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Pharmaceutical Guidelines

INSTALLATION QUALIFICATION

RAPID MIXER GRANULATOR (150 Liters)


Document No: PG/IQ/001 Page no 1 of 17

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

RAPID MIXER GRANULATOR (150 Liters)


Document No: PG/IQ/001 Page no 2 of 17

TABLE OF CONTENTS
Sr. No. Content Page No.

1.0 Pre Approval 3


2.0 Purpose 4
3.0 Scope 4
4.0 Reference 4
5.0 Study of Qualification 4
6.0 Responsibility 5
7.0 Documentation 5
8.0 Machine Description 6
9.0 Procedure 6
10.0 Acceptance Criteria 6
11.0 Installation Qualification Report 7
11.1 Equipment Description and Identification 7
11.2 List of Drawing 7
11.3 List of Reference Documents 7
11.4 List of Test Certifications 7
11.5 List of Spares 8
12.0 Major Installation Verification Checklist 8
12.1 Basic Installation Specification 8
12.2 Material Quality and Surface Processing 9
12.3 Utilities 9
13.0 Main Constitution Check 9
13.1 Bowl Check 9
13.2 Stand Check 10
13.3 Impeller Check 11
13.4 Droving Unit Check 11
13.5 Railing and Ladder Check 12
13.6 Electrical Controller Constitution Check 13
13.7 Material of Construction 14
13.8 Safety Features Verification Check 14
13.9 Utilities Inspection Record 14
13.10 Verification of Environmental Conditions 14
13.11 Identification of SOPs/ PMP 15
13.12 Installation Verification 15
14.0 Summary of Installation Qualification 15
15.0 Post Approval 17

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Document No: PG/IQ/001 Page no 3 of 17

1.0 PRE-APPROVAL:

Prepared by Designation Signature Date

Reviewed By Designation Signature Date

HOD Production

HOD Engineering

Executive Quality
Assurance

Unit Head

Approved By Designation Signature Date

HOD Quality
Assurance

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Document No: PG/IQ/001 Page no 4 of 17

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.

3.1 INTENDED USE: For uniform mixing of powder.

3.2 LOCATION: ABC Pharmaceuticals Ltd. at Location.

4.0 REFERENCE: Operating Instruction Manual for Rapid Mixer Granulator RMG 150.

4.1 ATTACHMENTS: Purchase order and drawing

5.0 STUDIES FOR QUALIFICATION:


Design Qualification: To design, engineer, and supply the Rapid Mixer Granulator RMG 150
as per cGMP and cGEP and to provide assurance that the machine is manufactured as per
the URS and it complies with the Scope of Supply.

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

Operation Qualification: To measure the dimension wherever possible.


To ensure that all the instruments if any associated with the machine are calibrated before
operation qualification.

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INSTALLATION QUALIFICATION

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Document No: PG/IQ/001 Page no 5 of 17

Performance Qualification: To operate the machine as per proposed procedure.


To challenge the operating parameters associated with the machine.
To challenge the safety features associated with the machine.

6.0 RESPONSIBILITY:

6.1 Pharmacist/ Officer Production and Engineering:


1. Carry out the activity as per protocol

2. Compile the results

3. Prepare summary report


6.2 HOD Production, HOD Engineering and General Manager:
Review the results
6.3 HOD- QA & QC
Conclude and approve the results

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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8.0 MACHINE DESCRIPTION:


The Rapid Mixer Granulator is a high shear machine, developed for mixing as well as
granulation. The multibladed dual speed impeller & chopper performs the mixing and breaking
of materials. The granulating solution is gently distributed in the base material as it is added.

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:

1. Fill the equipment description and identification.


2. List the equipment master files.
3. Check the installation of the major components and enter the details in major
components installation verification checklist.
4. Check the material of construction of contact parts and enter the details in Material of
construction verification record.
5. Check the safety features for proper installation and enter the details in safety
Features verification record.
6. Check the utilities connected and enter the details in utilities inspection record.
7. Verification of Environmental conditions
8. Identify the standard operating procedures / preventive maintenance procedures
required.
9. Fill the installation verification checklist.

10.0: ACCEPTANCE CRITERIA:


The Rapid Mixer Granulator should be installed as per the specifications given by the
manufacturer.

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Document No: PG/IQ/001 Page no 7 of 17

11.0 INSTALLATION QUALIFICATION REPORT:


11.1 EQUIPMENT DESCRIPTION AND IDENTIFICATION:
Equipment description
Name and address of Manufacturer
/ Supplier
Equipment model number
Equipment serial number
Purchase order number and date
Location of equipment
Date received
Date installed

11.2 LIST OF DRAWING:


Sr. No. Title Drawing Number Checked By

11.3 LIST OF REFERENCE DOCUMENTS:


Sr. No. Name Checked By

11.4 LIST OF TEST CERTIFICATES:


Sr. No. Description of Test Certificate Certificate Number Checked By

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Document No: PG/IQ/001 Page no 8 of 17

11.5 LIST OF SPARES:

Sr. No. Description of The Part Quantity Checked By

12.0 MAJOR INSTALLATION VERIFICATION CHECKLIST:


12.1 BASIC INSTALLATION SPECIFICATION:
Check the basic installation specification that is required in installation of RMG –150 liter

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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Document No: PG/IQ/001 Page no 9 of 17

12.2 MATERIAL QUALITY AND SURFACE PROCESSING:


1. Check the quality of material used in the equipment that is in direct contact with the product
(i.e. powder)
2. Check all steel pipes and plates
3. Check all the welding seams
4. Check the absence of weep holes

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

13.0 MAIN CONSTITUTION CHECK:


13.1 BOWL CHECK:
1. Check the dimension and orientation of the bowl for Rapid Mixer Granulator.
2. Check the finish of the bowl from inside and outside.
3. Check for unevenness, dents or marks on all the surfaces of the bowl.
4. Check the conditions of the gaskets used with the bowl of the equipment.
5. Check the operation of bowl top lid.

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INSTALLATION QUALIFICATION

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Document No: PG/IQ/001 Page no 10 of 17

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

13.2 STAND CHECK:


1. Check the weld seams on the stand
2. Check the cladding on the external surfaces of the stand
3. Check the coating of the MS parts
4. Check the straightness of the platform
5. Check for burrs or sharp edges on all the edges of the stand

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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Document No: PG/IQ/001 Page no 11 of 17

6 Stand MS with epoxy painted and


side panel covering of SS
304. Top plate cladded
with SS checkered plate

13.3 IMPELLER AND CHOPPER CHECK:


1. Check the geometry of the impeller and chopper blades
2. Check the finishing of the impeller blades & chopper blades
3. Check the clearance of the impeller blades with the bowl
4. Check the locking of the chopper blades on the chopper blades.
5. Check for the burrs on the impeller blades & chopper blades
6. Check the alignment of the blades with the drive.

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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Document No: PG/IQ/001 Page no 12 of 17

13.4 DRIVING UNIT CHECK:


1. Check the alignment of the driving units
2. Check the driving shaft and output shaft for corrosion.
3. Check the specification of the drive and driven pulley.
4. Check the specification of the main (impeller) motor
5. Check specification of the gearbox used with the impeller motor
6. Check specification of the chopper motor

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

13.5 RAILING AND LADDER CHECK:


1. Check the weld seams on the pipes of the railing
2. Check the fixation of the railing and the ladder onto the stand.
3. Check the steps of the ladder for straightness and uniformity.

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Document No: PG/IQ/001 Page no 13 of 17

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.

13.6 ELECTRICAL CONTROLLER CONSTITUENT CHECK:


Check the specification & quantity of each electrical controller part & their connection.
CRITERION
Each controller part should be in accordance with specification and their connection as per
approved wiring design.

Sr. Supplier/ Checked


Item Specification Qty. Observation
No. Make By/Date
1. PLC FX1n-24MT 1 Mitsubishi
2. MCB 63 A, 3 pole 1 Merlin
16 A, 3 pole 1 Gerin
6 A, 2 pole 1
4. Contactor 3TF34 3 Siemens
3TF30 3
3TF46 1
5. Current 50/5 1 Prices
transformer 30/5 1
6. SMPS 24 V, 2.5 1 Shavison
amp Electronics
7. Current 4 – 20 mA 2 Rishabh
transducer Electricals
8. Over load 16 – 25 A 1 Siemens
relay 12.5 – 20 A 1
3.2 – 5 A 1
2.5 – 4 A 1
9. Relay card 8 – way 1 Shavison
10. HMI E300 1 Beijer

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Document No: PG/IQ/001 Page no 14 of 17

13.7 MATERIAL OF CONSTRUCTION (Contact Parts):


Sr. Checked
Description Specified Observation
No. By /Date
1 Mixing Bowl SS 316
2 Bowl Lid SS 316
3 Impeller SS 316
4 Chopper SS 316
5 Discharge Port SS 316
6 Flanges SS 316
7 Platform MS with SS cladding
8 Ladder MS with SS cladding

13.8 SAFETY FEATURES VERIFICATION RECORD:


Sr. Checked
Description Of Safety Feature Observation
No. By /Date
Proximity sensors for Bowl Lid and
1
Discharge Port cylinder
2 Emergency Stop
3 Impeller Motor Overload Relay
4 Chopper Motor Overload Relay
5 Pressure switch for low air pressure

13.9 UTILITIES INSPECTION RECORD:


Sr. Checked
Description Observation
No. By /Date
1 Electrical
Source JKSEB/Generator
Volts 415V+ 10%
Frequency 50Hz+ 2%
Phase 3 phase
2 Compressed Air
Source Air compressor.
Quality of Air Dry air.
Air Pressure 7 Kg/Cm2
Location Granulation - II

13.10 VERIFICATION OF ENVIRONMENTAL CONDITIONS:


Test Calibration Calibration Checked
Sr. Acceptable
Parameter Instrument done on due on By /Date
No. limit
& I.D. No.
1 Temperature 15°C-25°C
2 Relative NMT 60 %
Humidity RH

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Document No: PG/IQ/001 Page no 15 of 17

13.11 IDENTIFICATION OF STANDARD OPERATING PROCEDURES/PREVENTIVE


MAINTENANCE PROCEDURE:
Sr.
Description / Title Document No.
No.

13.12 INSTALLATION VERIFICATION:


Sr. Checked
Description Observation
No. By /Date
Equipment is installed as manufacturers
1
recommendations
2 Earthing is connected properly.
3 Sufficient room for servicing provided.
4 All utilities are connected properly.
0.2 micron filter installed in compressed
5
air line for purging.
Proximity sensors for rpm measurement
6
are installed properly.

14.0 LIST OF ABBREVATIONS:


cGMP Current Good Manufacturing Practices
cGEP Current Good Engineering Practices
MS Mild steel
NON-FLP Non Flame Proof
SS Stainless Steel
K.W. Kilo Watt
DQ Design Qualification
RPM Revolution Per minute
URS Users Requirement Specifications
FAT Factory Acceptance Test
NOM Nominal speed of motor

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Document No: PG/IQ/001 Page no 16 of 17

14.0 SUMMARY OF INSTALLATION QUALIFICATION:


14.1 OBSERVED DEVIATION:

14.2 RECOMMENDATIONS:

14.3 CONCLUSION:

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Document No: PG/IQ/001 Page no 17 of 17

15.0 POST APPROVAL:

Reviewed By Designation Signature Date

HOD Engineering

HOD Production

Executive Quality
Assurance

Unit Head

Approved By Designation Signature Date

HOD Quality
Assurance

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