The Air cleanliness standard of clean room (area) of the pharmaceutical industry
Air cleanliness class
Maximum amounts of particle per square meter
Maximum amounts of animalcule
≥0.5μm
≥5μm
Amounts of airborne microbe per square meter
Amounts of colony forming microbe per Petri dish in 30min
100
3500
0
5
1
10000
350,000
2,000
100
3
100000
3,500,000
20,000
500
10
300000
10,500,000
61,800
NA
15
It is published by State Food and Drug Administration (SFDA) on Aug, 1st, 1999
The degree of cleanliness in the clean room and clean area
Air cleanliness class (N)
Equals or exceeds the max density of the dust size(pc/m3)
0.1μm
0.2μm
0.3μm
0.5μm
1μm
5μm
1
10
2
2
100
24
10
4
3
1000
237
102
35
8
4
10000
2370
1020
352
83
5
100000
23700
10200
3520
832
29
6
1000000
237000
102000
35200
8320
293
7
352000
83200
2930
8
3520000
832000
29300
9
35200000
8320000
293000
Code for design of clean room GB 50073-2001
Checking list of some countries’ air cleanliness based on the particle sizes ≥0.5μm
AmountsPer m3 ≥0.5μm
ISO 14644-1
(1999)
US
209E
(1992)
US
209D
(1988)
EEC
GGMP
(1989)
FRANCE
AFNOR
(1981)
GERMAN
VDI 2083
(1990)
JAPAN
JAOA
(1989)
1
-
-
-
-
-
-
-
3.5
2
-
-
-
-
0
2
10.0
-
M1
-
-
-
-
-
35.3
3
M1.5
1
-
-
1
3
100
-
M2
-
-
-
-
-
353
4
M2.5
10
-
-
2
4
1,000
-
m3
-
-
-
-
-
3,530
5
m3.5
100
A+B
4,000
3
5
10,000
-
M4
-
-
-
-
-
35,300
6
M4.5
1,000
1,000
-
4
6
100,000
-
M5
-
-
-
-
-
353,000
7
M5.5
10,000
C
400,000
5
7
1,000,000
-
M6
-
-
-
-
-
3,530,000
8
M6.5
100,000
D
4,000,000
6
8
10,000,000
-
M7
-
-
-
-
-
Class of clean operating room (vacant state or static state)
Class
Name of operating room
The maximum average density of colony forming (airborne) microbe
Air cleanliness class
Operating area
Surrounding area
Operating area
Surrounding area
I
Special clean operating room
0.2/30min·φ90 Petri dish(5/m3)
0.4/30min·φ90Petri dish（10/m3）
100class
1000class
II
Standard Clean operating room
0.75/30min·φ90Petri dish（25/m3）
1.5/30min·φ90Petri dish（50/m3）
1000class
10000class
III
Common clean operating room
2/30min·φ90Petri dish（75/m3）
4个/30min·φ90Petri dish（150/m3）
10000class
100000class
IV
Clean operating room
5/30min·φ90Petri dish（175/m3）
300000class
Architecture technical code for hospital clean operating department
Class of clean supplementary operating room (vacant state or static state)
Class
The maximum average density of colony forming (airborne) microbe
The maximum density of microbe on surface(amounts / m3)
Air cleanliness class
I
Partial: 0.2 / 30min·φ90 Petri dish (5 /m3)Others: 0.4 / 30min·φ90 Petri dish (10 /m3)
5
Partial: Class 100
Class 1000
II
1.5/30min·φ90Petri dish（50/m3）
5
Class 10000
III
4/30min·φ90Petri dish（150/m3）
5
Class 100000
IV
5/30min·φ90Petri dish（175/m3）
5
Class 300000
Note: The maximum average density of airborne microbe method should be used the datum in the parenthesis. The microbe density was tested directly, not obtained by conversing colony forming microbes with airborne units.
‘Architectural and Technical Code for Biosafety Laboratories’ GB50346-2004
The main technical index of main lab
Class
Air cleanliness class
Minimum air change rate
(times/hour)
The minimum negative pressure to the connected outward rooms
(Pa)
Temperature
℃
Relative humidity
%
Noise dB(A)
Minimum illumination
lx
I
--
Openable windows
--
18--28
≤70
≤60
200
II
--
Openable windows
--
18--27
30--70
≤60
300
III
7 or 8
15 or 12
-10
18--25
30--60
≤60
350
IV
7 or 8
15 or 12
-10
18--24
30--60
≤60
350
Note:
1.The minimum negative pressure of the main lab BSL-3 is no less than -30Pa, the minimum negative pressure of the main lab BSL-4 is no less than -40Pa.
2.The minimum negative pressure of the main lab ABSL-3 is no less than -40Pa, meanwhile its dissecting room is no less than -50Pa; The minimum negative pressure of the main lab ABSL-4 is no less than -50Pa, at the same time its dissecting room is no less than -60Pa.
3.The noises of biosafety cabinet, animal isolation are not including in this table, if the noises of the equipments are included, they are no more than 68dB(A)
4.The parameter of biosafety cabinet lab should conform to‘Laboratory animal--Requirements of environment and housing facilities’GB14925.
‘Architectural and Technical Code for Biosafety Laboratories’ GB50346-2004
The main technical index of supplementary biosafety laboratories about class3 and class4
Room name
Air cleanliness class
Minimum air change rate
(times/hour)
The minimum negative pressure to the outward connected rooms (Pa)
Temperature
℃
Relative humidity
%
Noise dB(A)
Minimum illumination lx
Buffer room of the main lab
7 or 8
15 or 12
-10
18--27
30--70
≤60
200
Separated passage
7 or 8
15 or 12
-10
18--27
30--70
≤60
200
Preparing room
7 or 8
15 or 12
-10
18--27
30--70
≤60
200
The second locker room
8
10
-10
18--26
--
≤60
200
Buffer room of the second locker room
8
10
-10
18--26
--
≤60
200
Chemistry shower
--
4
-10
18--28
--
≤60
150
The first locker room(put on or take off close or uniform)
--
--
--
18--26
--
≤60
150
Note: if biosafety cabinet was installed, the maximum noise must not be less than 68dB(A).
‘Architectural and Technical Code for Biosafety Laboratories’ GB50346-2004
The checking table of air filters’ class in some countries
