Relevant concepts and standards of clean room cleanliness

May 22, 2019 Industry News 364 views

Cleanliness refers to the amount of dust (including microorganisms) in the clean air

The air cleanliness of the clean room generally requires the following tests to draw conclusions:

l Idle, static test

The clean room has been installed, the clean air conditioning system is in normal operation, and the indoor production equipment and operators are not in place.

Or the clean room purification air conditioning system is already in normal operation, the process equipment has been installed, and the test is carried out without production personnel in the room.

l Run, dynamic test

The clean room has been tested under normal production conditions. The detection of air volume, wind speed, positive pressure, temperature, humidity, and noise in the clean room can be carried out in accordance with the relevant regulations of general use and air conditioning.

Cleanliness-the number of dust particles comparison table

	Idle state		Operating status
grade	Maximum number of particles per cubic area allowed
grade	0.5μm	5μm	0.5μm	5μm
A	3,500	20	3,500	1*
B	3,500	29	350,000	2,000
C	350,000	2,000	3,500,000	20,000
D	3,500,000	20,000	No specific requirements	No specific requirements

Cleanliness-EU and ISO standards

grade	Idle state	Operating status	Remarks
Class A	ISO 5	ISO 5	Local area for high-risk operations
Class B	ISO 5	ISO 7	Sterile preparations and canning
Class C	ISO 7	ISO 8	Non-critical process area
Class D	ISO 8	No specific requirements	Non-critical process area

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