CLEAN AREA CLASSIFICATION ACCORDING TO DIFFERENT REGULATORIES BODIES




Here are the cleanroom classifications according to different regulatory bodies:-


1.ISO Cleanroom Classification:-

ISO organization ke dwara banai gayi ye classification ka use particle count ko define karne ke liye kiya jata hai.

Is classification ke anusar cleanroom ka level particles per cubic meter of air ke upar nirbhar karta hai.

Isme kuch alag alag classes hai jisme particles ke size ke anusar maximum allowable particle count fix kiya jata hai.

The classifications are as follows:

ISO Class 1: Maximum 10 particles per cubic meter (≥0.1 μm)

ISO Class 2: Maximum 100 particles per cubic meter (≥0.1 μm)

ISO Class 3: Maximum 1,000 particles per cubic meter (≥0.1 μm)

ISO Class 4: Maximum 10,000 particles per cubic meter (≥0.1 μm)

ISO Class 5: Maximum 100,000 particles per cubic meter (≥0.1 μm)

ISO Class 6: Maximum 1,000,000 particles per cubic meter (≥0.1 μm)

ISO Class 7: Maximum 352,000 particles per cubic meter (≥0.5 μm)

ISO Class 8: Maximum 3,520,000 particles per cubic meter (≥0.5 μm)


2.US Federal Standard 209E:-

US Federal Standard 209E ek standard hai jisme cleanroom classifications ke baare mein bataya gaya hai.

Ye classification maximum allowable particle count per cubic foot of air par nirbhar hai.

Is classification ke anusar 6 classes hai jo ki particle count ke size ke anusar fix kiya gaya hai.

The classifications were as follows:

Class 1: Maximum 35 particles per cubic foot (≥0.5 μm)

Class 10: Maximum 350 particles per cubic foot (≥0.5 μm)

Class 100: Maximum 3,500 particles per cubic foot (≥0.5 μm)

Class 1,000: Maximum 35,000 particles per cubic foot (≥0.5 μm)

Class 10,000: Maximum 350,000 particles per cubic foot (≥0.5 μm)

Class 100,000: Maximum 3,500,000 particles per cubic foot (≥0.5 μm).


3.EU GMP Cleanroom Classification:-

European Union Good Manufacturing Practice (EU GMP) guidelines pharmaceutical manufacturing ke liye cleanroom classifications provide karta hai.

Grade A: Maximum 3,520 particles per cubic meter (≥0.5 μm)

Grade B: Maximum 3,520 particles per cubic meter (≥5 μm)

Grade C: Maximum 35,200 particles per cubic meter (≥0.5 μm)

Grade D: Maximum 352,000 particles per cubic meter (≥0.5 μm)


Inn classification ke anusar cleanroom ka level particles per cubic meter of air ke upar nirbhar karta hai.

Isme 4 grades hai jisme particles ke size ke anusar maximum allowable particle count fix kiya jata hai.

Ye cleanroom classifications alag alag regulatory bodies ke dwara provide kiye gaye hai aur industry aur application ke anusar specific requirements vary karte hai.


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