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Profile - Bovis Lend Lease
Services provided range from strategic and management consultancy
through to major project implementation, providing a single point of
responsibility.
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of IQ, OQ and RD protocols. Development of ISO 9000 Quality Systems.
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The design and realisation of Research, Development, Production and
Administration Facilities. This includes concept through to detail design, cost
engineering, project management, management of construction, equipment
installation, commissioning, facility Start-Up and ongoing operation.
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Is the following familiar?
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HEPA & ULPA Filters
Scope of Presentation
Standards
Selection efficiency & velocity
In Situ Testing
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Standards & Regulatory
Requirements for HEPA & ULPA
filters
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HEPA Filter Standards
HEPA Filters are tested in 2 basic ways.
Factory or manufacturers tests
Europe + exported product EN 1822
In-situ testing of installations
GMP expectations (aerosol/photometer), leaks
0.01% irrespective of filter spec H14 or
U15 to pass test.
BSI PD 6609:2007 (aerosol/photometer)
BS EN ISO 14644-3 (aerosol/photometer +
particle counter method)
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Some Other Test Standards
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EN 12463:1999
for Microbiological Safety Cabinets
Replacement for parts of BS5726:1992 produced
by CEN TC233-Biotechnology.
KI-Discus & spore containment tests are
specified for type testing. In the UK version Ki-
Discus is specified for In-Situ testing.
Aerosol/Photometer filter test:-
Filter class not specified
Scan test penetration 0.003%
Mineral oil & suitable generator.
MMD of aerosol is defined.
Alternatives can be used e.g. DOP, DEHS, or
Parafin oil.
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MPPS here
Filter Performance ~ 0.2
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Efficiency MPPS shifts with
Velocity Change
Double the
velocity
loose an
order of 0.0007% @ 0.2
magnitude
in filter
Penetration!
0.005% @ 0.15
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Filter Test Methods Test
aerosols are different MMD
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EN 1822-4 Scan testing the filter
element - Manufacturer
A face scan test to determine the extent of local
leaks. The local Efficiency or Penetration at
MPPS.
Integrate results to give the overall Efficiency or
Penetration %age.
Automatic scanning particle counter.
Record the values
The test DOES NOT require scanning of the
frame and seals of the filter. Some suppliers have
decided to do this as part of their testing.
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EN 1822-4 Scan testing the filter
element - Manufacturer
HEPA & ULPA Filters
EN 1822
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EN 1822-1 compared with
Eurovent 4/4 (NaCl)
Eurovent 4/4 EN 1822
Filter Class Efficiency % Filter Class Efficiency %
H 10 85
H 11 95
EU 10 95 - 99.9
H 12 99.5
EU 11 99.9 99.97
EU 12 99.97 99.99 H 13 99.95
EU 13 99.99 99.999
H 14 99.995
EU 14 > 99.999
H 15 99.9995
H 16 99.99995
H 17 99.999995
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Now, lets look at aerosols for
In-situ leak testing
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BS EN ISO 14644-3
Test Standard
Informative Annex B6 Applies to HEPA & ULPA Filters
Aerosol Photometer Filter Installation Leak Test
For cleanrooms less clean than ISO 5
For filters with MPPS local penetrations > 0.005%
Pneumatic or thermal generation using DOP or
equivalent materials giving an aerosol of MMD
between 0.5 to 0.7 m & SD of 1.7
Upstream Challenge 10 - 100 mg/m3 + sensitivity
comments for conc < 20 mg/m3
Leaks designated as readings > 0.01% (guidance
value)
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BS EN ISO 14644-3
Test Standard
Informative Annex B6 Applies to HEPA & ULPA Filters
DPC Filter Installation Leak Test
For cleanrooms cleaner than ISO 5
For filters with MPPS penetrations < 0.005%
DOP or DEHS challenge enhancement if required
to obtain adequate sensitivity.
Isokinetic sampling and defined scanning rate
required for valid results.
Leaks designated as readings > an acceptance
value calculated from the MPPS of the filter.
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Different Aerosol Generators Generate
Different Size Distributions
Thermo-Pneumatic Aerosol Generator
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Different Aerosol Generators Generate
Different Size Distributions
Laskin Nozzle
Cold Generator
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Photometer is a Mass Spectrometer NOT a
Particle Counter
Aerosol Photometer
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Filter Test Aerosols MMD Thermal
by mass 0.2
micron. Near to
filter MPPS
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So, now remember the following:
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The special issues of high
temperature filters
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High Temperature Filters
Ovens and De-pyrogenisation Tunnels have
some special problems:-
Temperature 250-300 degC.
Thermal expansion & contraction transient particle
shedding .
Oil test aerosols can cause carbon deposits to be left on
media.
Cannot aerosol test hot. Aerosol Leak Test cold,
particle count check when hot.
When conditioned, filters at best are H 13 Local
Penetration allowed is 0.25%, a long way from 0.01%.
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How to resolve the problems!
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Resolving the problems
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EN 1822-1 Filter x2 vs x5 Option
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In-Situ Testing -Summary
Select test method, aerosol & generator.
Determine the acceptance criteria and justify.
Agree repair/replacement criteria.
Determine challenge up-stream.
Scan test final filter face for leaks
Determine acceptance or rejection.
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Conclusions
Be aware of the Filter Standards
Specify filters correctly
Install carefully
Test In-situ, define appropriate
acceptance criteria
Plan re-testing, rationalise frequency
based on track record of the application
and process criticality.
Have faith in risk-based.
Keep records
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This presentation has been prepared
and delivered by:-
Gordon J Farquharson
Bovis Lend Lease Technology
Consultants and Engineers
Tanshire House
Shackleford Road
Elstead
Surrey, GU8 6LB
UK
tel +44 1252 703663
fax +44 1252 703968
e-mail gordon.farquharson@eu.bovislendlease.com
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