Guangzhou Anlai Air Purification Equipment Manufacturing Co.,Ltd
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Implementation of product standards

Reference table of clean level and dust particles


Air filter efficiency comparison table (EN)


Biological Clean Room Standards

Standard Name

Clean Class Level

Clean Room Testing

HEPA Filter Class

HEPA Filter Testing

USA FDA/GMP

US FED 209 D & E

IEST-RP-CC006.3

IEST-RP-CC023.1

IES-RP-CC001.1

IEST-RP-CC006.3

IEST-RP-CC0021.2

IEST-RP-CC0034.2

European EU/GMP

GGMP EEC Annex 1

ISO14644

ISO14644-2 & 3

ISO 14698

EN1822

EN1822

CHINA GMP-2011

FED 209 D & E

ISO 14644-1

GB 50073-2001

GB/T 16292-2010

GB/T 16293-2010

GB/T 16294-2010

GB/T 13554-2008

GB/T 6165-2008

Air Clean Class Level
Bio- clean room air clean area is divided into four areas:
Class A - high-risk operation area, which directly affects the operation area. Like sterilization tunnel oven, aseptic filling, bottle opening, autoclave cooling zones required 100 clean class laminar flow. Direct impact on the quality of products, called Class A.
Class B - indirect effects of the sterile operating area directly surrounding the class A area, like aseptic filling room, autoclave cooling room.
Class C and D - into the transition clean zone of the sterile production area. Preparation Room, changing rooms and a buffer room.

 

Clean Class Level

Max. Allowable Number of Dust Particles / m

Max. Allowable Number of Microorganisms

Air Velocity

≥0.5µm

≥5µm

 

 

Static / Dynamic

Static / Dynamic

Dynamic

Dynamic

Class A ( Dynamic 100 )

3.5×103 / 3.5×103

0 / 0

1

0.125

0.36-0.54

Class B ( Static 100 )

3.5×103 / 3.5×103

0 / 2.0×103

10

0.625

-

Class C ( 10,000 )

3.5×103 / 3.5×103

2.0×103 / 2.0 ×103

100

6.25

-

Class D ( 100,000 )

3.5×103 / ------

2.0×103------

200

12.5

-

GMP RSP Grading in Different Standards Roughly Contrast

China GMP -1998

China GMP -2010

US FED 209D

US FED 209E

ISO 14644-1

EU/GMP Annex 1

Recommended Terminal Filter

100(Dynamic)

A

100(Dynamic)

M3.5(Dynamic)

ISO5(Static)

A

H14

100(Static)

B

100(Static)

M3.5(Static)

ISO5(Static)

B

H14

10000

C

10000

M5.5

ISO7

C

H14

100000

D

100000

M6.5

ISO8

C

H14

300000

-

-

M7

 

-

H11


Product Testing Report




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