INSTALLATION QUALIFICATION PROTOCOL CUM REPORT FOR …€¦ · • Monitoring of Installation Process. Production • Giving clearance to install the unit. • Execution of Installation

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


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

PHARMA SCHOLARS


PROTOCOL CUM REPORT

FOR

HVAC SYSTEM

(AHU No.: ……………)


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

PHARMA SCHOLARS


PROTOCOL CUM REPORT

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HVAC SYSTEM

(AHU No.: ……………)


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


PROTOCOL CUM REPORT

FOR

HVAC SYSTEM

(AHU No.: ……………)


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.

PHARMA SCHOLARS


PROTOCOL CUM REPORT

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HVAC SYSTEM

(AHU No.: ……………)


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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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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PROTOCOL No.:

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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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WASH ROOM

PROTOCOL No.:

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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


PROTOCOL CUM REPORT

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HVAC SYSTEM

(AHU No.: ……………)


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


PROTOCOL CUM REPORT

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HVAC SYSTEM

(AHU No.: ……………)


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.


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


PROTOCOL CUM REPORT

FOR

HVAC SYSTEM

(AHU No.: ……………)


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.


• The installation and connection of Utilities should be as per DQ.


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


PROTOCOL CUM REPORT

FOR

HVAC SYSTEM

(AHU No.: ……………)


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.


The Material of Construction of All Components should be as per DQ.


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


PROTOCOL CUM REPORT

FOR

HVAC SYSTEM

(AHU No.: ……………)


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.


All the provided Utility should be as per DQ.


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


PROTOCOL CUM REPORT

FOR

HVAC SYSTEM

(AHU No.: ……………)


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.


All the Safety features should be as per DQ.


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


PROTOCOL CUM REPORT

FOR

HVAC SYSTEM

(AHU No.: ……………)


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.


• 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


PROTOCOL CUM REPORT

FOR

HVAC SYSTEM

(AHU No.: ……………)


WASH ROOM

PROTOCOL No.:

…………………

EFFECTIVE DATE:

PAGE No.: 16 of 29

8.7 CHECKLIST FOR INSTALLATION :


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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WASH ROOM

PROTOCOL No.:

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PAGE No.: 17 of 29


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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(AHU No.: ……………)


WASH ROOM

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EFFECTIVE DATE:

PAGE No.: 18 of 29


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


Terminal HEPA Filter:

Porosity 0.3 microns (EU-13)

Media Fiberglass media

Type Flange Type

Efficiency 99.97% down to 0.3 Micron


Damper:

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WASH ROOM

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PAGE No.: 19 of 29


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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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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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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PAGE No.: 22 of 29


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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WASH ROOM

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EFFECTIVE DATE:

PAGE No.: 23 of 29


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

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PROTOCOL CUM REPORT

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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


PROTOCOL CUM REPORT

FOR

HVAC SYSTEM

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WASH ROOM

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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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14.0 CONCLUSION:

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15.0 RECOMMENDATION:

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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

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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

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17.0 POST APPROVAL:

REVIEWED BY:

DESIGNATION NAME SIGNATURE DATE

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