Cleanroom Standards: An Overview


In today’s booming technological scene, cleanrooms are no longer a thing of mystery. For many, they are a part of everyday work life.

According to PR Newswire, North America generated the largest revenue in cleanroom technologies. The technology’s uses include food manufacturing and packaging, aerospace manufacturing, pharmaceutical companies, medical devices, and more.

In a study by Grand View Research, the global cleanroom market was $3,097.8 million in 2016. The main cause of this increase was demanding regulatory standards for cleanrooms.

Comparing Different Cleanroom Standards

ISO 14644-1 Cleanroom Classifications

ISO 14644-1 is now widely accepted as the industry standard. Set by The International Organization for Standardization (ISO), ISO 14644-1:2015 specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones.

It states that clean rooms must not exceed a certain particulate count, measured in cubic meters. The amount stipulated for each cleanroom application depends on the class of air cleanliness required.

Maximum concentration limits (particles/m3 of air) for particles equal to and larger than the sizes listed below
ISO 14644-1 Classification0.1 micron0.2 micron0.3 micron0.5 micron1 micron5 micron
ISO 1102
ISO 210024104
ISO 31,000237102358
ISO 410,0002,3701,02035283
ISO 5100,00023,70010,2003,52083229
ISO 61,000,000237,000102,00035,2008,320293
ISO 7352,00083,2002,930
ISO 83,520,000832,00029,300
ISO 935,200,0008,320,000293,000

FED STD 209E Cleanroom Classifications

FED STD 209E was a federal standard regarding classification of air cleanliness outlined for clean rooms and controlled environments. The standard set forth classifications based on the number of airborne particles concentrated in a particular amount of air space.

FED STD 209E Cancellation

Originally titled Airborne Particulate Cleanliness Classes in Cleanrooms and Cleanzones FED STD 209E was canceled on November 29, 2001 by the United States General Services Administration (GSA). The document was superseded by standards written for the International Organization for Standardization (ISO).

Maximum concentration limits (particles/m3 of air) for particles equal to and larger than the sizes listed below
FED STD 209E Classification0.1 micron0.2 micron0.3 micron0.5 micron1 micron5 micron

GMP EU Cleanroom Classifications

The European Commission outlined the European Union (EU) GMP (Good Manufacturing Practice) standards in the EudraLex, The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use.

Maximum permitted number of particles/m^3 equal to or above
at rest (b)in operationFederal Standard 209E and the ISO classifications approximate equivalency
Grade0,5m m5m m0,5m m0,5m
A3 50003 5000100, M 3.5, ISO 5
B(a)3 5000350 0002 000100, M 3.5, ISO 5
C(a)350 0002 0003 500 00020000class 10000, M 5.5, ISO 7
D(a)3 500 00020 000not defined (c)not defined (c)class 100000, M 6.5, ISO 8

These charts are intended for reference only. Make sure to follow protocol specific to your cleanroom.