The ISO 14644-3 Guidelines for Cleanrooms and Associated Controlled Environments details a list of required and optional tests performed during certification of a cleanroom. Included in the list of optional tests is the installed filter system leakage test, including criteria for aerosol challenge testing, HEPA filter leak scanning, and leak penetration testing. These tests, as evidenced below, may not be required for a given application and should be mutually selected and agreed upon by the customer and supplier prior to order placement.
Table 2 lists other tests appropriate for testing of an installation. These tests can be applied in each of the three designated occupancy states. These tests may not be all-inclusive, nor may all of the tests be required for any given certification project. Tests and test methods should be selected in a manner agreed between the customer and supplier. Selected tests can also be repeated on a regular basis as part of a routine facility monitoring program (see ISO 14644-2). Guidelines for the selection of tests and a checklist of tests are given in Annex A. Test methods are outlined in Annex B.
The test methods described in Annex B are in outline form only. Specific methods should be developed to meet the needs of the particular application.
Optional tests
Reference in ISO 14644-3:2005
Referenced in
Principle
Procedure
Apparatus
Airborne particle count for ultrafine particles
4.2.1
B.2
C.2
ISO 14644-1
Airborne particle count for macroparticles
4.2.1
B.3
C.3
ISO 14644-1
Airflow testa
4.2.2
B.4
C.4
ISO 14644-1 and ISO 14644-2
Air pressure difference testa
4.2.3
B.5
C.5
ISO 14644-1 and ISO 14644-2
Installed filter system leakage test
4.2.4
B.6
C.6
ISO 14644-2
Airflow direction test and visualization
4.2.5
B.7
C.7
ISO 14644-2
Temperature test
4.2.6
B.8
C.8
ISO 7726
Humidity test
4.2.6
B.9
C.9
ISO 7726
Electrostatic and ion generator test
4.2.7
B.10
C.10
-
Particle deposition test
4.2.8
B.11
C.11
-
Recovery test
4.2.9
B.12
C.12
ISO 14644-2
Containment leak test
4.2.10
B.13
C.13
ISO 14644-1 and ISO 14644-2
a: This is a required test based on ISO 14644-2. These optional tests are not presented in order of importance. The order in which tests should be performed may be based upon the requirements of a specific document or after agreement between the customer and supplier.
Most cleanroom applications will necessitate the required tests, based on the ISO 14644-2 and 14644-3 guidelines: an airborne particle count test, an air flow test, and an air pressure difference test. Specific applications, such as class 10 or cleaner aseptic spaces, or industrial regulations, such as USP <797> guidelines for sterile drug compounding, stipulate additional, regularly optional tests, including, but not limited to, filter system leakage measurements.
For the majority of cleanroom applications, Terra offers a standard, roomside-replaceable HEPA-filtered fan unit, designed to meet published specifications and industry standards. For certain applications requiring filter system leakage tests, Terra offers a premium, roomside-replaceable HEPA-filtered fan unit tested and certified in accordance with the ISO 14644-2 and 14644-3 guidelines for leakage rates.
Each customer must specify either the standard filter fan unit or the leak-tested filter fan unit prior to order placement in order to ensure the appropriate units are delivered to meet the unique specifications of each application.
Available Certified ISO Grade Designs: ISO 5, ISO 6, ISO 7, ISO 8
EC brushless motors for quiet, energy-efficient operation and infinitely variable speed control
Air conditioning unit powered at 8,000 BTU, with a cooling range of 340 square ft.
Connect to automatic smart console for centralized fan control and cleanroom pressure balancing
Minimize cleanroom service downtime with room-side-replaceable (RSR) fan filter units
Note: Requires dedicated 20A circuit
Integrated air conditioning (AC) and fan filter unit (FFU) system for cleanrooms that require additional cooling
AC units come in different cooling ranges to fit cleanroom needs
WhisperFlow® baffling technology supports uniform velocity across the face of the filter for uniform air flow
Room-side-replaceable filter units feature a Gel-sealed filter and easy-open clips to allow fast filter replacement without breaching the cleanroom ceiling
Forward-curved centrifugal fans
Generates less vibration, noise and heat than standard FFUs with AC motors
Ethernet ports for remote monitoring and control
Includes a Merv 7 pre-filter and main HEPA filter to help meet ISO cleanliness standards
HEPA filters remove particles down to 0.3 µm at 99.99% efficiency
Complies with Title 24 and ErP 2015 Directives
Brushless EC motors have internal micro-processors
Internal baffling plate and diffuser panel provide quiet uniform air flow across the filter face
1/4-20 UNC threaded inserts on corners to allow suspension by guy-wires
MERV 7 pre-filter, 30% ASHRAE rated
Low-profile design is ideal for cleanrooms with limited ceiling space
Filters are leak tested in accordance with IEST standards and meet UL 900
See performance data and submittal sheets for additional information
Optional Accessories:
Challenge port kit
Power plug adapter
Steel surface mount frame for hard ceiling installation
Overview video of Terra Universal's comprehensive portfolio of filter fan unitsTerra Universal WhisperFlow® Filter Fan UnitsOverview video of Terra Universal's comprehensive portfolio of filter fan units
Did You Know? HEPA/ULPA Filters Do More Than Meet ISO Requirements - they also prevent infection.
Most cleanroom professionals understand that HEPA and ULPA filters capture contaminants that degrade particle-sensitive samples. But they also help remove bacteria, mold spores, and many viruses that contribute to a host of infections.
Most common bacteria are contained by the 0.3-micron pore size of high-efficiency particular air (HEPA) filters. Ultra-Low Penetration Air (ULPA) filters, which are rated 99.999% efficient at retaining particles of 0.12 microns and larger in diameter, capture ultra-fine contaminants, including many large viruses and mold spores.
These filters also remove aerosol-born pathogens - germs that hitch a ride on larger particles and liquid droplets that are captured in a HEPA or ULPA filter. HEPA- or ULPA-based Fan/Filter Units (FFUs) thus can play an important role in infection prevention in surgical theaters, ICUs and other medical settings.
Additionally, HEPA filters can help filter pollen, tiny insects, bacteria, mold, and other fungal spores that might be present during plant tissue culture or cannabis production. Contaminants such as these can find a way in via personnel or normal HVAC units and can blight crops and reduce yields. HEPA Filters help increase crop yields, pass inspection/meet regulations, and reduce contamination.
Here is a list of common human pathogens that HEPA/ULPA filters capture and remove from circulation:
Pathogens: Bacteria and Diseases
SARS-CoV-2: Coronavirus (COVID-19)
Escherichia coli: Gastrointestinal infection
Bacillus anthracis : Anthrax
Aspergillus brasiliensis: Sinus infections
Francisella tularensis: Tularemia
Bordetella pertussis : Whooping cough
Mycoplasma pneumoniae: Pneumonia
Chlamydia pneumoniae: Bronchitis
Chlamydia psittaci : Psittacosis
Klebsiella pneumoniae: Opportunistic infections
Haemophilus influenzae : Meningitis
Coxiella burnetii: Q fever
Pseudomonas aeruginosa: Opportunistic infections
Actinomyces israelii: Actinomycosis
Legionella pneumophila: Legionaire's disease
Thermoactinomyces sacchari: Farmer's lung
Alcaligenes: Opportunistic infections
Streptococcus pyogenes: Scarlet fever
Mycobacterium Tuberculosis: Tuberculosis
Protect Against Contaminants and Pathogens
HEPA and ULPA filters help capture many bacteria, viruses (COVID-19), and mold spores that contribute to a host of infections for both humans and plant/animal tissue cultures
Gel-Filled Channel on Room-Side Replaceable Filter
Gel-filled channel on room-side replaceable filter forms a tight seal against knife edge on fan housing, allowing fast, simple filter replacement from inside the cleanroom without the need for costly cleanroom shut-down.
Airflow Uniformity Improves Laminar Flow
Non-uniform air speeds produce turbulence that can recirculate particles into the air stream. Unique WhisperFlow® FFU baffling system and anodized diffuser plate promotes uniform laminar airflow to minimize turbulence and effectively carry away contaminating particles.
Full Range of Designs, Configurations!
WhisperFlow FFUs come in all styles: room-side replaceable, all-stainless steel, HEPA or ULPA filtration, EC energy-saving fans, reverse flow and more (shown: vapor filtration module with UV sanitation lamp).
Smart Fan Filter Unit with EC Motor
Smart WhisperFlow® Fan Filter Units are quiet, energy-efficient and easily adjustable, either manually or via automatic smart console, for centralized fan speed control and cleanroom pressure balancing.
Catalog of CE-Marked Products
Terra offers over 1,700 CE-marked products configured for international voltage requirements
Products Compliant With Your ISO Rating
High-capacity, durable, ISO-compliant system rated for thousands of operating hours.
Available Accessories
Popular Accessories
For a full list of accessories, select a product then click Choose Accessories on that product page.
Fan Filter Unit Control System
Provides room-by-room monitoring and control of Smart WhisperFlow FFUs to maintain target pressure differentials for ISO classification; temperature, humidity and particle monitoring and data logging, as well as dynamic fan set-point control, also available.
Filter Replacement Alarm
The filter replacement alarm monitors filter backpressure and issues an alarm when filter needs replaced (requires selection of fan filter unit with challenge port, order separately).
Night Service Saves Energy, Extends Filter Life!
Night service switch, shown mounted on Modular Hardwall Cleanroom panel, puts FFUs in low-energy mode during off-hours; saves 25% of fan operating costs and extends filter life.
Challenge Port; for Fan/Filter Unit
Challenge port for Fan/Filter Units simplifies filter leak testing and connection of Filter Backpressure Alarm (shown mounted on SS FFU, order separately).
Cord Adapter, MIN4 PL to 16AWG Power Cord for Terra Fan/Filter Unit
Four-pin power cord adapter for fan/filter unit allows connection to standard 120VAC/60Hz power receptacle.
FFU Mounting Frame; Stainless Steel
Stainless steel Fan Filter Unit (FFU) mounting frame supports FFU on drywall or other rigid ceiling material, viewed from above ceiling panel (FFU not included).
Power Distribution Modules for Cleanroom FFUs and Lights
UL-listed power distribution modules include all breakers, transformers and other electrical components for FFU/light connections; allows fast addition or relocation of FFUs or lights without the need for rewiring.
Energy-Efficient Lighting
Energy-efficient LED lighting panels and strips help to lower electrical costs and minimize heat build-up in temperature-controlled environments.
Purchase replacement filters ahead of time to prevent costly operational interruptions and avoid damage to fan blowers caused by excessive backpressure from long overdue filter replacements.
On a tight schedule?Choose FasTrak 24/7 Priority Service to help meet your critical schedule for Terra-manufactured products, either before or after your order is placed.*
FasTrak 24/7 provides a 24/7 commitment to meet the shipping date YOU specify, regardless of quoted lead times.
FasTrak 24/7 assigns a dedicated production team plus a dedicated senior expeditor working three shifts to meet your delivery specification.
FasTrak 24/7 guarantees* to meet the agreed-to specified ship date.
Call for pricing. FasTrak service fees cover costs of additional services only, without additional profit.
* Terra's FasTrak services limited guarantee: to ship on the ESD or date specified OR to refund up to 100% of FasTrak charges. This guarantee covers no direct, special, consequential or other damages and is strictly limited to up to 100% of the amount paid for FasTrak service. When a specified ship date is missed due to factors outside Terra's control (vendor performance, deliveries by shipping companies, etc.) and random factors such as accidents, the credit of up to 100% of the FasTrak 24/7 may not apply. FasTrak service requested after order placement will be quoted and accepted based on available time remaining before required ship date.
The ISO 14644-3 Guidelines for Cleanrooms and Associated Controlled Environments details a list of required and optional tests performed during certification of a cleanroom. Included in the list of optional tests is the installed filter system leakage test, including criteria for aerosol challenge testing, HEPA filter leak scanning, and leak penetration testing. These tests, as evidenced below, may not be required for a given application and should be mutually selected and agreed upon by the customer and supplier prior to order placement.
Table 2 lists other tests appropriate for testing of an installation. These tests can be applied in each of the three designated occupancy states. These tests may not be all-inclusive, nor may all of the tests be required for any given certification project. Tests and test methods should be selected in a manner agreed between the customer and supplier. Selected tests can also be repeated on a regular basis as part of a routine facility monitoring program (see ISO 14644-2). Guidelines for the selection of tests and a checklist of tests are given in Annex A. Test methods are outlined in Annex B.
The test methods described in Annex B are in outline form only. Specific methods should be developed to meet the needs of the particular application.
Optional tests
Reference in ISO 14644-3:2005
Referenced in
Principle
Procedure
Apparatus
Airborne particle count for ultrafine particles
4.2.1
B.2
C.2
ISO 14644-1
Airborne particle count for macroparticles
4.2.1
B.3
C.3
ISO 14644-1
Airflow testa
4.2.2
B.4
C.4
ISO 14644-1 and ISO 14644-2
Air pressure difference testa
4.2.3
B.5
C.5
ISO 14644-1 and ISO 14644-2
Installed filter system leakage test
4.2.4
B.6
C.6
ISO 14644-2
Airflow direction test and visualization
4.2.5
B.7
C.7
ISO 14644-2
Temperature test
4.2.6
B.8
C.8
ISO 7726
Humidity test
4.2.6
B.9
C.9
ISO 7726
Electrostatic and ion generator test
4.2.7
B.10
C.10
-
Particle deposition test
4.2.8
B.11
C.11
-
Recovery test
4.2.9
B.12
C.12
ISO 14644-2
Containment leak test
4.2.10
B.13
C.13
ISO 14644-1 and ISO 14644-2
a: This is a required test based on ISO 14644-2. These optional tests are not presented in order of importance. The order in which tests should be performed may be based upon the requirements of a specific document or after agreement between the customer and supplier.
Most cleanroom applications will necessitate the required tests, based on the ISO 14644-2 and 14644-3 guidelines: an airborne particle count test, an air flow test, and an air pressure difference test. Specific applications, such as class 10 or cleaner aseptic spaces, or industrial regulations, such as USP <797> guidelines for sterile drug compounding, stipulate additional, regularly optional tests, including, but not limited to, filter system leakage measurements.
For the majority of cleanroom applications, Terra offers a standard, roomside-replaceable HEPA-filtered fan unit, designed to meet published specifications and industry standards. For certain applications requiring filter system leakage tests, Terra offers a premium, roomside-replaceable HEPA-filtered fan unit tested and certified in accordance with the ISO 14644-2 and 14644-3 guidelines for leakage rates.
Each customer must specify either the standard filter fan unit or the leak-tested filter fan unit prior to order placement in order to ensure the appropriate units are delivered to meet the unique specifications of each application.
