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Airborne Contamination Control

GirişValidasyon Nedir & TerimlerSteril Alan Havalandırma Sistemi HVAC ValidasyonuHepa-Ulpa Filtre Sızdırmazlık TestiHava Akış Hızı Ölçümü ve Hava Degişim Sayısının HesaplanmasıBasınç Farkları ÖlçümüSıcaklık ve Nem ÖlçümüDekontaminasyon Geri Kazanım TestiLaminar Air Flow (LAF) Kabinleri ValidasyonuAirborne Contamination ControlPartikül Sayımı ve Temiz Odanın Sınıflandırılması TestiLaminar Akışlı Temiz OdaTürbülans Akışlı Temiz OdaHava Kanalı Sızdırmazlık Testi
ISO/FDIS 14644-1 Cleanliness Classes for Cleanrooms and Associated Controlled Environments
Classification Maximum permitted number of particles/m3 ofa size equal to and greater than, the considered size calculated to whole numbers
0.1 μm 0.2 μm 0.3μm 0.5 μm 1.0 μm 5.0μm
1 10 2 --- --- --- ---
2 100 24 10 4 --- ---
3 1.000 237 102 35 8 ---
4 10.000 2.370 1.020 352 83 ---
5 100.000 23.700 10.200 3.520 832 29
6 1.000.000 237.000 102.000 35.200 8.320 293
7 --- --- --- 352.000 83.200 2.930
8 --- --- --- 3.520.000 832.000 29.300
9 --- --- --- 35.200.000 8.320.000 293.000


Notes:
• The above table is based on the Final Draft lnternational Standard 14644-1
• Concentration limits for intermediate classes can be calculated, approximately, using the following equation: Cn = 1 ON x (0.1/0)2.08
• Always refer to complete standard for exact details


US Federal Standard 209 E Cleanliness Classes of Cleanrooms and Associated Controlled Environments
US Fed.Std. class name2)
Si English3)
Class Limits1)
0.1 μm (m3) 0.2 μm (m3) 0.3 μm (m3) 0.5 μm (m3) 0.5 μm (m3)
  M1  
350 75,7 30,9 10,0 ---
M1.5   1
1.240 265 106 35,3 ---
  M2  
3.500 757 309 100 ---
M2.5   10
12.400 2.650 1.060 353 ---
  M3  
35.000 7.570 3.090 1.000 ---
M3.5   100
--- 26.500 10.600 3.530 ---
  M4  
--- 75.700 30.900 10.000 ---
M4.5   1.000
--- ---   35.300 247
  M5  
--- ---   100.000 618
M5.5   10.000
--- ---   353.000 2.470
  M6  
--- ---   1.000.000 6.180
M6.5   100.000
--- ---   3.530.000 24.700
  M7  
--- ---   10.000.000 61 .800


Notes:
1) The class limits shown in table 1 are defined for classification purposes only and do not necessarily represent the size distribution to be found in any particular situation.
2) Concentration limits for intermediate classes can be calculated, approximately, from the following equations: particles/m3 = 10M (0.5/d)2/2 where M is the numerical designation of the class based on Si units, and d is the partide size in micrometers, or: particles/ft3 = Ne (0.5/d)2.2.
3) For naming and describing the classes, Si names and units are preferred; however, English (U.S.) customary units may be used.


Comparison Classes Cleanroom Standards
US Fed.Std.
209E 1992
ISO.EN
FDIS 14644-1
Japan
JACA 1989
VDI 2083
Part 3 1990
AFNOR
NFX 44-101
BS
52951989
--- 1 1 --- --- ---
--- --- --- --- --- ---
--- 2 2 0 --- ---
  M1  
--- --- --- --- ---
M1.5   1
3 3 1 --- C
  M2  
--- --- --- --- ---
M2.5   10
4 4 2 --- D
  M3  
--- --- --- --- ---
M3.5   100
5 5 3 4.000 E(F)
  M4  
--- --- --- --- ---
M4.5   1.000
6 6 4 --- G(H)
  M5  
--- --- --- --- ---
M5.5   10.000
7 7 5 400.000 J
  M6  
--- --- --- --- ---
M6.5   100.000
8 8 6 4.000.000 K
  M7  
--- --- --- --- ---
M7.5   1.000.000
9 9 --- 40.000.000 L


Notes:
1) Scandinavian standards conform US federal Standard 209E
2) Always refer to complete standard for exact details


Comparison Cleanroom Standards and GMP Guides
US FS 209E
1992
Max.number of particles Per m3
Metric us ≥0.5 μm ≥0.5 μm
FD-GMP
1997 USP Chapter 1116 Viable
micro-organisms
Class Max.CFU Per m3
Ec Guide to GMP1) 1997 Revision to Annex
1 Viable micro-organisms
Class Max.CFU Per m3
M3.5 100 3.530 0
Critical area2) 3
A)3 <1
M3.5 100 3.530 0
NA NA
B 10
M5.5 10.000 353.000 2.470
NA 20
C 100
M6.5 100.000 3.530.000 24.700
controlled 100
D 200
  area  


Notes:
1) For more detailed information refer to "Rules Governing Medicinal Products in the European Community", Volume iV, Guide to Good Manufacturing
Practice. References to velocity and air chages have been deleted.
2) FDA prescribes for critical areas 0.45 m/s, ± 0.1 m/s.
3) For laminar airflow work stations.


EU GMP 1997 Revision -Total Particle Count
  Afrest In Operation
Grade Maximum oermitted number of oarticleslm3 eaual to or above
  0.5 μm 5.0 μm 5.0 μm 5.0 μm
A 3.500 --- 3.500 ---
B1) 3.500 --- 350.000 2.000
C1) 350.000 2.000 3.500.000 20.000
D1) 3.500.000 20.000 --- ---


Notes:
1) In order to reach the B, C and O grades, the number of air chages should generally be higher than 2) per hour in a room with a good airflow pattern and appropriate filters, HEPA for grades A, B and C. 2) Appropiate alert and action limits should be set for the particular operation.

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