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MENUClean Room Standards
The ISO 14644:
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. ISO 1 is the “cleanest” class and ISO 9 is the “dirtiest” class. Even though it is categorized as the “dirtiest” class, an ISO 9 cleanroom environment is cleaner than an ordinary room.The most common ISO cleanroom classes are ISO 7 and ISO 8.
Federal Standard 209 (FS 209E) :
The old Federal Standard 209E (FS 209E) included the following cleanroom classes: Class 100,000; Class 10,000; Class 1,000; Class 100; Class 10; and Class 1. This standard was replaced by ISO-14644-1 in 1999. The standard was withdrawn in 2001, but is still widely used.
FDA Cleanroom Standard
Cleanrooms must also comply with industry-specific and international standards. For example, the EU GMP (A.B.C.D) applies to pharmaceuticals and USP (795, 797 and 800) applies to dispensing pharmacies.
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ISO 5 Cleanroom (Class 100 Cleanroom)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 Nanofabrication cleanroom facility | 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.
Some of our ISO 6 Cleanroom past projects : ISO 6 cleanroom for semiconductor Cleanroom for electronics manufacturing services ( ISO 6 ) ISO 6 Cell Production cleanroom for animal laboratory | |
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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.
Non-unidirectional air flow Some of our ISO 7 Cleanroom past projects : ISO 7 cleanroom for Electronic Component Production ISO 7 cleanroom for Nutraceutical Industry | 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.
Some of our ISO 8 Cleanroom past projects : ISO 8 cleanroom for Pharmaceutical Manufacturing Cleanroom for Pharmaceutical Industry Cleanroom wall addition for Medtech Manufacturer ISO 8 cleanroom for Medical Device Manufacturing ISO 8 cleanroom for the Automotive Industry |
Airborne Particulate Cleanliness Classes (by cubic meter) | ||||||
| CLASS | Number of Particles per Cubic Meter by Micrometer Size | |||||
| 0.1 micron | 0.2micron | 0.3micron | 0.5micron | 1 micron | 5 microns | |
| IS01 | 10 | 2 | ||||
| ISO2 | 100 | 24 | 10 | 4 | ||
| IS03 | 1,000 | 237 | 102 | 35 | 8 | |
| IS04 | 10,000 | 2,370 | 1,020 | 352 | 83 | |
| IS05 | 100,000 | 23,700 | 10,200 | 3,520 | 832 | 29 |
| IS06 | 1,000,000 | 237,000 | 102,000 | 35,200 | 8,320 | 293 |
| IS07 | 352,000 | 83,200 | 2,930 | |||
| IS08 | 3,520,000 | 832,000 | 29,300 | |||
| IS09 | 35,200,000 | 8,320,000 | 293,000 | |||
Comparison table of ISO grade standards and ventilation times | |
| ISO Class | ACH(AIRCHANGE PER HOUR) |
| ISO 3 | 360-540 |
| ISO 4 | 300-540 |
| ISO 5 | 240-480 |
| ISO 6 | 50-60 |
| ISO 7 | 30-40 |
| ISO 8 | 15-25 |
| ISO Class FED STD 209E Equivalent | |||||||
| ISO Class | Maximum Particles/m | FED STD 209E equivalent | |||||
| ≥0.1μm | ≥0.2um | ≥0.3um | ≥0.5um | ≥11m | ≥5um | ||
| ISO1 | 10 | 2 | |||||
| ISO2 | 100 | 24 | 10 | 4 | |||
| ISO3 | 1,000 | 237 | 102 | 35 | 8 | Class1 | |
| ISO4 | 10,000 | 2,370 | 1,020 | 352 | 83 | 3 | Class10 |
| ISO5 | 100,000 | 23,700 | 10,200 | 3,520 | 832 | 29 | Class100 |
| ISO6 | 1,000,000 | 237,000 | 102,000 | 35,200 | 8,320 | 293 | Class 1,000 |
| ISO7 | 352,000 | 83,200 | 2,930 | Class10,000 | |||
| ISO8 | 3,520,000 | 832,000 | 29,300 | Class 100,000 | |||
| ISO9 | 35,200,000 | 8,320,000 | 293,000 | Room Air | |||
| Comparison Table GMP/USP/ISO/FED209E | ||||||||||||
| project | China GMP/Europe GMP | ISO | FED STD 209E | |||||||||
| Suspended particles P/m3 | level | Static | dynamic | level | Static | level | dynamic | |||||
| ≥0.5um | ≥5μm | ≥0.5μm | ≥5μm | ≥0.5um | ≥5μm | ≥0.5um | ≥5μm | |||||
| A | 3520 | 20 | 3520 | 20 | M3.5 | 3530 | 100 | 5 | 2220 | 20 | 100 | |
| B | 3520 | 29 | 352000 | 2900 | - | - | 6 | 3520 | 29 | 1000 | ||
| C | 352000 | 2900 | 3520000 | 29000 | M5.5 | 353000 | 10000 | 7 | 352000 | 2930 | 10000 | |
| 8. | 3520000 | 29300 | 100000 | |||||||||
| D | 3520000 | 29000 | No regulations | No regulations | M6.5 | 3530000 | 100000 | 9 | 3520000 | 29300 | 100000 | |
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FAQ
What is clean room classification?
It is based on the norms given by such organizations as ISO (International Organization for Standardization). Hence, these classifications, painting from ISO 1 and finishing with ISO 9, in terms of the number of particles per cubic meter of air for a given size of particles (for example, 0.5 micrometers). The higher the classification given to the clean room (such as ISO 1), the cleaner the room will be.
What cleanroom classifications exist?
ISO 14644-2:ISO 1、ISO 2、ISO 3、ISO 4、ISO 5、ISO 6、ISO 7、ISO 8、ISO 9
FS 209E: Class 1,Class 10,Class 100,Class 1000,Class 1000,Class 10000
What is FDA classification of clean rooms?
Class A clean area: Number of airborne particles belongs to ISO 5 clean area and that of airborne particles >5.0μm.
Class B clean area: Type of airborne particles belongs to ISO 6 clean area and that of airborne particles > 0.5μm and >5.0μm
Class C clean area: Airborne particles belong to ISO 7 clean area under static and dynamic conditions respectively.
Class D clean area: Airborne particles belong to ISO 8 clean area under static conditions.
What about clean room Class 7 or 8?
ISO Class 7 clean room: Particle count allowed (0.5μm): 352000 particles/m3.
ISO Class 8 clean room: Particle count allowed (0.5μm): 3520000 particles/m3.
What does the term class 1000 cleanroom mean?
According to the Federal Standard 209E (FS209E), the definition of a Class 1000 cleanroom helps in ensuring the environment is regulated to limit the quantity of particles per cubic foot to 1,000 (around 35,300 particles for one cubic meter).
What does class 10 clean room mean?
According to the Federal Standard 209E (FS209E) a Class 10 cleanroom implies that the level of particles that are 0.5 micrometers (μm) should be 10 particles per cubic foot (around 353 particles per cubic meter).
What standards does the ISO 6 clean room follow?
Key Specifications for ISO 6 Clean Rooms:
For particles of 0.5 micrometers (μm) in size: 1,000,000 particles per cubic meter (approximately 35,300 particles per cubic foot).
For particles of 5.0 micrometers (μm) in size: 29,300 particles per cubic meter (approximately 1,000 particles per cubic foot).
ISO 6 defines a clean room environment with specific limits on airborne particulate contamination, providing guidance for industries that require controlled environments but do not need the stricter cleanliness levels of ISO 5 or higher classifications.
What is lSO 14644 cleanroom classification?
ISO 14644 is an international standard that provides guidelines for cleanrooms and controlled environments. It includes a series of standards that define the classification of air cleanliness according to the concentration of airborne particulate contamination.
The classifications range from ISO Class 1 (the cleanest) to ISO Class 9 (the least clean).
What are the differences between GMP Class A and B cleanroom settings?
Class A: In a static environment, there must not be more than 3520 particles 0.5 microns in size and 20 around and bigger than 5 microns in a cubic meter of air. The counts in a dynamic environment do not change and remain the same as in static.
Class B (Class B): per cubic meter, static environment, close to Class A cleanroom, suspended particles greater than or equal to 0.5 microns are allowed 3520, and suspended particles greater than or equal to 5.0 microns are allowed 29. In a dynamic environment, 352,000 suspended particles greater than or equal to 0.5 microns and 2900 suspended particles greater than or equal to 5.0 microns are allowed.
What is lSO 14644 clean room classification?
Both ISO (International Organization for Standardization) and GMP (Good Manufacturing Practice) are standards that provide regulations for modular cleanrooms. However, if ISO focuses on the classification of cleanroom spaces, GMP establishes regulations for the proper management of the cleanroom environment and its functioning.
