 |
|
|
| |
|
|
|
|
|
The standard is specified by National Aeronautics & Space Administration(NASA) which indicates the table below.
|
|
|
|
Bio
Clean the Room
Cleanliness |
Particle |
Microbial particles |
Pressure |
Temperature |
Humidity |
Flow
|
Roughness |
|
Diameter ㎛ |
Cumulative particle |
Unit flow |
Precipitation amount |
|
|
|
Lux |
|
per/ft³ |
per/ℓ |
per/ft³ |
per/ℓ |
per/㎥
|
1.3이상 |
지정상 |
45 |
Laminar way
0.45M/s
±0.1M/sTurbulence scheme
≥20/s |
1,080
1,620 |
|
100 |
≥0.5 |
≤100 |
≤3.5 |
0.1 |
0.0035 |
12,900 |
|
10,000 |
≥0.5
≥5.0 |
≤10,000
≤65 |
≤350
≤2.3 |
0.5 |
0.0176 |
64,600 |
|
100,000 |
≥0.5
≥5.0 |
≤100,000
≤700 |
≤3500
≤2.5 |
2.5 |
0.0884 |
323,000 |
|
|
|
|
|
|
|
|
The standard is specified by Korea Good Manufacturing Practice (KGMP) which indicates the table below.
|
|
|
|
|
Cleanliness
|
Color
|
Place
|
Management criteria
|
|
4
|
Black
|
Entrance, Drawing room, Machine room, warehouse
|
Common place
|
|
3
|
Gray
|
Locker room, Shower, Breathing room, Lounge,
Warehouse
|
Worker
1) Change the shoes
2) wear protective clothes
3) wash hands
Raw materials : peel off and clean
|
|
2
|
Light gray
|
(a)Refreshing room, (b)Manufacturing room, (c)Packing room, (d)Air lock
|
Air
(a)(b) Ventilate minimum 10times /hr,
Collecting greater than 5㎛ particle,
Maximum value of viable: 200 units/㎥
Worker
(a) Medical examination, Caring hands without contamination
(b) wear a mask
© wear axenic clothes and hand washing
Raw materials : clean container with a disinfecting fluid then UV irradiation
|
|
1
|
White
|
Manufacturing room, aseptic room
|
Air : keeping positive pressure
(a) Ventilate minimum 20times /hr,
utilization of HEPA filter, Maximum value of viable: 20/㎥
(b) Distiller, HEPA filter maximum 1 unit/hr (9 Cmφ)
|
|
| |
|
|
|
|
|
As a standard of ICR clean room, it is specified by Federal standard(Federal Standard 209B) in 1963. The standard is regulate the cleanliness as well as pressure, air current speed, temperature, moisture, and illuminance. It has been changed few times until now.
Otherwise, other countries are using their own standard with reference to FS209. Especially in Japan, they use the standard with N out of 10N/㎥.
Finally, international standards about cleanliness have been settled in 1999. The standard for BCR clean room is specified by NASA which are NHB 5340.1 and 5340.2.
|
|
|
|
This is similar to FS209B but added microbial concentration.
Most of bacteria and virus can be eliminated by removing air floating particle so that it leads to bacteria free conditions. Besides, there is GMP standard which is mange to produce qualified medicine. Measurement of Particle can be done by LPC and CPC. It usually held by measuring amounts of colony. |
|
|
|
|
|
|
|
|
|
Federal standard had been specified by GSA (General Services Administration). It had few changed after it was announced on December, 1963(F.S 209). The current standard is 209E which was announced in 1992.
This is the definition of the class limit which is specified by Federal standard.
|
|
|
|
CLASS |
Mouth diameter measurement( ㎛ ) |
|
|
0.1 |
0.2 |
0.3 |
0.5 |
5 |
|
1 |
35 |
7.5 |
3 |
1 |
NA |
|
10 |
350 |
75 |
30 |
10 |
NA |
|
100 |
NA |
750 |
300 |
100 |
NA |
|
1,000 |
NA |
NA |
NA |
1,000 |
7 |
|
10,000 |
NA |
NA |
NA |
10,000 |
70 |
|
100,000 |
NA |
NA |
NA |
100,000 |
700 |
|
|
|
|
|
Class limits |
|
Class Name ** |
0.1m |
0.2m |
0.3m |
0.5m |
5m |
|
|
Volume
units |
Volume units |
Volume units |
Volume units |
Volume
units |
|
SI |
English*** |
(㎥) |
(ft3) |
(㎥) |
(ft3) |
(㎥) |
(ft3) |
(㎥) |
(ft3) |
(㎥) |
(ft3) |
|
M1 |
|
350 |
9.91 |
75.7 |
2.14 |
30.9 |
0.875 |
10 |
0.283 |
-
|
-
|
|
M1.5 |
1
|
1,240 |
35 |
265 |
7.5 |
106 |
3 |
11 |
1 |
-
|
-
|
|
M2 |
|
3,500 |
99.1 |
757 |
21.4 |
309 |
8.75 |
100 |
2.83 |
-
|
-
|
|
M2.5 |
10
|
12,400 |
350 |
2,650 |
75 |
1,060 |
30 |
353 |
10 |
-
|
-
|
|
M3 |
|
35,000 |
991 |
7,570 |
214 |
3,090 |
87.5 |
1,000 |
28.3 |
-
|
-
|
|
M3.5 |
100
|
-
|
-
|
26,500 |
750 |
10,600 |
300 |
3,530 |
100 |
-
|
-
|
|
M4 |
|
-
|
-
|
75,700 |
2,140 |
30,900 |
875 |
10,000 |
283 |
247 |
7 |
|
M4.5 |
1,000 |
-
|
-
|
-
|
-
|
-
|
-
|
35,300 |
1,000 |
618 |
17.5 |
|
M5 |
|
-
|
-
|
-
|
-
|
-
|
-
|
100,000 |
2,830 |
2,470 |
70 |
|
M5.5 |
10,000 |
-
|
-
|
-
|
-
|
-
|
-
|
353,000 |
10,000 |
6,180 |
175 |
|
M6 |
|
-
|
-
|
-
|
-
|
-
|
-
|
1,000,000 |
28,300 |
24,700 |
700 |
|
M6.5 |
100,000 |
-
|
-
|
-
|
-
|
-
|
-
|
3,530,000 |
1,000,000 |
61,800 |
1,750 |
|
M7 |
|
-
|
-
|
-
|
-
|
-
|
-
|
10,000,000 |
283,000 |
-
|
-
|
|
|
|
|
|
|
Estimation of filter capture efficiency |
|
|
AFI |
ㆍAir filter insitute
ㆍDust weight Arrest EFF
ㆍOver 1㎛ particles
ㆍPre-Filter |
|
NBS |
ㆍNational Bureau of Standard
ㆍDust Spot Efficiency
ㆍBelow 1㎛ particles
ㆍMedium Filter |
|
DOP |
ㆍDioctyl Phthalate
ㆍFractional Efficiency
ㆍBelow 0.3㎛ particles
ㆍHEPA Filter, ULPA Filter |
|
|
|
|
|
|
|
|
| |
|
