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PERFORMANCE QUALIFICATION
PROTOCOL FOR
VERTICAL LAMINAR AIR FLOW UNIT

CUSTOMER:

EQUIPMENT:
VERTICAL LAMINAR AIRFLOW UNIT
( Wx Dx H mm)

SUBMITTED BY:

P HARMA E N G I N E E R S

PLO T N O. 11 3 / A / 1 , L A NE 8 , P HA SE I I,

IDA CHERLAPALLI, HYDERABAD- 500051 .

Tel No. 91 - 40 27261113 , 27261114

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PERFORMANCE QUALIFICATION PROTOCOL

APPROVAL

This document is prepared by the documentation team of M/S. PHARMA ENGINEERS

for
EQUIPMENT : VERTICAL LAMINAR AIR FLOW UNIT ( TAG NO)
PLANT /PROJECT :
CLIENT :
Hence this document before being effective shall be approved by Client / Customer
M/s. PHARMA ENGINEERS:

Name Designation Signature Date

Prepared By

Reviewed By

CLIENT / CUSTOMER:

Name Designation Signature Date

Reviewed By

Approved By
Clie

Supplier/ Manufacturer: PHARMA ENGINEERS,

Equipment: VERTICAL LAMINAR AIR FLOW UNIT ( Wx Dx H

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PERFORMANCE QUALIFICATION

TABLE OF CONTENT

1. OBJECTIVE....................................................................................................................................4

2. FILTER INTEGRITY TEST.........................................................................................................4

3. AIR VELOCITY TEST..................................................................................................................7

4. AIRFLOW VISUALISATION TEST.................................................................................... 9

5. PARTICLE COUNTING.............................................................................................................11
Clie

Supplier/ Manufacturer: PHARMA ENGINEERS,

Equipment: VERTICAL LAMINAR AIR FLOW UNIT ( Wx Dx H

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PERFORMANCE QUALIFICATION

1. OBJECTIVE

The objective of this document is to qualify and certify the performance of

Vertical LAF ( TAG NO) with due considerations
as specified in DQ of Vertical LAF ( TAG NO).

2. FILTER INTEGRITY TEST

PURPOSE:
This test is to confirm that the HEPA filter was installed in proper assembly
and to ensure that no leakage of air in across the filter gasket & to ensure that
the filter is with stated rating
PRE-REQUISITES
1. Gas Generator (Leskin 6 nozzle)
2. Photometer (ATI-2I, ATI-2H & PH -5)
3. PAO (Poly-Alpha olefin) Oil.
4. Compressed air at a pressure of (20 PSI)
TEST METHOD:
1. Percentage of leakage between upstream and downstream is to be
confirmed across the filter.
2. Cold gas generator is to be selected to generate upstream concentration,
for range 20 to 80 micro grams per liter which is equivalent to millions of
particles.
3. Arrangements to be made to maintain consist quantity at the upstream
side of the filter.
4. Downstream concentration to be measured with the help of photometer
5. The operation of the instrument is to be followed strictly as per the
recommendations of the equipment.
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Supplier/ Manufacturer: PHARMA ENGINEERS,

Equipment: VERTICAL LAMINAR AIR FLOW UNIT ( Wx Dx H

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PERFORMANCE QUALIFICATION

6. Downstream concentration will be displayed in terms of the percentage

of leakage, compared to upstream concentration.
7. The allowed percentage of leakage must not be more than filter efficiency.
8. This test is to be conducted for every terminal filter and results to be
mentioned in the test data sheet.
9. Care to be taken while conducting the test for selection of oil to
generate smoke, which must be non-cacogenic.
10. During the above test, it’s recommended to put off the control system of
smoke detection.
 Clie

Supplier/ Manufacturer: PHARMA ENGINEERS,

Equipment: VERTICAL LAMINAR AIR FLOW UNIT ( Wx Dx H

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PERFORMANCE QUALIFICATION

Instrument Used
Name Make

Model Sr. No
Calibrated
Calibration Due
On
TEST RESULTS
Upstream Obtained Result in
Acceptable Remarks
Concentration downstream
HEPA Filter Identity No downstream
From Filter From Side
µg/Ltr % (% leakage)
Face Joint

ACCEPTANCE:
Percentage of leakage must be less compared to filter efficiency.
However, the acceptance is up to the judgment of experts if any deviations in the readings.

REMARKS (IF ANY):

Test conducted By Test Witnessed By

 Clie

Supplier/ Manufacturer: PHARMA ENGINEERS,

Equipment: VERTICAL LAMINAR AIR FLOW UNIT ( Wx Dx H

Page 7 of 13

PERFORMANCE QUALIFICATION

3. AIR VELOCITY TEST:

PURPOSE:
This test is to confirm that the equipment is capable of delivering sufficient
laminar air velocities in the range of 90 FPM ±20%

PRE-REQUISITES
1. Duly Calibrated Anemometer
TEST METHOD:
1. Make sure that the filter integrity test is completed before the
mentioned test.
2. Run the equipment and start measuring the velocity of air from HEPA
Filter at 150mm below the filter.
3. Enter the velocity readings in the below sheet.

INSTRUMENT USED
NAME OF
MAKE
INSTRUMENT
MODEL SERIAL NO.
CALIBRATED CALIBRATIO
ON N DUE ON
TEST RESULTS
VELOCITY READINGS IN FPM
LOCATION ACCEPTABLE RANGE (FPM)
150MM BELOW HEPA FILTER
Clie

Supplier/ Manufacturer: PHARMA ENGINEERS,

Equipment: VERTICAL LAMINAR AIR FLOW UNIT ( Wx Dx H

Page 8 of 13

PERFORMANCE QUALIFICATION

ACCEPTANCE

Equipment must deliver and maintain laminar air velocities in the range of 90 FPM
±20%
However, the acceptance is up to the judgment of experts if any deviation in the
readings.
REMARKS (IF ANY):

Test conducted By Test Witnessed By

Clie

Supplier/ Manufacturer: PHARMA ENGINEERS,

Equipment: VERTICAL LAMINAR AIR FLOW UNIT ( Wx Dx H

Page 9 of 13

PERFORMANCE QUALIFICATION

4. AIRFLOW VISUALISATION TEST

PURPOSE
To ensure that the movement of air in the equipment is not stagnant and flow is
moderately conventional air flow.

PRE-REQUISITES
1. Smoke generator
2. Video camera

TEST METHOD:

1. This test is to be performed after completion of perfect air balancing.

2. Place the Smoke generator just below the filter to ensure air is not stringent.
3. Flow visualization has to be checked by generating smoke near the section
grille.
4. Smoke movement to be recorded by video camera and the movement of
smoke must be towards return grill, ensuring maximum sweep of the
equipment.
 Clie

Supplier/ Manufacturer: PHARMA ENGINEERS,

Equipment: VERTICAL LAMINAR AIR FLOW UNIT ( Wx Dx H

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PERFORMANCE QUALIFICATION

INSTRUMENT USED

NAME OF INSTRUMENT MAKE

MODEL SERIAL NO.

CALIBRATION DUE
CALIBRATED ON
ON
TEST RESULTS
AIR FLOW
EQUIPMENT MODEL FILTER NO REMARKS
DIRECTION

ACCEPTANCE

The flow must be towards return air grill, ensuring maximum sweep of the
equipment.
However, the acceptance is up to the judgment of experts if any deviations in
the readings.

REMARKS (IF ANY):

Test conducted By Test Witnessed By

Clie

Supplier/ Manufacturer: PHARMA ENGINEERS,

Equipment: VERTICAL LAMINAR AIR FLOW UNIT ( Wx Dx H

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PERFORMANCE QUALIFICATION

5. PARTICLE COUNTING

PURPOSE
To check the correct functioning of the equipment with respect to filtration
efficiency, by measuring the particle concentration at 0.5 micron as per
ISO- 14644-1 (2015).

PRE-REQUISITES
1. Particle counter with duly calibrated

TEST METHOD:

1. Test to be conducted while the Equipment is at rest condition i.e. its

running at the ideal condition.
2. Particle counter must be having valid calibration certificate.
3. Particle counter must have minimum of 1.7 Cfm capacity.
4. Particle counting must be verified at 0.5 micron only.
5. Number of locations and place of location to be decided before conducting
the test.
6. Drawing is to be prepared showing the locations of the particle counting
and same drawing is to be attached along with the particle count report.
7. The print out of the particle counter must specify the location number,
time interval and sampling time, other than the concentration of particles.
8. All the print outs are to be attached along with this as a test data sheets
and it must be signed by the person who had conducted the test as well as
person who witnessed the test.
 Clie

Supplier/ Manufacturer: PHARMA ENGINEERS,

Equipment: VERTICAL LAMINAR AIR FLOW UNIT ( Wx Dx H

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PERFORMANCE QUALIFICATION

INSTRUMENT USED
Name Make
Model Serial Number
Flow rate Sampling Time
Calibrated On Calibration Due on

TEST RESULTS
Average No. of Particles Average No. of
Equipment Name Location ID
> 0.5 µm/m3 Particles > 5 µm/m3

Mean Average
CERTIFICATION RESULTS AS PER ISO14644 -1 (2015)
Maximum number of particles allowed per cubic meter of air
CLASS ISO 5 AT REST 0.5µm 5µm
3520 29
 Clie

Supplier/ Manufacturer: PHARMA ENGINEERS,

Equipment: VERTICAL LAMINAR AIR FLOW UNIT ( Wx Dx H

Page 13 of

PERFORMANCE QUALIFICATION

ACCEPTANCE

Particle concentration should comply with ISO-14644-1(2015) standards.

However, the acceptance is up to the judgment of experts if any deviations in the readings.

REMARKS (IF ANY):

Test conducted By Test Witnessed By