HEPA or ULPA filter integrity test
In order to ensurecleanroomconformity, integrity and efficiency of your HEPA filtersis the criticalparameter you need to tests toallows goodperformance of yourinstallation. More precisely, youmust demonstrate demonstratethat there is noleak onyourinstalledfiltrationequipment.The filter integrity test is performed with aphotometer or a particle counter associated with a dilutor.The procedure is described in ISO 14 644-3 and is performed on filter elements of ISO classes 5 to8, annually or every 6 months depending on recommendations.To performintegrity filter test, Aerometrik offers a complete range of cold and hot generators,photometers, dilutors and associated consumables (EMERY 3004, DEHS, Ondina oil). A range ofdedicated accessories (adapters, positive pressure pump for sheath injection, printer) is alsoavailableto facilitate execution ofyour tests.In order tostartfacilitate theimplementationof these tests, Aerometrik provides you with additionalservices:
- Supply and execution of IQ/OQ protocols,
- Rental of equipmentavailable during calibration or qualification,
- Maintenance and metrological verification.
Professional and dedicated equipment solution, for on-site tests execution
Our equipment serves several purposes:
- Annual and bi-annual cleanrooms qualification ;
- Periodic control of production areas in case of filter changes ;
- Initial qualification of new installations or installations that have undergone maintenance or redesign cleanroom
This equipment package is designed for operating control of cleanrooms, microbiological safety stations, isolators, rabs and laminar flow.
Filter integrity test, normative context and references
- ISO 14644-1 : Clean rooms and related controlled environments
Part 1 : Classification of air particulate cleanliness - ISO 14644-2 : Cleanrooms and Related Controlled Environments
Part 2 : Monitoring the maintenance of cleanroom performance for particulate air cleanliness - ISO 14644-3 : Cleanrooms and Related Controlled Environments
Part 3 : Test Methods - Test Methods for Leak Testing of Installed Filtration Elements (HEPA or ULPA)
- Criteria and requirements for test equipment and products used
- Acceptance criteria
Our equipments are used for 2 types of methods described in ISO 14644-3 for the same purpose:
- Particle counter integrity test
Generally used for filtration elements containing few filters (PSM, isolator, RABS, sterilization tunnel), this method guarantees an easy, fast and reproducible implementation. Indeed, the use of a particle counter in association with a 1/100 dilutor allows to perform an upstream measurement serving as 100% value in order to determinate acceptable leak level according to expected filter specifications. This method offers advantage of generating low aerosol concentrations.
- Aerosol photometer integrity test
Suitable for all surfaces to be tested, this method is the standard for cleanrooms and can be used with a hot or cold generator, if generation requirements are less. Zero and 100% are performed directly and automatically by the photometer, allowing a direct leakage percentage measurement on the gun used to scan the filter and its perimeter.
Our equipments: for which types of controls and test methods?
Our equipments for HEPA filter integrity tests
Photometer portable ATI 2i
- The ATI 2i portable digital photometer allows you to check your HEPA filters. Equipped with its iProbe handheld scanner and remote controls, its portabilitymakes it easy to use.
- Designed for in situ filtration system integrity testing.
- Complies with NSF 49, IEST and ISO-14644 standards.
Thermal Aerosol Generator 5D
The Thermal Aerosol Generator is designed for users who want to be able to perform leakage testing on cleanroom air handling systems as well as HEPA filter integrity testing.
Cold Aerosol Generators ATI 4B / 4Blite / 6D
ATI's portable, lightweight and rugged cold aerosol generators are available with and without integrated compressors.
Specifically designed to generate a poly-dispersed aerosol in a wide variety of filtration systems, the applications are varied: laminar flow stations, negative pressure filtration units, biological safety cabinets, ceiling modules and more. ATI aerosol dispensers can also be used to test positive pressure systems using an optional positive injection pump and hose adapter.
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- The TDA 6D cold generator (self-contained, integrated compressor) is designed for use on microbiological safety cabinets, laminar flow hoods, RABS, isolators, negative pressure filtration units, ceiling modules, etc
- The TDA 4B / 4B Lite cold generators (without integrated compressor) allow testing of filter systems of all sizes.
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Generators and Diluters TOPAS
The ATM 226 and ATM 228 (adjustable flow rate) associated with the DIL 554 dilutor (1/100th) offer
an alternative to the generator and photometer solution to perform integrity tests on small
equipment (isolators, rabs ...).
Our equipment guarantees
Only one supplier. We provide you all necessary equipment for cleanroom qualification and all accessories and consumables.
Equipment advice and support. Telephone assistance is included in your contract. You don’t pay any extra fees if you need to contact us.
Metrological verification of your equipment. We maintain your equipment in operational condition with regular involvement from our metrology center. We are the sole manager of our equipment fleet.
Rental capacity. We can rent all necessary equipment on short notice.
