PD 6609:2007

PUBLISHED DOCUMENT

Environmental
cleanliness in enclosed
spaces – Guide to in situ
high efficiency filter leak
testing
ICS 13.040.30

NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW

PD 6609:2007

Publishing and copyright information

The BSI copyright notice displayed in this document indicates when the
document was last issued.

© BSI 2007

ISBN 978 0 580 54666 2

The following BSI references relate to the work on this standard:

Committee reference LBI/30
Draft for comment 05/30123389 DC

Publication history
First published July 2000
Second edition published July 2007

Amendments issued since publication

Amd. no. Date Text affected

 PD 6609:2007

Contents
Foreword ii
0 Introduction 1
1 Scope 1
2 Normative references 1
3 Requirements for testing 1
Annexes
Annex A (informative) High efficiency filter specification table 6
Annex B (informative) In situ leak test report 11
Bibliography 14
List of figures
Figure 1 – Diagram of an aerosol challenge to multiple filters via an air
handling unit 2
Figure 2 – Diagram of aerosol filter testing 4
Figure A.1 – Filter dimensions 7
List of tables
Table A.1 – High efficiency filter specification 8
Table B.1 – In situ leak test report sheet 12

Summary of pages
This document comprises a front cover, an inside front cover,
pages i and ii, pages 1 to 14, an inside back cover and a back cover.

© BSI 2007 • i
PD 6609:2007

Foreword
Publishing information
This Published Document is published by BSI and came into effect
on 31 July 2007. It was prepared by Technical Committee LBI/30,
Cleanroom technology. A list of organizations represented on this
committee can be obtained on request to its secretary.

Supersession
This Published Document supersedes PD 6609:2000, which is
withdrawn.

Relationship with other publications

BS 5295:1989 (all parts) has been replaced by BS EN ISO 14644 (all
parts). However, the withdrawn BS 5295:1989 contained information
about in situ high efficiency filter testing using an oil aerosol challenge
and a photometer that is not given in BS EN ISO 14644 (all parts). That
information, which has been revised with respect to the new
requirements in BS EN ISO 14644-3:2005, is published in this
document.

Presentational conventions
The provisions in this standard are presented in roman (i.e. upright)
type. Its recommendations are expressed in sentences in which the
principal auxiliary verb is “should”.
Commentary, explanation and general informative material is
presented in smaller italic type, and does not constitute a
normative element.

Contractual and legal considerations

This publication does not purport to include all the necessary provisions
of a contract. Users are responsible for its correct application.
Compliance with a British Standard cannot confer immunity
from legal obligations.

ii • © BSI 2007
 PD 6609:2007

0 Introduction
Where high efficiency filters are fitted, it is important to ensure that the
filter and its housing and sealing device do not permit the ingress of
particles into a cleanroom or clean zone. This is checked by challenging
the filter with an aerosol of particles dispersed upstream of the filter and
scanning over the downstream face, frame and gasket of the filter to
ensure that there are no leaks that exceed a specified level of
penetration.
The object of the in situ leak test described in this document is to
determine if the filter has been damaged between manufacture and
installation, and during subsequent use.
In situ testing with oil aerosols might not be acceptable for some
cleanroom applications where airborne chemical contamination needs
to be controlled, as oil deposited on the filter will outgas. In such cases,
an alternative method that uses inert particles and a particle counter can
be used. This method is not discussed in this document but is described
in B.6.3 of BS EN ISO 14644-3:2005.

1 Scope
This Published Document provides information supplementary to the
provisions of BS EN ISO 14644-3:2005. In particular, it gives
recommendations and explanatory guidance for in situ leak testing of
high efficiency filters using an oil aerosol challenge and photometer. It
also provides guidance on the procurement of replacement filters
(Annex A) and information that might be required in a test report
(Annex B).
The guidance contained in this document is for the leak testing of high
efficiency air filters that can be face scanned. The document does not
provide information on other tests carried out on high efficiency filters
installed in cleanrooms, such as pressure differentials, air supply
volumes, and airflow uniformity.

2 Normative references
BS EN ISO 14644-3:2005, Cleanrooms and associated controlled
environments – Part 3: Test methods

3 Requirements for testing

3.1 Aerosol injection
The filter integrity test relies on a homogeneous distribution of aerosol
test challenge upstream and across the whole filter face. Homogeneous
distribution is defined as a variation in concentration of less than ±15%
in time about the average measured value. The upstream aerosol
challenge should be measured as close as possible to the filter, and
ideally not more than 50 mm from the upstream face.

© BSI 2007 • 1
PD 6609:2007

To ensure good mixing it is essential that the aerosol is injected

correctly. For ducted systems, aerosol injection ports will normally be
required. When injecting into long ducted systems with distribution legs
along the main duct (see Figure 1), good mixing will not occur unless
the distance D is at least 15 duct diameters. However the correct use of
distribution sparge pipes may allow injection as near as one metre from
the filter face to achieve homogeneous distribution of the challenge
aerosol.
The aerosol injection point or port should be of sufficient size to accept
the entry of the challenge aerosol and achieve the required upstream
concentration. In some cases, oil aerosol injection pumps may be
required to overcome the pressure in positive pressure ducts.
Where an aerosol challenge is injected upstream of an air conditioning
unit, the refrigeration, heating and humidification circuits should be
switched off to avoid attenuation of the aerosol challenge. Any
pre-filters between the injection point and the high efficiency filter(s)
should be removed prior to test.
The sample flow rate should always be maintained at the calibrated
value of the sampling instrument being used. Where a filter is installed
in a negative pressure extract duct and the photometer is unable to
overcome the negative pressure in the duct then leaks will not be
detected. To overcome this, the photometer may be used in a
“differential sampling mode”, if possible, where the exhaust of the
photometer is returned to the exhaust duct.

Figure 1 Diagram of an aerosol challenge to multiple filters via an air

handling unit

Distance D - 15 to 20 duct

Fan
Duct

Normal
system
flow
rate

Aerosol Pre - filters Air conditioning Normal Normal Normal

inject remove system - switch off system system system
for test for test filter filter filter
flow flow flow
rate rate rate

2 • © BSI 2007
 PD 6609:2007

3.2 Aerosol challenge

Each filter requires a homogeneous oil aerosol challenge upstream of
the filter of between 20 mg/m3 and 80 mg/m3 (4g/l) of air. This can be
provided by means of a thermal generator or (a) Laskin nozzle(s).
BS EN ISO 14644-3:2005 considers that the mass median particle
diameter of the test aerosol should be between 0.5 4m and 0.7 4m with
a geometric standard deviation of up to 1.7. This is a size distribution
typical of that produced by a Laskin nozzle. However, it is known that
the mass median diameter of particles produced by a thermal generator
is likely to be below the size suggested in BS EN ISO 14644-3:2005, and
closer to the most penetrating particle size (MPPS) of high efficiency
filters. It is therefore likely that more leaks will be found when a thermal
generator is used, but this is not considered a disadvantage.
The upstream aerosol concentration is the 100% challenge and the
percentage penetration is the downstream concentration expressed as
a percentage of the upstream concentration. The percentage leakage
penetration L can be calculated (see Figure 2) as follows:

100Y
L = ---------------
X
where:
Y is the largest measured leak in mg/m3 (4g/l), and
X is the average upstream challenge concentration in mg/m3 (4g/l).
Prolonged exposure of filters to the challenge aerosol should be
avoided. In the case of controlled environments that are served with
multiple high efficiency filters, it is recommended that means be
provided to challenge and test filters one at a time. Where such a
provision is impractical, the upstream aerosol concentration may be
reduced to a level agreed between the customer and the supplier,
provided the downstream concentration at the pass/fail level is within
the sensitivity of the photometer.
The upstream aerosol concentration should remain the same
throughout the duration of the scan of each filter and should therefore
be checked and recorded both at the start and upon completion of each
filter scan.

© BSI 2007 • 3
PD 6609:2007

Figure 2 Diagram of aerosol filter testing

Homogenous aerosol
distribution
Filter
Filter scanned
with overlapping
sweeps up to 30 mm
from filter face

Air flow
X μg/l Y μg/l

15 to 20 Duct
from filter

Point of injection

3.3 System scanning

Systems that do not have the means of accessing the upstream
concentration cannot be tested by the method described in this
document.
A sampling probe should be used that ensures that the velocity of air
being drawn into the opening of the probe is the same as the velocity of
air coming from the filter face. This can be calculated in accordance
with BS EN ISO 14644-3:2005 B.6.2.4. A variation in velocity of up to
±20% is acceptable.
The filter should be scanned at a distance of approximately 30 mm from
the filter face using overlapping scans.
NOTE BS EN ISO 14644-3:2005 B.6.2.7 states that “designated leaks
are deemed to have occurred where [there is] a reading greater
than 10-4 (0.01%) of the upstream challenge aerosol concentration”, but
that “alternative acceptance criteria may be agreed between the customer
and the supplier”. BS EN ISO 14644-3:2005 B.6.1.2b) states that an
aerosol photometer can be used for MPPS penetrations equal to or greater
than 0.003%. It has been well established that the use of linear photometers
can readily measure aerosol penetrations down to 0.001%.
The sealing device, housing and filter are all subject to the in situ test.
Scans should therefore be made around the gasket seal, along the joints
of the filter frame, along the bond between the filter pack and the frame,
and over the whole area of the filter face.

4 • © BSI 2007
 PD 6609:2007

A slow scanning velocity may improve sensitivity for finding leaks, and
a fast scanning velocity may fail to find leaks. The filter should therefore
be scanned at a velocity v (in cm/s) in accordance with the formula
given in BS EN ISO 14644-3:2005 B.6.2.5, namely:

15
v = ---------
Wp

where Wp is the probe dimension at right angles to the scan direction.

3.4 Airflow through filters

Filter penetration varies with flow rate through the filter. If the airflow
through the installed filter is higher than the airflow at which it was
tested by the manufacturer, the filter penetration may increase above
that to which the filter was manufactured, to a point where it gives an in
situ test failure.

3.5 Repair of filters

BS EN ISO 14644-3:2005 B.6.6 says that “leakage repair should only be
acceptable by agreement between the customer and the supplier”. It
should be noted that an effective repair at the gasket, and between the
filter pack and frame, can often be achieved, but the repair of media
leaks is difficult to achieve and, because of blockage, may have adverse
effects on the uniformity of airflow. In a non-unidirectional cleanroom
the air supply will quickly mix with room air and a less than perfect
repair can be tolerated. However, in unidirectional flow, especially if the
air is supplied directly to a critical area, the filter would normally be
renewed. Where temporary repairs are made for expediency, e.g. to
allow vital work to continue, a replacement filter needs to be installed
at the earliest possible opportunity.

© BSI 2007 • 5
PD 6609:2007

Annex A (informative) High efficiency filter specification

table
A.1 High efficiency filter specification checklist
It is important when changing filters to choose the correct replacement
filter, as failure to do this could affect the ability of the filter to pass the
in situ leak test and could also affect the overall performance of the
system to which the filter is fitted. Unambiguous specifications in
relation to the following aspects should be clearly stated on all
requisitions or orders to ensure compatibility with application and to
avoid inappropriate filters being supplied:
a) application and orientation;
b) volumetric flow rate, uniformity of airflow and “clean” pressure
drop;
c) pass/fail criteria for leakage and penetration with reference to the
in situ test method to be used;
d) pass/fail criteria for leakage and penetration with reference to
manufacturers’ tests (A.2);
e) sealing arrangement;
f) size and form of construction.
When specifying the size of a standard type of filter, it is a commonly
accepted practice to quote “height by width by depth”. The convention
for filters is for height and width to define the dimensions of the face
area of the filter, where the pleats are in the vertical or “height”
direction, and for depth to define the dimension in the direction of
airflow, as illustrated in Figure A.1. Failure to observe this system can
result in a filter of inappropriate dimensions being supplied.
Table A.1 is a suggested high efficiency filter specification checklist.
This can also be used as the basis for the manufacturer’s certificate of
conformance where required.

6 • © BSI 2007
 PD 6609:2007

Figure A.1 Filter dimensions

Depth

Height
Airflow direction

th
id
W

A.2 Manufacturers’ high efficiency filter tests

Eurovent 4/4 (BS 3928:1969) specifies a volumetric test method
commonly used by filter manufacturers for testing high efficiency
filters. The Eurovent 4/4 test method uses an aerosol of sodium chloride
with a relatively large mass median diameter of 0.7 4 m. The
Eurovent 4/4 test measures overall efficiency only and is not a scan test.
Therefore a Eurovent 4/4 filter for use in a cleanroom should be subject
to an additional scan test by the filter manufacturer, using a method
similar to that used for the in situ test, to ensure that local penetrations
are within specified limits.
BS EN 1822 (all parts) is a manufacturers’ standard for the
classification and testing of high efficiency air filters. Filters are
classified in terms of overall and local efficiency at the most penetrating
particle size (MPPS).

© BSI 2007 • 7
PD 6609:2007

Filters tested to BS EN 1822 may have a suitable overall efficiency but

too high a local penetration. An example of this is a BS EN 1822 H14
filter, which has a maximum overall efficiency of 99.995% and a
maximum local penetration of 0.025%. This maximum local penetration
may be too great to ensure that the filter passes the in situ test. It is
therefore essential to inform the filter manufacturer of the type of in situ
leak test to be carried out on the installed filter, and the maximum local
penetration permitted, so that a suitable filter is provided.

Table A.1 High efficiency filter specification

This table is provided as a check list for assisting customers and suppliers to draw up a specification for a high
efficiency filter that will be fit for purpose. A new specification sheet should be drawn up for every different size and
type of filter
Application information
Location and function, e.g. supply air
filter in ceiling – see attached plan
About the application
Normal operating temperature °C
Maximum temperature °C
Operating humidity %RH

Safe removal method Tick Comments

Not applicable
Disinfection/decontamination
Encapsulation
Bagging

Filter disposal method Tick Comments

Solid general waste
Contaminated waste
Incineration

Original filter supplier Manufacturer’s code Model/type

Airflow (complete only one, i.e. either non-unidirectional or unidirectional)

Non-unidirectional flow
Volume (m3/hr)
Face velocity (m/s)
Initial differential pressure (Pa)

Unidirectional flow
Airflow velocity 150 mm to 300 mm from filter face (m/s)
Uniformity of airflow velocity across filter face (%±)
Initial differential pressure (Pa)

8 • © BSI 2007
 PD 6609:2007

Table A.1 High efficiency filter specification (continued)

Manufacturer’s filter test method
BS EN 1822 Filter class Tick Comments
Volumetric efficiency
99.999995% U17
99.99995% U16
99.9995% U15
99.995% H14
99.95% H13
99.5% H12
Eurovent 4/4 (BS 3928) Volumetric efficiency (%)

Manufacturer’s leak test scan

NOTE To be carried out by the manufacturer with the object of ensuring that the filter will meet the specified
criteria for the in situ leak test for local penetration after installation.
Penetration Comments
%
BS EN 1822
EN ISO 14644-3
PD 6609
Other

In situ leak test method

NOTE In situ leak test to be carried out to verify that the filter meets the specified criteria for local penetration
after installation.
Penetration Comments
%
PD 6609
EN ISO 14644-3
Other

Aerosol type Thermal generation (hot) Laskin nozzle (cold) Other

Shell Ondina EL
Durasyn 164 / Emery 3004
Other (state type)

Filter mechanical specification

Filter sizes Height Width Depth
mm mm mm
Filter outside case dimensions
Filter cell (inside case) dimensions

For filters with knife edge seals

Height of knife edge (mm)
Inset of knife edge from edge of filter (mm)
Depth of gel channel (mm)
Width of gel channel (mm)

© BSI 2007 • 9
PD 6609:2007

Table A.1 High efficiency filter specification (continued)

Frame material Tick one Comments
Particle board – MDF
Plywood
Chipboard
Aluminium
Galvanized steel
Stainless steel (specify grade)
Other (specify)

Gasket Tick one Comments

Strip closed-cell neoprene
One piece closed-cell neoprene
Single pour “D” type
Gel (specify type)
Other (specify)

Gasket location
Side of filter Dirty Clean Both Comments
Thickness (mm)

Airflow laminator
Mesh guard (filter face protection)
Thickness (mm)
Diamond size (mm)

Mesh guard material

Stainless steel (specify grade)
Steel unpainted
Aluminium
Powder coated steel
Painted steel
Powder coated stainless steel
Other (specify)

Separator (tick type)

String Kraft Dimple
Hot melt Plastic Polyurethane
Aluminium Other

Filter media type (tick type)

Glass High Temp PTFE Membrane

Construction (tick type)

Mini-pleat Deep pleat with separators
Deep pleat with no separator Wedge, delta-V, other type (specify)

10 • © BSI 2007
 PD 6609:2007

Annex B (informative) In situ leak test report

This annex sets out a table that can be used for an in situ test report
sheet. Table B is exclusively for the in situ leak test. Other tests on filters
such as tests for differential pressure, airflow uniformity and air supply
volumes should also be recorded and it may be useful to have a
combined test report sheet for all tests.
The in situ leak test report should include the following information:
a) facility details;
b) date of test;
c) test method, test parameters, acceptance criteria;
d) instrumentation and calibration status;
e) measured upstream aerosol concentrations at the beginning and
end of each test, and variation;
f) maximum downstream percentage local penetration measured per
filter;
g) pass/fail test result;
h) corrective actions; and
i) name of tester(s) and testing qualification.

© BSI 2007 • 11
 Table B.1 In situ leak test report sheet
Page 1 IN SITU LEAK TEST REPORT REPORT NUMBER :

Customer Test Supplier

PD 6609:2007

12 • © BSI 2007
FACILITY DETAILS
Facility Identification Aerosol Injection Port ID
Filter ID Upstream Sample Port ID
ISO Class Test Standard / Method
Date of Test Maximum permitted penetration

AEROSOL PHOTOMETER DETAILS

Make/Model Number
Serial Number
Calibration Cert No.
Date of Calibration
Period of Validity of Calibration
 Page 2 IN SITU LEAK TEST REPORT REPORT NUMBER :

AEROSOL GENERATOR DETAILS POSITIVE INJECTION PUMP DETAILS (when applicable)

Make/Model Number Make/Model Number
Serial Number Serial Number
Cert of Conformity No.
Date of Certification
Period of Validity of Calibration

TEST DATA
Upstream challenge concentration 4g/l Rated air volume flow of filter m3/s
Actual air volume flow of filter m3/s

FILTER MEDIA SCAN DATA FILTER FRAME AND GASKET SCAN DATA
Maximum measured penetration % Maximum measured penetration %

PASS OR FAIL PASS OR FAIL

Name of tester
Signature of tester

CORRECTIVE ACTION
Audited by

Signature of auditor

© BSI 2007
•
13
PD 6609:2007
PD 6609:2007

Bibliography
Standards publications
BS 3928:1969, Method for sodium flame test for air filters
(other than for air supply to I.C. engines and compressors)
(confirmed 2003)
BS 5295-1:1989, Environmental cleanliness in enclosed spaces –
Part 1: Specification for clean rooms and clean air devices
(withdrawn)
BS 5295-2:1989, Environmental cleanliness in enclosed spaces –
Part 2: Method for specifying the design, construction and
commissioning of clean rooms and clean air devices (withdrawn)
BS EN 1822-1, High efficiency air filters (HEPA and ULPA) –
Part 1: Testing flat sheet filter media
BS EN 1822-2, High efficiency air filters (HEPA and ULPA) –
Part 2: Aerosol production, measuring equipment, particle
counting statistics
BS EN 1822-3, High efficiency air filters (HEPA and ULPA) –
Part 3: Classification, performance testing, marking
BS EN 1822-4, High efficiency air filters (HEPA and ULPA) –
Part 4: Determining leakage of filter element (scan method)
BS EN 1822-5, High efficiency air filters (HEPA and ULPA) –
Part 5: Determining the efficiency of filter element
BS EN ISO 14644-1:1999, Cleanrooms and associated controlled
environments – Part 1: Classification of air cleanliness
BS EN ISO 14644-2:2000, Cleanrooms and associated controlled
environments – Part 2: Specifications for testing and monitoring to
prove continued compliance with ISO 14644-1
BS EN ISO 14644-4:2001, Cleanrooms and associated controlled
environments – Part 4: Design, construction and start-up
BS EN ISO 14644-5:2004, Cleanrooms and associated controlled
environments – Part 5: Operations
BS EN ISO 14644-7:2004, Cleanrooms and associated controlled
environments – Part 7: Separative devices (clean air hoods, glove
boxes, isolators and minienvironments)

14 • © BSI 2007
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