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    What is Cleanroom

    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.

    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.
    Industrial Clean Room(ICR)
    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
    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
    Drum, Tape
    Photoconductive CRT, Tube Brown, Printing Plates, Small Relay
    Electrical Testing Instrument
    Precision Electrical Testing Instrument


    Other Industry Area
    Aviation, Universe Industry
    Artificial, Gyroscope
    To Prevent Dust, Fungus, Mildew, To Prevent The Mutually Pollution between Earth and Universe
    Precision Instrument
    Miniature Bearing, Plain Bearing, High Reliability Parts, Assembly
    To Prevent Quality Deterioration Due to Mixed of the Dust
    Optical Equipment
    Lens Grinding, Medical Camera, Film Manufacturing, Microfilm, Imaging, Dry
    Precision Machinery
    Measurement, Control Fabricate by Machine
    To Prevent Dust, Fungus, Mildew In Order to Enhance and Ensure The Quality of the product
    Control Checks
    Environment Control, Laboratory, Research Labs
    To Prevent Incident (Develop product checks)
    Ultra Precision Printing
    To Prevent Dust, Fungus, Mildew in Order to Enhance and Ensure the Quality of the Product


    Biological Clean Room(BCR)
    General Biological Cleanroom
    Pharmaceutical Industry
    Non-sterile Medicine
    Solid Dosage and Liquid Forms
    Sterile Medicine
    Fluid Injection, Lyophilized Powder Injection, Non-parenteral Preparation etc.
    Food Industry
    Storage Room for Drinking Water, Dairy Products etc.
    Packing Room for Meat Product, Ham etc.
     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
    General Operation Room Class D
    Urologic Surgery, Gynecologic Surgery, Thoracic Surgery, Cosmetic Surgery
    Infection Operating Room Class D
    Thoracic Surgery, Infected Patients Surgery (Syphilis, Hepatitis)
    Biosafety Cleanroom
    Level 1 Lower Risk to Human Body and Public
    Bacillus Subtilis, Escherichia Coli
    Biosafety Cleanroom Level 2 Mildly Risk to Human Body, Limited to Public
    Salmonella Typhimurium, Hepatitis B, Mycobacterium Tuberculosis, Lymphocytic Choriomeningitis Virus
    Level 3 High Risk to Human Body, But Lower Risk to Public
    Brucella, Lassa Virus, Histoplasma Capsulatum
    Level 4 High Risk to Human Body and Public
    High Level Hermetic
    Marburg Virus, FMD Virus
    According to the classification of clean grade (0.5μm)
    ● Class  1                 ● Class  10                ● Class  100
    ● Class  1K               ● Class  10K              ● Class  100K
    Classification of Cleanroom based on Air-flow Direction:
    • Laminar Flow Type

    • Turbulent Flow Type

    • Horizontal Flow Type

    Difference between FS-209E & ISO 14644-1 Standard
    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
    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
    M1 — M7
    ISO1—ISO9 Level
    Cleanroom Status When Testing
    No Specific
    One or More Status
    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
    The Sample Minimum Volume
    Sampling Point
    Non-unidirectional flow: A×64/(10M)0.5
    Unidirectional flow: A/2.32,A×64/(10M)0.5 in whichever is less
    Sampling Times
    One or more Times
    One Times( take 3 times if only have little time)
    Ultrafine Particle
    Large Particle
    No Specific
    Isokinetic Power
    Non Included
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