hepa filters in safety applications · 2018-02-14 · refers to filter grades in accordance with en...
TRANSCRIPT
HEPA Filters
Gordon Farquharson
July 2017
Slide 2 © PharmOut 2017
Images courtesy of CamfilFarr
Air Filters at work
Slide 3 © PharmOut 2017
How filters work
Sieving Effect
Straining
Slide 4 © PharmOut 2017
Filter Efficiency curve
MPPS, typically at 0.2 micron particle size
Slide 5 © PharmOut 2017
Some important filter considerations
• The correct pre-filters protect systems& prolong life of final filters
• HEPA filters are the GMP filters.They are required in cleanroom & safety ventilationapplications.
• Designs and installation must allow for convenient & safe filter testing
• Make sure you know what filters are installed in the system
Slide 6 © PharmOut 2017
Filter Test Methods
MPPS = 0.2 m
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Some Test Equipment
Thermo-Pneumatic Aerosol Generator
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Some Test Equipment
Laskin Nozzle Cold Generator
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Some Test Equipment
Aerosol Photometer
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CEN TC 195 - Air Filtration
EN 1822-3
Testing Planar Filter Medium to determine the MPPS -- Most Penetrating Particle size. The processes of Interception, Diffusion & Straining give the following classic curve. Performance is velocity dependent.
HEPA & ULPA Filters
v1
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HEPA & ULPA FiltersEN 1822 - Factory Test
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EN 1822-1 Filter Classifications
To avoid problems with In-situ test, always specify a face
scanned filter from the supplier !
Local efficiency = 5x 0verall
Overall Effic/Pen Local Effic/Pen
H10 85 / 15% na / na
H11 95 / 5 na / na
H12 99.5 / 0.5 na / na
H13 99.95 / 0.05 99.75 / 0.25%
H14 99.995 / 0.005 99.975 / 0.025
U15 99.9995 / 0.0005 99.9975 / 0.0025
U16 99.99995 / 0.00005 99.99975 / 0.00025
U17 99.999995 / 0.000005 99.9999 / 0.0001
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Local & Overall EfficiencyH 14 example
Overall penetration
< 0.005 % @ MPPS
Local pen
< 0.025 %
Local pen
< 0.025 %
Local pen
< 0.025 %
@ MPPS
Local & Overall
Pen % must pass
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Leak test In-situ
Overall penetration
< 0.001 or 0.003 % @ MPPS
Local pen
< 0.01 %
Local pen
< 0.01 %
Local pen
< 0.01 %
PAO test
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Choosing the Right HEPA Filter
http://www.phss.co.uk/Refers to filter grades in accordance with EN 1822 ULPA , & HEPA
EU GMP Grade
ClassAt Rest
14644-1 209E
0.5 m
ClassIn Operation14644-1 209E
0.5 m
Air flow regimeand final filterconfiguration
Final Filterspecification to
EN 1822
In situ test leak testmethod
Testacceptancecriteria =stated %
U15 0.001 %A
ISO 5100M3.5
ISO 5100M3.5
UDAFTerminal HEPAfilter H14
Face scan withaerosol &photometer 0.01 %
BISO 5100M3.5
ISO 7
10,000M5.5
N-UDAFTerminal HEPAfilter
H14Face scan withaerosol &photometer
0.01 %
CISO 710,000M5.5
ISO 8100,000M6.5
N-UDAFTerminal HEPAfilter
H14Face scan withaerosol &photometer
0.01 %
DISO 8100,000M6.5
Not definedN-UDAFIn plant final filter
H13 Volumetric overallpenetration.
0.01 %
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The Installed HEPA Filter
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Typical Aseptic Facility Design (From ISPE HVAC GPG)
Outside air treatment AHU
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HEPA Filter Systems for Potent, Toxic, Biohazard applications
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BIBO (Bag-In, Bag-Out Housing
Cover Panel
Access door for BT damper
Scan section
Hepa Section
Pre filter section
Air intake
levelling feet
Fully Self contained system with fan, integrated dampers & automatic scan section optional
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Filter Leak Test Procedure!
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Filter Leak Test Procedure!
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Duct mounted double exhaust housingSafety ventilation systems - typical contemporary BSL-3 exhaust system
• High Total Cost of Ownership
• Large
• Each system must be specifically oriented
• Costly to test
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High Efficiency Particulate Air(HEPA) Filter
Typical BSL-3 HEPA Filter Exhaust System
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Filter leak testing – manual scanning a ducted filter
• Potential Risk to Certifier
• Requires lab shutdown and system decontamination
• Slow process
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Control Unit
Field system leak testing – automated scanning
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Conclusions
Be aware of the Different Standards
Understand the configuration
Specify filters correctly (including leak testing)
Install carefully
Test In-situ
Plan re-testing
Keep records
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Thank you for your time.Questions?
Gordon Farquharson
www.pharmout.net
Executive Consultant