HVAC Qualification

Module Number: TP/00026/R0

•
 Index

 Objectives
 Basics of HVAC
 Basic Refrigeration Cycle.
 Air changes Calculation.
 Filtration in HVAC.
 Air Lock Types
 Classification of Air Cleanliness
 Clean Room and Contaminants
 Design of HVAC
 Qualification Tests Procedure

2
 Objective

• To understand HVAC System

3
 Basics of HVAC

• Heating, ventilation, and air conditioning (HVAC) is the process or

mechanism, designed to control the environment in the manufacturing as
well as the storage area of the pharmaceutical facility
• Types of HVAC
 Constant Volume Systems
Once –thru Air – Air is conditioned, enters the space and is
discarded
Recirculated Air - Air is conditioned, enters the space and portion
is reconditioned. Some may be discarded.

 Variable Air Volume Systems

Recirculated Air - Air is conditioned, enters the space and portion
is reconditioned. Some may be discarded

4
 Basics of HVAC

• Parameters controlled through HVAC

 Temperature
 By adding heat or by removing heat
 Relative Humidity
 Humidification through addition of water vapor
 De humidification by removing the water vapor by bring down the air
temperature to Dew point and by using absolute moisture eliminator
 Maintaining the O2 Level
 By addition of Fresh air
 Control airborne particles, dust and micro-organisms
 Through filtration.
 Cross contamination
 By differential pressure

5
 Basics of HVAC

• Major components of HVAC system

 AHU , Chilling plant , Hot water generator, Dehumidifier Unit, Boiler ,
Ducting , Piping and control system/Building Management system.
 Treated fresh air system, Exhaust systems /Ventilation unit

6
BASIC REFRIGERATION CYCLE

7
 Air changes Calculation
 Total room Air flow = Air velocity X Effective Grill Size

 Air changes = Total room Airflow X 60

-----------------------------------
Volume of the room
Eg:
Air flow = 1784 CFM
Volume of the room = 3364
No of Air changes = [1784 X 60]/3364 = 32 ACPH.
CFM = Cubic Feet per minute
ACPH = Air changes per hour.

8
 Filtration in HVAC

• The filtration system is the heart of a cleanroom. The filters are designed to filter
the particulates in the air down to sub-micron sizes. The “standard high efficiency
particulate air” (HEPA) filter will filter the air down to 0.3 microns at an efficiency
or 99.975%. The “ultra low particulate air (ULPA) filter” will filter the air down to
0.12 microns at an efficiency of 99.999%

• Filter Effectiveness
The ability of a filter to remove particles from the air is reflected by its
efficiency rating. The American Society of Heating, Refrigerating, and
Air Conditioning Engineers (ASHRAE) has developed a standard for measuring filter
effectiveness. The standard describes test procedures to classify filters in terms of
arrestance and efficiency. Two terms are commonly used.

9
 Filtration in HVAC
Air Filter Arrestance

Arrestance is a measure of the ability of an air filtration device to remove synthetic

dust from the air.

The arrestance describes how well an air filter removes larger particles - such as dirt,
lint, hair, and dust. ASHRAE arrestance is a measure of the ability of a device to
remove ASHRAE dust from test air.

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 Filtration in HVAC

Air Filter Efficiency

Efficiency describes how well an air filter removes microscopic particles - such as dust,
dust mites, pollen, mold, bacteria, and smoke.

In the ASHRAE 52.1 Standard test method, efficiency is a measure of ability to remove
the staining portion of atmospheric dust from test air - officially termed "Atmospheric
Dust Spot Efficiency".

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 Airlock types

1.
2

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 Classification of air cleanliness

ISO 14644-1 Classification of air cleanliness

ISO 14644-2 Testing & monitoring to prove compliance

ISO 14644-3 Methodology and test methods

ISO 14644-4 Clean room design construction & startup

ISO 14644-5 Clean room Operations

ISO 14644-6 Terms, definitions & units

ISO 14644-7 Enhanced clean Devices

ISO 14644-8 Molecular contamination

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 ISO 14644 -1 Classification
CLASS LIMITS (particles/m3)
ISO
Maximum concentration limits (particles/m3 of air) for particles equal to and larger
classification than the considered sizes shown below
number (N)
0.1 um 0.2 um 0.3 um 0.5 um 1 um 5 um

ISO Class 1 10 2        

ISO Class 2 100 24 10 4    

ISO Class 3 1000 237 102 35 8  

ISO Class 4 10000 2370 1020 352 83  

ISO Class 5 100000 23700 10200 3520 832 29

ISO Class 6 1000000 237000 102000 35200 8320 293

ISO Class 7       352000 83200 2930

ISO Class 8       3520000 832000 29300

•
ISO Class 9       35200000 8320000 293000

Note: Uncertainties related to the measurement process require that concentration data with no more than three
significant figures be used in determining the classification level.

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 Clean room and Contaminants

• Clean room is a controlled environment in which the concentration of

airborne particles (Contamination) is controlled to Specified limits

 The presence of unwanted materials such as dust and particles during

the manufacturing and transportation time is called contamination.
The term contaminants includes any unwanted matter that is found
in the product which is measured in terms of particulate matter.
• What is Particulate? Simply stated, airborne particles are solids suspended
in the air
• External sources consist of the following:

 Outside make-up air introduced into the room: this is typically the
largest source of external particulates
 Infiltration through doors, windows and other penetration through
the cleanroom barriers

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 Clean room and Contaminants

•Control Action:
Make-up air filtration
Room pressurization
Sealing of all penetrations into the space

•Internal sources consist of the following:

People in the clean area: people are potentially the largest source of internally generated particulates
Cleanroom surface shedding
Process equipment
Material ingress
Manufacturing processes

•Control Action:

Design airflow path to shield humans from surroundings

Use of air showers [to continually wash occupants with clean air]

Using hard-surfaced, non-porous materials such as polyvinyl panels, epoxy painted walls, and glass board
ceilings

Proper gowning procedures, head wear

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 Design of HVAC
• Basic Input parameters
 Room size and layout

 Area Classification

 Temperature and RH requirements

 Type of equipment installed and type of operations

 Source of sensible Heated generated within the room

 DP across adjacent rooms

 No of people presence

 No of times door opened and closed.

 Fixed openings.

 Type of building martial used

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 Design of HVAC

• Out put parameters

 AHU capacity in terms of CFM

 Cooling and heating load required in terms of TR / Kw
 Static head required
 Filtration system
 Control system
 Size of the ducting
 Fresh air CFM

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 A Qualification approach for HVAC systems

URS- User Requirements

DQ - Design Qualification

IQ - Installation Qualification

OQ - Operational Qualification

PQ - Performance Qualification

RQ - Re- Qualification

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 Frequency of tests performed
Performance

•
RQ Evaluation
Test
S No. PQ (5 years
Description Every Every Two
Once)
One Year Year
Air Flow Velocity and No. of Air
1 √ √ √ -
changes Test
2 Containment Leak Test √ - - -

3 Filter System Leakage Test √ √ √ -

4 Air Pressure Difference Test √ √ - -

Air Flow Direction and Visualization
5 √ √ - √
Test
6 Temperature and Relative Humidity Test √ - - -

7 Non-viable Particle Count Check √ √ √ -

√
√ √
8 Recovery Test (Grade -
(Grade C) (Grade C)
C)
9 Viable Particle Count Check √ √ - -
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 1. Air velocity Test
Purpose:
To verify the air system is capable of delivering sufficient air volume to maintain cross sectional
velocity and the air is circulated sufficiently within area.

Tools required: Anemometer.

TEST PROCEDURE:
• This test shall be carried out at each supply air grills.
• Check the air velocity at approximately 150mm to 300mm from the filter face.
• Each measurement shall be taken for at least 10 seconds.
• Each grill shall be checked at least for 5 test spots and average velocity shall be Recorded
• Cumulative total volume of air received at the terminal supply air points shall be made.
• Total volume shall be multiplied with the effective opening surface area of the grill.
• Thus the total airflow is calculated and No of air changes
• ACCEPTANCE CRITERIA:
The average air velocity and No. of air changes should be within the design limit

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 Air velocity test EQUIPMENT:

Vane type anemometer

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 Velocity and CFM report

REPORT OF AIR VELOCITY TEST

TEST REPORT REFERENCE SSEPL / AV - AHU18 / TR / 2015 - 2016
CLIENT M/s. Strides Shasun Limited
SITE Pondicherry
AREA / EQUIPMENT UNDER TEST AHU - 18
DATE OF TESTING 06.03.2016
TESTED BY Mr. G. Ananthan of M/s. Shree Sulaj Envirotech Pvt. Ltd.
IN THE PRESENCE OF Mr. E. Murugan of M/s. Strides Shasun Limited
Details of Test Equipment's Used
Vane Type Anemometer of make "LUTRON, model AM4201 bearing serial number Q843429 Calibrated on 02/07/2015 and Calibration Valid up to
02/07/2016 Vide Calibration Certificate No. MTO 0964-01/15-16 - Dt 02/07/2015 of M/s. Macro Calibration Services, Chennai.
Results of measurement at the Grille face:
Average
Velocity readings Eff. Filter Airflow Total
velocity Room Vol. Air Changes per Hour
Location Grille Ref. Area in Sq.
in fpm in fpm Rate in CFM in cft
ft.
V1 V2 V3 V4 V5   CFM   Achieved Designed
SAG/18/1 120 110 110 120 120 116 2.8 325
Blister SAG/18/2 110 110 120 110 110 112 2.8 314
1333 2155 37 ≥ 35
Packing - II SAG/18/3 110 100 130 120 130 118 2.8 330
SAG/18/4 150 130 110 130 130 130 2.8 364
SAG/18/5 150 120 110 130 150 132 2.8 370
Blister SAG/18/6 160 150 130 150 160 150 2.8 420
1652 2663 37 ≥ 35
Packing - I SAG/18/7 170 140 140 160 160 154 2.8 431
SAG/18/8 160 130 150 170 160 154 2.8 431
Note: To Calculate Air Changes (ACPH) = Total Air Quantity (CFM) x 60 / Room Volume (Cu.ft).

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 2. Containment Leak test :
Purpose:

To check the leakage of unfiltered air into the clean room from the lights, trapdoor and coving.

Tools required:
Anemometer.

Test procedure:

Before starting the test, switch off the ahu.

Check the air velocity at distance of not more than 5cm from the lights, trapdoor and coving.
Each measurement shall be taken for at least 15 seconds.
Each lights, trapdoor and coving shall be checked and velocity shall be recorded.

ACCEPTANCE CRITERIA:

The airflow velocity should be zero

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 3. HEPA filter integrity test
Purpose:

To check the leakages in the HEPA filters.

Tools required:
Aerosol generator
Di Octyl phthalate (or) poly alpha olefin
compressed air
aerosol photometer
 

Acceptance Criteria:
For the fixed filters if any leak observed should be less than 0.01%.

25
 3. HEPA filter integrity test

Test procedure :
Remove the grills / diffuser from the filter frame.
Di Octyl phthalate (or) poly alpha olefin aerosol shall be generated with the particle size of
0.5µm to 0.7µm using compressed air purging through generator chamber at a pressure of
20psi. The aerosol generated shall be fed into the AHU fresh air inlet by opening the fresh
air damper. Ensure the aerosol concentration in the upstream of filter face is around 20 to 80
mg/m3. Set the upstream concentration as 100% in the photometer. Scan the filter
downstream for leakage through photometer at the distance of approximately 3cm from the
filter and record the penetration level
Photometer scanning probe shall be traversed at a scan / sampling rate of not exceeding
5cm/sec by using slightly overlapping strokes.
Scanning shall be performed at entire face of filter, seal between the filter frame, gasket,
edges and grid structure.
Once the test is completed, set the fresh air dampers to its original position, fix the grills /
diffuser in to the filter frame and ensure the room differential pressure is within the limit.

Record the same in the integrity test report

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 REPORT OF FILTER INTEGRITY TEST
REPORT OF FILTER INTEGRITY TEST USING PAO AEROSOL
TEST REPORT REFERENCE SSEPL / FI / TR / 2015 - 2016
CLIENT M/s. Strides Shasun Limited
SITE Formulation Division, Pondicherry
EQUIPMENT/AREA UNDER TEST AHU 18
DATE OF TESTING 06.03.2016
TESTED BY Mr. G. Ananthan of M/s. Shree Sulaj Envirotech Pvt. Ltd.
IN THE PRESENCE OF Mr. E. Murugan of M/s. Strides Shasun Limited
DETAILS OF THE TESTING EQUIPMENT USED
"TEC Services, Inc., USA", Model No. PH 5 " Aerosol Photometer" having Serial number 1862 calibrated on 09.06.2015 and valid upto 09.06.2016 vide
Calibration certificate No. CC/TVSPL-042P-SN-1862/15-16 dated 09.06.2015 of M/s. Technovalue Solutions Pvt. Ltd., Mumbai.
2. Laskin Nozzle PAO generator.
FILTER INTEGRITY TEST PROCEDURE
The filter under test is challenged with an aerosol produced by mixing the output of the Laskin nozzle PAO generator with ambient air resulting in an
upstream aerosol PAO concentration of around 10 mcg / lit. The compressed air pressure is maintained at 20 psi. The test is conducted at the operating air
flow volume of the equipment under test. 100% and 0 % settings are done on the photometer for the relevant aerosol and the filter is scanned for leaks.
The maximium allowable leak is 0.010%.
Results of measurement at the Filter Face:
Location Filter No. Upstream concentration % Measured Leakage % Result Remarks
SAG/18/01 100% 0.000% Passed NIL
SAG/18/02 100% 0.000% Passed NIL
Blister Packing - II
SAG/18/03 100% 0.000% Passed NIL
SAG/18/04 100% 0.000% Passed NIL
SAG/18/05 100% 0.002% Passed NIL
SAG/18/06 100% 0.000% Passed NIL
Blister Packing - I
SAG/18/07 100% 0.000% Passed NIL
SAG/18/08 100% 0.001% Passed NIL
SAG/18/09 100% 0.001% Passed NIL
SAG/18/10 100% 0.000% Passed NIL
Bulk Packing - I
SAG/18/11 100% 0.000% Passed NIL
SAG/18/12 100% 0.000% Passed NIL
SAG/18/13 100% 0.002% Passed NIL
SAG/18/14 100% 0.000% Passed NIL
SAG/18/15 100% 0.001% Passed NIL
Bottle Packing - I
SAG/18/16 100% 0.000% Passed NIL
SAG/18/17 100% 0.000% Passed NIL
SAG/18/18 100% 0.000% Passed NIL 27
 4. Pressure difference test

Purpose:
To verify the pressure difference in the each area which is controlled by the AHU as per the
design qualification

Tools required:
Magnehelic gauge (OR) Digital monometer
 
Test procedure for Room:
Pressure difference shall be noted using a Magnehelic gauge (OR) Digital manometer
connecting one end to the room to be tested and another end to the adjacent area.

Test procedure for Corridor:

Pressure difference shall be noted using a Magnehelic gauge (OR) Digital manometer
connecting one end to the corridor to be tested and another end to the atmosphere

ACCEPTANCE CRITERIA:
The pressure difference should be within the design limit (5 to 20 Pascal)
For Corridor: NLT 20 pascal

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 Pressure Control Test Report

REPORT OF PRESSURE CONTROL TEST

TEST REPORT REFERENCE SSEPL / DP - AHU 18 / TR / 2015 - 2016

CLIENT M/s. Strides Shasun Limited

SITE Formulation Division, Pondicherry

AREA / EQUIPMENT UNDER TEST AHU 18

DATE OF TESTING 06.03.2016

TESTED BY Mr. G. Ananthan of M/s. Shree Sulaj Envirotech Pvt. Ltd.

IN THE PRESENCE OF Mr. E. Murugan Of M/s. Strides Shasun Limited

Differential Pressure Gauge of make Sensocon bearing serial no. S14022892
DETAILS OF EQUIPMENT USED calibrated on 29.04.2015 and valid upto 29.04.2016 vide certificate No.
LK/C/PS/14672

Room Name Pressure in Pascal With Respect to Acceptable Range in Pascal

Blister Packing - II 16 Corridor 5 - 20

Blister Packing - I 14 Corridor 5 - 20

Bulk Packing - I 14 Corridor 5 - 20

Bottle Packing - I 12 Corridor 5 - 20

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 5. Nonviable particle count test

Purpose:
To verify the airborne particles in the clean room area are within the design requirement
Tools required: Light scattering laser particle counter
Test procedure :
This test shall be carried out only after the velocity and over all penetration tests are completed
successfully. While taking the room particle count it is suggested to take the reading in the plane of the
work activity or 30” – 40” above the floor level.
The minimum number of sampling location to be tested shall be selected based on the Area of clean
room.
ACCEPTANCE CRITERIA:
No of 0.5 Micron and Larger Particles per Cubic meter volume of air shall not exceed 35,20,000 for
ISO class-8 and should not exceed 3,52,000 for ISO class-7.

No of 5 Micron and Larger Particles per Cubic meter volume of air shall not exceed 29,300 for ISO
class-8 and should not exceed 2,930 for ISO class-7.

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 Nonviable particle count test considerations

The minimum sample volumes for each of the grade areas & number of days monitoring is listed in table below.

Minimum Sample volume in

Number of Number of
litters
Type of testing days testing days at
Sl. No. Area Grade
qualification at Rest In Operation
At Rest In Operation
condition condition

1 Initial Qualification Grade “A” 1 M3 1 M3 1 Day 3 Days

2 Initial Qualification Grade “B” 1 M3 * 1 Ft3 1 Day 3 Days

3 Initial Qualification Grade “C” * 1 Ft3 * 1 Ft3 1 Day 3 Days

4 Initial Qualification Grade “D” * 1 Ft3 NA 3 Days NA

5 Re-Qualification Grade “A” # NA 1 M3 NA 1 Day

6 Re-Qualification Grade “B” * 1 Ft3 * 1 Ft3 1 Day 1 Day

7 Re-Qualification Grade “C” * 1 Ft3 * 1 Ft3 1 Day 1 Day

8
* Minimum 3Re-Qualification Grade
samples shall be taken “D” identified
at each * 1 Ftsampling location
3
NA 1 Day
with minimum sampleNA
volume of 1ft 3 of air
during the study. The sample volume of 1ft3 shall be reported in M3.

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 Particle count test report

Particle count tester

Laser particle counter

32
 6. Particle Recovery test

Purpose:
To demonstrate whether the installation is capable of returning to cleanliness level
within a defined period, after being exposed briefly to a source of airborne particulate challenge.
This test shall be performed for Grade “B” & Grade “C” areas.
This recovery test shall be performed once in six months (during re-qualifications) only for
aseptic filling area & the frequency of recovery test for remaining areas is once in two years as
per VMP.
Tools required: Light scattering laser particle counter.
Test procedure for Room:
Take the particle count reading while the AHU is in operation as per the clean room layout.
Switch off the AHU and expose these areas to the atmosphere to accumulate the maximum
number of particles in the clean room by opening all doors / increase the particle concentration to
100 or more times the target cleanliness level by using aerosol.
Close the doors and Restart the AHUs, note down the reading till the particle count in the results
meet or nearer to the results obtained before switch off the AHU within acceptance criteria.
Note down the time taken to regain the initial conditions of clean room.

ACCEPTANCE CRITERIA:
The recovery time should not be more than 20 minute

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 7. Air flow pattern test

Purpose:
To check the air flow pattern in the environmental air supplied areas.
Tools required:
Dry ice (OR) Titanium tetra chloride and Digital video camera.
Test procedure:
Inform to QA department and the user department before the execution of activity.
Ensure the area and equipment shall be in cleaned condition. Ensure the differential
pressure in the tested room and their adjoining rooms are within the designed limit.
Ensure the Dry ice (OR) Titanium tetra chloride shall be placed to near the supply grill.

Start the respective AHU. In presence of QA personnel generate the smoke.

For results recording provision of video shooting shall be made.
Intense smoke will be generated showing the airflow direction.
Take the video shooting from upside down towards the return filter.
Preserve it as smoke test result records and hand over the recorded CD to QA

34
 The Air Flow Pattern

35
 7. Air flow pattern

36
 8. Temperature and RH mapping

Objective:
To demonstrate the ability of the AHU system to provide temperature and RH
of the area within the specified range.

Equipment Used:
Calibrated Temperature and Humidity Data logger.

Method:
Air conditioning system shall be in continuous operation for at least 24 hours
prior to Performing this test.
Place the calibrated data logger in the predetermined sampling location and
monitor the temperature and RH for 4 consecutive days.

Acceptance criteria:
Temperature and RH should be within the design limit.

37
HUMIDITY DATA LOGGER.

38
 8.Viable Particle Count Check

As per the current SOP on “Environmental Monitoring (SOP-SFMB-044)”

Viable particle count tests performed during qualification/ RQ and
performance test are

• Active Air Sampling.

• Surface monitoring

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 Re-qualification Of AHU’s Is Being Carried Out At A Frequency Of About 5 Years Once
± 2 Months.
AHU Performance Verification Schedule Is Being Carried Out At A Frequency As Below
As Per Validation Master Plan
Performance Evaluation &
Equipment/System
Requalification Frequency
HEPA FILTER TESTS - HVAC
Filter Integrity Test (PAO) One Year : Grade C/D
Air Velocity One Year : Grade C/D
Air Changes for Clean rooms One Year : Grade C/D

Particle Count (For Clean rooms/Area) One Year : Grade C/D

Recovery for Clean rooms Two Years : Grade C

Air Flow pattern Two Years

Temperature Mapping of Approved Raw

Three Years
Material stores & Finished goods stores
40
Thank You

41