Installation Qualification Protocol For Walk - in Incubator System Name: Walk - in Incubator Document No.: NECPL/IQ/11220I/1 Page No.: 1 of 25

INSTALLATION QUALIFICATION PROTOCOL FOR
WALK IN INCUBATOR
System Name
Walk In Incubator
Document No.
NECPL/IQ/11220I/1
Page No.
1 of 25

WALK - IN INCUBATOR
Newtronic Equipment Company Pvt. Ltd.

WALK IN INCUBATOR
System Name
Walk In Incubator
Document No.
NECPL/IQ/11220I/1
Page No.
2 of 25
PROTOCOL PRE-APPROVAL COVER PAGE

Signing of this approval page of Protocol No.: NECPL/IQ/11220I/1 indicates agreement with the
qualification approach described in this document. If any modification in the System, qualification
approach becomes necessary and an addendum shall be prepared and approved.
Name and Designation of Authorized Person
Prepared By :
Reviewed By :
Approved By :
Signature
Date

WALK IN INCUBATOR
System Name
Walk In Incubator
Document No.
NECPL/IQ/11220I/1
Page No.
3 of 25
TABLE OF CONTENT
1.0.0
GENERAL................................................................................................................4
1.1.0
Objective.......................................................................................................................... 4
1.2.0
Scope................................................................................................................................ 4
1.3.0
Equipment Selection.......................................................................................................5
1.4.0
Vendor Details.................................................................................................................. 5
1.5.0
Test Qualification Instruments........................................................................................5
2.0.0
EXECUTION.............................................................................................................6
2.1.0
General............................................................................................................................. 6
2.2.0
Identification of Executor................................................................................................6
2.3.0
Test Procedure (S)........................................................................................................... 7
3.0.0
INSTALLATION QUALIFICATION TESTS..............................................................9
3.1.0
Test System Details.......................................................................................................10
3.2.0
Verification of Master Documents................................................................................12
3.3.0
Verification of Scope of Equipment..............................................................................13
3.4.0
Verification of Control System Hardware Components..............................................15
3.5.0
Verification of Utility......................................................................................................18
4.0.0
INSTALLATION QUALIFICATION TEST STATUS...............................................20
5.0.0
INSTALLATION QUALIFICATION DISCREPANCY REPORT.............................21
6.0.0
CONCLUSION AND COMMENTS........................................................................22
6.1.0
Conclusion..................................................................................................................... 22
6.2.0
Comments...................................................................................................................... 22
7.0.0
QUALIFICATION COMPLETION AND APPROVAL.............................................23
8.0.0
TERMINOLOGIES.................................................................................................24
9.0.0
SUPPORTING DOCUMENTATION.......................................................................25

WALK IN INCUBATOR
System Name
Walk In Incubator
Document No.
NECPL/IQ/11220I/1
Page No.
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1.0.0 GENERAL
1.1.0 Objective
The objective of developing and executing this Protocol is to collect sufficient data
pertaining to Walk - In Incubator and define the qualification requirements and acceptance
criteria for Walk - In Incubator at
.
Successful completion of these qualification requirements will provide assurance that the
Walk - In Incubator is installed as required in the processing environment and meets
Installation requirements.
1.2.0 Scope
The qualification study shall be performed for Walk - In Incubator installation.
This Protocol shall define the test procedures, documentation, references and acceptance
criteria to establish that the Walk - In Incubator is installed as intended and is in
accordance to the directives from the manufacturer/supplier of the Walk - In Incubator.
This study verifies
Qualification of the unit installation and examination of all background information is

performed to assure conformance of project requirements of
Limited and manufacturers specifications.
The equipment meets the current Good Manufacturing Practices (cGMP) requirements
and all other regulatory obligations.
No unauthorized or unrecorded modifications have taken place.
All critical instrumentation has been identified.
All utilities are properly connected.
All relevant test reports, Drawings, Manuals have been attached.

WALK IN INCUBATOR
System Name
Walk In Incubator
Document No.
NECPL/IQ/11220I/1
Page No.
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1.3.0 Equipment Selection

Equipment name
Walk - In Incubator
Process and product To control temperature in working chamber
requirement
Regulatory obligations Equipment should maintain temperature with in 2 C than set
temperature.
Safety requirements
Temperature overshoots protection. Critical instrumentation such as
Compressor safety protection devices.
1.4.0 Vendor Details

Name
Address
Contact person
Phone no.
Fax no.
Email

117CD, Kandivli Co-Op. Industrial Estate, Charkop, Mumbai 400067
Mrs. Yogeeta Pawar
91 22 28679326
91 22 28676059
service@newtronic.in
1.5.0 Test Qualification Instruments

To execute this protocol, the following will be needed by the executor:
Standard devices (used for reference readings) calibration certificates shall be provided.
Multimeter - 500 volts minimum, 10 amperes.
Temperature Indicator Minimum range 0~60C
The above test instruments should have valid calibration on the date of report
execution and validity certificate to that effect should be available

WALK IN INCUBATOR
System Name
Walk In Incubator
Document No.
NECPL/IQ/11220I/1
Page No.
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2.0.0 EXECUTION
2.1.0 General
The satisfactory installation of Walk - In Incubator shall be verified by executing the
qualification studies described in this protocol. The successfully executed protocol will
indicate that the Walk - In Incubator is satisfactorily installed.
2.2.0 Identification of Executor

All executors involved in this protocol execution are to sign within the prescribed format
given below:
Name
Designation
Signature
Initial
Date

WALK IN INCUBATOR
System Name
Walk In Incubator
Document No.
NECPL/IQ/11220I/1
Page No.
7 of 25
2.3.0 Test Procedure (S)

The installation for Walk - In Incubator shall be verified by reviewing the installed systems
and physical parameters, using the test data sheets provided in this protocol. The test data
sheets will be used to document the installation of the Walk - In Incubator and to verify that
the components of the Walk - In Incubator confirm to design specifications.
2.3.1
Verification of Test System Details

This test data sheet of the IQ is intended to provide identification of executable System
verification.
Test data sheet attached in Installation Qualification Test 3.1.0
2.3.2
Verification of Master Documents

Compile list of specifications, documents, and manuals associated with system and record
document number, title, Revision No and date of issue (if available).
2.3.3
Verification of Scope of Equipment

Compile list of physical specifications associated with Walk - In Incubator
2.3.4
Verification of Control System Hardware Components

Physical system installation is verified with following documents and drawings. Verify the
installed control system by visual inspection and record the relevant details of the
individual control hardware components.
2.3.5
Verification of Utility
Verify that the utility for the Walk - In Incubator have been installed and is available as
specified.
Using the Multi meter, voltage at the unit power input end are measured and recorded.
Measured readings are verified with system specification documents.

WALK IN INCUBATOR
System Name
Walk In Incubator
Document No.
NECPL/IQ/11220I/1
2.3.6
Page No.
8 of 25
Installation Qualification Discrepancy Report

Document any discrepancies or variations noted during the execution of the Installation
Qualification. Include the resolution of these items and/or any item outstanding that will
require further effort to resolve. When all the items are satisfactorily completed, document
that the system is ready for the Operational Qualification.
2.3.7
Conclusion and Comments

All the IQ Data Sheets and discrepancy report shall be reviewed by validation team to
prepare summary report. The summary of IQ shall be used to draw conclusion for
approval of Installation Qualification Package.
2.3.8
Qualification Completion and Approval

1. Verify that all tests required by this reports are completed, reconciled and attached to
this protocol.
2. Verify that all amendments and Discrepancies are documented, approved and
attached to this protocol.
3. If all items in the Qualification Protocol for the control system for Walk - In Incubator
have been reviewed and found to be acceptable, sign the corresponding block in the
Qualification Completion and Approval form.

WALK IN INCUBATOR
System Name
Walk In Incubator
Document No.
NECPL/IQ/11220I/1
Page No.
3.0.0 INSTALLATION QUALIFICATION TESTS

Sr. No.
Test Name
Verification Of Master Documents
Verification Of Utility
Installation Qualification Test Status
Installation Qualification Discrepancy Report
Summary And Conclusion
9 of 25

WALK IN INCUBATOR
System Name
Walk In Incubator
Document No.
NECPL/IQ/11220I/1
Page No.
10 of 25
3.1.0 Test System Details

Objective
: This test sheet of the IQ is intended to describe which and what system is
being validated.
Procedure
:
1. Confirm the following parameters from the system.
Identification Tag no.
Manufacturer/Supplier
Model No.
Serial No.
2. Record the equipment/system location with location tag plate.
3. Record the verification source. (i.e. Nameplates, Room location tag etc.)
Acceptance criteria
: Data recorded from the name tag plates/room plates shall match with the
data specified in test data table.
3.1.1
System Identification
Description
Specified As
As Observed
System Tag
Number
Location
(Room #)
Supplier
Newtronic
Equipment
Company Pvt.
Ltd.
Model No.
Serial No.
Verification
Source
Discrepancy?
(Y / N)
Tested By
/ Date

WALK IN INCUBATOR
System Name
Walk In Incubator
Document No.
NECPL/IQ/11220I/1
Page No.
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Remarks:
Meet the acceptance Criteria

Verified by
] Yes
] No
: ____________________
Date
: ______________________
Reviewed by : ____________________
Date
: ______________________

WALK IN INCUBATOR
System Name
Walk In Incubator
Document No.
NECPL/IQ/11220I/1
Page No.
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3.2.0 Verification of Master Documents

Objective
: To ensure the system is adequately documented and this documentation

is under appropriate document control.
Procedure
: Verify availability of the listed documents with their reference no., revision
no., date, etc details as specified in the test table.
Acceptance criteria
: All the relevant documents listed in the test sheet must be available. Also
the details specified in the test data sheet shall match with the documents.
3.2.1
DOCUMENTATION VERIFICATION
Sr.
No.
Document Title
Document No.
Rev. No./ Date
Availability?
(Y / N)
Checked
By / Date
1. System Operation
Manual
2. General Assembly
Drawing
3.
System Wiring &

Interconnection
Diagram
Remarks:

Verified by
] Yes
] No
: ____________________
Date
: ______________________
Reviewed by : ____________________
Date
: ______________________

WALK IN INCUBATOR
System Name
Walk In Incubator
Document No.
NECPL/IQ/11220I/1
Page No.
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3.3.0 Verification of Scope of Equipment

Objective
: To verify scope of equipment with system documents and drawings.
Procedure
: Verify the scope of equipment by visual inspection and record the relevant
details of the individual.
Acceptance criteria
: Physical installation of the system shall be verified and details shall be

recorded. Scope of the system shall match with details given in the Bill of
Material or in the Manual of the system.
3.3.1
Scope of Equipment
Manufacturer
Description
Specification
Make
Newtronic
Model
NEC 11220IRSI
Inner chamber
size in mm
2400(H) 2500(W)
5700(D)
Actual Observation
Number of Trays 168 Nos.

Tray Size in mm
750 x 800 mm
Temperature
Range
10 ~ 60 C
Power Supply
415V, 50Hz,
Material of construction
Outer chamber
SS-304
Inner chamber
SS-304
Insulation
Material
PUF
Remarks:
Discrepancy?
(Y / N / NA)
Tested By /
Date

WALK IN INCUBATOR
System Name
Walk In Incubator
Document No.
NECPL/IQ/11220I/1

Verified by
Page No.
] Yes
14 of 25
] No
: ____________________
Date
: ______________________
Reviewed by : ____________________
Date
: ______________________

WALK IN INCUBATOR
System Name
Walk In Incubator
Document No.
NECPL/IQ/11220I/1
Page No.
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3.4.0 Verification of Control System Hardware Components

Objective
: To verify Physical system installation with system documents and

drawings.
Procedure
: Physical system installation is verified with following documents and

drawings.
Verify the installed control system by visual inspection and record the
relevant details of the individual control hardware components.
Acceptance criteria
3.4.1
: Physical installation of the system shall be verified and details shall be

recorded. Model number and quantity of the Control System component
shall match with details given in the Bill of Material of the system &
physical system installation.
Hardware Components Verification (As Per Physical Installation)

Manufacturer
Specification
Description
Actual Observation
Cooling System
Compressor
Make
Compressor
Model
Condenser
Motor Make
Condenser
Motor Model
Quantity
Emerson
KCM 511CAL
MARATHON
1/5 HP
2
Air Circulation
Manufacturer /
Supplier
ELTEK
Type, Size
1/6 HP
Quantity
Discrepancy?
(Y / N)
Tested By /
Date

WALK IN INCUBATOR
System Name
Walk In Incubator
Document No.
NECPL/IQ/11220I/1
Manufacturer
Specification
Description
Page No.
Actual Observation
PLC
Manufacturer /
Schneider Electric
Supplier
Model No. / Cat.
TWDLCDE40DRF
No. / Type
Quantity
1
HMI
Manufacturer /
Schneider Electric
Supplier
Model No. / Cat.
XBT N200
No. / Type
Quantity
1
Temperature Sensors
Manufacturer /
Supplier
Simplicon
Sensor
PT-100
Quantity
1
Heating System
Manufacturer /
Rishina Electricals
Supplier
Model No. / Cat. U Type Tubular
No. / Type
heaters with fins
1000 Watts x 3
Quantity
Nos.
SMPS
Manufacturer /
Schneider Electric
Supplier
Model No. / Cat.
ABL1REM24025
No. / Type
Quantity
16 of 25
Discrepancy?
(Y / N)
Tested By /
Date

WALK IN INCUBATOR
System Name
Walk In Incubator
Document No.
NECPL/IQ/11220I/1
Manufacturer
Specification
Description
Page No.
Actual Observation
17 of 25
Discrepancy?
(Y / N)
Tested By /
Date
Contactor
Manufacturer /
Schneider Electric
Supplier
Model No. / Cat.
LC1D12
No. / Type
Quantity
4
Electromagnetic Relay
Manufacturer /
Schneider Electric
Supplier
Model No. / Cat.
RXM2AB2P7
No. / Type
Quantity
Remarks:

Verified by
] Yes
] No
: ____________________
Date
: ______________________
Reviewed by : ____________________
Date
: ______________________

WALK IN INCUBATOR
System Name
Walk In Incubator
Document No.
NECPL/IQ/11220I/1
Page No.
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3.5.0 Verification of Utility

Objective
: To verify that the utilities is installed and are available as specified.
Procedure
:
1. Power on the system and put the Multimeter in AC voltage
measurement range and measure the voltage at terminal end. Note
down the voltage reading in the test data sheet.
2. Place the temperature near equipment. Note down temperature reading
in the test data sheet.
3. Observe water tank size, quality and note down results.
4. Physically check water drainage location and note down observations.
Acceptance criteria
: Recorded measurements for voltage shall fall within the specified range.
3.5.1
Verification of Utility
Description
Specified
Actual
Observation /
Measurement
Walk - In Incubator
Voltage
200-230 V AC
UPS Supply for Monitoring System (Sensor and Display)

Voltage
200-230 V AC
System network communication media
Network
communication
10/100 MBPS
Environment Conditions
Temperature: 25
Conditions
to 30 C
Drainage
Location
At the back side

bottom of the
equipment
Discrepancy?
(Y / N)
Tested By / Date

WALK IN INCUBATOR
System Name
Walk In Incubator
Document No.
NECPL/IQ/11220I/1
3.5.2
Page No.
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Test Instruments Used
Test Instrument
Manufacturer
Tag number
Calibrated
Date
Calibration
Due Date
Tested
By / Date
Remarks:

Verified by
] Yes
] No
: ____________________
Date
: ______________________
Reviewed by : ____________________
Date
: ______________________

WALK IN INCUBATOR
System Name
Walk In Incubator
Document No.
NECPL/IQ/11220I/1
Page No.
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4.0.0 INSTALLATION QUALIFICATION TEST STATUS

Test
Number
Test Name
Pass/Fail
Pass
Verification Of Master Documents
Verification Of Utility
Fail
Discrepancy
Found
Yes
No

WALK IN INCUBATOR
System Name
Walk In Incubator
Document No.
NECPL/IQ/11220I/1
Page No.
21 of 25
5.0.0 INSTALLATION QUALIFICATION DISCREPANCY REPORT

Discrepancy and Corrective Action Report Form
Discrepancy Number
Document Ref. No.
Chapter ref. No.
Discrepancy
Describe the
Discrepancy
Discrepancy Level
Major
Minor
Reported by
Critical
Date
Corrective Action
Describe corrective action taken (Attach additional sheets if necessary)
Reported by
Date
Disposition Action
Acceptable?
Yes
No
Discussion
Approved by : QA
Date
Completion
Completed by
Date
Approved by : QA
Date

WALK IN INCUBATOR
System Name
Walk In Incubator
Document No.
NECPL/IQ/11220I/1
Page No.
22 of 25
6.0.0 CONCLUSION AND COMMENTS

IQ Data Sheets and discrepancy report shall be reviewed by validation team to prepare summary
report. The summary of reports shall be used to draw conclusion for approval of Installation
Qualification Package.
6.1.0 Conclusion
6.2.0 Comments
Prepared by
Reviewed by
Approved by
_____________________
_____________________
_____________________

WALK IN INCUBATOR
System Name
Walk In Incubator
Document No.
NECPL/IQ/11220I/1
Page No.
23 of 25
7.0.0 QUALIFICATION COMPLETION AND APPROVAL

Verified that all test cases required by this reports are completed, reconciled and attached to this
protocol and are included in the Qualification summary report.
Signatures in the block below indicate that all items in this Installation Qualification protocol of the
Walk - In Incubator have been reviewed and found to be acceptable.
QUALIFICATION APPROVAL PAGE
Name and Designation of Authorized Person
Signature
Date

WALK IN INCUBATOR
System Name
Walk In Incubator
Document No.
NECPL/IQ/11220I/1
Page No.
24 of 25
8.0.0 TERMINOLOGIES
A.
Alarm
A device or function that signals the existence of an abnormal condition by means of
an audible or visible discrete change, or both, intended to attract attention.
B.
Control System
A system in which deliberate guidance or manipulation is used to achieve a prescribed
value of a variable.
C.
EEPROM
Is a PROM that is electrically erasable. The EEPROM can be programmed or erased
while it is still in the circuit and used like a nonvolatile read / write memory.
D.
Interlock
An arrangement of signals, which perform a logical function in a control system.
E.
LED
Light Emitting Diode. Status indicators available on the PLC modules to reflect the
Input/output and processor status.
F.
HMI
Human Machine Interface

WALK IN INCUBATOR
System Name
Walk In Incubator
Document No.
NECPL/IQ/11220I/1
Page No.
25 of 25
9.0.0 SUPPORTING DOCUMENTATION

Sr. No.
Description Of Attachment
Reference
Remark
Checked By /
Date

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INSTALLATION QUALIFICATION PROTOCOL FOR