PQ Hvac

PSYCHOTROPICS INDIA LIMITED
Plot No-46 & 49, Sector-6A, SIDCUL, Haridwar (Uttarakhand)
Department : Quality Assurance Document No. QA/PQP/AHU/00

Revision No. R-01
Subject: HVAC Performance Qualification Protocol Effective Date. 21.10.2013
Review Date 20.10.2015
Page No. 1 of 22
PERFORMANCE QUALIFICATION
PROTOCOL
FOR
HVAC SYSTEM

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Page No. 2 of 22
INDEX
Sr. No. Contents Page No.
1 PROTOCOL PRE-APPROVAL 3
2 OVERVIEW 4
3. RESPONSIBILITY 9
4. PERFORMANCE QUALIFICATION CHECKS 10
5. DEFICIENCY AND CORRECTIVE ACTION REPORT 17
6. REQUALIFICATION 18
7. FINAL REPORT 19
8. REPORT APPROVAL 20
9. APPENDIX 20
10 DATA SHEET 21

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PRE-APPROVAL
Signing of this Approval page of Performance Qualification Protocol No. QA/PQP/AHU/00, indicates
agreement with the Performance Qualification approach described in this document. Should
Modifications to the Performance Qualification become necessary; an addendum will be prepared and
approved.
Written By Signature Date
Sr.Officer - Quality Assurance
Checked By Signature Date
Executive-Quality Assurance
Head-Production ( Main Block)
Head-Production ( Derma Block)
Head-Quality Control
Head - Engineering
A Approved By Signature Date
Head Quality Assurance


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2.0 OVERVIEW
2.1 Purpose:
The objective of this protocol is to check the performance of the Heating Ventilation and Air
conditioning System (HVAC) and collect sufficient data to assure that it meets the intended purpose.
Performance Qualification Protocol shall provide the Methodology of qualification studies, formats
for recording the observation, Acceptance Criteria of Qualification and a guideline for documentation
of the study.
2.2 Scope
This protocol is applicable to HVAC System, installed at the first floor Second floor of main block &
& ventilation unit installed at second floor of External Block Facility.
2.3 System Description.

2.3.1 General description
HVAC System is designed to provide the required environmental conditions i.e. temperature,
differential pressure and relative humidity in the process area. A Total number of 29 Air Handling
Units at block A and 11 ventilation units at block b are provided in the Psychotropics India limited.
All these air handling and ventilation units cater to different areas of the plant. Dedicated air handling
units are provided for each process area to eliminate any possible potential of cross contamination
from one processing area to another.
The complete HVAC system (which includes Air supply equipment, Air cooling & heating system,
Air distribution network, Air filtration system, Refrigeration system and Instrumentation & control
system) is designed to provide required temperature, relative humidity, differential pressure, air
changes and particle concentration in the controlled area.
Broadly, the entire HVAC system can be functionally grouped under following two heads:
1. High side HVAC system
2. Low side HVAC system
The high side HVAC system comprises of:
1. Water Cooled Screw Chiller (Refrigeration System)
2. Distribution Circuit for Chilled and Cooling water
3. Cooling tower
4. Primary circuit consisting of Primary chilled water pumps.
5. Secondary chilled water circuit consisting of secondary chilled water pumps.

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2.3.2 Refrigeration System (HIGH SIDE)

The Screw Chiller on the high Side of the HVAC System works on the principle of Vapour
Compression Refrigeration system, the principle and operation of which is explained as below:
A. Vapor Compression refrigeration system

In the vapor compression system, the wet vapor as soon as it is formed is admitted into the
compressor from the evaporator at low temperature and pressure. The refrigerant vapors are
compressed to high temperature and pressure due to screwing action of the compressor. This high
temperature vapour is then discharged into the condenser, where in the cooling water (from the
cooling tower) flowing into the condenser coil extracts the latent heat of evaporation from the vapor.
The refrigerant in turn is converted into a high pressure liquid.
This high pressure refrigerant liquid enters the expansion valve wherein the high pressure saturated
liquid is expanded, lowering the temperature and pressure of the fluid causing partial evaporation.
The low pressure refrigerant liquid-vapor after entering the evaporator comes into contact with the
evaporator tubes through which the water to be chilled is circulated. The refrigerant in the liquid
vapor form extracts latent heat from the cooling medium in turn cooling it, producing refrigeration
effect.
On absorbing the latent heat, the liquid refrigerant boils to vapor form, which again is sucked in by
the compressor to complete the cycle.
The cooling medium thus cooled in the evaporator is distributed to the header supplying chilled water
to the different AHUs.
The Major Components of this system are:-

a) Compressor
b) Condenser
c) Expansion Valve
d) Evaporator
a) Compressor:-
The Screw Chiller incorporates a screw type compressor wherein the refrigerant used in the system
(R134a) is compressed by the screwing action of the compressor, this compression is necessary to
bring about a change of state of the refrigerant vapour (high temperature and pressure).
b) Condenser
The refrigerant gas in the compressed form is discharged into condensing unit (condenser). The
condenser is shell and tube type with cooling water flowing through the tubes of condenser and the
Warm refrigerant surrounds the tube in the shell.
c) Expansion Valve:-

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The expansion valve throttles the condensed refrigerant causing its expansion into liquid vapor form.
The expansion valve allows the liquid refrigerant under high pressure in the condenser to pass at
controlled rate into the low pressure part of the system i.e. the evaporator.
d) Evaporator:-
The evaporator is shell and tube type, with to be cooled water flowing through the copper tubes and
the refrigerant vapor in liquid form surrounding the tubes in the shell.
Distribution circuit
The circuit to distribute the chilled water to the cooling water coils in the AHU is fabricated from MS
pipes, which are designed to meet the flow and pressure requirement of the system.
Cooling tower
The warm water from the condenser outlet is sprayed into the cooling tower through nozzles. An axial
flow fan mounted on the cooling tower draws the atmospheric air against the flow of the spraying
water carrying away the heat from the water through a process of heat transfer, in turn cooling the
water. The cooled water is collected in the cooling tower basin and is pumped back into the condenser
inlet repeating the condenser process cycle.
Primary chilled and condenser (cooling) water pumps.

The Primary chilled water pump and condenser water pumps are used to circulate the chilled water
and cooling water into and out of the chiller evaporator and condenser respectively thus facilitating
the smooth functioning of the vapor compression cycle.
Secondary chilled water pumps

The secondary chilled water pumps are used to circulate chilled water through the AHU cooling coils.
The low side comprises of air handling units which include:-

1. Supply fan/Blower.
2. Chilled Water Coil.
3. Hot Water Coil
4. Air filtration system.
5. Air distribution network.
6. Instrumentation and control system.
2.3.3 Air Handling Unit (LOW SIDE)

The major components of the air handling unit are briefly described as below:
2.3.3.1 Blower:
One number of blowers provided in the unit is belt driven by the motor shaft. The blower takes in air
either from the atmosphere or from the rooms as return air, and delivers it to the working areas.
2.3.3.2 Cooling coil


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Chilled water produced by the vapor compression system is circulated through the cooling coils of the
air handling units. The cooling water coils are of 6 rows (½” O.D.) and made up of copper, while the
fins of these coils are made up of aluminum. Air movement within the AHU is effected by the blower
and air passes over the cooling coils, wherein the heat transfer takes place and the air gets cooled.
This cooled air then passes through a network of supply duct and produces cooling effect in the
desired process area.
2.1.2.3 Heating Coil
Hot Water Generated by Hot Water Generator is circulated through the Heating Coils of the Air
Handling Unit. The hot water coils are of 2 rows (½” O.D.) and made up of copper, while the fins of
these coils are made up of aluminum. Air movement within the AHU is effected by the blower and air
passes over the heating coils, wherein the heat transfer takes place and the air gets heated to maintain
the desired relative humidity .This air then passes through a network of supply duct and produces
cooling effect in the desired process area.
2.3.3.4 Air Distribution Network
An air distribution network is provided to supply the air delivered by the blowers in to the working
areas. This network made up of G.I sheet is provided with volume controls dampers, on both supply
and return ducts from the room.
2.3.3.5 Filtration system
Filters are provided at different locations to arrest the contamination of air. The return air from the
room is first passed through a 10 micron filter provided in the return air riser (wherever applicable)
and again through a 10 micron pre-filter inside the air handling unit and It is then passed through a 3
micron intermediate filter (after blower) and then finally, passed through a Plenum mounted 0.3
micron HEPA filter before entering into working area.
2.3.3.6. Instrumentation and Control system

1. Thermostat for controlling the chilled water flow into the coils by actuating a two way valve.
2. Humidistat for controlling the Hot water flow into the coils by actuating 3 way Valve.
DUCTING:
Ducting in the HVAC system plays the role in routing the air from AHU to the corresponding facility.
These ducts are of Box type & are made up of 22G & 24G G.I. sheet.
INSULATION:

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Insulation is done to prevent energy lose due to conduction through the duct surfaces. In the Supply
Ducting insulation is of 50mm EPS Slab Section and in the Return Ducting insulation is of 25mm
EPS Slab Section.
Insulation is also provided to the chilled water pipe line and Hot water pipe line. In the Chilled water
supply line insulation is of 50mm EPS Pipe Section and in the Chilled water Return line insulation is
of 25mm EPS Pipe Section. Glass wool insulation is provided for Hot water lines.
DAMPER:
Dampers are provided to control the air flow in the duct. Dampers are of two types:
Volume Control Damper (VCD): These Dampers control the flow of air in the duct. Three type of
VCDs are there one each for Supply air, Return air & Fresh air volume control damper.
To keep the area in controlled conditions, no. of air changes/hr shall be based on the activities carried
out in the areas. Minimum 10% fresh air intake to keep area with normal oxygen percentage.
Fire Damper: These dampers act as a protecting device in case of fire hazards. These units contain the
fusible links which gets cut off as soon as it senses any smoke. As a result of which the damper gets
closed, thereby creates resistance to the flow of the air.
2.1.3 Ventilation System:
The ventilation system maintains the proper circulation of unconditioned but filtered air in the
areas/rooms where the product is not directly exposed to the atmosphere. This system consists of a
belt driven blower (Air Supply Unit) for delivering the fresh air from the atmosphere to the rooms, a
ducting network, a filtration system and exhaust fan (exhaust unit) to throw out the air from the rooms
to the atmosphere again. The total amount of air delivered into the area/room is thrown out to the
atmosphere by exhaust fans to ensure proper circulation of the air in the ventilated area. The major
components of the ventilation system are:
Blower: -
Same as described under Low Side HVAC (Point 2.1.2.1)
Air Distribution Network: -
Same as described under Low Side HVAC (Point 2.1.2.4)
Filtration System: - Filters are provided at different locations to arrest the contamination of air. The
fresh air from the atmosphere is first passed through 10-micron pre filters and then through 5µ
intermediate filters before entering into the working area. The air inside the room is then thrown out
to the atmosphere through 10µ filters by the exhaust blower in the exhaust unit.
2.3.2 System Identification


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Required Information As-Found Condition
The subjected equipment is identified as HVAC System 2.

3. 3
Name and address of the Manufacturer
Purchase Order Number / Date

Standard Operating Procedure established during Operational Qualification
Title : Operation of Air Handling Units
SOP No. : PIL/SOP/UT/005
3.0 RESPONSIBILITY
The validation group comprising of representatives from each of the following departments shall be
responsible for the overall compliance of this protocol:
Department Responsibility
Preparation and review of the protocol, Execution of the
Quality Assurance protocol after approval and Compilation of the data of the PQ
tests, Preparation and review of the PQ Final Report.
Arranging the contract agency for carrying out the HEPA filter
Engineering/Plant integrity testing and measurement of air velocities of terminal
HEPA filters. Calculation of number of air changes per hr in
each room. Review of the protocol and PQ Final Report.
Review of the protocol, carrying out viable counts monitoring
Quality Control in core areas and reporting the results.
Review of PQ Final Report.
Quality Assurance Approval of the protocol and PQ Final Report.
4.0 PERFORMANCE QUALIFICATION CHECKS
4.1 Purpose:
 The purpose of this protocol is to provide a procedure for the performance qualification of
the HVAC system, to verify that:

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 The HVAC System is performing as intended, to give desired set of environmental conditions
required for manufacturing operations.
 The air velocity and the number of air changes in respective areas are as per acceptance
criteria.
 All the High Efficiency Particulate Air (HEPA) Filters pass the Integrity test.
 The Pressure Differentials, Temperature and Relative Humidity in the different rooms are
maintained as per the acceptance criteria.
 The viable and non-viable particulate count complies with the acceptance criteria.
 The air flow pattern is observed to establish that the supply air flows towards the return air
terminals / risers.
 Recovery test to conclude:
a) The minimum time required for maintaining the required set of environment conditions in the
control area after the ‘start’ of the HVAC system from standstill.
b) To determine the period for the area in returning to its specified cleanliness class limit.
Acceptance criteria for temperatures, Relative Humidity (as where applicable) and Differential
Pressures in different area are define in SOP PIL/SOP/QA/012.
Acceptance criteria for Air Changes per hour (ACPH) in different area in not less than 20.
4.2 Performance Qualification Procedure

4.2.1 Test Instrument Calibration Status
All test instruments shall be checked for their calibration status prior to use.
4.2.2 Performance Qualification Test Details:
For Block A:

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S. No. REQUIRED TESTS TEST INSTRUMENT

1 Air Flow Test Anemometer
2 Integrity Testing of HEPA Filters Aerosol Photometer
3 Non-Viable Particle Count Test Particle Counter

4 Recovery test Particle Counter
5 Viable Particle Count By settle plate method
For Block B:
S. REQUIRED TESTS TEST INSTRUMENT

No.
1 Air Flow Test Anemometer
4.3 Airflow Test
4.3.1 Objective
The purpose of this test is to evaluate airflow to verify that the HVAC system is capable of delivering
required airflow velocities and airflow volumes in the control area for providing required number of
air changes.
4.3.2 Test Apparatus: Anemometer
4.3.3 Procedure
4.3.3.1 This test shall be performed by an authorized external agency competent to carry out the
testing as per the required test standards.
4.3.3.2 Method and formula: Place the Anemometer 2” below the filter surface and record the air
velocities at four corners and center of the filter. Calculate the Average Air Velocity (FPM).
4.3.3.3 Calculate the total air delivered by the filter by using the formula given below.
4.3.3.4 Total Air Flow (CFM) = Average Air Velocity (FPM) x Filter Surface Area (Ft 2).
4.3.3.6 Calculate the total CFM delivered by all the supply filters in the room / control area.
4.3.3.7 Calculate the Number of Air changes per hour (ACPH) in the room by using the formula given
below.

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ACPH= Total Air Flow x 60/ Room Volume

2.3.8 Record the observations and attach the reports.
4.3.4 Acceptance Criteria

The minimum number of air changes should meet the acceptance criteria stipulated in Annexure 03.
4.4 Integrity Test of HEPA Filters
4.4.1 Objective: To verify the integrity of HEPA filters against filter failure due to damage during
transportation, installation or operation.
4.4.2 Test Apparatus
 Aerosol Generator
 Aerosol photometer with logarithmic or linear readout, a nominal sampling flow rate which
is (28 + 0.4) L/min.
4.4.3 Procedure
4.4.3.1 This test shall be performed by an authorized external agency competent to carry out the testing
as per the required test standards.
4.4.3.2 Position the smoke generator so that the PAO aerosol is introduced into the system in the
upstream direction.
4.4.3.3 Scan each filter by holding the photometer probe approximately 1 inch below the filter surface
at a rate of not more than 10 ft / min.
4.4.3.4 Record the observations and attach the reports .
.4.4 Acceptance Criteria:

The leakage of PAO aerosol downstream of each HEPA filter should not be more than 0.01% of the
upstream challenge aerosol concentration.
4.5 Pressure Differential, Temperature and Relative Humidity Test
4.5.1 Objective
To demonstrate the capability of the HVAC System to consistently maintain Differential Pressures,
Temperatures and Relative Humidity in the control areas.
4.5.2 Test Apparatus


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Sling Psychrometer and Magnahelic Gauges.
4.5.3 Procedure
4.5.3.1 This test shall be performed after the System has been operated continuously for 24 hours as
per the laid down SOPs to ensure that the system has been stabilized.
4.5.3.2 All the doors in the facility must be closed and the test shall be carried out “at rest” condition.
4.5.3.3 Record the Pressure Differential, Temperature and Relative Humidity for a period of 72 hours
at an interval of 1 hour for initial 8 hours and if no deviation from the acceptance criteria is observed
record the conditions at an interval of 4 hours for remaining 64 hours and attach the reports in the
Annexure 07.
4.5.4 Acceptance criteria:
The Pressure Differentials, Temperatures and Relative Humidity recorded for 72 hours should meet
the acceptance criteria is defined as per SOP PIL/SOP/QA/028.
4.6 Air Borne Non-Viable Particle Monitoring:
4.6.1 Objective:
To establish that at different locations within the controlled areas, a count of less than specified
number of particles per cubic meter of air of 0.5m or larger is maintained.
5.2 Test Apparatus : Particle Counter
5.3 Procedure
 Particulate cleanliness of the critical and controlled areas shall be evaluated as per the
guidelines of ISO14644 Clean rooms and associated controlled environments, Part1
(Classification of airborne particulates) and Part2 (Specifications for testing and monitoring to
prove continued compliance with ISO14644-1).
 The specified air cleanliness classification of the clean room is ISO Class 8.
 The conformance with the specified airborne particulate cleanliness classification shall be
determined in the “at rest” state.
 The considered particle size is 0.5m.
 The maximum permitted concentration of particles (C n) for the considered particle size (D) is
determined from the formula:

Cn=10N X (0.1/D) 2.08
Where:

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Cn =The maximum permitted concentration (in particles/m3) of airborne particles that are equal to or
larger than the considered particle size. Cn is rounded to the nearest whole number, using no more than
three significant figures.
N=The ISO classification number, which shall not exceed a value of 9
D=The considered particle size in m
0.1=A constant with a dimension of m
The maximum permitted airborne particle concentrations shall be:
For CLASS 8:
Cn=108 X (0.1/0.5) 2.08
=3516757
= Rounded to 3520 000 particles/m3
4.6.3.1 The minimum number of sampling point locations is decided as per ISO14644-1, section B.4
Sampling and B.4.1 Establishment of sampling locations, which is detailed as follows:
Section B.4.1.1
Derive the minimum number of sampling point locations from the formula: -
NL=√A
Where:
NL=The minimum number of sampling locations (Rounded up to a whole number)
A=The area of the clean room or clean air controlled space in m 2.
“Ensure that the sampling locations are evenly distributed throughout the area of clean room and
positioned at the height of the work activity”.
. Based on area for class D and other areas minimum locations should be not less than 5.
4.6.3.2 The Single sample volume per location is decided as per ISO14644-1,
The single sample volume Vs per location is determined by using the formula:
Vs=20/Cn.m X 1000
Where:
Vs=The minimum single sample volume per location expressed in liters
Cn.m=The class limit (number of particles/m 3) for the largest considered particle size specified
for the relevant class.
20=The defined number of particles that could be counted if the particle concentration were
at the class limit.
4.6.3.3. “The volume sampled at each location shall be at least 2 litres with a minimum sampling time
at each location of 1 minute.”
4.6.3.4 “Where only one sampling location is required, take a minimum of three single sample
volumes at that location.”

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Considering 0.5m particle size as the largest considered particle for Specified ISO CLASS 8
areas “at rest” conditions, the minimum single sample volume required shall be (By using the
above formula):
For ISO Class 8:

Vs=20/Cn.m X 1000
=(20/3520000) X1000
=0.00568 Litres
But as per Section B.4.2.2, “The volume sampled at each location shall be at least 2 liters with
a minimum sampling time at each location of 1 minute.” Hence, the samples shall be taken
for 1-minute time and volume drawn shall be 28.34 Liters (1cubic feet).
4.6.3.5 Section B.5.1.2 States, “When only one sample location is used, calculate the average value of
the sample data”.Section B.5.1.3 States, “When more than one single sample volume is taken
at a location, compute the average particle concentration from the individual sample particle
Concentrations”.
5.3.6 Determine the number of sampling locations in the room place the sensor at each of the
location (at working level) and record the observations.
4.6.4 Acceptance Criteria:
The classified area should meet the specified air cleanliness classification and the averages of the
particles concentrations measured at each of the locations should not exceed the limit i.e., 3520 000
particles/m3 for Class 8, for particles equal to or larger than 0.5m.
4.7 Air borne Viable Particle Monitoring:
4.7.1 Objective:
To check and ensure that the control area meets the desired level of area classification with respect to
microbiological counts.
4.7.2 Test Instrument/Sampling aids:
 Media plates
4.7.2 Procedure:
4.7.3.1 Settling plate method:

Media plates containing Soya bean – casein Digest Agar shall be exposed at various locations in
different area/rooms to monitor viable organisms that fall onto the nutrient medium. Monitoring of the
area/rooms shall be done for 3 consecutive days.
The observations shall be recorded in the test report.
4.7.4 Acceptance Criteria:


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Viable Particle Count (cfu/plate/4Hr.): NMT 100

4.8 Area Recovery Test
4.8.1 Objective:
To determine the Non-viable particle count recovery time in the classified areas and the minimum
time required for maintaining the required set of environment conditions in the control area after the
‘start’ of the HVAC system from standstill.
4.8.2 Test Instrument: Particle counter, sling Psychomotor and Stop watch.
4.8.3 Procedure:
a) Simulate the conditions by using fog generator so that the room count (Non Viable particle count)
exceeds the desired class limit. Place the Met one particle counter at the center of the room and record
the particle count at work level. Record the particle count at 1 minute time intervals. Note down the
time taken to attain the specified class limit. Record the particle counts & recovery time and attach
the reports .
b) The minimum time required for maintaining the required set of environment conditions in the
control area should be determined after the starting the AHUs from stand still i.e. at the start of shift
operation once the high side HVAC conditions are established.
The temperature, Relative Humidity and differential pressure in the control area should be recorded
and time required to attain the desired condition should be noted after staring the AHUs from stand
still. The readings of temperature, RH and differential pressure should be taken at an interval of every
5 minutes in the control area. Record the data and attach the test data sheet .
4.8.4 Acceptance Criteria: To be established.
4.9 Air flow Visualization Test:
4.9.1 Purpose: To record the airflow pattern by using a Video Camera and to ensure that it meets the
acceptance criteria.
4.9.2 Test instruments / Materials
(i) Video camera

(ii) Titanium Tetrachloride
4.9.3 Test Procedure
 This test shall be performed by an authorized external agency competent to carry out the
testing as per the required test standard.
 Switch on the AHUs Allow it to run continuously for minimum 15 minutes.


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 Fix the lint free cloth to rod. Pour the titanium tetrachloride on cloth. Hold the same rod
below the supply air filter. Fog generation shall start in the direction of airflow.
 Visually observe the air flow pattern and record the same in the tabular form and attach as
Annexure 12.
 Pictures the direction of fog by the help of a Video camera. Attach the videocassette.
4.9.4 Acceptance Criteria
The video recording of the airflow pattern shall be able to demonstrate the following:
The airflow is from the supply air terminals towards the return air terminal / risers.
5.0 DEFICIENCY (IF ANY) AND CORRECTIVE ACTION REPORT Description of

deficiency and date observed :
______________________________________________________________________________
______________________________________________________________________________
_____________________________________________________________________________
Person, responsible for corrective action and date assigned:

______________________________________________________________________________
__________________________________________________________________
________________________________________________________________________
____________________________________________________________________________
Corrective actions taken and date conducted :

______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
____________________________________________________________________________
Comments:
______________________________________________________________________________
__________________________________________________
______________________________________________________________________________
__________________________________________________________________
Name Signature Date


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Deficiency Reported
by
Corrective action
Conducted by
Checked and certified
by
6.0 REQUALIFICATION
Performance Qualification of HVAC to be requalified in case of:
 Substitution of existing HVAC system with a new system.
 Replacement of installed HEPA-Filter / instrument / component.
 Any major modification in the existing HVAC system after the last performance
qualification.
 System is found to be malfunctioning.
Frequency of Testing Required to Conform with the Standard for ISO 8:

Maximum Time
Sr. No Test Parameters
Interval
01 Air Velocity 12 months
02 Installed Filter Leakage 12 Months
03 Particle Count Test 12 Months
04 Airflow Visualization 24 Months
.
7.0 FINAL REPORT
7.1 Results and Evaluation
Results shall be documented in the test data sheets provided as Annexure to the Protocol. Based on
the observations recorded in the performance qualification tests, evaluation of the results shall be
carried out.

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All the results meeting the acceptance criteria establish that the HVAC System qualifies for all
relevant parameters and can be used for routine jobs.
Failure to meet any of the acceptance criteria requires investigation and initiation of suitable action.
7.2 Summary
On the basis of the results and evaluation, a summary report shall be prepared. The summary report
shall draw a conclusion to state the successful qualification of the HVAC System in a consistent
manner (or) re qualification (if required in case of failure). The summary report shall be attached with
the protocol along with the test reports.
8.0 REPORT APPROVAL
The summary report shall be reviewed by the Quality assurance, User, Quality Control and
Engineering. The final approval of the report shall be done by the Quality Assurance.
8.1 Documentation
A summary shall be prepared which should contain:

 The objective of the study, brief of qualification methodology
 Acceptance criteria
 Summary result
 Summary of any Out of Specification result and actions taken
 Evaluation of result and conclusion.
 Post Approval Signatures
Summary report shall be backed up by Qualification Protocol, Raw data of Test results, Calibration
Certificate and other Reference if any

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9.0 APPENDIX
9.1 Abbreviations and Definitions
HVAC – Humidity Ventilation and Air Conditioning
CFM – Cubic Feet per Minute
CFU – Colony Forming Units
HEPA – High Efficiency Particulate Air
PAO – Polyalfa-olefin
% - Percent
Min. – Minute
Ft. – Feet
mm – millimeter
RH – Relative Humidity
0
C – Degree Centigrade
SOP – Standard Operating Procedure


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Performance qualification Documented verification that the equipment

performs as intended for the process, as specified
by operating ranges .
Acceptance criteria The product , equipment , and /or process

specifications and limits , such as acceptable
quality level and unacceptable quality level , that
are necessary for making a decision to accept or
reject.

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PSYCHOTROPICS INDIA LIMITED

Plot No-46 & 49, Sector-6A, SIDCUL, Haridwar (Uttarakhand)

Department : Quality Assurance Document No. QA/PQP/AHU/00

Department : Quality Assurance Document No. QA/PQP/AHU/00

Sr. No. Contents Page No.

4. PERFORMANCE QUALIFICATION CHECKS 10

5. DEFICIENCY AND CORRECTIVE ACTION REPORT 17

Department : Quality Assurance Document No. QA/PQP/AHU/00

Department : Quality Assurance Document No. QA/PQP/AHU/00

Written By Signature Date

Sr.Officer - Quality Assurance

Checked By Signature Date

Head-Production ( Main Block)

Head-Production ( Derma Block)

A Approved By Signature Date

Head Quality Assurance

Department : Quality Assurance Document No. QA/PQP/AHU/00

2.3 System Description.

Department : Quality Assurance Document No. QA/PQP/AHU/00

2.3.2 Refrigeration System (HIGH SIDE)

A. Vapor Compression refrigeration system

The Major Components of this system are:-

Department : Quality Assurance Document No. QA/PQP/AHU/00

Primary chilled and condenser (cooling) water pumps.

Secondary chilled water pumps

The low side comprises of air handling units which include:-

2.3.3 Air Handling Unit (LOW SIDE)

2.3.3.2 Cooling coil

Department : Quality Assurance Document No. QA/PQP/AHU/00

2.1.2.3 Heating Coil

2.3.3.4 Air Distribution Network

2.3.3.5 Filtration system

2.3.3.6. Instrumentation and Control system

Department : Quality Assurance Document No. QA/PQP/AHU/00

2.1.3 Ventilation System:

2.3.2 System Identification

Department : Quality Assurance Document No. QA/PQP/AHU/00

Required Information As-Found Condition

The subjected equipment is identified as HVAC System 2.

Purchase Order Number / Date

Quality Assurance Approval of the protocol and PQ Final Report.

4.0 PERFORMANCE QUALIFICATION CHECKS

Department : Quality Assurance Document No. QA/PQP/AHU/00

 Recovery test to conclude:

4.2 Performance Qualification Procedure

Department : Quality Assurance Document No. QA/PQP/AHU/00

S. No. REQUIRED TESTS TEST INSTRUMENT

2 Integrity Testing of HEPA Filters Aerosol Photometer

3 Non-Viable Particle Count Test Particle Counter

S. REQUIRED TESTS TEST INSTRUMENT

4.3 Airflow Test

4.3.2 Test Apparatus: Anemometer

Department : Quality Assurance Document No. QA/PQP/AHU/00

ACPH= Total Air Flow x 60/ Room Volume

4.3.4 Acceptance Criteria

4.4 Integrity Test of HEPA Filters

4.4.2 Test Apparatus

4.4.3.4 Record the observations and attach the reports .

.4.4 Acceptance Criteria:

4.5 Pressure Differential, Temperature and Relative Humidity Test

4.5.2 Test Apparatus

Department : Quality Assurance Document No. QA/PQP/AHU/00

Sling Psychrometer and Magnahelic Gauges.