installation qualification protocol cum report for …€¦ · • monitoring of installation...
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PHARMA SCHOLARS
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 1 of 29
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
HVAC SYSTEM
(AHU No.: ……………..)
MEDIA PREPARATION ROOM & WASH
ROOM
EQUIPMENT/INSTRUMENT ID. No.
LOCATION
DATE OF QUALIFICATION
SUPERSEDES PROTOCOL CUM REPORT NO. NIL
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PHARMA SCHOLARS
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 2 of 29
CONTENTS
S.No. TITLE PAGE No.
1.0 Pre Approval 3
2.0 Objective 3
3.0 Scope 3
4.0 Responsibility 4
5.0 Equipment Details 5
6.0 System Description 6
7.0 Pre- qualification Requirement 8
8.0 Critical Variables to be Met 10
9.0 References 24
10.0 Documents to be Attached 24
11.0 Deviation from Pre-defined Specification, if Any 25
12.0 Change Control, if Any 25
13.0 Review (Inclusive of Follow Up Action, If Any ) 25
14.0 Conclusion 26
15.0 Recommendation 26
16.0 Abbreviations 27
17.0 Post Approval 29
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PHARMA SCHOLARS
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 3 of 29
1.0 PROTOCOL CUM REPORT PRE- APPROVAL:
PREPARED BY CHECKED BY REVIEWED BY
NAME
SIGNATURE
DATE
2.0 OBJECTIVE:
• To prepare Installation Qualification Protocol cum Report of HVAC System (AHU No.: …………).
• To verify that the HVAC System is installed in accordance with the Design User Requirements as
defined by set acceptance criteria and complies with relevant cGMP Requirements.
• Successful completion of this Installation Qualification activity will verify that the HVAC System
(AHU No.: …………..) meets all the acceptance criteria and is ready for OQ.
3.0 SCOPE:
• The Protocol Cum Report covers all aspects of Installation Qualification for the HVAC system (AHU
No.: …………….) serving Media Preparation Room & Wash Room in Microbiology block at
……………….).
• This Protocol Cum Report will Comply the methods and documentation used to qualify the HVAC
system (AHU No.: ………………) for IQ.
-
PHARMA SCHOLARS
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 4 of 29
4.0 RESPONSIBILITY:
The Validation Group, comprising of a representative from each of the following departments,
shall be responsible for the overall compliance of this Report:
DEPARTMENTS RESPONSIBILITIES
Quality Assurance
• Preparation, Review and Approval of the Installation Qualification Report.
• Co-ordination with Production and Engineering to carryout Installation
Qualification.
• Monitoring of Installation Process.
Production
• Giving clearance to install the unit.
• Execution of Installation Qualification activity.
• Ensure that the equipment is installed as per Protocol.
• Review of Report.
Engineering
• To co–ordinate and support Installation Qualification activity.
• Calibration of Process instruments.
• Ensure that the equipment is installed as per Protocol.
• Review of Report.
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PHARMA SCHOLARS
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 5 of 29
5.0 EQUIPMENT DETAILS:
Equipment Name Air Handling Unit
Equipment ID. No. …………………………
Area Covered Media Preparation Room & Wash Room
Manufacturer’s Name ………………………….
Supplier’s Name …………………………..
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PHARMA SCHOLARS
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 6 of 29
6.0 SYSTEM DESCRIPTION:
The HVAC System of Media Preparation Room & Wash Room comprises of the following units.
• AHU - Air Handling Unit
• Air Distribution System
S. No. PARAMETER
DESCRIPTION
1. AHU Details It comprises of:
• AHU Body
• Pre Filter (EU-4)
• Heating coil with Pressure gauge & Temperature Gauge.
• Cooling coil with Pressure gauge & Temperature Gauge.
• Blower
• Blower Motor
• Fine Filter (EU-5) for lower section
• Fine Filter (EU-7) for upper section
• HEPA filter (EU-13)
• Drive
• Damper
• Magnehelic Gauge across all filter bank.
2. Air Distribution System It comprises of:
• Ducts for supply and return of air.
• Dampers (Supply Air Damper, Return Air Damper, Fresh Air Damper, Exhaust Air Damper and Fire Damper).
• Fine filter with housing in Supply duct.
• Valves (Three way valves, Balance valve and Ball Valve, Solenoid control valves, Y strainer).
• Final filters in return duct.
3.
Environmental conditions:
Temperature
Relative Humidity
NMT 25°C
NMT 55%
4. Quantity of Air Circulation Total air quantity: 2000 CFM Recirculation of air.
5. Air Changes Per Hour 40
6. Class D
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PHARMA SCHOLARS
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 7 of 29
6.1 AHU DESIGN DESCRIPTION FOR AHU No.: SA/AHU-002:
The User Requirements shall be met by installing AHU having the following configuration:
6.1.1 AHU specification:
Type: Re-circulating.
The Air Handling Unit will be a cabinet type unit, in double skin thermal break modular construction.
AHU will have Alminium frame with sandwiched panel of GSS sheet duly powder coated from outside
& thick PUF filled in between. It consists of mixing chamber for return air, fan section & supply air
section. Port for fresh air complete with damper & 10 micron filter is provided for fresh air. Fan section
will have plug fan & directly coupled motor. Return air mixes with fresh air in the mixing chamber
which is passed to 5µ coil protection filter by blower. Prefiltered air passes through the cooling coil
section with CHW coil of 6 row deep copper tubes & 12 FPI Al fins. CHW coil will be placed on
condensate tray, sandwiched type in SS construction & proper drain point. Supply plenum will have
single stage filtration of 3μ filters. Filtered air will be supplied to the room via leak proof GSS ducting
(Joints sealed with silicon sealant) through Terminal HEPA Filter 0.3μ of (99.99% Efficiency down to
0.3μ) & will return through return air risers & return duct to air mixing chamber. Both ends of the GI
ducts will have Angle iron flanges & flanged joints will have neoprene gasket. Air volume control
dampers should be installed at inlet & out let of AHU, at terminal filter module, at return air risers &
fresh air module. Fire Damper should be installed at the return air duct. Bleed Module is Installed
between fan & pre filter.
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PHARMA SCHOLARS
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 8 of 29
6.1.2 Principle of Operation:
Air handling unit will re-circulate air from the room with the help of plug fan. The air carrying the room
sensible heat and latent heat will be sucked from the room through low level pick up risers via GI ducts
to mixing chamber. Approximately 10% fresh air filtered through 10 micron filter is mixed with
returned air in mixing box. Than the air is passed through 5µ filter and CHW coil. The cooled &
conditioned air shall be passed through blower & 3µ filter. In this process the air is filtered, conditioned.
This conditioned air is fed to the area via GI sealed ducts and through terminal HEPA filters having
99.97% Efficiency down to 0.3 microns.
For RH Conditions NMT 55% achieved with CHW Coil is used in line with the AHU.
This scheme will control microbial contents & particulate matter as well as controlled temperature &
humidity thus will maintain Grade “D” status in the rooms.
7.0 PRE –QUALIFICATION REQUIREMENT:
7.1 Verification of Documents & General Arrangement Drawing:
To verify that Approved Drawings and supporting documents of HVAC System (AHU No.:
………………..) conform to the Design Qualification.
7.1.1 Procedure:
• Verify that Approved Drawings and supporting documents are available and conform to the DQ
Protocol Cum Report.
• Approved Drawings and supporting documents would form a part of the IQ Report.
7.1.2 Acceptance Criteria:
• Drawing and documents should conform to Design Qualification Protocol cum Report. Any
Deviations observed must be recorded and approved.
• The General Arrangement should confer to the approved GA Drawing. Any Deviations observed,
must be recorded and approved.
-
PHARMA SCHOLARS
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 9 of 29
Pre-Qualification Checks Acceptance Criteria Observation
Observed By
(Engineering)
Sign& Date
Drawing:
• Air Flow Diagram
Should be as per Approved
Drawing
• GA of AHU Should be as per Approved General Arrangement
Drawing
Checked By:
Sign & Date _________________
Inference:_________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
Reviewed By:
Sign & Date_________________
-
PHARMA SCHOLARS
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 10 of 29
8.0 CRITICAL VARIABLES TO BE MET:
8.1 Verification of Piping & Instrumentation:
To verify that the installation of HVAC System (AHU No.: ……………..) is carried out as per
the approved P & ID Drawing.
8.1.1 Procedure:
• Perform physical check and verify that the installation has been done as per the Approved P & ID
Drawing.
• As-built and Approved P&ID would form a part of the IQ Report.
8.1.2 Acceptance Criteria:
The Installed Piping and Instrumentation should confirm to the approved P & ID.
Installation Checks Acceptance Criteria Observation
Observed By
(Engineering)
Sign & Date
Piping and Instrumentation Diagram Verification:
• P &ID Verification The installed Piping and
instrumentation should confirm to the
approved P & ID. Any Deviations
observed, must be Recorded and
Approved.
Checked By:
Sign & Date _________________
Inference:_________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
Reviewed By:
Sign & Date_________________
-
PHARMA SCHOLARS
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 11 of 29
8.2 VERIFICATION OF UTILITY CONNECTION:
To identify that all Utilities have been installed and connected to the HVAC System as per the DQ.
8.2.1 Procedure:
• Verify that all Utilities have been connected as per the requirements in Design Qualification.
• Carryout installation Checks for Utilities to ensure smooth Commissioning.
• The method of Checking & Observations has to be recorded.
• Any Deviations have to be recorded and approved giving reasons for the same.
8.2.2 Acceptance Criteria:
• The installation and connection of Utilities should be as per DQ.
Installation Checks Acceptance Criteria Observation
Observed By
(Engineering)
Sign & Date
Electrical Supply
3 Phase plus Earthing, 4 Wire Line up to the panel
board terminal.
Voltage: 415 ± 10% V
Frequency: 50 ± 3% Hz
Room Condition
Should be able to meet the
required controlled
environment with Temp.
NMT 25°C & Relative
Humidity NMT 55%.
Chilled water piping/
Temperature 50.8 mm/7-9°C
Electrical Motor 3.7 KW
3 Phase wire input
Checked By:
Sign & Date _________________
Inference:_________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
Reviewed By:
Sign & Date_________________
-
PHARMA SCHOLARS
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 12 of 29
8.3 VERIFICATION OF MATERIAL OF CONSTRUCTION (MOC):
To verify that the Material used for construction in HVAC System is as per the Design Requirement in
DQ Protocol Cum Report.
8.3.1 Procedure:
• MOC has to be verified during installation by verifying the Certificates.
• Certificates for all Major Components to be identified.
• Material Test Certificates would form a part of the IQ Report.
8.3.2 Acceptance Criteria:
The Material of Construction of All Components should be as per DQ.
Installation Checks Acceptance Criteria Observation
Observed By
(Engineering)
Sign & Date
GRILLS FOR SUPPLY & RETURN AIR:
Chilled Water Piping Copper
Ducting GI Sheet
Insulation Thermo
VALVES:
Butterfly valve Cast iron
Balancing valve Cast iron
Three way valve Cast iron
FILTER & FILTER FRAMES:
Primary Filter Settled in Al frame
Secondary Filter Settled in Al frame
Absolute HEPA Filter Settled in Al frame
Checked By:
Sign & Date _________________
Inference:_________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
Reviewed By:
Sign & Date_________________
-
PHARMA SCHOLARS
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 13 of 29
8.4 VERIFICATION OF ALL THE PROVIDED UTILITIES TO THE EQUIPMENT:
To verify all the provided Utility used for construction in HVAC System is as per the Design
Requirement in DQ Protocol Cum Report.
8.4.1 Procedure:
• All the provided Utility has to be verified during installation.
8.4.2 Acceptance Criteria:
All the provided Utility should be as per DQ.
Installation Checks Acceptance Criteria Observation
Observed By
(Engineering)
Sign & Date
Electric Connections
Should be tight, weather
proof and grounded
General Method of the
electrical wiring
No loose hanging Cables
Well-insulated Electrical
Wirings.
Located in a safe place well
protected from Water
Seepage during Machine or
Floor Cleaning and also safe
for Operator during
Operation.
Identification Tags and
Electrical Drawing
Identification tags should be
available where eventual.
Electrical Drawing available
either pasted in the inside of
the circuit box or as in the
Manual.
Checked By:
Sign & Date _________________
Inference:_________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
Reviewed By:
Sign & Date_________________
-
PHARMA SCHOLARS
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 14 of 29
8.5 VERIFICATION OF SAFTY FEATURES:
To verify all safety features in HVAC System is as per the Design Requirement in DQ Protocol Cum
Report.
8.5.1 Procedure:
• All the Safety features have to be verified during installation.
8.5.2 Acceptance Criteria:
All the Safety features should be as per DQ.
Installation Checks Acceptance Criteria Observation
Observed By
(Engineering)
Sign & Date
MECHANICAL:
ON/OFF Switch AHU stops as required
Fire Dampers Trips the AHU and isolate
area in case of fire.
Safety Guards For Drive assemblies
like pulleys & belts For Operational Safety.
Checked By:
Sign & Date _________________
Inference:_________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
Reviewed By:
Sign & Date_________________
-
PHARMA SCHOLARS
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 15 of 29
8.6 VERIFICATION OF CRITICAL INSTRUMENTS CALIBRATION:
To verify that all Critical Instruments for the HVAC System have been calibrated before starting
Operation Qualification.
8.6.1 Procedure:
• All Critical Instruments are to be calibrated before installation and their Calibration Certificates have
to be attached with IQ Report.
• The next due date for Calibration has to be noted.
• Deviations are to be recorded and follow-up action is to be recommended.
8.6.2 Acceptance Criteria:
• All Critical Instruments should be Calibrated and qualified for installation.
CALIBRATION DETAILS:
INSTRUMENT
NAME
EQUIPMENT
ID.
DATE OF
CALIBRATION
CALIBRATION
CERTIFICATE
No.
CALIBRATION
DUE DATE OBSERVATION
OBSERVED BY
(ENGINEERING)
Sign &Date
Checked By:
Sign & Date _________________
Inference:_________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
Reviewed By:
Sign & Date_________________
-
PHARMA SCHOLARS
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 16 of 29
8.7 CHECKLIST FOR INSTALLATION :
Installation Checks Acceptance Criteria Observation
Observed By
(Engineering)
Sign & Date
AHU ( Make & Type):
Make ……………………….
Body Dimensions 3000 x 850 x 1700 mm
Air Quantity 2000 CFM
Static Pressure 140 mm of WC
Frame Work 2.0 mm thick hollow profile
MOC Aluminum
Type Double Skin
Insulation 40±2 kg/m3 CFC free PUF
Outer Skin 0.6 mm pre painted
Inner Skin 0.6 mm GI
Location of AHU:
Site of Installation Service Floor
Block Microbiology block
Vibration AHU to be mounted on Anti –
Vibration Pads
Slope
Slope to be adjusted so that
condensate will flow to drain
line easily. Confirm this by
pouring water in condensate
tray of AHU
AHU Section:
Mixing Chamber Should be Installed properly
Coil Section for CHW Coil Should be Installed properly
Blower Section Should be Installed properly
Supply Plenum with
section for 3µ filters. Should be Installed properly
Pre filter section with filter Should be Installed properly
Cooling Coil:
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PHARMA SCHOLARS
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 17 of 29
Installation Checks Acceptance Criteria Observation
Observed By
(Engineering)
Sign & Date
Make …………………………
Type CHW- Coil
Quantity 1
Fin Height 571.5 mm
Fin Length 651 mm
Row Deep 6 RD
Fins Per Inch 12 fins/inch
Area 4.0 Sqft.
Tube Size (Outer Diameter) ½”
MOC of Tube Copper
MOC of Fin Al
Drain pan SS 304
Fan:
Fan RPM/Hz 2490/52
Fan Discharge TH
Fan Make Nicotra
Motor
Motor 3.7 Kw
Motor Pole 02
Motor RPM 2830
Motor Frame 100
Motor Make ABB/SIEMENS
Motor Phase 3 PH
Heating Coil
Quantity 1
FH 571.5
FL 651
RD 2
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PHARMA SCHOLARS
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 18 of 29
Installation Checks Acceptance Criteria Observation
Observed By
(Engineering)
Sign & Date
FPI 10
Area 4.0 Sqft.
Tube Size (Outer Diameter) ½”
Tube Material Copper
Tray Material SS-304-18G
Fin Material Aluminium
Header Material MS
Fine-Filter Details:
Porosity 5 microns (EU-5)
Media Non Woven Synthetic Media
(Washable)
Air Filter Type Fine Filter
Flange/Box Type Flange type
Efficiency 99.0 % Down to 5 micron
Size & Number of filters 610 x 305 x 305 mm 1 Nos.
Fine Filter Section (3 microns):
Porosity 3 microns (EU-7)
Media Non Woven Synthetic Media
(Washable)
Type Flange type
Efficiency 99.0 % Down to 3 micron
Size & Number of filters 610 x 610 x 305 mm 1 Nos.
Terminal HEPA Filter:
Porosity 0.3 microns (EU-13)
Media Fiberglass media
Type Flange Type
Efficiency 99.97% down to 0.3 Micron
Size & Number of filters 610 x 610 x 150 mm 2 Nos.
Damper:
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PHARMA SCHOLARS
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 19 of 29
Installation Checks Acceptance Criteria Observation
Observed By
(Engineering)
Sign & Date
Type Opposed Blade
MOC Aluminium
Fresh Air Damper:
Size 320 x 300 x 50 mm
Number of Dampers 1 Nos.
10 micron Filter size 305 x 305 x 50 mm
Number of Filter 1 Nos.
Exhaust/Bleed Air Damper
Size 320 x 300 x 50 mm
Number of Dampers 1 Nos.
0.3 micron Filter size (EU-13) 305 x 305 x 305 mm
Number of Filter 01 No.
RETURN AIR DAMPER 220 x 500 mm
SUPPLY AIR DAMPER 220 x 500 mm
FIRE DAMPER 320 x 300 mm
TOTAL NUMBER OF
DAMPERS 05 Nos.
FILTER & FILTER FRAMES:
Pre-Filter Settled in Aluminium frame
Fine Filter Settled in Aluminium frame
HEPA Filter Settled in Aluminium frame
Ducting:
MOC 24 SWG GI
Flanges
Angle iron Flanges shall be
provided for ducts using
rivets.
Flange Joints All Flange joints will have 3.0
mm rubber gasket
Layout Approved Ducting layout
should be available.
Ducting Insulation:
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PHARMA SCHOLARS
INSTALLATION QUALIFICATION
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HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 20 of 29
Installation Checks Acceptance Criteria Observation
Observed By
(Engineering)
Sign & Date
Insulation
Should be well insulated and
no projecting parts of GI
Sheet should be left
uncovered.
Cladding 26 SWG Thickness
Fire Damper:
Location It should be Installed on
Ducting Line.
Electric Connection:
Voltage 415 ± 10% V
Phase 3
Frequency 50 ± 3% Hz
Earthing Connected with existing
earthing grid
Return Air Risers:
Material of Construction
The Riser for low level pickup
shall be inbuilt in PUF panels.
Return air pick up will be
through Aluminum extruded
powder coated grill.
Size 120 mm × 200 mm
Dimensions of Room in meter for Which the AHU is:
Room
Length
(in
Meter)
Width
(in
Meter)
Height
(in
Meter)
Length
(in
Meter)
Width
(in
Meter)
Height
(in
Meter)
Media Preparation room 3.475 4.536 2.592
Wash room 3.475 4.229 2.592
Duct Leakage Test:
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PHARMA SCHOLARS
INSTALLATION QUALIFICATION
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HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 21 of 29
Installation Checks Acceptance Criteria Observation
Observed By
(Engineering)
Sign & Date
Duct Leakage Testing
Air Leakage through ducts
should be tested before
Insulation of ducts by
Pressure test as per SOP for
Checking Duct Leakage.
SOP
SOP for Duct Leakage Test
should be available.
Control Panel:
AHU ‘START’ Button Start Button
AHU ‘STOP’ Button Stop Button
Indicator for AHU ‘ON’ On Indicator
Indicator for AHU ‘OFF’ Off Indicator.
In the Supply Area /Room:
Supply Air Diffuser/Grills Well Fixed with the duct body
leaving no gaps in between.
Return Air Diffuser/Grills Well Fixed with the duct body
leaving no gaps in between.
Volume Control Damper Should be installed
Preventive Maintenance Schedule:
AHU in Preventive
Maintenance Schedule Should be Included
Labeling of Supply and Return Ducts:
Colour used for Supply
Ducts Green
Colour used for return
Ducts Red
Digital Display for Temperature, Relative Humidity & Pressure Differential:
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PHARMA SCHOLARS
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 22 of 29
Installation Checks Acceptance Criteria Observation
Observed By
(Engineering)
Sign & Date
Location At entry of the room
Range
Temperature NMT 25oC
Relative
Humidity NMT 55%
Pressure
Differential
Media preparation
Wash room
Cleaning:
Cleaning of AHU
Ensure proper cleaning of
AHU from inside & outside
with dry cloth.
Cleaning of Ducts
Ensure proper cleaning of
ducts at the time of
Installation from inside &
outside, ducts should be free
from particulate matter. To be
observed visually.
Standard Operating Procedure:
SOP for Operation &
Cleaning of Air Handling
Unit
SOP for Operation &
Cleaning of Air Handling
Unit should be available.
SOP for Preventive
Maintenance of AHU
SOP for Preventive
Maintenance of AHU should
be available.
General Checks :
General Installation Checks
During Installation
Qualification.
Placement of rubber pad on
foundation
Placement of AHU on
foundation with proper
alignment with rubber pad
Connection of AHU and main
duct by means of canvass
connection.
Noise level of AHU at 1 meter
distance as per performance
curve of blower
Airtight Connection of AHU
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PHARMA SCHOLARS
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 23 of 29
Installation Checks Acceptance Criteria Observation
Observed By
(Engineering)
Sign & Date
to return air duct & fresh air
duct.
Leakages through inspection
door and access door.
Proper Connection of AHU to
chilled water piping.
Whether servicing to AHU is
easily accessible or not.
Dimension of the AHU as per
AHU GA drawing.
Individual dimension for
every section.
Proper positioning of pre
filter, coil, blower, Fine Filter
in the AHU.
Statically and Dynamically
balance.
Proper placement of
Humidistat and thermostat in
the Return Air Duct
Magnehelic Gauge location as
per AHU GA drawing.
Electrical connection to AHU
as per requirement.
8.8 INSTALLATION VERIFICATION:
Check that all the Ducting connections are as per drawing .
Parameters Acceptance Criteria Observation Remark Checked By
Sign & Date
Verify that the “as built”
drawing are complete &
represent the design
concept
The “as built” drawing
should be as per the
design concept
Verify that all ducts
have been properly
insulated
All ducts should be
insulated
There is no observable
physical damage for
AHU
No physical damage to
the AHU to be
confirmed
Sufficient room for
servicing provided
Space for servicing will
be provided
-
PHARMA SCHOLARS
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 24 of 29
Parameters Acceptance Criteria Observation Remark Checked By
Sign & Date
Verify that all
component of manifold
have been installed
according to the drawing
All components should
have been done
according to the drawing
Valves identification
nameplate is visible
All valve should be
identified, tested &
labeled
8.9 Checks on General Erection & Installation:
Checks that the Components are installed as described in AHU Schematic Drawing. Follow the
construction & highlight with fluorescent yellow the parts that are assembled correctly & with blue
those show deviation.
9.0 REFERENCES
• Design Qualification Protocol Cum Report
• GA and P&ID Drawings
• Approved Design & Specification.
• Any Other Relevant documents.
10.0 DOCUMENTS TO BE ATTACHED:
• A Copy of Purchase order
• Technical details for Equipment Requirement with Engineering Drawings.
• Approved Design and Specifications.
• Certificate of MOC
• Calibration Certificates
• Operation and Maintenance Manual
• GA and P & ID Drawings
• Any other relevant documents
-
PHARMA SCHOLARS
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 25 of 29
11.0 DEVIATION FROM PRE-DEFINED SPECIFICATIONS, IF ANY:
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12.0 CHANGE CONTROL, IF ANY:
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13.0 REVIEW (INCLUSIVE OF FOLLOW UP ACTION, IF ANY):
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-
PHARMA SCHOLARS
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 26 of 29
14.0 CONCLUSION:
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15.0 RECOMMENDATION:
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-
PHARMA SCHOLARS
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 27 of 29
16.0 ABBREVIATIONS:
HVAC : Heating Ventilation and Air Conditioning
AHU : Air Handling Unit
HEPA : High Efficiency Particulate Air
Nos. : Number
cGMP : Current Good Manufacturing Practice
A/L : Air Lock
GA : General Arrangement
Pvt. : Private
Ltd. : Limited
DQ : Design Qualification
IQ : Installation Qualification
°C : Degree Centigrade
V : Volt
Hz : Hertz
HP : Horse Power
KW : Kilo Watt
MOC : Material of Construction
CFM : Cubic Feet per Minute.
WC : Water Column
PUF : Poly Urethane Foam
GI : Galvanized Iron
FAD : Fresh Air Damper
EAD : Exhaust Air Damper
mm : Millimeter
CHW : Chilled Water
TR : Ton of Refrigeration
Sft : Square Feet
Al : Aluminium
SS : Stainless Steel
DIDW : Double Inlet Double Width
-
PHARMA SCHOLARS
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 28 of 29
RDH : Rapid Displacement Heat
m/s : Meter per Second
rpm : Revolution per minute
TEFC : Totally Enclosed Fan Cooled
SWG : Standard Wire Gauge
% : Percentage
RH : Relative Humidity
ID. : Identification
S.No. : Serial Number
GA : General Arrangement
SOP : Standard Operating Procedure
IQ : Installation Qualification
P&ID : Piping & Instrumentation Diagram
-
PHARMA SCHOLARS
INSTALLATION QUALIFICATION
PROTOCOL CUM REPORT
FOR
HVAC SYSTEM
(AHU No.: ……………)
MEDIA PREPARATION ROOM &
WASH ROOM
PROTOCOL No.:
…………………
EFFECTIVE DATE:
PAGE No.: 29 of 29
17.0 POST APPROVAL:
REVIEWED BY:
DESIGNATION NAME SIGNATURE DATE
…………….….
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