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What is Cleanroom |
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ISO 14644-1 Clause
A room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the room and in which other relevant parameters, e.g. temperature, humidity and pressure are controlled as necessary.
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Classification of Cleanroom based on Functionality
A. Industrial Clean Room,ICR
Example: Semiconductor, Electronic Mechanic, Precision Machinery, Painting, Optics, Printing,Machine etc.
B. Biological Clean Room,BCR
Except same with the ICR requirement, BCR also have to control the biological particles by filter or sterilization method. |
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Industrial Clean Room（ICR）
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Semiconductor |
IC.LSI Fabrication |
Crystalline Refined, Proliferation, Etching, Alignment, Surface Treatment, Metal Attached Grinding, Assembly, Checks, Semi-finished Custody, Packaging. |
Ultra-precision Machining, Prevent Dust from Adhering, Prevent Mold Generation, In Order to Enhance and Ensure the Quality of the Product |
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Electronic Industry |
Electronic Processor |
Drum, Tape |
Machining, Assembly, To Prevent Dust from Adhering, To Prevent Mold Generation, In Order to Enhance and Ensure The Quality of the Product |
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Drum, Tape |
Photoconductive CRT, Tube Brown, Printing Plates, Small Relay |
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Electrical Testing Instrument |
Precision Electrical Testing Instrument |
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Other Industry Area |
Aviation, Universe Industry |
Artificial, Gyroscope |
To Prevent Dust, Fungus, Mildew, To Prevent The Mutually Pollution between Earth and Universe |
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Precision Instrument |
Miniature Bearing, Plain Bearing, High Reliability Parts, Assembly |
To Prevent Quality Deterioration Due to Mixed of the Dust |
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Optical Equipment |
Lens Grinding, Medical Camera, Film Manufacturing, Microfilm, Imaging, Dry |
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Precision Machinery |
Measurement, Control Fabricate by Machine |
To Prevent Dust, Fungus, Mildew In Order to Enhance and Ensure The Quality of the product |
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Control Checks |
Environment Control, Laboratory, Research Labs |
To Prevent Incident (Develop product checks) |
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Printing |
Ultra Precision Printing |
To Prevent Dust, Fungus, Mildew in Order to Enhance and Ensure the Quality of the Product |
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Biological Clean Room（BCR） |
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General Biological Cleanroom |
Pharmaceutical Industry |
Non-sterile Medicine |
Solid Dosage and Liquid Forms |
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Sterile Medicine |
Fluid Injection, Lyophilized Powder Injection, Non-parenteral Preparation etc. |
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Food Industry |
Storage Room for Drinking Water, Dairy Products etc.
Packing Room for Meat Product, Ham etc. |
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Medical facilities |
Sterile Operating Room Class A |
Artificial Joint Surgery, Visceral Organ Transplant ( Heart, Kidney, Liver and Other Organs), Brain Surgery, Eye Surgery (Corneal Transplant), Cesarean Surgery |
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General Operation Room Class D |
Urologic Surgery, Gynecologic Surgery, Thoracic Surgery, Cosmetic Surgery |
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Infection Operating Room Class D |
Thoracic Surgery, Infected Patients Surgery (Syphilis, Hepatitis) |
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Biosafety Cleanroom |
Level 1 Lower Risk to Human Body and Public |
Basis |
Bacillus Subtilis, Escherichia Coli |
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Biosafety Cleanroom Level 2 Mildly Risk to Human Body, Limited to Public |
Basis |
Salmonella Typhimurium, Hepatitis B, Mycobacterium Tuberculosis, Lymphocytic Choriomeningitis Virus |
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Level 3 High Risk to Human Body, But Lower Risk to Public |
Hermetic |
Brucella, Lassa Virus, Histoplasma Capsulatum |
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Level 4 High Risk to Human Body and Public |
High Level Hermetic |
Marburg Virus, FMD Virus | |
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According to the classification of clean grade （0.5μm）
● Class 1 ● Class 10 ● Class 100
● Class 1K ● Class 10K ● Class 100K
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Classification of Cleanroom based on Air-flow Direction： |
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• Laminar Flow Type |
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• Turbulent Flow Type |
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• Horizontal Flow Type |
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Difference between FS-209E & ISO 14644-1 Standard |
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FS-209E |
ISO14644-1 |
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Level Classification |
Strong suggest referring to the level which listed in level classification table and list out the formula also |
Strong suggest refer to level formula |
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Formula for Level |
Cm= (0.5/D)2.2×10M
Particle number/ft3=Nc*(0.5/D)2.2(inch)
Cm— Under certain level, ≥D the suspended particulates maximum concentration limits Pc/m3
D — Particle size um
M — Cleanliness level
Nc— The cleanliness level in Inch |
Cm= (0.1/D)2.08×10N
Cn— Same as Cm
D — Same as
NSame as M |
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Level |
M1 — M7 |
ISO1—ISO9 Level |
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Cleanroom Status When Testing |
No Specific |
One or More Status |
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Particle Size Require for Testing |
One or More Times |
One or more, its particle size should be at least 1.5 times smaller particle size for the next |
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The Sample Minimum Volume |
2.83L |
2L |
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Sampling Point |
Non-unidirectional flow: A×64/(10M)0.5
Unidirectional flow: A/2.32,A×64/(10M)0.5 in whichever is less |
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Sampling Times |
One or more Times |
One Times( take 3 times if only have little time) |
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Ultrafine Particle |
≤0.02um |
<0.1um |
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Large Particle |
No Specific |
>5um |
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Isokinetic Power |
Included |
Non Included | | |
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