ISO 14644-1 Cleanrooms and associated controlled environments--Part 1: Classification of air cleanliness.

In the past, cleanroom certification and classification was conducted according to Federal Standard 209E. However, the International Organization for Standardization (ISO) has recently approved a new standard, ISO 14644-1, entitled "Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness." Although ISO 14644-1 derived its structure from Federal Standard 209E, there are some significant differences that will most likely affect medical device and pharmaceutical manufacturers.

Scope of ISO 14644-1

ISO 14644-1 covers the classification of air cleanliness in cleanrooms and associated controlled environments. Classification in accordance with this standard is specified and accomplished exclusively in terms of concentration of airborne particles. Furthermore, the only particle populations consideration for classification purposes are those have cumulative distributions based on threshold (lower limit) sizes ranging from 0.1 µm to 5 µm.

Definitions

Cleanroom: A special type of controlled environment facility in which, as a minimum, all incoming air passes through a filter capable of removing a minimum of 99.99% of all particles 0.3 microns and larger. In a cleanroom temperature, humidity, and pressure are controlled. External sources of particulate contaminants are excluded and internal sources are controlled to assure cleanliness levels.

Particles: An object that is solid, liquid, or both, usually between 0.001 and 1000 micron in size.

Micron (µm or micrometer): (µm, often abbreviated as um, micron or µ) A unit of length; one-millionth of a meter or 10,000 angstroms. This is about forty-millionths of an inch. A human hair is approximately 75 microns wide. Particulate: A substance that consists of particles (minute quantities of solid or liquid matter).

Contaminant: Any unwanted substance present in or on a material or any surface within a clean zone.

Maximum concentration limits (particles/m3) for particles equal to larger than the considered sizes show below

ISO 14644-1 FED STD 209E 0.1µm 0.2µm 0.3µm 0.5µm 1µm 5µm ISO Class 1   10 2         ISO Class 2   100 24 10 4     ISO Class 3 M1.5   1 1,000 237 102 35 8   ISO Class 4 M2.5   10 10,000 2,370 1,020 352 83   ISO Class 5 M3.5   100 100,000 23,700 10,200 3,520 832 29 ISO Class 6 M4.5   1,000 1,000,000 237,000 102,000 35,200 8,320 293 ISO Class 7 M5.5   10,000       352,000 83,200 2,930 ISO Class 8 M6.5   100,000       3,520,000 832,000 29,300 ISO Class 9         35,200,000 8,320,000 2,930,000