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 ISO Ratings: ISO 5, ISO 6, ISO 7, ISO 8
Explosion-proof FFU meets NEC requirements for Class I/Class II, Division 1 Hazardous locations
Non-sparking motor, mounted in a cast-iron, explosion-proof housing
Cleanroom FFU provides avg velocity of 90+ FPM, airflow of 640+ CFM
Internal baffling plate and diffuser panel provide quiet and uniform air flow across the filter face
Minimize cleanroom service downtime with room-side-replaceable (RSR) fan filter units
Explosioon-proof FFU permits single speed operation (on/off).
Proper installation of explosion proof equipment is critical to maintaining the explosion-proof protection aspects of the system.
Customers must hard wire the motor/ffu in correlation to their specified voltage at time of installation Therefore all wiring for explosion proof systems should be done in the field per local code by a licensed electrician.
Room-side-replaceable filter units feature a Gel-sealed filter and easy-open clips to allow fast filter replacement from below without breaching the cleanroom ceiling
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
Explosion-Proof WhisperFlow® Fan-Filter Units use sealed or non-sparking components for safe operation around flammable/explosive vapors and dustsExplosion-Proof Fan-Filter UnitExplosion-Proof WhisperFlow® Fan-Filter Units use sealed or non-sparking components for safe operation around flammable/explosive vapors and dusts; meet NEC standard for Class I, Division 1 hazardous locations.
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 pertusis : Whooping cough
Mycoplasma pneumoniae: Pneumonia
Chlamydia pneumoniae: Bronchitis
Clamydia 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
Alkaligenes: Opportunistic infections
Streptococcus pyogenes: Scarlet fever
Mycobacterium Tuberculosis: Tuberculosis
Diffuser Panel Promotes Air Flow Uniformity and Protects Filter Integrity
Unlike other manufacturers, Terra’s FFUs include a unique perforated panel beneath the filter, acting as a shower head, to guarantee filter protection and laminar air flow uniformity, which prevents localized air swirling, particle build-up and turbulence.
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.
Explosion-Proof Power Switches
UL-rated explosion-proof switches are connected to the lights and blowers using specialized conduit with potted fittings. All electrical components are sealed to eliminate potential ignition points.
Explosion-Proof Potted Fittings
Conduit is filled with an expanding cement mixture to isolate explosion-proof components from potential sources of ignition; explosion-proof fittings meet requirements of NEC for Class I, Division 1 hazardous locations.
Pre-Filter Grounding Clip
A grounding wire connects the body of the Explosion-Proof FFU to a metal wireframe embedded in the pre-filter as a safeguard against sparking.
Non-Sparking Direct-Drive Motor
Explosion-proof motors use a non-sparking polypropylene fan and cast-iron brackets attached to the heavy duty rolled steel frame
Explosion-Proof Junction Box
The reinforced junction box of the explosion-proof fan filter unit is built to withstand and contain an explosive reaction within the conduit system.
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.
Network of International Reps
Terra employs an international network of more than 20 local sales reps trained to provide comprehensive service on Terra's complete catalog of products
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.
Energy-Efficient Lighting
Energy-efficient LED lighting panels and strips help to lower electrical costs and minimize heat build-up in temperature-controlled environments.
Explosion-Proof 40W LED Light
UL-listed for Class I, Division 1 and 2, Groups C and D areas, this low profile LED light produces 3,600 lumens and operates from 120 to 277VAC, 50/60Hz. The heat-dissipating housing increases the efficiency and lifespan of the LEDs.
Explosion-Proof Power Distribution Module
Explosion-Proof Power Distribution Module (PDM) meets NEC code for a Class I/Division 1 hazardous location; includes all relays, breaks and other cleanroom electrical components
Challenge Port for Fan Filter Unit
Challenge port for Fan/Filter Units simplifies filter leak testing and connection of Filter Backpressure Alarm (shown with optional pressure gauge; must be ordered with FFU).
Safely Mount FFU’s Above Floor for Horizontal Laminar Airflow
The portable FFU base stand can be easily positioned to supply Class 100 horizontal laminar flow into a room or enclosure. It can also be positioned next to sensitive equipment/materials that are mounted close to the floor.
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.