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INSTALLATION QUALIFICATION
Pharmaceutical Guidelines
Installation Qualification
Equipment: Rapid Mixer Granulator
Equipment ID: PG/MFG/EQ/001
Document No: PG/IQ/001
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Pharmaceutical Guidelines
INSTALLATION QUALIFICATION
TABLE OF CONTENTS
Sr. No. Content Page No.
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Pharmaceutical Guidelines
INSTALLATION QUALIFICATION
1.0 PRE-APPROVAL:
HOD Production
HOD Engineering
Executive Quality
Assurance
Unit Head
HOD Quality
Assurance
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Pharmaceutical Guidelines
INSTALLATION QUALIFICATION
2.0 PURPOSE: To ensure that the Rapid Mixer Granulator is installed as per the
specifications given by the manufacturer and also meets the design criteria.
3.0 SCOPE: This protocol is applicable for installation of the Rapid Mixer Granulator. The
Installation Qualification is an essential part of GMP documentation and serves as a base
document for the validation activity.
4.0 REFERENCE: Operating Instruction Manual for Rapid Mixer Granulator RMG 150.
This is a validation document for the machine, to prove that each operation proceeds as per
the design specification prescribed there in the document.
Installation Qualification: To check that machine and accessories are supplied as per
purchase order requirement.
To check that the machine is installed at its specified location
To check that the utilities required by the machine is provided
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Pharmaceutical Guidelines
INSTALLATION QUALIFICATION
6.0 RESPONSIBILITY:
7.0 DOCUMENTATION:
All documentation work shall be completed concurrently during execution of the qualification.
However the protocol does not define the sequence of the test/ documentation to be carried
out.
1. Use indelible black ink for the recording.
2. Fill out complete information in the format provided.
3. Do not leave any blank space.
4. Correct the wrong entry by drawing single line through incorrect data, recording the correct
data and then signing and dating the change.
5. Enter “N/A” in space that is not applicable.
6. During execution of the protocol any deviation must be implemented as per defined
procedure.
7. During protocol execution, report shall be prepared with following details.
Discussion of all study in observation column
Qualification is successfully completed or not
Conclusion
Recommendation, if any.
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Pharmaceutical Guidelines
INSTALLATION QUALIFICATION
The Impeller makes the uniform mixer of materials and binder. Impeller is designed to mix by
circulating the materials from up to low and vise versa while running. The chopper set in the
centerline of the material flow has the effect of constant cutting action by which it breaks the
mass. The effect of the impeller blades is often to compact the material during discharge. So
the Lumps can be easily crumbled but the dense particles that they are composed of retain
their form.
9.0 PROCEDURE:
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Pharmaceutical Guidelines
INSTALLATION QUALIFICATION
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Pharmaceutical Guidelines
INSTALLATION QUALIFICATION
CRITERION:
Basic installation specification should be in accordance with required specification
Sr. Checked
Check Point Required Specification Observation
No. By/Date
1. Model RMG – 150 liter
2. Power source 415+10%V, 50+5 Hz
3. Impeller Motor rpm 730 / 1475
4. Impeller Motor power 10 / 15 HP
5. Chopper motor RPM 1420 / 2880
6. Chopper motor power 2 / 3 HP
7. Pneumatic pressure 4-5 kg/cm2
8. Horizontal leveling of Machine should be leveled
the equipment perfectly horizontal
9. Positioning of the Aligned vertically straight with
equipment sufficient space for
maintenance
10. Balancing of the floor Floor should be perfectly
balanced with no vibrations
11. General method of Electrical wiring should be well
electrical wiring insulated and there should be
no hanging cables. It should
be located at a safe place
protected from water seepage
and also at convenient place
for operator convenience.
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Pharmaceutical Guidelines
INSTALLATION QUALIFICATION
Sr. Checked
Item Material Finish Observation
No. By/Date
1. Bowl Should be SS 316 Product
2. Bowl top lid Should be SS 316 contact parts
should be
3. Discharge valve Should be SS 316 Mirror finish
4. Impeller blade Should be SS 316
Non-contact
5. Chopper blade Should be SS 316 parts should
be Matt finish
6. Platform Should be MS SS cladding
7. Ladder Should be MS SS cladding
8. Steel pipes & Should be cleaned
plates and corrosion free
prior usage
9. Welding seams Should be free of
cracks, pores /
holes, grind
deposits etc
12.3 UTILITIES:
Check the utilities used in the system in accordance with the specification.
CRITERION
The utilities used for the system should be in accordance with the specification.
Sr. Checked
Item Requirement Observation
No. By/Date
1. Electric power 415 V, 50 Hz
2. Compress air 4-5 kg/cm2
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INSTALLATION QUALIFICATION
Sr. Checked
Item Specification Observation
No. By/Date
1. Dimension & Should be as per the
orientation of approved drawing
the bowl
2 Bowl Material – SS 316
External surface – Matt
polish
Internal surface – Mirror
polish
3 Unevenness, Should be no dents /
dents or marks marks or unevenness of
the surface of the bowl
4 Conditions of Should be in proper and
the gaskets intact condition
5 Operation of Should be easily operate-
bowl top lid able and counter weight
provides ease in operation
Sr. Checked
Item Specification Observation
No. By/Date
1 Weld seams on Should be free from pores,
the stand holes, cracks and
corrosion
2 Cladding on the Should be cladded with SS
external
surfaces of the
stand
3 Coating of the Should be epoxy painted
MS parts to prevent it from getting
corroded
4 Straightness of Should be straight and
the platform should not bend under
weight
5 Burrs or sharp Should be free from burrs
edges on all the and sharp edges
edges of the
stand
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INSTALLATION QUALIFICATION
Sr. Checked
Item Specification Observation
No. By/Date
1 Geometry of the Should be as per the
impeller and approved drawing
chopper blades
2 Finishing of the Should be mirror polished.
impeller blades
& chopper
blades
3 Clearance of the Should be not more than
impeller blades 1.5 mm.
with the bowl
4 Locking of the Should be positively locked
chopper blades so that they do not get
on the chopper loosened during
blades operation
5 Burrs on the Should be free from burrs
impeller blades
& chopper
blades
6 Alignment of the Should be true and square
blades with the
drive
7 Impeller blades Material – SS 316
Product contact parts –
8 Chopper blades
Mirror finish.
Non contact parts – Matt
finish
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Pharmaceutical Guidelines
INSTALLATION QUALIFICATION
Sr. Checked
Item Specification Observation
No. By /Date
1 Alignment of the Should be true and
driving units square
2 Driving shaft and Should be free from
output shaft for corrosion
corrosion
3 Specification Should be 9” and the
of
the drive anddriven pulley should be
driven pulley 10” size
Type Dual speed FLP
SupplierCrompton Greaves
Impeller Specific 10/15 HP, 730/1425
4
Motor ation RPM, 415 + 10% V, 50
+ 5% Hz
Quantity 1
Type Dual speed FLP
Supplier Crompton Greaves
Chopper Specific 2/3 HP, 1450 / 2800
5
Motor ation RPM, 415 + 10% V, 50
+ 5% Hz
Quantity 1
Make Greaves Cotton Limited
Type & V 600
6 Gearbox size
Ratio 10:1
Quantity 1
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Pharmaceutical Guidelines
INSTALLATION QUALIFICATION
Sr. Checked
Item Specification Observation
No. By/Date
Weld seams on Should be free from holes,
1 the pipes of the cracks
railing
Fixation of the Should be tightly fixed
railing and the onto the stand of the RMG
2
ladder onto the
stand
The steps of the Should be uniform,
ladder for straight and ergonomically
3
straightness and convenient for the
uniformity operator to climb on it
Railing should be SS 304
Ladder should be MS,
4 Railing & Ladder steps cladded with
checkered plate and the
rest epoxy painted.
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Pharmaceutical Guidelines
INSTALLATION QUALIFICATION
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Pharmaceutical Guidelines
INSTALLATION QUALIFICATION
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Pharmaceutical Guidelines
INSTALLATION QUALIFICATION
14.2 RECOMMENDATIONS:
14.3 CONCLUSION:
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Pharmaceutical Guidelines
INSTALLATION QUALIFICATION
HOD Engineering
HOD Production
Executive Quality
Assurance
Unit Head
HOD Quality
Assurance
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