Cleanroom Design

Design of HVAC and utilites for Cleanrooms to grades D, C, B or A in accordance with the European Standards, or to ISO standard 14644-1.
Calculation of airflow requirements, pressure regimes, filtration, cooling and heating requirements to safeguard the product and to provide comfortable conditions for the operators.Determination of materials and personnel flows and change regimes to ensure compliance with the regulatory authorities, (FDA, MHRA, ACDP).






The following tables indicate the different standards commonly referred to within the industry.  Although the ISO 14644-1 has superceded all other standards, the BS and European standards are sometimes used by professionals and operators, when referring to cleanroom classifications.


European Cleanroom Standards

   
   
  maximum particles/m³
 Grade   at rest  in operation 
   ≥0.5 µm   ≥5 µm  ≥0.5 µm   ≥0.5 µm 
 A  3 500 0 3 500 0
 B  3 500 0 350 000 2 000
 C  350 000 2 000 3 500 000 20 000
 D  3 500 000 20 000 not defined not defined


               
US FED STD 209E cleanroom standards        
               
Class maximum particles/ft³ ISO  
≥0.1 µm ≥0.2 µm ≥0.3 µm ≥0.5 µm ≥5 µm equivalent  
1 35 7 3 1   ISO 3  
10 350 75 30 10   ISO 4  
100   750 300 100   ISO 5  
1,000       1,000 7 ISO 6  
10,000       10,000 70 ISO 7  
100,000       100,000 700 ISO 8  
               
US FED STD 209E was officially cancelled in November 2001, although it is referred to from time to time
 

 		              
ISO 14644-1 cleanroom standards        
               
Class maximum particles/m³ FED STD 209E
≥0.1 µm ≥0.2 µm ≥0.3 µm ≥0.5 µm ≥1 µm ≥5 µm equivalent
ISO 1 10 2          
ISO 2 100 24 10 4      
ISO 3 1,000 237 102 35 8   Class 1
ISO 4 10,000 2,370 1,020 352 83   Class 10
ISO 5 100,000 23,700 10,200 3,520 832 29 Class 100
ISO 6 1,000,000 237,000 102,000 35,200 8,320 293 Class 1000
ISO 7       352,000 83,200 2,930 Class 10,000
ISO 8       3,520,000 832,000 29,300 Class 100,000
ISO 9       35,200,000 8,320,000 293,000 Room air
 

 		              
               
BS 5295 Cleanroom Standards          
               
  maximum particles/m³  
Class ≥0.5 µm ≥1 µm ≥5 µm ≥10 µm ≥25 µm    
Class 1 3,000            
Class 2 300,000   2,000 30      
Class 3   1,000,000 20,000 4,000 300    
Class 4     200,000 40,000 4,000