Tabela de Classificação de Limpeza de AR - ISO, comparação EU GMP X ISO 14644

Pharmaceutical Microbiology: Cleanroom cleanliness classes

Cleanroom cleanliness classes

Here is a table showing the comparison between EU GMP cleanroom grades and ISO 14644 cleanroom classes.

	At Rest
	0.5 µm				5.0 µm
Grade	Annex 1		ISO 14644-1 (Class) Count		Annex 1		ISO 14644-1 (Class) Count
A	3,520		(5) 3,520		20		(4.8) 20
B	3,520		(5) 3,520		29		(5) 29
C	352,000		(7) 352,000		2,900		(7) 2,930
D	3,520,00		(8) 3,520,000		29,000		(8) 29, 300
		Operational
		0.5 µm				5.0 µm
Grade		Annex 1		ISO 14644-1 (Class) Count		Annex 1		ISO 14644-1 (Class) Count
A		3,520		(5) 3,520		20		(4.8) 20
B		352,000		(7) 352,000		2,900		(7) 2,930
C		3,520,000		(8) 3,520,000		29,000		(8) 29,300
D		Not Defined				Not Defined

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