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QUALIFICATION PROTOCOL

Equipment
Equipment Name AIR HANDLING UNIT AHU -20
Number
Protocol Number CDP/QP/AHU-20/01 Effective Date Jun. 2009

QUALIFICATION PROTOCOL

Page No. 1 of 25
QUALIFICATION PROTOCOL
Equipment
Equipment Name AIR HANDLING UNIT AHU -20
Number
Protocol Number CDP/QP/AHU-20/01 Effective Date Jun. 2009

TABLE OF CONTENTS

01.0 PROTOCOL APPROVAL..................................................................3

02.0 OBJECTIVE...................................................................................4

03.0 SCOPE..........................................................................................4

04.0 EXECUTION TEAM.........................................................................5

05.0 EQUIPMENT / SYSTEM DESCRIPTION..........................................5

06.0 ACCEPTANCE AND REVALIDATION CRITERIA...............................8

07.0 TEST PROCEDURE.........................................................................9

08.0 DEFICIENCY AND CORRECTIVE ACTION REPORT.......................20

09.0 SUMMARY AND EVALUATION OF RESULTS.................................22

10.0 APPENDIX..................................................................................24

11.0 FINAL REPORT APPROVAL..........................................................25

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QUALIFICATION PROTOCOL
Equipment
Equipment Name AIR HANDLING UNIT AHU -20
Number
Protocol Number CDP/QP/AHU-20/01 Effective Date Jun. 2009

01.0 PROTOCOL APPROVAL

01.1 Protocol Prepared by

Preparation of this qualification plan is the responsibility of Validation Co-


coordinator.

NAME DESIGNATION SIGNATURE


MAINTENANCE
ENGINEER

01.2 Protocol Checked by

Checking of this qualification plan is the responsibility of Validation Task Force

NAME DESIGNATION SIGNATURE


DY. MANAGER
Mr. M. CHELLAPPA
-PRODUCTION

01.3 Protocol Approved by

Pre approval of this qualification plan is the responsibility of the Head QA

NAME DESIGNATION SIGNATURE

MANAGER -QA

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QUALIFICATION PROTOCOL
Equipment
Equipment Name AIR HANDLING UNIT AHU -20
Number
Protocol Number CDP/QP/AHU-20/01 Effective Date Jun. 2009

02.0 OBJECTIVE
The objective of this protocol is to provide an outline for the Verification
of Performance of Air Handling Unit against the predetermined
acceptance criteria, when operated as per the set standard operating
procedures.

03.0 SCOPE

The scope of this protocol is to establish final

Standard Operating Procedures

Standard Cleaning Procedures

Critical process control checkpoints,

Critical Process control points,

Alert and action limits

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QUALIFICATION PROTOCOL
Equipment
Equipment Name AIR HANDLING UNIT AHU -20
Number
Protocol Number CDP/QP/AHU-20/01 Effective Date Jun. 2009

4.0 EXECUTION TEAM

Name Responsibility Designation Signature


To provide adequate
MAINTENANCE
manpower and
ENGINEER
supervise the execution
activities
To execute the protocol
and to provide sufficient MANAGERPROD
manpower from M/s UCITON
CRP for execution.
To provide protocols/
datasheets and to
EXECUTIVE QA
review the executed
Protocols.

05.0 EQUIPMENT / SYSTEM DESCRIPTION

This AHU-20 unit is designed to handle the Granulation-I. Air handling


unit is a close system, which re-circulates the air free from particulate
matter to different areas.

Dampers (Volume and Fire Control)


At the junction of each branch duct with main duct and split of main
duct, Volume control dampers are provided.

All supply and return air ducts in air handling units and main branches
shall be provided with approved fire dampers of at least 2 hours fire
rating. Fire damper blades shall be one piece folded high strength
galvanized steel construction. In normal position, these blades shall be
gathered and stacked at the frame head providing maximum air passage
and preventing passing air current from creating noise chatter. The
blades shall be held in position through fusible links. In case of fire
intrinsic energy of the folded blades shall be utilized to close the
openings. The thrust from closing of dampers shall operate a limit switch
mounted in the bottom of fire damper within the duct. Closing of this
limit switch shall shut off the power supply to the AHU-20 where by
stopping the air flow unstintingly.

Capacity

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QUALIFICATION PROTOCOL
Equipment
Equipment Name AIR HANDLING UNIT AHU -20
Number
Protocol Number CDP/QP/AHU-20/01 Effective Date Jun. 2009

The AHU-20 has a capacity of 6250 CFM supplies to the granulation-I.


This AHU-20 covers Ground floor of process areas

S.No Floor Area Class


1. Ground Granulation-I 1,00,000

05.0 EQUIPMENT / SYSTEM DESCRIPTION


The HVAC system consists of:
i. Air Circulation System
ii. Air Cooling & Heating System
iii. Air Distribution System
iv. Air Filtration System

FUNCTION: The system is designed to circulate the air in the area after
passing it over cooling and heating coils to maintain the required
environmental conditions and passing it through the series of filters to
maintain desired cleanliness level in the area. The air in-take and out-take of
the system is designed to maintain certain degree of pressure gradient in the
area as per the requirement. The major components of the air-handling unit
are briefly described as below:

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QUALIFICATION PROTOCOL
Equipment
Equipment Name AIR HANDLING UNIT AHU -20
Number
Protocol Number CDP/QP/AHU-20/01 Effective Date Jun. 2009

5.1 AIR CIRCULATION SYSTEM


5.1.1 Supply Blower: Supply blowers are provided in the unit to supply
air in the working area. This blower is belt driven by a motor. The
blower takes the air from the atmosphere and / or from the rooms
as return air and delivers it to the working areas through air
distribution network.
5.1.2 Return Blower: AHU-20 is equipped with Return blowers to pick
air from the working area. This blower is belt driven by a motor.
The blower takes the air from the rooms as return air and delivers
it in Mixing Chamber to get it mixed with fresh air. During de-
fumigation, this blower is to be used at exhaust blower.
5.2 AIR COOLING AND HEATING SYSTEM
5.2.1 Cooling Coil: Chilled water produced by a water chilling plant is to
be circulated into the chilled water coils of air handling units. Air
passes through the coil and in turn gets cooled. Cooling coil is
placed after the pre filters in coil section of AHU-20
5.2.2 Heating Coil: Hot water produced by a hot water tank is to be
circulated into the hot water coils of air handling units. Air passes
through the coil and in turn gets hot. Heating coil is placed after
the cooling coil in coil section of AHU-20
5.3 AIR DISTRIBUTION SYSTEM
5.3.1 Air Distribution Network: An air distribution network is provided
to supply the air, delivered by the blowers, into the working areas.
By using the same network, return air flows back to the air
handling unit to maintain certain pressure gradient and other
parameters like temperature & RH.
5.4 AIR FILTRATION SYSTEM

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QUALIFICATION PROTOCOL
Equipment
Equipment Name AIR HANDLING UNIT AHU -20
Number
Protocol Number CDP/QP/AHU-20/01 Effective Date Jun. 2009

5.4.1 Fresh Air Filters: Pre filters having filtration efficiency upto 90%
down to 10 are provided in the Fresh air suction to filter out
heavy dust particles from the fresh air and to avoid chocking of
cooling and heating coils.

5.4.2 Secondary Filters: Fine filters having filtration efficiency up to


99% down to 5 are provided after the cooling and heating coils to
remove fine particles up to 5 from the treated air.

06.0 ACCEPTANCE AND REVALIDATION CRITERIA

06.1 ACCEPTANCE CRITERIA

06.1.1 The air velocity and air changes should be less than the design criteria

06.1.2 The particle count of the area should not be more than 1,00,000 (
0.3 size) and 700 ( 5.0 size) per cubic feet under At Rest
Condition.

06.1.3 Temperature of the all areas should be 25 2OC and Relative Humidity
Between 50 5%.

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QUALIFICATION PROTOCOL
Equipment
Equipment Name AIR HANDLING UNIT AHU -20
Number
Protocol Number CDP/QP/AHU-20/01 Effective Date Jun. 2009

07.0 TEST PROCEDURE

07.1 AIR VELOCITY AND AIR CHANGES TEST

a) Purpose

To demonstrate that the air system is balanced and capable of delivering


sufficient air volume to maintain a minimum cross sectional velocity
under the absolute filter.

b) Equipment and Instrument


Anemometer Make -Millipore Model MP - 212

c) Procedure

07.1.1 These tests are executed in every room where an diffuser / grill is
installed.

07.1.2 Keep the Anemometer range as 0 - 1500 FPM.

07.1.3 Keep the probe at 1.5 to 2 below the Diffuser / grill and velocity
recording to be noted.

07.1.4 Each diffuser / grill requires minimum 5 tests spots. Measure the air
velocity at 4 corners of the diffuser/grill and one at the center.

07.1.5 Allow no object within 10 ft of the Anemometer. Minimize the no of


people during at rest testing.

07.1.6 Reading should be taken for a minimum of 15 seconds.

07.1.7 Calculate the CFM and Air changes.

NOTE
5% variation of actual CFM with respect to the Design CFM is
acceptable at each outlet. However the Total CFM in a room
should not be less than the Design CFM.

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QUALIFICATION PROTOCOL
Equipment
Equipment Name AIR HANDLING UNIT AHU -20
Number
Protocol Number CDP/QP/AHU-20/01 Effective Date Jun. 2009

All Damper positions are marked permanently after air


balancing.

V1 V2

V3 V4
Calculations

1. Total Air Flow CFM

Air Velocity in FPM x Area of Diffuser/GrillWhere, FPM is Feet per minute


CFM is Cubic Feet per minute
2. Air Changes

Total CFM x Time (60 minutes)


__________________________
Volume of Room (ft3)

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QUALIFICATION PROTOCOL
Equipment
Equipment Name AIR HANDLING UNIT AHU -20
Number
Protocol Number CDP/QP/AHU-20/01 Effective Date Jun. 2009

d) TEST RESULTS

i) ROOM DETAILS :

Room Name Length Width Height Area


(Cu. ft)
Granulation - I
25 25 10 6250

e) Acceptance Criteria

5% of variation on actual CFM with respect to the design CFM is


acceptable at each outlet. However the total CFM in a room should not
be less than the desired CFM.

f) Conclusion

The Air Velocity (CFM) and air changes per hour (ACPH) of the AHU-20
Complies/ Not complies with the acceptance criteria.

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QUALIFICATION PROTOCOL
Equipment
Equipment Name AIR HANDLING UNIT AHU -20
Number
Protocol Number CDP/QP/AHU-20/01 Effective Date Jun. 2009

07.2 FILTER INTEGRITY TEST

a) Purpose

To ensure that the filters installed are not damaged during transit,
installation or operation and / or fixed properly in the appropriate place,
such that there is no leakage from the filter media and the other joint
gaskets, frames etc.

c) Procedure

07.2.1 Filter integrity test is performed after Operational air velocities have
been verified and adjusted.

07.2.2 Introduce the DOP cloud / Aerosol as a challenge agent into the
upstream side of the filter system and searching for leaks down
stream with an aerosol photometer.

07.2.3 Adjust the aerosol photometer such that the pressure is in the range
of 1to 2
kg/cm2.

07.2.4 Position the smoke generator to the pre-filter so that DOP aerosol will
be introduced into the upstream system ahead of filters.

07.2.5 Once the 100% setting are established at the upstream side turn the
instrument
Knob to down stream. Keep the scanning probe 1 below the filter
grill, and start scanning the filter face area and fitment of filter with
frame.

Ensure that the scanning speed does not exceed 10 ft /min


velocity.
07.2.9 Make separate passes with the photometer probe, ground the entire
periphery of the filter, along the bond between filter medium and
frame and along other joints in the filter.

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QUALIFICATION PROTOCOL
Equipment
Equipment Name AIR HANDLING UNIT AHU -20
Number
Protocol Number CDP/QP/AHU-20/01 Effective Date Jun. 2009

07.3 TEMPERATURE, RELATIVE HUMIDITY MONITORING

a) Purpose

To demonstrate that the Air Handling Unit is capable of achieving the


desired set of environmental conditions (Temperature, RH in the
subjected area / room.)

c) Procedure

07.3.1 Execute these tests after all the balancing procedures have been
concluded.

07.3.2 Air conditioning system should be in operation for at least 24 hour


prior to performing this test.

07.3.3 All lights in the subjected room should be kept ON during the testing
as well as during the preconditioning period.

07.3.4 Record the temperature, Relative Humidity for 72 hours at the time
interval of 1 hour.

07.3.5 This test should be carried out at rest (Static) and In operation
(dynamic) conditions.

7.3.6 Plot the trend charts for the studied parameters*.

d) Test Results

Record the Temperature and Relative Humidity in Table: 1 At Rest


Condition.

Record the Temperature and Relative Humidity in Table: 2In


Operation Condition.

Table No: 1 Environmental Control Recording Chart for At rest


Condition

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QUALIFICATION PROTOCOL
Equipment
Equipment Name AIR HANDLING UNIT AHU -20
Number
Protocol Number CDP/QP/AHU-20/01 Effective Date Jun. 2009

Granulation I
Time (Hrs)
Temp. (C) RH (%)

Table No: 2 Environmental Control Recording Chart for At rest


Condition

Time Granulation I
(Hrs) Temp. (C) RH (%)

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QUALIFICATION PROTOCOL
Equipment
Equipment Name AIR HANDLING UNIT AHU -20
Number
Protocol Number CDP/QP/AHU-20/01 Effective Date Jun. 2009

d) Acceptance Criteria

Temperature : 25 2C
Relative Humidity : 50 5%

e) Conclusion
Temperature and relative humidity monitoring of GranulationI AHU-20
was (At rest condition) Complies / Not Complies with acceptance
criteria.

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QUALIFICATION PROTOCOL
Equipment
Equipment Name AIR HANDLING UNIT AHU -20
Number
Protocol Number CDP/QP/AHU-20/01 Effective Date Jun. 2009

Table No: 3 Environmental Control Recording Chart for In


Operation Condition

Time Granulation I
(Hrs) Temp. (C)
RH (%)

Table No: 4 Environmental Control Recording Chart for In


Operation Condition

Granulation I

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QUALIFICATION PROTOCOL
Equipment
Equipment Name AIR HANDLING UNIT AHU -20
Number
Protocol Number CDP/QP/AHU-20/01 Effective Date Jun. 2009

Time
Temp. (C)
(Hrs)
RH (%)

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QUALIFICATION PROTOCOL
Equipment
Equipment Name AIR HANDLING UNIT AHU -20
Number
Protocol Number CDP/QP/AHU-20/01 Effective Date Jun. 2009

d) Acceptance Criteria
Temperature : 25 2C
Relative Humidity : 50 5%

e) Conclusion
Temperature and relative humidity monitoring of Granulation-I AHU-20
was (At rest condition) Complies/ Not Complies with acceptance
criteria.

07.4.6 In case there is a deviation from acceptance criteria, various


components related to the system operation are need to be reviewed
and accordingly adjustments to be done.

d) Acceptance Criteria

Class 100 000


0.3 Micron Not more than 100 000 5.0 Micron Not more
than 700

Note
The particle Count locations for the specified
clean room shall be enclosed with the results sheet.

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QUALIFICATION PROTOCOL
Equipment
Equipment Name AIR HANDLING UNIT AHU -20
Number
Protocol Number CDP/QP/AHU-20/01 Effective Date Jun. 2009

08.0 DEFICIENCY AND CORRECTIVE ACTION REPORT

08.1 Description of deficiency and date observed

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08.2 Person responsible for corrective action and date assigned

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QUALIFICATION PROTOCOL
Equipment
Equipment Name AIR HANDLING UNIT AHU -20
Number
Protocol Number CDP/QP/AHU-20/01 Effective Date Jun. 2009

08.3 Corrective actions taken and date conducted

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SIGNATURES
Conducted By: Date:

Approved By: Date:

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QUALIFICATION PROTOCOL
Equipment
Equipment Name AIR HANDLING UNIT AHU -20
Number
Protocol Number CDP/QP/AHU-20/01 Effective Date Jun. 2009

09.0 SUMMARY AND EVALUATION OF RESULTS

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QUALIFICATION PROTOCOL
Equipment
Equipment Name AIR HANDLING UNIT AHU -20
Number
Protocol Number CDP/QP/AHU-20/01 Effective Date Jun. 2009

09.1 FINAL REPORT

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QUALIFICATION PROTOCOL
Equipment
Equipment Name AIR HANDLING UNIT AHU -20
Number
Protocol Number CDP/QP/AHU-20/01 Effective Date Jun. 2009

10.0 APPENDIX

ABBREVIATIONS
AHU Air Handling Unit

AMP Ampere

CFM Cubic Feet per Minute

Db Decibels

DOP Di Octyl Pthylate

DP Differential Pressure

FPM Feet Per Minute

G.I. Galvanized Iron

HVAC Heating Ventilation and Air Conditioning

MOC Material Of Construction

PUF Poly Urethane Foam

RH Relative Humidity

SOP Standard Operating Procedure

Sq.ft Square feet

UCL Upper Confidence Limit

URS User Requirement Specification

Micron

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QUALIFICATION PROTOCOL
Equipment
Equipment Name AIR HANDLING UNIT AHU -20
Number
Protocol Number CDP/QP/AHU-20/01 Effective Date Jun. 2009

11.0 FINAL REPORT APPROVAL

11.1 Prepared by

The Signature indicates that the qualification protocol was executed and all
tests cases and discrepancies were properly documented.

NAME DESIGNATION SIGNATURE DATE


MAINTENANCE
ENGINEER

11.2 Checked by

The Signature indicates that qualification, documentation and reports have


been reviewed and they meet the requirements specified.

NAME DESIGNATION SIGNATURE DATE

EXECUTIVE- QUALITY
ASSURANCE
MANAGER-
PRODUCTION

11.3 Approved by

The Signature indicates that the results have been reviewed and is in
agreement with those results and their conclusions.

NAME DESIGNATION SIGNATURE DATE

MANAGER- QA

Now the equipment is READY FOR ROUTINE USE.

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