Make clean Room Classifications
(ISO 8, ISO vii, ISO 6, ISO 5)

Clean Room Classifications

Clean rooms are classified according to the cleanliness level of the air inside the controlled environment. The make clean room course is the level of cleanliness the room complies with, according to the quantity and size of particles per cubic meters of air. The primary authority in the U.s. and Canada is the ISO nomenclature system ISO 14644-1.

This ISO standard includes these clean room classes : ISO 1, ISO 2, ISO iii, ISO 4, ISO five, ISO six, ISO 7, ISO 8 and ISO nine. ISO 1 is the "cleanest" form and ISO ix is the "dirtiest" course. Even if information technology's classified as the "dirtiest" form, the ISO 9 clean room surroundings is cleaner than a regular room.

The most common ISO make clean room classes are ISO 7 and ISO 8. The Federal Standard 209 ( FS 209E ) equivalent for these ISO classes are Course 10,000 and Class 100 000.

The erstwhile Federal Standard 209E ( FS 209E ) includes these clean room classes : Course 100,000; Class 10,000; Course i,000; Grade 100; Class 10; Grade 1. This standard was replaced in 1999 by ISO-14644-1. It was withdrawn in 2001, merely information technology is nevertheless widely used.

Clean rooms must likewise follow industry-specific and international standards. For example, Eu GMP (A-B-C-D), applies to pharmaceutical products and USP (795, 797 and 800) to compounding pharmacies.

Y'all might also like this article —>How Nomenclature Impacts your Cleanroom Design

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ISO Cleanroom Standards and layouts

Depending on the course of make clean room system you would like to reach, it is important to allow for enough square footage. This is critical non just for the make clean zone, but besides for the airlocks/gowning room which forestall the migration of particles from outside into the clean space.

The rule of thumb is that you should not skip over more than one form when you move towards a cleaner room (for example, from ISO vii to ISO 6, not from ISO 8 to ISO 6), as illustrated below. In reality, however, yous tin can reach a cleaner class with fewer airlocks than described below with the appropriate air changes per 60 minutes.

This depends on the process taking place within the cleanroom, the size of the cleanroom, the number of people working inside, the equipment inside, etc. Seek the help of a cleanroom skillful who tin create the optimal layout for your particular needs.

Already in the pattern procedure of your cleanroom? Download our Cleanroom Checklist to requite a jump kickoff to your cleanroom project!

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ISO 6 clean room layout

ISO vi Cleanroom (Class 1,000 Cleanroom)

In theory, for an entire room to reach ISO 6 air cleanliness, yous need to enter the cleanroom via an ISO eight (ante-room), then become through an ISO 7, to finally go into the ISO 6, every bit shown in the image.

In reality however, you can achieve an ISO half-dozen cleanroom with 1 (recommendation is 2) airlock. Once more, it depends of the size of the room, the procedure taking place within the cleanroom, the number of people working within, the equipment inside, etc.

Unidirectional air menses is sometimes recommended to attain ISO 6 nomenclature. For a room of less than 4–6 meters in width (depending on the activities taking place inside the cleanroom), air returns can be positioned on the side of the walls instead of in the floor. Installing air returns in the floor is more expensive.

  • ISO 6 zone | 90–180 air changes per hour
  • ISO 7 zone | 30–60 air changes per hour
  • ISO 8 zone | fifteen–25 air changes per hour (dues-room)

Some of our ISO half dozen Cleanroom past projects :

ISO half-dozen cleanroom for semiconductor
Cleanroom for electronics manufacturing services ( ISO six )
ISO six Cell Product cleanroom for animal laboratory

ISO 5 clean room layout

ISO five Cleanroom (Course 100 Cleanroom)

In theory, for a classified room (not just beneath a LAFW hood) to reach ISO class five air cleanliness, you need to enter the cleanroom via an ISO 8 (dues-room), and then go through an ISO vii, followed by an ISO vi to finally go into the ISO class 5 cleanroom.

In reality, even so, you tin reach an ISO 5 cleanroom with 2 or 3 airlocks. The optimal layout depends on the process taking place inside the cleanroom, the size of the room, the number of people working inside, the equipment inside, etc.

In addition, an ISO 5 or course 100 clean room needs to use unidirectional air flow. Unidirectional air flow cleanrooms use much more air than non-directional air catamenia cleanrooms. Loftier efficiency filters are installed across the entire ceiling.

The filtered air sweeps down the room in a unidirectional way, at a velocity generally between 0.iii m/s and 0.v m/due south, and exits through the flooring, removing the airborne contamination from the room. Cleanrooms using unidirectional air menses are more expensive than non-unidirectional ones, simply tin comply with more stringent classifications, such as ISO v or lower.

  • ISO 5 zone | 240–360 air changes per hour
  • ISO 6 zone | xc–180 air changes per hour
  • ISO vii zone | 30–60 air changes per hr
  • ISO viii zone | 15–25 air changes per hour (ante-room)

Some of our ISO 5 Cleanroom by projects :

ISO 5 Nanofabrication cleanroom facility

Comparing between selected equivalent of FS 209E ( FED STD-209E ) and ISO 14644-ane

ISO 14644-i FS 209E
ISO 3 Course 1
ISO 4 Class 10
ISO five Class 100
ISO 6 Class 1,000
ISO 7 Course 10,000
ISO 8 Form 100,000

Clean room classification particle concentration

The basis of clean room standards is the micrometer, or micron for brusk (µm), which is the size of the particles to be filtered. As stated before, make clean rooms are classified by how clean the air is, co-ordinate to the number of particles and size of particles per volume of air. The clean room classification table below shows the maximum concentration limits (particles/m3 of air) for particles equal to and larger than the considered sizes shown.

Some classifications do not require certain particle sizes to be tested because the respective concentrations are too depression or too high to be tested, but they should non exist nix.

ISO Make clean ROOM STANDARDS AND THE FS 209E EQUIVALENT

ISO Class Maximum Particles/g3 Particles/ftiii FS 209E Equivalent
≥0.1µm ≥0.2µm ≥0.3µm ≥0.5µm ≥1µm ≥5µm ≥0.5µm
ISO ane 10
ISO 2 100 24 10
ISO 3 1,000 237 102 35 1 Class 1
ISO 4 x,000 2,370 1,020 352 83 10 Class 10
ISO v 100,000 23,700 10,200 3,520 832 29 100 Form 100
ISO 6 1,000,000 237,000 102,000 35,200 8,320 293 1,000 Grade 1,000
ISO seven 352,000 83,200 2,930 x,000 Form 10,000
ISO 8 3,520,000 832,000 29,300 100,000 Class 100,000
ISO 9 35,200,000 viii,320,000 293,000

** Old FS 209E classes were calculated in particles per cubic foot, whereas ISO classes are in cubic meter of air.

HOW TO READ THE Make clean ROOM Classification PARTICLE COUNT GRAPH

ISO Class Maximum Particles/grandthree Particles/ftthree FS 209E Equivalent
≥0.1µm ≥0.2µm ≥0.3µm ≥0.5µm ≥1µm ≥5µm ≥0.5µm
ISO 7 352,000 83,200 2,930 10,000 Form 10,000

For ISO 7, particles smaller than 0.5 microns (≥0.ane µm, ≥0.2 µm, ≥0.3 µm) are not taken into consideration. The concentration of particles of ≥0.5 µm and to a higher place should be below 352,000, for particles of 1 micron and above 83,200 or lower and for particles of 5 microns and above two,930 or lower.

Cleanroom classification and air changes per 60 minutes

Air cleanliness is achieved past passing the air through HEPA filters using menstruum principles such as laminar catamenia. The more than often the air passes through the HEPA filters, the fewer particles are left in the room air. The volume of air filtered in one 60 minutes divided past the volume of the room gives the number of air changes per hour.

The number of air changes per hour according to the ISO class

ISO Form Boilerplate number of air changes per hour
ISO five 240–360 (unidirectional air catamenia)
ISO 6 ninety–180
ISO vii 30–threescore
ISO 8 10–25
Conventional building two – 4

The above-suggested air changes per 60 minutes are only a design dominion of thumb. They should be computed past an HVAC clean room expert, as many aspects must be taken into consideration, such as the size of the room, the number of people in the room, the equipment in the room, the processes involved, the heat gain, etc.

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Disclaimer

This article will assistance you understand the bones differences between an ISO 5, ISO half-dozen, ISO 7 and ISO viii clean room every bit per ISO 14644. Please note that this data is only provided for educational purposes.

The definitions in this article are oversimplified in social club to assist with agreement. This article will not help you decide which clean room classification you lot must reach. If help is needed in this respect, seek the advice of an expert in your industry (pharmaceutical, medical devices, sterile compounding, electronics, etc.).

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