Technical Resources

Cleanroom Standards

ISO 14644-1 Cleanroom standards

Particle Count

Class Maximum particles/m³ FED STD 209E
equivalent
≥0.1 µm ≥0.2 µm ≥0.3 µm ≥0.5 µm ≥1 µm ≥5 µm
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  

Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use

Annex 1: Manufacture of Sterile Medicinal Products.

  Maximum permitted number of particles per m3 equal to or greater than the tabulated size
GRADE At Rest   In Operation  
  0.5 µm 5.0µm 0.5 µm 0.5 µm
A 3520 20 3520 20
B 3520 29 352 000 2900
C 352 000 2900 3 520 000 29 000
D 3 520 000 29 000 NOT DEFINED NOT DEFINED

  RECOMMENDED LIMITS FOR MICROBIAL CONTAINMENT (a)
GRADE Air Sample cfu/m3 Settle Plates (diam. 90 mm) cfu/4hours(b) Contact Plates (diam. 55mm) cfu/plate Glove Print 5 fingers cfu/gloves
A <1 <1 <1 <1
B 10 5 5 5
C 100 50 25 -
D 200 100 50 -

Note:

US-FDA Requirements

TABLE 1- Air Classifications

Clean Area Classification (0.5 um particles/ft3) ISO Designation > 0.5 μm particles/m3 Microbiological Active Air Action Levelsc (cfu/m3 ) Microbiological Settling Plates Action Levelsc,d (diam. 90mm; cfu/4 hours)
100 5 3,520 1e 1e
1000 6 35,200 7 3
10,000 7 352,000 10 5
100,000 8 3,520,000 100 50


ISO 14644-1


Temperature  
Humidity  
Airflow Volume  
Air Change Rate >20
Room Differential Pressure 5Pa-20Pa (0.0201 inH2O -0.0804 inch h20)