Detailed Explanation Of Classification Of Cleanroom Levels

The Classification Of Levels In Clean Workshops Is Key To Ensuring That The Production Environment Of Various Industries Meets The Requirements. The Classification Criteria Are Mainly Based On The Concentration Of Suspended Particles In The Air, And Different Levels Are Applicable To Different Production Scenarios And Product Manufacturing. At Present, The Commonly Used International Standard Is ISO 14644-1, And There Is Also A Corresponding National Standard GB/T 25915.1-2010 In China. These Standards Classify Clean Workshops Into Multiple Levels From Low To High, Providing Precise Adaptation To The Production Needs Of Different Industries.

Scale Division Between ISO 14644-1 Standard And Corresponding Domestic Standards

In The ISO 14644-1 Standard And The Domestic GB/T 25915.1-2010 Standard, Cleanrooms Range From ISO Class 1 To ISO Class 9, Corresponding To Different Levels Of Cleanliness. ISO Class 1 Is The Highest Level, With A Maximum Allowable Number Of 0.1 μ M Suspended Particles Per Cubic Meter Of Air Of Only 10. It Is Commonly Used In Ultra Precision Semiconductor Chip Manufacturing And Other Scenarios That Require Extremely High Cleanliness, Such As The Production Of Nanoscale Chips. Even Small Particles May Cause Chip Performance Defects, So It Needs To Be Carried Out In Such A Nearly "zero Pollution" Environment. ISO Class 2-4 Grades Allow For An Increasing Number Of Suspended Particles Of Different Sizes Per Cubic Meter Of Air, Mainly Suitable For Semiconductor Manufacturing Pre Processes With Equally Stringent Cleanliness Requirements, High-end Optical Lens Grinding, And Other Fields.

ISO Class 5 Cleanrooms Allow A Maximum Of 3520 Suspended Particles Of 0.5 μ M Per Cubic Meter. This Level Is Widely Used In The Production Of Sterile Preparations And Hard Disk Manufacturing In Biomedicine.

. In The Biopharmaceutical Industry, Drugs Come Into Direct Contact With The Human Body And Must Be Produced In An Environment That Strictly Controls Microorganisms And Dust Particles To Ensure Drug Safety And Effectiveness. The Cleanliness Of ISO Class 6-8 Is Relatively Low, And The Allowable Number Of Suspended Particles Per Cubic Meter Is Further Increased. It Is Suitable For Medical Device Assembly, High Cleanliness Production Areas For Food And Beverage, Electronic Instrument Assembly, Etc. For Example, In The Production Of Food And Beverages, Although It Does Not Require Harsh Environments Like Pharmaceutical Production, It Is Still Necessary To Control Dust And Microorganisms To Avoid Product Contamination, Which Can Affect Quality And Shelf Life. ISO Class 9 Is A Relatively Low Cleanliness Level And Is Commonly Used In Places Where Cleanliness Is Required But The Standards Are Not As Strict, Such As Preparation Areas In Clean Laboratories.

Scale In Traditional Partitioning Methods

In Addition To The International Standard System Mentioned Above, In The Past, "how Many Levels" Were Commonly Used In China To Describe Clean Workshops, Such As Hundred Level, Thousand Level, Ten Thousand Level, Hundred Thousand Level, Etc. A Class 100 Clean Workshop Refers To A Facility Where, Under Static Conditions, There Are No More Than 100 Dust Particles With A Particle Size Of ≥ 0.5 μ M Per Cubic Foot Of Space. It Is Commonly Used For Processes Such As Sealing, Packaging, And Plugging Sterile Drugs; The Number Of Dust Particles With A Particle Size Of ≥ 0.5 μ M Per Cubic Foot Space In A Class 1000 Clean Room Shall Not Exceed 1000, Suitable For Concentrated Injection Or Dilute Injection Using A Closed System; The Number Of Dust Particles With A Particle Size Of ≥ 0.5 μ M Per Cubic Foot Of Space In A Class 10000 Clean Room Shall Not Exceed 10000, And Can Be Used For Sealing Large Volume Injections; The Number Of Dust Particles With A Particle Size Of ≥ 0.5 μ M Per Cubic Foot In A 100000 Level Clean Room Does Not Exceed 100000, Which Is Common In The Production Of Non Sterile Drugs, Initial Packaging Of Medical Devices, And Other Processes.

With The Continuous Improvement Of Product Quality And Production Environment Requirements In Various Industries, The Precise Division And Strict Implementation Of Cleanroom Levels Will Continue To Safeguard The High-quality Development Of Industries Such As Semiconductors, Biomedicine, Food, Electronics, Etc., While Also Promoting The Continuous Development Of Cleanroom Technology Towards More Precision And Efficiency.

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