IQ Air Compressor

PHARM PROTOCOL NO.
:
INSTALLATION QUALIFICATION IQ/AC001-00
A
DIVISI PROTOCOL CUM REPORT FOR EFFECTIVE DATE:
ON AIR COMPRESSOR
SH
ISSUE BY:
ANGRILA (SP/ENG/17/AC001) SIGN& DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.:1 of 16
INSTALLATIONQUALIFICATION
PROTOCOL CUM REPORT
FOR AIR COMPRESSOR
OF
UTILITY BLOCK
EQUIPMENT/INSTRUMENT ID. NO. SP/ENG/17/AC001

LOCATION UTILITY BLOCK
DATE OF QUALIFICATION
SUPERSEDES PROTOCOL NO. NIL
FORMAT No: F04-00/QAD 046

PHARM PROTOCOL NO.:
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ISSUE BY:
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PROTOCOL CUM REPORT CONTENT
SL. TITLE PAGE NO.

NO.
01 PROTOCOL CUM REPORT PRE APPROVAL 03
02 OBJECTIVE 04
03 SCOPE 04
04 RESPONSIBILITY 04
05 VALIDATION TEAM SIGNATURE 05
06 EQUIPMENT DETAILS 05
07 SYSTEM DESCRIPTION 06
08 PRE-QUALIFICATION REQUIREMENT 06
09 CRITICAL VARIABLES TO BE MET 07
10 REEFERENCES 13
11 DOCUMENT TO BE ATTACHED 13
12 DEVIATION FROM PRE DEFINED SPECIFICATION, IF ANY 13
13 CHANGE CONTROL, IF ANY 14
14 REVIEW (INCLUSIVE OF FOLLOW UP ACTION, IF ANY) 14
15 CONCLUSION 14
16 RECOMMENDATION 14
17 ABBREVIATIONS 15
18 PROTOCOL CUM REPORT POST APPROVAL 16
1. PROTOCOL CUM REPORT PRE APPROVAL:
PREPARED BY:

PHARM PROTOCOL NO.:
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ON AIR COMPRESSOR
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ISSUE BY:
INDUSTRIES (P)
DESIGNATION NAME SIGNATURE DATE
OFFICER/EXECUTIVE
(QUALITY ASSURANCE)
REVIEWED BY:

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

HEAD
(QUALITY ASSURANCE)
AUTHORISED BY:

PLANT HEAD
2. OBJECTIVE:
The objective of this Installation Qualification protocol is:
 To verify that the equipment installed in accordance with the design and user requirements as defined
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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.
 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
Compressed Air 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 Air
compressor machine (SP/ENG/17/AC001) as per preset acceptance criteria. The equipment is to be
used to provide compressed air for manufacturing.
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.
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.
Production  Review of protocol cum report and verify the installation.
Engineering  Review of protocol cum report and verify the installation.
 Co-ordination and technical support in qualification activity.
5. VALIDATION TEAM SIGNATURE REGISTER:

Sl. Participants Name Designation Employee Code Dept. Participants
No. Signature

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Checked By:
Sign & Date
6. EQUIPMENT DETAILS:
Equipment Name Air Compressor
Model SM45-AC
Equipment ID SP/ENG/17/AC001
Manufacturer’s Name Ingersoll Rand (India) Limited
Location of Installation Ground Floor
7. SYSTEM DESCRIPTION:
Air Compressor is horizontal, Air cooled, two stage and oil free (Rotary screw type). Ambient air is
sucked by L.P. air end through suction filter and compressed. Compressed air is then discharge to H.P.
air end through intercooler and moisture separator where air is cooled down in inter cooler and
moisture is removed out in moisture separator before air enters into H.P. air end. Air is further
compressed and its pressure increased in H.P. air end. Both inter cooler is fin-blade type. Air then
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from after cooler passed through discharge line. As there is no oil in the compression chamber, the
compressed air is 100% oil free and meets Class 0 quality of air standards.
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
4. Purchase order is available
5. User Manual is available
Inferences:
……………………………………………………………………………………………………………
…………………………………………………………………….…………………………………
Reviewed By:
(QA)
Sign & Date………………
8.2. Pre Installation Check:

Sl. Test/Checks Requirements Observation Checked by Verified By
No. QA
1. Area There should be enough
space around the
components for operation
& Maintenance.
3. Drawings/ test Check all the related
Certificates drawings & test
certificates are available.
Inferences:
……………………………………………………………………………………………………………
…………………………………………………………………….…………………………………
Reviewed By:
(QA)
PHARM PROTOCOL NO.:
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ON AIR COMPRESSOR
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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. Check the wiring of control panel / operating panel as per
wiring diagram before starting the machine
5. Check for body earthing connectivity arrangement
6. Check for the motor directional connectivity required

Clockwise / Anti clockwise
7. Check for any vibrations observed while machine run on
trial
8. Check for Noise Level observed while machine run on
trial
Checked By: Verified By:

(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 manual

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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. Installation Check for Air Compressor:

Sl.No Test / Checks Requirements Observation
.
1. Air delivery Capacity 230 CFM
2. Lubricant Ultra coolant
3.
Compressor Model SM 45 - AC
4.
Capacity 605 Cu M/Min
5. Max. Discharge
8.5 Barg
Pressure
6.
Nominal Drive Motor 45SF1.25 Kw
7.
Nominal Fan Motor 4 Kw
8.
Total package AMPS 106
9.
Control Voltage 110
10. Operating pressure 8.5 Bar (g) as per ISO 1217
11.
Serial No. NAB10393349
12. Locked Motor Amp.
655
Rating of assy

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13. Suction filter Paper type filter
14. Noise level NMT 85 db. (in free field

condition)
15. Motor for compressor Capacity-45 Kw; 3 phase
motor
16. Inter cooler Air is cooled down in inter
cooler type fin-blade
17. After cooler Compressor is suited with
fin-blade type Air cooled
18. Compressor Motor
Type Induction
Electrical power 3 phase
Voltage 415 volts ± 10, 50 Hz
Connected Load 6.0 HP
Insulation Class F
Direction Clockwise
19. Blower Motor
Type 2HS1 123-0403—A00008
Electrical power 3 phase
Voltage 415 volts ± 10, 50 Hz
Connected Load 0.5 HP
RPM 1440
20. Compressed Air filter Sl. No.: 08072316
21. Coolant filter Sl. No.: 39911615

PHARM PROTOCOL NO.:
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22. Control Panel
Quantity One
Make Ingersoll Rand
Controller Sl. No.: 05211-16179-GCE

39900519
23. Microprocessor
Quantity One
Type Directional
Make ABB
Model MS 132
24. Contractors
Quantity Three
Type AX 95-30
Make ABB
25. Relay
Quantity One
Range 60-80 A
Make ABB
26. Compressed Air System
Length 2250 mm
Width 1400 mm

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Height 1900 mm
27. Refrigerated Air Dryer
Type D 100
Maximum Pressure 16 Bar
Maximum 40˚ C
Temperature
28. Air Filter
IR Part No. 22309272
Max/Min Pressure 20 bar g/290 psi g & 0 bar

g/0 psi g

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

Sl. No. Name of Parts MOC Observation
1. Support Structure MS Powder Coated
2. Control Panel Box MS Powder Coated
3. Operating Panel Box MS Powder Coated
4. Supply pipe line Made of SS 303, ¾”

(Engineering) (QA)
PHARM PROTOCOL NO.:
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ON AIR COMPRESSOR
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INDUSTRIES (P)
9.4. Visual Inspection Report:

Sl. No. Specified Acceptable [Y/N] Verified By
QA
1. Installation of Air Compressor is completed
2. Air Compressor& filters 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
9.5. 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 Test certificate
4. Power and Utility checklist
5. Instrumentation Verification
Inferences:
……………………………………………………………………………………………………………
…………………………………………………………………….…………………………………
Reviewed By:
(QA)
9.6. Requalification:
Installation Qualification to be requalified on:
 Replacement of major component of the equipment with a new component.
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 Any major modification in the existing equipment.

 Shifting of the equipment from one location to another.
10. REEFERENCES:
 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:

 Test results
 Any other Relevant Document
12. DEVIATION FROM PRE DEFINED SPECIFICATION, IF ANY:

.................................................................................................................................................................
.................................................................................................................................................................
.................................................................................................................................................................
.................................................................................................................................................................
...................
13. CHANGE CONTROL, IF ANY:

.................................................................................................................................................................
.................................................................................................................................................................
.................................................................................................................................................................
.................................................................................................................................................................
14. REVIEW (INCLUSIVE OF FOLLOW UP ACTION, IF ANY):

PHARM PROTOCOL NO.:
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…………………………………………………………………………………………………………
…...
………………………………………………………………………………………………………….
…..
……………………………………………………………………………………………………….
……..
…………………………………………………………………………………………………….
………..……………………………………………………………………………………
15. CONCLUSION:
…………………………………………………………………………………………………………
…...
………………………………………………………………………………………………………….
…..
……………………………………………………………………………………………………….
……..
…………………………………………………………………………………………………….
………..……………………………………………………………………………………
16. RECOMMENDATION:
…………………………………………………………………………………………………………
…...
………………………………………………………………………………………………………….
…..
……………………………………………………………………………………………………….
……..………………………………………………………………………………

PHARM PROTOCOL NO.:
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ON AIR COMPRESSOR
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17. ABBREVIATIONS:
SOP : Standard Operating Procedure
SS : Stainless Steal
QA :Quality Assurance
NLT :Not less than
NMT :Not More Than
Hz :Hertz
RPM :Revolution per Minutes
QA :Quality Assurance
NL : Non-Lubricating
cGMP : Current Good Manufacturing Practices
CFM : Cubic feet per minute
LP : Low Pressure
HP : High Pressure
ENG : Engineering
(P) Ltd : Private Limited
DQ : Design Qualification
IQ : Installation Qualification
kW : Kilo Watt
Kg/sq. cm : Kilogram per Centimeter Square
CFM : Cubic Feet per Minute
MS : Mild Steel
°C : Degree Celcius

PHARM PROTOCOL NO.:
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ON AIR COMPRESSOR
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ISSUE BY:
INDUSTRIES (P)
18. PROTOCOL CUM REPORT POST-APPROVAL:
PREPARED BY:

OFFICER/EXECUTIVE
(QUALITY ASSURANCE)
REVIEWED BY:

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

HEAD
(QUALITY ASSURANCE)
AUTHORISED BY:

PLANT HEAD

IQ Air Compressor

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PHARM PROTOCOL NO.

EQUIPMENT/INSTRUMENT ID. NO. SP/ENG/17/AC001

FORMAT No: F04-00/QAD 046

SL. TITLE PAGE NO.

1. PROTOCOL CUM REPORT PRE APPROVAL:

FORMAT No: F04-00/QAD 046

DESIGNATION NAME SIGNATURE DATE

DESIGNATION NAME SIGNATURE DATE

DESIGNATION NAME SIGNATURE DATE

by set acceptance criteria and complies with relevant cGMP requirements.

5. VALIDATION TEAM SIGNATURE REGISTER:

FORMAT No: F04-00/QAD 046

8.2. Pre Installation Check:

9. CRITICAL VARIABLES TO BE MET:

6. 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

FORMAT No: F04-00/QAD 046

4. Check for the horizontal leveling and

Checked By: Verified By:

9.3. Installation Check for Air Compressor:

2. Lubricant Ultra coolant

FORMAT No: F04-00/QAD 046

13. Suction filter Paper type filter

14. Noise level NMT 85 db. (in free field

Electrical power 3 phase

Voltage 415 volts ± 10, 50 Hz

Connected Load 6.0 HP

19. Blower Motor

Type 2HS1 123-0403—A00008

Electrical power 3 phase

Voltage 415 volts ± 10, 50 Hz

Connected Load 0.5 HP

20. Compressed Air filter Sl. No.: 08072316

21. Coolant filter Sl. No.: 39911615

FORMAT No: F04-00/QAD 046

22. Control Panel

Make Ingersoll Rand

Controller Sl. No.: 05211-16179-GCE

26. Compressed Air System

FORMAT No: F04-00/QAD 046

27. Refrigerated Air Dryer

Maximum Pressure 16 Bar

IR Part No. 22309272

Max/Min Pressure 20 bar g/290 psi g & 0 bar

Checked By: Verified By:

9.3. Material of Construction (MOC):

3. Operating Panel Box MS Powder Coated

4. Supply pipe line Made of SS 303, ¾”

Checked By: Verified By:

Sign & Date…………………. Sign & Date……………

9.4. Visual Inspection Report:

2. Air Compressor& filters is clean

3. All instrument/component packaging is removed

4. All instrument/ component hoses, piping, clamps, wire etc.

9.5. Checklist of all tests and checks:

 Any major modification in the existing equipment.

11. DOCUMENT TO BE ATTACHED:

12. DEVIATION FROM PRE DEFINED SPECIFICATION, IF ANY:

13. CHANGE CONTROL, IF ANY:

14. REVIEW (INCLUSIVE OF FOLLOW UP ACTION, IF ANY):

FORMAT No: F04-00/QAD 046