FAQ

1.What is Cleanroom?

2.Why we need Cleanroom?

3.Where do all these tiny particles come from?

4.How big is a micron?

5.How to classified cleanroom?

Cleanroom can be divide into two kinds by application: Industrial Cleanroom and Biological Cleanroom. Biological Cleanroom with cleanroom function like Industrial Cleanroom, also need to control contamination density of micro-organism.

Cleanroom can be classified according to the level of cleanliness. We usually use U.S Federal Standard, which We messured the class of Cleanroom by the numbers of particle larger than 0.5 micron in diameter contained in one cubic foot of air. For example. Class 100 cleanroom contains fewer than 100 of such particle in one cubic foot. Beside US Federal standard, ISO 14644 also another type of classification. Tables below show the two standard.

Table 1: Airborne Particle Requirements for ISO 14644 and Federal Standard 209

ISO 14644-1

Obsolete

Federal Standard 209

Number of particles per m 3 by micrometer size

0.1μm

0.2μm

0.3μm

0.5μm

1μm

5μm

1

-

10

2

-

-

-

-

2

-

100

24

10

4

-

-

3

1

1,000

237

102

35

8

-

4

10

10,000

2,370

1,020

352

83

-

5

100

100,000

23,700

10,200

3,520

832

29

6

1,000

1,000,000

237,000

102,000

35,200

8,320

293

7

10,000

-

-

-

352,000

83,200

2,930

8

100,000

-

-

-

3,520,000

832,000

29,300

9

-

-

-

-

35,200,000

8,320,000

293,000

 

Table 4: Comparison of FDA, NASA, EU-GMP Standards

Cleanliness Class

FDA

NASA

EU-GMP

CFU/m 3 (CFU/ft 3)

CFU/m 3 (CFU/ft 3)

CFU/ m 3

At Rest

In Operation

0.5 μm/ m 3

5 μm/ m 3

0.5 μm/ m 3

5μm/ m 3

A

100

-

-

<1

3,500

-

3,500

-

B

100

3.5

(0.1)

3.5

(0.1)

10

3,500

-

350,000

2,000

C

10,000

-

18

(0.5)

100

350,000

2,000

3,500,000

20,000

D

100,000

88

(2.5)

88

(2.5)

200

3,500,000

20,000

-

-

Note: The above information is for reference only. Please refer to the respective Standards for exact details.

6.How about our surrounding environment?

7.How do cleanrooms stay clean?

8.What is laminar flow?

9.What does HEPA filter stand for?

10.What does ULPA filter stand for?

11.What exactly is an airshower?

12.What is a pass-through?

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