed inside
Bowl
6. Chopper blade Assembled with
Chopper drive,
enclosed inside bowl
7. Quick acting clamps Fitted with Bowl,
locked with Bowl top
lid during operation
8. Discharge port assembly Fitted with Bowl
9. Gear Box for Drive Motor Bottom cabinet of the
machine
10. Full gear Coupling for Bottom cabinet of the
Main Drive machine, fitted with
Main Drive assembly
11. Pulley for Main Motor Bottom cabinet of the
machine, fitted to Main
motor drive shaft
12. Pulley for Drive Gearbox Bottom cabinet of the
machine, fitted to
Gearbox drive shaft
13. O-rings for the discharge Discharge Port
gate. assembly
14. V-belts Bottom Cabinet of the
machine, wound
around the motor
pulley and gearbox
pulley
15. Gasket for Top Lid Sealing groove of the
Top lid
16. Gasket for Charging Lid Sealing groove of the
Charging lid
17. Gasket for Bowl Outer periphery of the
bowl, at the bottom
portion
18. Vent Filter bag Inside SS cover, on the
Bowl Top Lid
Electrical
1. Main Motor Bottom cabinet of the
machine
2. Chopper Motor Attached to Chopper
bearing housing fitted
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to main Bowl
3. MCB for Main Motor Inside Electrical
Control Panel.
4. MCB for Chopper Motor Inside Electrical
Control Panel.
5. MCB for Control Circuit Inside Electrical
Control Panel.
6. VFD for Main Motor Inside Electrical
Control Panel.
7. VFD for chopper motor Inside Electrical
Control Panel.
8. SMPS Inside Electrical
Control Panel.
9. Current Transformers Inside Electrical
Control Panel.
10. Current Transducers Inside Electrical
Control Panel.
11. PLC Inside Electrical
Control Panel.
12. HMI Operating Panel
13. Relay Card Inside Electrical
Control Panel.
14. Proximity Sensor for Discharge Port
Discharge port
15. Proximity Sensor for Top Main Bowl
Lid
16. Exhaust Fan Inside Electrical
Control Panel.
17. R-Y-B Phase indicating Electrical Control
lamps Panel, mounted from
outside
18. Emergency Stop Push Operating Panel
Button
19. Selector Switch Operating Panel
Pneumatic
1. FRL Unit Electrical Control
Panel, mounted from
outside
2. Pressure Switch for Main Electrical Control
air pressure Panel, mounted from
outside

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3. Solenoid Valve - Single Electrical Control

Acting Panel.
4. Solenoid Valve - Double Electrical Control
Acting Panel.
5. Solenoid Coils Inside Electrical
Control Panel.
6. Silencers Electrical Control
Panel, mounted from
outside
7. Cylinder for Discharge Discharge Port
Operation

(Engineering) (QA)
9.4. Technical Specification/Key Design Features:
Sl. No. Description Details Observation Remarks

1. Name Rapid Mixer Granulator
(RMG)-600Ltr.
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.)
4500 kg Approx.
– 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. Working Capacity 480 liter (Maximum)
(in liters) (240 kg @0.5 BD)

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180 liter (Minimum)

(90 kg @0.5 BD)
10. Output (in kg.) Depending on the BD of
the product
11. Type Fully Automatic with
PLC and HMI
12. Concept for usage Integration of dry
blending and wet
granulation process into
one-step mixing and
granulation
13. Surface Finish- Bowl (Inside)- Mirror
Bowl Polished
14. Bowl (Outside)- Mirror
Polished
15. Surface Finish- External surface to have
Frame a dull polished &
internal portion are
painted with epoxy
paints.
16. Mode of machine Manually
cleaning
17. Component for 3 blade (triangular type)
mixing ingredients Impeller
18. Component for
4 blade Chopper
granulation
19. Direction of Anti-Clockwise (from
Rotation for top)
Impeller
20. Direction of clockwise (from chopper
Rotation for blade side)
Chopper
21. Main Motor 50 HP, 415 V, 50 HZ,
NFLP
22. Drive Gearbox Ratio - 10:1, Type –
Upward shaft
23. Chopper Motor 7.5 HP, 415 V, 50 HZ,
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NFLP
24. Cone mill motor 5 HP, 415 V, 50 HZ,
NFLP
25. 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.
26. Gear Box
Make Premium energy
Type Worm & worm wheel
Specification V-1000, Ratio-10/1
27. Main Motor
Make Crompton
HP 50 HP
RPM 1475 (NOM)±10%
FLP/ Non FLP NFLP
Mounting Foot Mounted
Phase 3 Phase
Voltage 415 V

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Frequency 50 Hz
28. RTD sensor
Type PT 100
Make Apcon
29. Current Transducer
Make Canopus
30. Proxy Switch
Make Laptron
31. Filter Regulator
Type LFR ¼ D Mini
make Festo
32. Steam Actuated By
Type V-3-1/4-B
Make Festo
33. Solenoid Valve
Type JMFH-3-1/4
MFH-3-1/4
Make Festo
34. Pneumatic Actuator for vacuum nozzle
Type DFPB-60-090-S4
Make Festo
35. Pneumatic Actuator for Vent Assembly
Type DFPB-40-090-S3-F05
Make Festo
36. Pulley
Make Fenner
Specification 350 PCD, “C” section, 6-
groove
37. Vent Housing
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Size 200 X 557

Make KPC
38. Spray Ball & Nozzle
Make Spraytech
Sieve
39. Size 336 mmOD x 299 mm ID
x 174 mm Ht x 10 Dia
Hole
Make Tapasya
40. Chopper mechanical Seal
Dia 50 mm
Make Eagle Burgmann
41. Pulley
Make Fenner
Specification 250 PCD, “C” section,
6-groove
42. “V” Belt
Make Fenner
Specification “C” section
Location On Pulley of motor &
gear Box
Purpose For power transmission
43. Cone Mill Motor
Make Crompton
HP 5 HP
RPM 2850 (NOM)
FLP/ Non FLP NFLP
Mounting Foot Mounted
Phase 3 Phase
Voltage 415 V
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Frequency 50 Hz
44. Chopper Motor
Make Crompton
HP 7.5 HP
RPM 2880 (NOM)
FLP/ Non FLP NFLP
Mounting Flange Mounted
Phase 3 Phase
Voltage 415 V
Frequency 50 Hz
45. Hydraulic power pack unit
Make Indo Hydraulic
HP 1.5 HP
LPM 5 LPM
Type Double station, 70 Bar
Tank Capacity 30 L
46. Motor For Hydraulic Unit
Make Crompton
HP 1.5 HP
RPM 1440 (NOM)
FLP/ Non FLP NFLP
Phase 3 Phase
Voltage 415 V
Frequency 50Hz
47. Hydraulic Cylinder
Make Indo Hydraulic

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MOC SS 304
Specification 165 & 160 MM Stroke
Piston 85 & 48 MM
Type Both End Clevis
Pressure 70 BAR
48. Hydraulic hose Pipe
Make Shanti Industries / Yash
Industries
MOC Rubber
Size 3/8” BSP
Type Both Side swivel nut,
SAE 100
49. Hydraulic hose Pipe
Make Shanti Industries / Yash
Industries
MOC S.S Wire Braided
Size 3/8” BSP
Type Both Side swivel nut,
SAE 100
Blade Removing Gear Box
50. Make Bonfiglioli
Type Worm & Worm Wheel,
Hollow shaft
Specification W-63, Ratio-100/1
Blade Removing Main Motor
51. Make Crompton/Bonfiglioli
HP 0.5 HP
RPM 1440 (NOM)
FLP/ Non FLP NFLP
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Phase 3 Phase
Voltage 415 V
Frequency 50Hz
52. Discharge Cylinder
Make Festo
Model DNC-80-350-PPV-A
Type Flange Mounted
Pressure Gauge
Make Festo
Model FMA-63-10-1/4
Type Panel Mounted
Range 0-10 kg/sq cm
53. Filter Regulator
Make Festo
Model 1/4-D- MINI
54. Pressure Switch
Make Festo
Model PEV-1/4-B
55. Vacuum Pump
Make Rotovac
Model RSVP-160
Peristaltic Pump
56. Make Flow Tech
Model FP-05
Flow Rate 22LPM (For Water)

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57. A.C. Drive

Make Allen Bradley/ Siemens
Model 7.5 HP
58. A.C. Drive
Make Allen Bradley/ Siemens
Model 50 HP
Type Power Flex 753
59. HMI
Make Allen Bradley
Type Panel view-700
60. PLC
Make Allen Bradley
Type Micrologix-1400

(Engineering) (QA)
9.5. Material of Construction (MOC):

Sl. Name of Parts MOC Observation Checked By
No. Engineering
1. Bowl SS 616
2. Top Cover SS 316
3. Beater Blade SS 316
4. Chopper Blade SS 316
5. Frame MS with SS Cladded &

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Covered
6. Gasket Silicon Food Grade
7. Cone Mill Main Body SS 316
8. Mill Shaft SS 316
9. Mill Blade SS 316
10. Mill Mesh SS 316
11. Bottom Dish SS 316
12. Shell SS 316
13. Top Dish SS 316
14. Cone SS 316
15. Body Flange on top SS 316
dish
16. Body Flange on cone SS 316
17. Impeller Patta SS 316
18. Impeller Flat SS 316
19. Impeller Flange SS 316
20. Impeller Cone Flange SS 316
21. Charge Cover SS 316
22. View Port Cover SS 316
23. Hub Patta SS 316
24. Hub Flange SS 316

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25. Chopper Shaft SS 316
26. Chopper Blade SS 316
27. Chopper Cone SS 316
28. Cone Bolt Rod SS 316
29. Piston Flange SS 316
30. Discharge Flange SS 316
31. Discharge Shell SS 316
32. Discharge Pipe SS 316
33. Discharge Cover SS 316
34. Discharge Flange SS 316
35. Comill Shell SS 316
36. Comill Shaft SS 316
37. Comill Blade SS 316
38. Comill Hopper Flange SS 316
39. Non-Contact Parts SS 304
40. Gasket Silicon Food Grade

(Production) (QA)
9.6. Visual Inspection Report:

Sl. No. Specified Acceptable [Yes/No] Verified By
QA

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1. Installation of RMGis completed
2. RMG is clean
3. All instrument/component packaging is removed
4. All instrument/ component hoses, piping, clamps, wire etc.

firmly affixed
5. All accessories are available
9.7. Checklist of All Tests and Checks:

This checklist is provided to ensure that all tests or checks required for this IQ have been executed.
Sl. No. Name of Test Acceptance Criteria met Verified By QA
(Yes / No)
1. Equipment Verification
(Preliminary checklist)
2. Verification of major
components
3. Verification of MOC certificate
4. Verification of Test certificate
5. Check for any abnormal

vibrations observed while
machine run on trial
6. Power and Utility checklist
7. Instrumentation Verification
Inferences:
……………………………………………………………………………………………………………
…………………………………………………………………….……………………………
Reviewed By:
(QA)
Sign & Date………………

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9.8. Requalification:
Installation Qualification to be requalified on:
 Replacement of major component of the equipment with a new component.
 Any major modification in the existing equipment.
 Shifting of the equipment from one location to another.
10. REFERENCES:
 Validation Master Plan
 Schedule M: Good manufacturing practices and requirements of premises, plant and equipment for
pharmaceutical and inspection.”
 WHO Essential Drugs and Medicines policy, QA of Pharmaceutical, Vol.-2 Good Manufacturing
Practices and inspection.
11. DOCUMENT TO BE ATTACHED:

 MOC certificate
 GAand Test Certificate
 Any other Relevant Document
12. DEVIATION FROM PRE DEFINED SPECIFICATION, IF ANY:

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13. CHANGE CONTROL, IF ANY:

PHARM PROTOCOL NO.:
A
ON FOR
S
ISSUE BY:
INDUSTRIES (P)
...................................................................................................................................................................
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14. REVIEW (INCLUSIVE OF FOLLOW UP ACTION, IF ANY):

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15. CONCLUSION:
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16. RECOMMENDATION:
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17. ABBREVIATIONS:
SS : Stainless Steel
QA : Quality Assurance
RPM : Revolution per Minutes
GA : General Arrangement
cGMP : Current Good Manufacturing Practices
mmwc : Mili meter of Water Column
PHARM PROTOCOL NO.:
A
ON FOR
S
ISSUE BY:
INDUSTRIES (P)
mm : Length in Millimeter
M/Mtrs : Length in Meter
DQ : Design Qualification
IQ : Installation Qualification
OQ : Operational Qualification
Sl.No. : Serial Number
V : Volt
GI : Galvanized Iron
PLC : Programmable Logic Controller
HMI : Human Machine Interface
MCB : Miniature Circuit Breaker
PID : Proportional–Integral–Derivative
mA : Milliampere
RMG : Rapid Mixer Granulator
MS : Mild Steel
FRL : Filter Regulator and Lubricator
Sq. cm : Square Centi Meter
SOP : Standard Operating Procedure
MOC : Material of Construction
Kg : Kilogram
HP : Horse Power
FLP : Flame Proof
BD : Bulk Density
Ltr : Liter
Hz : Hertz
VFD : Variable frequency Drive

PHARM PROTOCOL NO.:
A
ON FOR
S
ISSUE BY:
INDUSTRIES (P)
18. PROTOCOL CUM REPORT POSTAPPROVAL:
PREPARED BY:

OFFICER/EXECUTIVE
(QUALITY ASSURANCE)
REVIEWED BY:

OPERATING MANAGER
(ENGINEERING)
HEAD
(ENGINEERING)
HEAD
(PRODUCTION)
APPROVED BY:

HEAD
(QUALITY ASSURANCE)
AUTHORISED BY:

PHARM PROTOCOL NO.:
A
ON FOR
S
ISSUE BY:
INDUSTRIES (P)
PLANT HEAD

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PHARM PROTOCOL NO.

EQUIPMENT/INSTRUMENT ID. NO. CUC/PD/RMG/01

PROTOCOL CUM REPORT CONTENT

SL. TITLE PAGE NO.

1. PROTOCOL CUM REPORT PRE APPROVAL:

DESIGNATION NAME SIGNATURE DATE

FORMAT No: F04-00/QAD 046

DESIGNATION NAME SIGNATURE DATE

DESIGNATION NAME SIGNATURE DATE

DESIGNATION NAME SIGNATURE DATE

FORMAT No: F04-00/QAD 046

FORMAT No: F04-00/QAD 046

FORMAT No: F04-00/QAD 046

9. CRITICAL VARIABLES TO BE MET:

9. Check for the motor directional connectivity required

Checked By: Verified By:

9.2. Preliminary Check List – Overall Condition:

Sl. Checks to be performed Observation Remarks

Checked By: Verified By:

9.3. Component Location List& Condition:

5. Impeller Assembled with Main

FORMAT No: F04-00/QAD 046

3. Solenoid Valve - Single Electrical Control

Checked By: Verified By:

9.4. Technical Specification/Key Design Features:

Sl. No. Description Details Observation Remarks

FORMAT No: F04-00/QAD 046

180 liter (Minimum)

FORMAT No: F04-00/QAD 046

Size 200 X 557

FORMAT No: F04-00/QAD 046

FORMAT No: F04-00/QAD 046

57. A.C. Drive

Checked By: Verified By:

9.5. Material of Construction (MOC):

2. Top Cover SS 316

3. Beater Blade SS 316

4. Chopper Blade SS 316

5. Frame MS with SS Cladded &

FORMAT No: F04-00/QAD 046

6. Gasket Silicon Food Grade

7. Cone Mill Main Body SS 316

8. Mill Shaft SS 316

9. Mill Blade SS 316

10. Mill Mesh SS 316

11. Bottom Dish SS 316

12. Shell SS 316

13. Top Dish SS 316

14. Cone SS 316

15. Body Flange on top SS 316

17. Impeller Patta SS 316

18. Impeller Flat SS 316

19. Impeller Flange SS 316

20. Impeller Cone Flange SS 316

21. Charge Cover SS 316

22. View Port Cover SS 316

23. Hub Patta SS 316

24. Hub Flange SS 316

FORMAT No: F04-00/QAD 046