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> Products > Clean Room

 

Clean room standard

NASA standards

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

 

 

KGMP standards

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)

 

 

Clean room standard

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

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