Clean Room Classifications

ISO 14644-1 Standards for Cleanrooms
Class	maximum particles / m3						FED STD 209E equivalent	Puracore®
	≥0.1 µm	≥0.2 µm	≥0.3 µm	≥0.5 µm	≥1 µm	≥1 µm
ISO 1	10	2.37	1.02	0.35	0.083	0.0029		(additional features required)
ISO 2	100	23.7	10.2	3.5	0.83	0.029		(additional features required)
ISO 3	1,000	237	102	35	8.3	0.29	Class 1
ISO 4	10,000	2,370	1,020	352	83	2.9	Class 10
ISO 5	100,000	23,700	10,200	3,520	832	29	Class 100
ISO 6	1.0 x 106	237,000	102,000	35,200	8,320	293	Class 1000
ISO 7	1.0 x 107	2.37 x 106	1,020,000	352,000	83,200	2,930	Class 10,000
ISO 8	1.0 x 108	2.37 x 107	1.02 x 107	3,520,000	832,000	29,300	Class 100,000
ISO 9	1.0 x 109	2.37 x 108	1.02 x 108	35,200,000	8,320,000	293,000	Room Air

The International Standards Organisation (ISO) has a 1 to 9 ranking system for cleanrooms, with 1 being the highest standard of cleanroom. The rating is based on the number of airborne particles per m3 and the particle sizes.

A cutting edge, sensitive pharmaceutical production facility may require an ISO 3 (Class 1) high specification cleanroom to meet the strict industry regulations whereas in medical packaging the cleanroom may only need to be ISO 7 classification (Class 10,000).

Puracore® cleanrooms have been designed and can be customised to each individual order to meet the standard and classification required.