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Jason@cleanroomequips.comClean 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 The standard was withdrawn in 2001, but is still widely used.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.
Your Reliable Manufacturer of Clean Room Standards
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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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Clean Room Standards Video Introduction
FAQ
What is clean room classification?
It follows standards set by organizations such as the ISO (International Organization for Standardization). The classifications, such as ISO 1 to ISO 9, denote the maximum allowable particle count per cubic meter of air for specific particle sizes (e.g., 0.5 micrometers). Higher classifications (e.g., ISO 1) indicate cleaner environments with fewer particles,
What are the cleanroom classifications?
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 the FDA classification of clean rooms?
Class A clean area: The level of airborne suspended particles is ISO 5, with ≥5.0μm suspended particles as the limit.
Class B clean area: The class of airborne suspended particles is ISO 6, which includes both ≥0.5μm and ≥5.0μm suspended particles.
Class C clean area: Airborne particles are classified as ISO 7 for static and dynamic conditions respectively.
Class D clean area: The airborne particulate level is ISO 8 for static conditions.
What is a Class 7 or 8 clean room?
ISO Class 7 clean room: Permissible dust particle count (0.5μm): not more than 352,000 particles per cubic meter.
ISO Class 8 clean room: Permissible dust particle count (0.5μm): not more than 3,520,000 particles per cubic meter.
What is class 1000 clean room?
A Class 1000 clean room, as defined by the Federal Standard 209E (FS209E), In a Class 1000 clean room, the environment is controlled to maintain an acceptable level of airborne particles, For particles of size 0.5 micrometers (μm)1,000 particles per cubic foot(approximately 35,300 particles per cubic meter).
What is a class 10 clean room?
A Class 10 clean room, as defined by the Federal Standard 209E (FS209E), For particles of size 0.5 micrometers (μm).10 particles per cubic foot (approximately 353 particles per cubic meter).
What are the ISO 6 standards?
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 clean room 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 is GMP Class A and B cleanroom environments?
Class A: 3520 suspended particles greater than or equal to 0.5 microns and 20 suspended particles greater than or equal to 5.0 microns per cubic meter in a static environment. The requirements for dynamic environments are the same as for 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?
ISO (International Organization for Standardization) and GMP (Good Manufacturing Practice) are both important frameworks that establish standards for modular cleanrooms, but they serve different purposes and focus on different aspects of cleanroom management and operation.
The impact of HEPA filters on clean room standards
HEPA filters significantly enhance clean room standards by capturing 99.97% of airborne particles as small as 0.3 microns, ensuring a highly controlled and contaminant-free environment. Their use is crucial in maintaining the stringent air quality requirements essential for industries like pharmaceuticals, biotechnology, and electronics manufacturing.
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