Performance qualification of HVAC/AHU

1.0 Protocol approval

2.0 Objective

2.1 To establish documented evidence which will provide a high degree of assurance and reliability about performance of the HVAC system by performing the following tests

2.1.1 Measurement of airflow velocity at fresh air grills to establish fresh air intake quantity

2.1.2 Air flow velocity, airflow volume and rate of air changes test

2.1.3 Air pressure differential measured test

2.1.4 Installed filter system leakage test

2.1.5 Airflow visualization test

2.1.6 Airborne particles count test

2.1.7 Temperature and relative humidity uniformity test

2.1.8 Recovery and containment leakage test

2.1.9 Viable particle count test(by active air sampling)

2.1.10 Viable particle count test(by passive air sampling)

2.1.11 Surface monitoring by contact plate method(RODAC Plate)

2.1.12 Area light level measurement (LUX measurement)

2.1.13 Area noise level measurement (dB level)

3.0 Scope

3.1 The scope of this protocol is to outline the procedure for performance qualification of HVAC System(Air handling unit)

3.2 To be performed after completion of operational qualification activity and its report approval

4.0 Equipment description

4.1 The scope of this protocol is to outline the procedure for performance qualification of HVAC System(Air handling unit)

4.2 The HVAC System is designed to supply conditioned air to Blend and tool room through ducting.

5.0 Training

5.1 Before execution of the protocol training shall be given to concerned personnel and record details in annexure.

6.0 Responsibilities and identification of Execution team

6.1 Responsibilities: The group comprising of representatives from each of the following departments shown in the table below and they shall be responsible for the overall compliance with this protocol

Department	Responsibility
Engineering	Execute the qualification protocol and recording the data as per the procedure in the protocol. Review of the compiled data, qualification report and its compliance to meet the acceptance criteria of the protocol.
Microbiology	Execute the qualification protocol and recording the data as per the procedure in the protocol. Review of the compiled data, qualification report and its compliance to meet the acceptance criteria of the protocol.
Vendor’s representative / external agency	Execute the qualification activity wherever applicable
Production	Provide necessary support for the qualification activity. Review of the compiled data, qualification report and its compliance to meet the acceptance criteria of the protocol
Quality assurance	Preparation of the protocol and monitoring the qualification activities. Review of the compiled data and preparation of the qualification report and its compliance to meet the acceptance criteria of the protocol.

6.2 Identification of the execution team: All the identified executors involved with this protocol are to record name, department, designation, signature and date.

7.0 Test procedure

Following test procedures are followed to qualify the equipment for its operation

7.1 Measurement of airflow velocity at fresh air grills to establish fresh air intake quantity

This test is performed to establish the quantity of fresh air intake by the equipment

7.1.1 Tools required: Standard instruments(Anemometer/Capture hood)

7.1.2 Test procedure

7.1.2.1 Ensure that the AHU (including dehumidifier, if any) is switched “ON” prior to the start of the observations.

7.1.2.2 Before start the observation, verify the instrument(s) calibration reports for the adequacy and validity. Attach calibration certificate.

7.1.2.3 Perform the test procedure as per the SOP

7.1.2.4 Review the observations/test reports for the compliance

7.1.3 Acceptance criteria:

average velocity & air flow volume at the fresh air grills should be within the design specifications range.

7.2 Air flow test (airflow volume and rate of air changes)

This test is performed to verify the air velocity, air volume and number of air changes in each room created by the equipment

7.2.1 Tools required:

Standard instruments(Anemometer/Capture hood)

7.2.2 Test procedure

7.2.2.1 Ensure that the AHU (including dehumidifier, if any) is switched “ON” prior to the start of the observations.

7.2.2.2 Before start the observation, verify the instrument(s) calibration reports for the adequacy and validity. Attach calibration certificate.

7.2.2.3 Perform the test procedure as per the SOP

7.2.2.4 Review the observations/test reports for the compliance

7.2.3 Acceptance criteria:

7.2.3.1 The variation among the average velocity across the final filters or supply diffusers/ grills supplying to the same room should be not more than ±20%

7.2.3.2 Average velocity and subsequent air flow across the final supply diffusers / grills should be within the design specifications range

7.3 Air pressure differential measured test

This test is performed to verify the pressure gradient (differential pressure) across the rooms to avoid cross contamination during the process.

7.3.1 Tools required:

Standard instruments(Differential pressure guage/manometer)

7.3.2 Test procedure

7.3.2.1 All AHU systems shall be continuous operation.

7.3.2.2 Before start the observation, verify the instrument(s) calibration reports for the adequacy and validity. Attach calibration certificate.

7.3.2.3 Avoid the unexpected changes in the pressure and to establish a baseline, all doors in the facility must be closed and no man movement to be allowed during observations.

7.3.2.4 Record the corresponding value of the differential pressure directly from differential pressure guage. If the indicating needle rests in between two divisions on the scale, record the average value of both the divisions.

e.g. Differential pressure guage with range of 1-10 mm of water column and least count of 0.2 mm of water column as each division and the indicator needle is in between 0.4 and 0.6 mm of water column, then reading shall be recorded as 0.5 mm of water column.

7.3.2.5 Carry recording of differential pressure with respect to adjacent rooms or corridor.

7.3.2.6 Perform the test procedure as per the SOP

7.3.2.7 Review the observations/test reports for the compliance

7.3.3 Acceptance criteria:

7.3.3.1 The differential pressure across the rooms or corridors shall be as per the design specifications.

7.4 Installed filter system leakage test

This test is performed to verify the integrity of installed HEPA filters system and ensure that no damage is happened to the filter during installation.

7.4.1 Tools required: Poly olefin(PAO),Standard instruments(Aerosol generator, aerosol photometer)

7.4.2 Test procedure

7.4.2.1 Ensure that the AHU (including dehumidifier, if any) is switched “ON” prior to the start of the observations.

7.4.2.2 Before start the observation, verify the instrument(s) calibration reports for the adequacy and validity. Attach calibration certificate.

7.4.2.3 Perform the test procedure as per the SOP No. EN029

7.4.2.4 Review the observations/test reports for the compliance

7.4.3 Acceptance criteria:

7.4.3.1 Designated leaks are deemed to have occurred where a reading greater than 0.01% of the upstream challenge aerosol concentration and any value other than ‘ZERO’ through mounting joints. Alternative acceptance criteria may be agreed based on the filter efficiency.

7.5 Air flow Visualisation test

This test is performed to visualize the flow pattern of air in the all areas to avoid cross contamination during the process.

7.5.1 Tools required: Purified water, dry ice, standard devices(video recording instrument/ still camera)

7.5.2 Test procedure

7.5.2.1 Ensure that the AHU (including dehumidifier, if any) is switched “ON” prior to the start of the observations.

7.5.2.2 Before start the observation, verify the instrument(s) calibration reports for the adequacy and validity. Attach calibration certificate.

7.5.2.3 Ensure that all doors in the facility must be closed and no man movement to be allowed to avoid unexpected changes in air flow pattern during the execution of test

7.5.2.4 Perform the test procedure as per the SOP No. EN029

7.5.2.5 Review the observations/test reports for the compliance

7.5.3 Acceptance criteria:

7.5.3.1 Air flow pattern shall be towards return air risers/grills of the room.

7.5.3.2 Air should flow from higher pressure zone to low pressure zone.

7.6 Airborne particle count test

This test is performed to establish that the area complies with the cleanliness classification as per the design specifications as per the design in “as built” or “at rest” condition or both.

This test is performed only after successful completion f Airflow test(Airflow volume and rate of air changes), air pressure differential measured test and installed filter system leakage test.

7.6.1 Tools required: Standard instruments (Discrete particle counter / light scattering device particle counter)

7.6.2 Test procedure

7.6.2.1 Before start the observation, verify the instrument(s) calibration reports for the adequacy and validity. Attach calibration certificate.

7.6.2.2 Ensure that all the equipment and area are cleaned as per the relevant cleaning procedures and operating personnel shall follow the change room entry & exit procedures.

7.6.2.3 Perform the test procedure as per the SOP

7.6.2.4 Review the observations/test reports for the compliance

7.6.3 Acceptance criteria:

7.6.3.1 Maximum permitted numbers of particles per cubic meter are given the following table.

7.7 Temperature and relative humidity uniformity test

This test is performed to determine the ability of the system to maintain the air temperature and relative humidity within control limits and uniform throughout the rooms over a period of time in “as built” or “at rest” states.

7.7.1 Tools required: Standard instruments (Thermo hygrometers/data logger, temperature sensor(RTD) and RH sensor(dielectric thin film capacitor)

7.7.2 Test procedure

7.7.2.1 Ensure that the AHU (including dehumidifier, if any) is switched “ON” prior to the start of the observations.

7.7.2.2 Before start the observation, verify the instrument(s) calibration reports for the adequacy and validity. Attach calibration certificate.

7.7.2.3 Ensure that all the equipment and area are cleaned as per the relevant cleaning procedures and operating personnel shall follow the change room entry & exit procedures.

7.7.2.4 Perform the test procedure as per the SOP

7.7.2.5 Review the observations/test reports for the compliance

7.7.3 Acceptance criteria:

7.7.3.1 Temperature: NMT 25degC

7.7.3.2 Relative humidity: 55%

7.8 Recovery and containment leak test

7.8.1 Recovery test

This test is performed to establish the time required to achieve the designed cleanliness as per the design in “as built” or “at rest” states.

7.8.1.1 Tools required: Standard instruments (discrete Particle counter, aerosol generator, video recording instrument/still camera), poly alpha olefin(PAO with food graded certificate)

7.8.1.2 Test procedure

7.8.1.2.1 Ensure that the AHU (including dehumidifier, if any) is switched “ON” prior to the start of the observations.

7.8.1.2.2 Before start the observation, verify the instrument(s) calibration reports for the adequacy and validity. Attach calibration certificate.

7.8.1.2.3 Perform the test procedure as per the SOP

7.8.1.2.4 Review the observations/test reports for the compliance

7.8.2 Containment Leak test

7.8.2.1 This test is performed to determine intrusion(if any) of contaminated air into the clean zone from surrounding non-controlled areas at the same or different static pressure level

7.8.2.2 Tools required: Standard instruments (discrete Particle counter, aerosol generator, video recording instrument/still camera), poly alpha olefin(PAO with food graded certificate)

7.8.2.3 Test procedure

7.8.2.3.1 Ensure that the AHU (including dehumidifier, if any) is switched “ON” prior to the start of the observations.

7.8.2.3.2 Before start the observation, verify the instrument(s) calibration reports for the adequacy and validity. Attach calibration certificate.

7.8.2.3.3 Perform the test procedure as per the SOP.

7.8.2.3.4 Review the observations/test reports for the compliance

7.8.3 Acceptance criteria

7.8.3.1 Recovery time

The clean room or zone shall meet the acceptance criteria for the recovery time should not be more than 15 minutes

7.8.3.2 Containment leakage

A reading on the photometer 0.1% setting as of 0.01% indicates leak.

7.9 Viable particle count test (By active air sampling)

7.9.1 Tools required: Air sampler

7.9.2 Test procedure

7.9.2.1 Microbiologist shall enter and exit and transfer environmental monitoring related accessories into the respective area by following the respective area entry and exit transferring procedure

7.9.2.2 Check the calibration label of the air sampler and ensure that instrument is within calibration period. Verify the battery status of the equipment before performing activity.

7.9.2.3 Perform the active air sampling at each location by following the area locations as per annexure-2

7.9.2.4 Use sterilized sieve at the start of day sampling and sanitize the sieve with filtered 70% IPA before sampling at each location. After each sanitization, place the sampling sieve and operate the air sampler to sample 100 Litres of air without keeping media plates.

7.9.2.5 After sampling of 100 Litres, remove the sampling sieve and insert a sterile 90mm agar plate

7.9.2.6 Per form the air sampling at respective location by operating the air sampler as per respective SOP 10 minutes ( For AES) to sample 1000 litres of air(1m3)

7.9.2.7 Avoid touching inside and outside of the area of the air sampler sieve and moving of hands over the open plates and avoid interference with air sampler during sampling.

7.9.2.8 Collect all the plates and transfer to microbiology laboratory in closed petri cans /SS box for incubation as per the respective transfer procedure. Sanitize the outer surface of SS box/ petricans with70% IPA before keeping inside the passbox and incubate the exposed air sampling plates and negative control plate in inverted position at 300C to350C for not less than 48 hours and followed by 20degC to 25degC incubation for not less than 72 hours for further incubation.

7.9.2.9 Observe the plates under digital colony counter and enter the observed results in the respective annexure

7.9.3 Acceptance criteria:

Class	Air sampling
100	Not more than <1 colony forming units (CFU)
1000	Not more than 10 colony forming units (CFU)
10000	Not more than 100 colony forming units (CFU)
100000	Not more than 500 colony forming units (CFU)

7.10 Viable particle count test (by passive air sampling)

7.10.1 Tools required: Petriplates with stands

7.10.2 Test procedure

Pre-Checks

7.10.2.1 Before start monitoring, ensure that the area is fumigated as per the current SOP

7.10.2.2 Ensure that the corresponding AHU is in operation for at least half an hour prior to starting the microbial count

7.10.2.3 Perform the passive air sampling at each location by following the area locations as per annexure

7.10.2.4 Expose plates on the petriplate exposure stands at working height in upright position (i.e 900 angle) in the area near raiser the stand should be bent around 450 angle in designed locations.

7.10.2.5 While opening the plates for exposing, first keep the plates on the stand then gently lift and slide open the lid of the plate and keep the lid facing down position to avoid contamination of the media.

7.10.2.6 After completion of exposure, close the lid with utmost care to avoid contamination and fingers does not touch the surface of the media, collect all the plates & write the exposure end time and place them in the petri carrier.

7.10.2.7 Plates shall be collected carefully after completion of exposure time in the same order as it was exposed.

7.10.2.8 Transfer to microbiology laboratory in closed petricans/SS box for incubation as per the respective transfer procedure. Sanitize the outer surface of SS box/ petricans with70% IPA before keeping inside the passbox.

7.10.2.9 Collect all the plates and transfer to microbiology laboratory in closed petricans/SS box for incubation as per the respective transfer procedure. Sanitize the outer surface of SS box/ petricans with70% IPA before keeping inside the passbox and incubate the exposed air sampling plates and negative control plate in inverted position at 30degC to35degC for not less than 48 hours and followed by 20degC to 25degC incubation for not less than 72 hours for further incubation.

7.10.2.10 Observe the plates under digital colony counter and enter the observed results in the respective annexure

7.10.3 Acceptance criteria:

Class	Settle plates(90 mm Dia) (CFU/Plate/4 hours)
100	Not more than <1 colony forming units (CFU)
1000	Not more than 5 colony forming units (CFU)
10000	Not more than 25 colony forming units (CFU)
100000	Not more than 50 colony forming units (CFU)

7.11 Surface monitoring by contact plate method (RODAC Plate)

7.11.1 Tools required: Swab sampling / contact plates

7.11.2 Test procedure

7.11.2.1 Perform surface monitoring by contact plate at each designed locations following the area locations as per the annexure

7.11.2.2 Surface monitoring with contact plate method, open the contact plate media with lecithin(0.07%) and Polysorbate 80(0.5%) at the site of monitoring and firmly press and roll the agar surface of the contact plate on the sample location such a way that the entire convex surface of agar plate comes in contact with the surface.

7.11.2.3 After completion of the contact plate sampling, immediately close the lid with care to avoid the contamination. Clean the sampled area with a clean room wipe moistened with filtered 70% IPA.

7.11.2.4 Collect all the plates and transfer to microbiology laboratory in closed petricans/SS box for incubation as per the respective transfer procedure. Sanitize the outer surface of SS box/ petricans with70% IPA before keeping inside the passbox and incubate the exposed air sampling plates and negative control plate in inverted position at 300C to350C for not less than 48 hours and followed by 200C to 250C incubation for not less than 72 hours for further incubation.

7.11.2.5 Observe the plates under digital colony counter and enter the observed results in the respective annexure.

Class	Contact plates(55mm Dia) specification Limit
100	Not more than <1 colony forming units (CFU)
1000	Not more than 5 colony forming units (CFU)
10000	Not more than 25 colony forming units (CFU)
100000	Not more than 50 colony forming units (CFU)

Note: Microbial monitoring (active/ passive/surface monitoring) shall be performed for 5 consecutive days

7.12 Noise level measurement

7.12.1 Tools required: dBA meter

7.12.2 Test procedure

7.12.2.1 Verify that the air conditioning system is operating in the stable condition and all equipment that is specified is running [In operational condition].

7.12.2.2 Map out the area under test as required by the specification in a 2400 mm x 2400 mm x grid or on a previously agreed location basis i.e divide the

area into fur equal parts.

7.12.2.3 Set the instrumentation to work and ensure unauthorized entry and exits from the room are prevented.

7.12.2.4 Measure the sound levels at work surface height or 750 mm from the finished floor level and layout of noise level.

7.12.2.5 Record the data. Note down all variations from the specification if any.

7.12.3 Acceptance criteria

7.12.3.1 Not more than 85 dB / As per Design Specification

7.13 Light Intensity Measurement: LUX Measurement

7.13.1 Tools required: LUX meter

7.13.2 Test procedure

7.13.2.1 Record the light levels on a pre-determined grid pattern/ layout of lux

level or in the absence of a specification on a 3m x 3m grid pattern.

7.13.2.2 Divide the room into four equal locations.

7.13.2.3 Record the light level at working height or 750 mm above finished floor height.

7.13.2.4 The area under test must have all fitted lights working and the area

structure should be complete also if required emergency lighting levels

can be recorded.

7.13.2.5 Record the light levels in lux for each position on the grid. Note down all variations from the specification if any.

7.13.3 Acceptance criteria

7.13.3.1 Not less than 300 lux / As per Design Specification

8.0 Recording observations

Record the observations after execution of each test procedures, in the annexure (recording of observations for performance qualifications)

If any specification is not meeting the against required specification/acceptance criteria, write ‘NO’ in the “Meeting requirements” column, specify the discrepancy under ‘comments’ and must be explained in ‘discrepancy and corrective actions report’

9.0 Discrepancy and corrective actions report

Document any discrepancies observed during the performance qualification of the equipment in the annexure. Include the corrective actions of the same.

When all the discrepancies are satisfactory resolved or an approved action paln is developed which ensures that the discrepancy will be resolved, document that the system is ready for next step in the qualification.

10.0 Compilation, review and summary report

Compile and review that all the test procedures have been completed, reconciled and attached to this protocol. Verify that the approvals for deviations (if any) have been taken and are resolved appropriately to the satisfaction.

Performance qualification shall be considered acceptable when all the conditions specified in the qualification procedures have been met.

Prepare the performance qualification report as per the SOP and submit this for review and approval to the validation core team.

11.0 Appendix

11.1 Abbreviations and definitions

Abbreviations	Definition
PQ	Performance qualification
SOP	Standard operating procedure
QA	Quality assurance
CFM	Cubic feet meter
No.	Number
NA	Not applicable
mm	Millimeter
µ	Micron
%	Percentage
HEPA	High efficiency particulate air
AHU	Air handling unit
PLC	Programmable Logic Control
⁰C	Degrees centigrade
RH	Relative humidity
NLT	Not less than
mm of water	milli meter of water column
Particles/m³	Particles per cubic meter
ISO	International organization for standardization
RTD	Resistance temperature detector
CFU/ m³	Colony forming units per cubic meter
NMT	Not more than
CRN	Change request Note
HVAC	Heating, ventilation and air conditioning