1.

0 PURPOSE
To lay down a procedure for the Qualification of HVAC.

2.0 SCOPE
This is applicable for the Qualification of HVAC.

3.0 PREREQUISITES
• URS
• User manuals
• Layouts
• Purchase order
• Trained personnel’s

4.0 RESPONSIBILITY

4.1 ENGINEERING
• The Engineering department is responsible for providing URS, DQ and Installation
qualification protocol.
• To perform the Temperature, Humidity, Air Pressure difference, and Air Changes Tests.
• To perform the DOP, Smoke Test from third Party and provides certificates to metrology
team.
• Count the CFM values and provide the data to metrology team.
• Provides the Approved Layout according to Design.

4.2 Metrology
• Officer Quality Control is responsible for the preparation of operational and performance
Qualification protocol, protocol execution, reporting of results, document any deviation and writing
of qualification report.
• Officer Quality Control Perform the Non-viable Count Test.
• Manager Quality Control is responsible for reviewing the protocol, results & reports.

4.3 Microbiology Lab

• Microbiologist Perform the Viable Count Test.
• Manager Microbiology is responsible for reviewing the results & reports.

4.4 Head of Departments

• Head of Quality Control is responsible to review the protocol.
• Head of Quality Assurance is responsible for reviewing the protocol.

4.5 Director of Divisions

• Director Manufacturing Operations is responsible for reviewing the protocol.
• Director Quality Operations is responsible for approving the qualification protocol.

5.0 PROCEDURE
5.1 PROCEDURE FOR DESIGN QUALIFICATION
5.1.1 User requirements should be considered when deciding on the specific
design of a system or equipment.
 5.1.2 A suitable supplier should be selected for the appropriate system or
equipment (approved vendor)
5.1.3 Layouts and design Review.
5.1.4 Review of Warranty Purchase Order.
5.1.5 Review of Warranty Certificates.

5.2 INSTALLATION QUALIFICATION

The installation qualification shall be performed as per the approved protocol and the
protocol shall be prepared by the engineering department. A typical installation
qualification protocol for equipment shall cover various headings as described below:

5.2.1 EQUIPMENT IDENTIFICATION

This section provides the description, name and address of the manufacturer/
supplier, equipment model number, equipment serial number, location of the
equipment, identification number and date installed.

5.2.2 EQUIPMENT DESCRIPTION AND SPECIFICATIONS

This section provides the description and specifications of the components of
the system including material of construction etc.

5.2.3 RELATED DOCUMENTS

This section identifies and lists all the standard operating procedures (SOPs)
and preventive maintenance procedures or cleaning procedures associated
with the equipment or instrument.

5.2.4 CALIBRATION VERIFICATION

This section provides the details of calibration of the system.

5.2.5 INSTALLATION SITE REQUIREMENTS

Requirements of site for installation are observed including electrical, utilities
connections and operating environment.

5.2.6 INSTALLATION QUALIFICATION PROCEDURE

5.2.6.1 INSTALLATION OF MAIN COMPONENTS

This section provides a summarized verification for proper installation of each

component of the system.
5.2.6.2 EQUIPMENT USED FOR QUALIFICATION
This section covers the details of equipment that is used to verify the
installation process.
5.2.7 INSTALLATION QUALIFICATION REPORT
There should be documented records for the verification of installation
(installation qualification report) to indicate a satisfactory operation.

5.3 OPERATIONAL QUALIFICATION

The operational qualification shall perform as per the approved protocol. A typical operational
qualification protocol for equipment shall cover various headings as described below.

5.3.1 TEST CONDITIONS

Before performing the operational qualification check that the equipment shall be completed in
different aspects like supplied with power, desired voltages are provided, utilities connections are
provided.

5.3.2 CONTROL PANELS TESTING

This section verifies the sequential menu operation along with all the keys/ components/ controls on
the control panel functions as designated.

5.3.3 SAFETY FEATURES TESTING

This section verifies that the safety interlocks and alarm’s function when the required conditions are
simulated.

5.3.4 AIRBORNE PARTICLE COUNT

QC officer perform this test. This method specifies the measurement of the airborne particles (Non-
Viable Count) concentration with size distribution having a threshold size between 0.5 µm and 5.0µm
as per Standard ISO 14644-1:2015 by performing the listed test procedures by qualified personnel.
A sufficient number of replicate studies will be performed to demonstrate the ability of the HVAC
system to achieve results.

Procedure
• Locate appropriate stations in the room at the working height i.e., approx.
4 feet
• Check the particles count with the help of a calibrated particle counter/Air
Testing and Balancing contractors and note down in the table.
• Repeat the same procedure for three consecutive days
ACCEPTANCE CRITERIA
The air particles count should meet the designed class in the room.

• Class (ISO 8) At Rest: 0.5µ (3,520,000/m3)

: 5.0µ (29,300/m3)

• Class (ISO 7) At Rest: 0.5µ (3,520,00/m3)

: : 5.0µ (29,300/m3)

• Class (ISO 5) At Rest: 0.5µ (3,520, /m3)

: 5.0µ (29 /m3)
5.3.5 Viable count

Microbiologist performs the viable count to verify that the microbial count is less than define
Criteria.

PROCEDURE

• Open the media plates at defined location

• Allow the medium to expose for 04 hours
• On completion of given time remove the plates from area
• Return to microbiological lab for incubation
• Repeat the same procedure for three consecutive days
ACCEPTANCE CRITERIA

Class (ISO 8) < 100 CFU

Class (ISO 7) < 50 CFU
Class (ISO 5) < 1 CFU

5.3.6 SURFACE SWAB

Microbiologist perform this test is to verify the microbial count on surface which is in contact of
product.

PROCEDURE
• Unscrew cap on the tube and remove the Enviro check contact slide
• Before testing any ensure that it is dry
• With two fingers hold the terminal end on the paddle against the surface to be tested
• With a firm and even pressure press one medium against the surface to be tested.
• Repeat the procedure with the other side of the paddle
• Replace the slide back into the tube and close tightly
• Repeat the same procedure for three consecutive days
Class (ISO 8)
ACCEPTANCE CRITERIA: < 50cfu/25cm2

5.3.7 Air Flow

Engineering Department perform this test to measure airflow velocity and uniformity, and supply
airflow rate in cleanrooms and clean zones.

Procedure
• All access doors are closed in that room
• Check the supply air quantity from each supply air diffuser located in the room.
• Check the return air quantity from each return air diffuser.
• Calculate the air changes per hours as per given calculations and note down
o Take the total volume of the room in cubic feet. i.e. V = Length x Breadth X Height
o Take the total supply air quantity in cubic feet per minute
o Calculate air changes per hour i.e. ACH = Air quantity x 60

Volume of room

Repeat the same procedure for three consecutive days

ACCEPTANCE CRITERIA

• > 20 ACH
The air quantity should be in the designed range.

5.3.8 Air Pressure Difference

Engineering Department perform this test is to verify the capability of the complete installation to
maintain specified pressure difference between the installation and its surroundings.

PROCEDURE
1.0 Check the air flow direction and quantity of air passing through the door cuts of the rooms and
note down in the given table.
2.0 Check the pressure differential between the adjacent rooms for three days with the interval of
four hours and note down in the given table.
3.0 Repeat the same procedure for three consecutive days
ACCEPTANCE CRITERIA

• ≥ 05 pascal
Differential Pressure & the air direction should meet with criteria as specified

5.3.9 Air flow direction and visualization

Engineering department perform this test from outsource to confirm either the airflow or airflow
pattern or both in regard to the design and operational specification

PROCEDURE
A portable smoke system generally used to create smoke to test the air visualization.
ACCEPTANCE CRITERIA
Air Pattern Should Follow the design criteria.

5.3.10 Temperature and Humidity

Engineering Department perform this test is to demonstrate the capability of the installation’s air-
handling system to maintain the air temperature level within the control limits.
A sufficient number of replicate studies will be performed to demonstrate the ability of the
HVAC system to achieve desirable results.

Procedure
.
• Check that the HVAC system is in Operation
• Locate five measurement point locations in the room at the working height i.e. approx 4
feet
• All doors are closed and there are no movements of personnel in the room
• Check the temperature & humidity with the help of a calibrated Whirling Psychrometer
and note down in the table
• Note down the temperature for three consecutive days with for three days with the interval
of four hours.
• Repeat the same procedure for three consecutive days

ACCEPTANCE CRITERIA

(Class ISO – 8)
Temperature : ≤ 25˚C
Relative Humidity : ≤ 55%
(Class ISO – 7)
Temperature : ≤ 25˚C
Relative Humidity : ≤ 40%

5.3.11 DOP Test

Engineering department perform this test from outsource to confirm free from manufacturing
Fault, no damage during shipping & transporting, installed properly, filter Deficiency, Gasket/Seal
and HEPA housing leaks.

ACCEPTANCE CRITERIA

• Leakage rate is NMT 0.01%.

5.4 OPERATIONAL QUALIFICATION REPORT

There should be documented records for the verification of operation (operational qualification report)
to indicate the satisfactory operation.
6.0 PERFORMANCE QUALIFICATION

Once it has been established that the operational qualification is satisfactory, Performance
Qualification shall be carried out.
The performance qualification of this equipment will be carried out by performing the listed test
procedures in this protocol by a qualified personal. Ensure the proper availability of all required utilities
to machines prior to carrying out performance tests. A sufficient number of replicate studies will be
performed to demonstrate the ability of the system to achieve reproducible results. Testing
procedures may include physical / visual inspections and tests as specified in testing standards.
Any exceptional conditions encountered during the Performance Qualification will be identified and
deviation form will be filled. The performance qualification will be based upon the function of the
equipment/ system installed. Performance qualification shall be carried out for three consecutive
batches or in case of HVAC’s three consecutive days as per the approved protocol.

6.1 Viable count

Microbiologist performs the viable count to verify that the microbial count is less than define
Criteria.

PROCEDURE

• Open the media plates at defined location

• Allow the medium to expose for 04 hours
• On completion of given time remove the plates from area
• Return to microbiological lab for incubation
• Repeat the same procedure for three consecutive days

ACCEPTANCE CRITERIA

• Class (ISO 8) < 100 CFU

• Class (ISO 7) < 50 CFU
• Class (ISO 5) < 1 CFU

6.2 Air Pressure Difference

Engineering Department perform this test is to verify the capability of the complete installation to
maintain specified pressure difference between the installation and its surroundings.

PROCEDURE
1.0 Check the air flow direction and quantity of air passing through the door cuts of the rooms and
note down in the given table.
2.0 Check the pressure differential between the adjacent rooms for three days with the interval of
four hours and note down in the given table.
3.0 Repeat the same procedure for three consecutive days
ACCEPTANCE CRITERIA

• ≥ 05 pascal
Differential Pressure & the air direction should meet with criteria as specified

6.3 Temperature and Humidity

 Engineering Department perform this test is to demonstrate the capability of the
installation’s air-handling system to maintain the air temperature level within the control
limits.
A sufficient number of replicate studies will be performed to demonstrate the ability of
the HVAC system to achieve desirable results.
Procedure
.
• Check that the HVAC system is in Operation
• Locate five measurement point locations in the room at the working height i.e. approx 4
feet
• All doors are closed and there are no movements of personnel in the room
• Check the temperature & humidity with the help of a calibrated Whirling Psychrometer
and note down in the table
• Note down the temperature for three consecutive days with for three days with the interval
of four hours.
• Repeat the same procedure for three consecutive days

ACCEPTANCE CRITERIA

• (Class ISO – 8)
• Temperature : ≤ 25˚C
• Relative Humidity : ≤ 55%
• (Class ISO – 7)
• Temperature : ≤ 25˚C
• Relative Humidity : ≤ 40%

There should be documented records for the verification of Performance (Performance qualification
report) to indicate satisfactory performance.

7.0 ANNEXURE
6.1 Protocols Annex – 1

8.0 REVISION HISTORY