Knowledge! Cleanroom Classification (Class A, B, C, D)

Posted on 2024-04-10

GMP Cleanliness Class A,B,C,D Main Parameter Requirement

Class A clean area

The air temperature in the clean operation area should be 20℃-24℃.

The relative humidity of the air in the clean operation area should be 45%-60%.

Air velocity in the operation area: horizontal air velocity ≥ 0.54m/s; vertical air velocity ≥ 0.36m/s

Leakage test of high efficiency filter is more than 99.97%

Illumination: >300lx-600lx

Noise: ≤75db (dynamic test)

Class B clean area

The air temperature in the clean operation area should be 20℃-24℃.

The relative humidity of the air in the clean operation area should be 45%-60%.

Room ventilation times: ≥ 25 times / h

Differential pressure: B-level area relative to the outdoor ≥ 10Pa, different areas of the same level

according to the direction of air flow should maintain a certain pressure difference.

Leakage check of high efficiency filter is more than 99.97%.

Illumination: >300lx-600lx

Noise: ≤75db (dynamic test)

Class C clean area

The air temperature in the clean operation area should be 20℃-24℃.

The relative humidity of the air in the clean operation area should be 45%-60%.

Room ventilation times: ≥ 25 times / h

Differential pressure: C-level area relative to the outdoor ≥ 10Pa, different areas of the same level

according to the direction of air flow should maintain a certain pressure difference.

Leakage check of high efficiency filter is more than 99.97%.

Illumination: >300lx-600lx

Noise: ≤75db (dynamic test)

Class D clean area

The air temperature in the clean operation area should be 18°C-26°C.

The relative humidity of the air in the clean operation area should be 45%-60%.

The number of room ventilation: ≥ 15 times / h

Differential pressure: 100. 000 level area relative to the outdoor ≥ 10Pa

Leakage detection of high-efficiency filters is greater than 99.97

Illumination: >300l×-600lx

Noise: ≤75db (dynamic test)

GMP workshop ABCD clean grade standard table reference：

cleanness level	Maximum permissible number of suspended particles/m³				Approximate correspondence to conventional specifications
	Static		Dynamic
	≥0.5μm	≥5μm	≥0.5μm	≥5μm
Grade A	3520(ISO5)	20	3520(ISO5)	20	Level 100
Grade B	3520(ISO5)	29	352000(ISO7)	2900	Level 100
Grade C	352000(ISO7)	2900	3520000(ISO8)	29000	Level 10,000
Grade D	3520000(ISO8)	29000	not regulated	not regulated	Level 10,0000

Comparison of the 1998 and 2010 editions of the GMP clean area standards for airborne particles

at all levels:

cleanness level	GMP 2010	Equivalent to ISO standards	GMP 1998	Equivalent to ISO standards
	A	Dynamic ISO5	Level 100	ISO5
		Static ISO5
	B	Dynamic ISO7
		Static ISO5
	C	Dynamic ISO8	Level 10000	ISO7
		Static ISO7
	D	Dynamic ISO7	10000 Levels	ISO8
		Static ISO8

The air cleanliness of a pharmaceutical production clean room

(area) is divided into four levels:

Clean room (area) air cleanliness level table

Cleanliness level	Maximum permissible number of dust particles/cubic meter ≥ 0.5μm number of dust particles	0.5μm number of dust particles Number of 5μm dust particles	Maximum permissible number of microorganisms planktonic bacteria/m³	Sedimentation bacteria/dish
Class 100	3,500	0	5	1
Class 10,000	350,000	2,000	100	3
Class 100,000	3,500,000	20,000	500	10
Class 300,000	10,500,000	60,000	1000	15

ISO 14644-1 (international standard)

Air cleanliness class (N)	Maximum concentration limit for particles larger than or equal to the indicated particle size (pcs/cubic meter of airborne particles)
Air cleanliness class (N)	0.1μm	0.2μm	0.3μm	0.5μm	1.0μm	5.0μm
ISO Class1	10	2
ISO Class2	100	24	10	4
ISO Class3	1,000	237	102	35	8
ISO Class4	10,000	2,3700	1,020	352	83
ISO Class5	100,000	23,700	10,200	3,520	832	29
ISO Class6	1,000,000	237,000	102,000	35,200	8,320	293
ISO Class7				352,000	83,200	2,930
ISO Class8				3,520,000	832,000	29,300
ISO Class9				35,200,000	8,320,000	293,000
Note: Due to the uncertainties involved in the measurement process, no more than three valid concentration figures are required to determine the level of the class.

Airborne Particle Cleanliness Classes for Cleanrooms and Clean Zones

Air Cleanliness Class	Maximum concentration limitsfor particle sizes greater than or equal to those in the table (pc/m)
Air Cleanliness Class	0.1μm	0.2μm	0.3μm	0.5μm	1.μm	5μm
1	10	2
2	100	24	10	4
3	1000	237	102	35	8
4 (tenth grade)	10000	2370	1020	352	83
5(Hundred levels)	100000	23700	10200	3520	832	29
6(Thousand levels)	1000000	237000	102000	35200	8320	293
7(Ten thousand levels)				352000	83200	2930
8(One hundred thousand level)				3520000	832000	29300
9(One million level)				35200000	8320000	293000

Approximate Comparison of Cleanliness Levels by Country

pcs/ M ≥0.5μm	ISO 14644-1(1999)	US 209E(1992)	US 209D(1988)	EEC cGMP(1989)	FRANCE AFNOR(1981)	GERMANY VDI 2083(1990)	JAPAN JAOA(1989)
1
3.5	2					0	2
10.0		M1
35.5	3	M1.5	1			1	3
100		M2
353	4	M2.5	10			2	4
1,000		M3
3,530	5	M3.5	100	A+B	4,000	3	5
10,000		M4
35,300	6	M4.5	1,000	1,000		4	6
100,000		M5
353,000	7	M5.5	10,000	C	400,000	5	7
1,000,000		M6
3,530,000	8	M6.5	100,000	D	4,000,000	6	8
10,000,000		M7

Cleanroom Classes and AHU Filter Matches

For cleanroom class A, air handling units should be selected with a high efficiency filter (HEPA) rating of H13 or above to ensure that the filtration effect meets the requirements.

For Cleanroom Class B, the air handling unit should be selected with a high efficiency filter (HEPA) rating of H14 or higher to provide higher filtration and better air quality control. For Cleanroom Class C, air handling units should be selected with a combination of a primary filter (G4 or F5 rating) and a high efficiency filter (HEPA) rating of H14 or higher to ensure higher filtration effectiveness and proper air quality.

For cleanroom class D, air handling units should be selected with a combination of a primary filter (G4 or F5 rating) and a high efficiency filter (HEPA) rating of H15.

Cleanroom class ABCD corresponds to different air handling unit filter specifications and performance

requirements. The following are the requirements for each class:

Class A cleanroom: the filter of air handling unit should be class H14. Class H14 filter can effectively filter 99.995% of 0.3 micron particles, and has high filtration efficiency and trapping capacity.

Class B cleanroom: the filter grade of air handling unit should be H13. H13 filter can effectively filter 99.95% of 0.3 micron particles, and has high filtration efficiency and capture capacity.

Class C cleanroom: the filter of air handling unit should be class H11. Class H11 filter can effectively filter 95% of 0.3 micron particles, and has high filtration efficiency and trapping capacity.

Class D clean room: the filter grade of the air handling unit should be H9. H9 filter can effectively filter 85% of 0.3 micron particles, and has high filtration efficiency and trapping capacity