CE Cleanroom folder 1
ISO ESD International Organization for Standardiz
ation Cleanrooms are classified according to the cleanliness level of the air inside them. The cleanroom class is the level of cleanliness the room complies with, according to the quantity and size of particles per volume of air. The primary authority in the US and Canada is the ISO classification system ISO 14644-1. This standard includes the cleanroom classes ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 and ISO 9, with ISO 1 being the “cleanest” and ISO 9 the “dirtiest” class (but still cleaner than a regular room). The most common classes are ISO 7 and ISO 8. The old Federal Standard 209 (class 100,000; 10,000; 1,000; 100; 10; 1) was withdrawn in 2001 and officially replaced by ISO-14644-1 in 1999, but it is still widely used. In addition, cleanrooms must also comply with industry-specific and regional standards. For example, EU GGMP (A-B-C-D) applies to pharmaceutical products and USP (795, 797 and 800) to compounding pharmacies. Electrostatic Discharge Electrostatic discharge (ESD) is the sudden flow of electricity between two electrically charged objects caused by contact, an electrical short, or dielectric breakdown. A buildup of static electricity can be caused by tribocharging or by electrostatic induction. The ESD occurs when differently-charged objects are brought close together or when the dielectric between them breaks down, often creating a visible spark. ESD can cause harmful effects of importance in industry, including explosions in gas, fuel vapor and coal dust, as well as failure of solid state electronics components such as integrated circuits. These can suffer permanent damage when subjected to high voltages. Electronics manufacturers therefore establish electrostatic protective areas free of static, using measures to prevent charging, such as avoiding highly charging materials and measures to remove static such as grounding human workers, providing antistatic devices, and controlling humidity 5