CLEANROOM CLASSIFICATIONS

(ISO 8, ISO 7, ISO 6, ISO 5)

 

CLEANROOM CLASSIFICATIONS

Cleanrooms are classified according to the cleanliness level of the air inside the controlled environment The clean room class 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 US and Canada is the ISO classification system ISO 14644-1.

This ISO standard includes these clean room classes : ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 and ISO 9. ISO 1 is the “cleanest” class and ISO 9 is the “dirtiest” class. Even if it’s classified as the “dirtiest” class, the ISO 9 clean room environment is cleaner than a regular room.

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

The old Federal Standard 209E ( FS 209E ) includes these clean room classes : Class 100,000; Class 10,000; Class 1,000; Class 100; Class 10; Class 1. This standard was replaced in 1999 by ISO-14644-1. It was withdrawn in 2001, but it is still widely used.

Clean rooms must also 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.

You might also like this article —>How Classification Impacts your Cleanroom Design

Want to learn more about Clean Rooms? —>What is a Clean room?

ISO CLEANROOM STANDARDS AND LAYOUTS

Depending on the class of clean room system you would like to reach, it is important to allow for enough square footage. This is critical not just for the clean zone, but also for the airlocks/gowning room which prevent the migration of particles from outside into the clean space.

The rule of thumb is that you should not skip over more than one class when you move towards a cleaner room (for example, from ISO 7 to ISO 6, not from ISO 8 to ISO 6), as illustrated below. In reality, however, you can reach a cleaner class with fewer airlocks than described below with the appropriate air changes per hour.

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

Already in the design process of your cleanroom? Contact us to give a jump start to your cleanroom project!

ISO 8 CLEANROOM (CLASS 100,000 CLEANROOM)

Let’s assume that an unclassified space (office or lab) is ISO 9. In this case, you can directly enter an ISO 8 cleanroom, without an airlock. Depending on the production process inside the cleanroom, however, you may have to add a gowning room.

ISO 8 zone | 15–25 air changes per hour

Non-unidirectional air flow

ISO 7 CLEANROOM (CLASS 10000 CLEAN ROOM)

This is one of the most common classes of cleanrooms If you need an ISO 7 cleanroom you should consider having an ISO 8 airlock/gowning room prior to entering the ISO 7 room. The air changes per hour will vary in both rooms as described below.

ISO 7 zone | 30–60 air changes per hour

ISO 8 zone | 15–25 air changes per hour (ante-room)

Non-unidirectional air flow

ISO 6 CLEANROOM (CLASS 1,000 CLEANROOM)

In theory, for an entire room to reach ISO 6 air cleanliness, you need to enter the cleanroom via an ISO 8 (ante-room), then go through an ISO 7, to finally get into the ISO 6, as shown in the image.

In reality however, you can reach an ISO 6 cleanroom with 1 (recommendation is 2) airlock. Again, it depends of the size of the room, the process taking place inside the cleanroom, the number of people working inside, the equipment inside, etc.

Unidirectional air flow is sometimes recommended to reach ISO 6 classification. 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 | 15–25 air changes per hour (ante-room)

ISO 5 CLEANROOM (CLASS 100 CLEANROOM)

In theory, for a classified room (not just below a LAFW hood) to reach ISO class 5 air cleanliness, you need to enter the cleanroom via an ISO 8 (ante-room), then go through an ISO 7, followed by an ISO 6 to finally get into the ISO class 5 cleanroom.

In reality, however, you can 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 class 100 clean room needs to use unidirectional air flow. Unidirectional air flow cleanrooms use much more air than non-directional air flow cleanrooms. High efficiency filters are installed across the entire ceiling.

The filtered air sweeps down the room in a unidirectional way, at a velocity generally between 0.3 m/s and 0.5 m/s, and exits through the floor, removing the airborne contamination from the room. Cleanrooms using unidirectional air flow are more expensive than non-unidirectional ones, but can comply with more stringent classifications, such as ISO 5 or lower.

ISO 5 zone | 240–360 air changes per hour

ISO 6 zone | 90–180 air changes per hour

ISO 7 zone | 30–60 air changes per hour

ISO 8 zone | 15–25 air changes per hour (ante-room)

COMPARISON BETWEEN SELECTED EQUIVALENT OF FS 209E ( FED STD-209E ) AND ISO 14644-1

ISO 14644-1	FS 209E
ISO 3	Class 1
ISO 4	Class 10
ISO 5	Class 100
ISO 6	Class 1,000
ISO 7	Class 10,000
ISO 8	Class 100,000

CLEAN ROOM CLASSIFICATION PARTICLE CONCENTRATION

The basis of clean room standards is the micrometer, or micron for short (µm), which is the size of the particles to be filtered. As stated before, clean rooms are classified by how clean the air is, according 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 low or too high to be tested, but they should not be zero.

ISO CLEAN ROOM STANDARDS AND THE FS 209E EQUIVALENT

ISO  Class	Class Maximum Particles/m³						Particles/ft³	FS 209E Equivalent
	≥0.1µm	≥0.2µm	≥0.3µm	≥0.5µm	≥1µm	≥5µm	≥0.5µm
ISO 1	10
ISO 2	100	24	10
ISO 3	1,000	237	102	35			1	Class 1
ISO 4	10,000	2,370	1,020	352	83		10	Class 10
ISO 5	100,000	23,700	102,00	3,520	832	29	100	Class 100
ISO 6	1,000,000	237,000	102,000	35,200	8,320	293	1,000	Class 1,000
ISO 7				352,000	83,200	2,930	10,000	Class 10,000
ISO 8				3,520,000	832,000	29,300	100,000	Class 100,000
ISO 9				35,200,000	8,320,000	293,000

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

Design Requirements for Cleanroom Classifications

Criteria	Class 10 ISO4	Class 100 ISO5	Class 1000 ISO6	Class 10,000 ISO7	Class 100,000 ISO8
Air Changes Per HR/Min	500-600 / 8 to 10	300 to 480 / 5 to 8	180 / 3	60 /1	20 /0.33
Filter Coverage %	90 – 100	60 – 70	20 – 30	7 – 15	4  – 5
CFM Per Square foot	85 – 90	36 – 65	18 – 32	9 – 16	4 – 8
Filter Efficiency	99.9997% ULPAs	99.997% ULPAs	99.997% ULPAs	99.997% ULPAs	99.97% ULPAs
Ceiling Type	Aluminum T-bar grid	Aluminum T-bar grid	Aluminum T-bar grid	Conventional T-bar grid	Conventional T-bar grid
Light Fixture Type	Tear drop or Flow thru	Tear drop or 2'x4' cleanroom fixture	2'x4' cleanroom fixture	2'x4' cleanroom fixture	2'x4' standard fixture
Ceiling Panel	FRP, Vinyl rock or Mylar	FRP, Vinyl rock or Mylar	Vinyl rock or Mylar	Vinyl rock or Mylar	Vinyl rock or Mylar
Wall System	Modular or standard built	Modular or standard built	Modular or standard built	Modular or drywall	Modular or drywall
Flooring Cover	Welded sheet vinyl or Epoxy	Welded sheet vinyl or Epoxy	Welded sheet vinyl or Epoxy	Sheet vinyl or VCT	Sheet vinyl or VCT
Flooring Base	2” to 6” cove	Cove or Aluminum base channel	Cove or Aluminum base channel	Cove or Aluminum base channel	Cove or Aluminum base channel
Air Returns	Raised floor or center returns	Low wall on long axis	Low wall at perimeter	Low wall	Low wall or ceiling

To learn more about Cleanroom Classifications, check out this article《FAQs About Cleanroom Classifications》