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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)
Class
Distinguish
Correspond
Detail
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
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)
Printing
Ultra Precision Printing
To Prevent Dust, Fungus, Mildew in Order to Enhance and Ensure the Quality of the Product

 

Biological Clean Room(BCR)
Class
Distinguish
Correspond
Detail
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
Basis
Bacillus Subtilis, Escherichia Coli
Biosafety Cleanroom Level 2 Mildly Risk to Human Body, Limited to Public
Basis
Salmonella Typhimurium, Hepatitis B, Mycobacterium Tuberculosis, Lymphocytic Choriomeningitis Virus
Level 3 High Risk to Human Body, But Lower Risk to Public
Hermetic
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
 
FS-209E
ISO14644-1
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
Level
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
2.83L
2L
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)
Ultrafine Particle
≤0.02um
<0.1um
Large Particle
No Specific
>5um
Isokinetic Power
Included
Non Included
 
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