ISO 6 Cleanrooms (Class 1,000 Cleanrooms)
Cleanrooms are modular or soft-sided structures designed to keep an area free of contaminants including organic and non-organic matter, static charge, and airborne or surface particles. While people are the primary source of contamination, fabrics and other materials can also introduce contaminants into the cleanroom environment. In addition to maintaining a specified level of particles, cleanrooms are used for uses such as temperature and humidity control, and to manage electrical conductivity and electromagnetic interference.
All cleanrooms are identified in classes ranging from ISO 1 to ISO 9, which is determined by the number of particles present per cubic foot or cubic meter of interior air. ISO6 cleanrooms, also referred to as class 1,000 cleanrooms, have a maximum particle count of 35,200 particles (≥0.5 µm) per cubic meter of inside air. Under the former US Federal Standard 209E cleanroom standards, the maximum particle count is 1,000 particles (≥0.5 µm) per cubic foot.
Class 1,000 cleanrooms maintain this level of cleanliness by using HEPA air filtration systems to remove particles and pass air through the system at an average rate of 180 air exchanges per hour. Filter coverage is 20-30% and air flows at a rate of 18-32 CFM per square foot.
ISO6 cleanrooms are widely used in scientific research facilities and for the manufacturing and assembly of PCBs, wire and other electronic components that are highly sensitive and easily degraded by moisture and airborne contaminants.
ISO 6 Cleanroom Standards
Contamination levels in cleanrooms are measured by the concentration of particles in a cubic foot or meter of air. These levels are measured in microns and were defined under US Federal Standard 209E until it was replaced by standard ISO 14644-1. Both standards are still used interchangeably by manufacturers and consumers to outline cleanroom specifications.
- US Federal Standard 209E: denotes the number of particles (≥0.5 µm or larger) per cubic foot (f³) of air.
- ISO 14644-1: replaced federal standard 209E in 2001 but is still used as a reference. It denotes the number of particles (≥0.1µm to ≥5µm or more) per cubic meter (m³) of air.
ISO 14644-1 Standard for Maximum Number of Particles Permitted/m³ for ISO 6 Cleanrooms
(FED STD 209E Equivalent: Class 1,000)
|≥0.1 µm||≥0.2 µm||≥0.3 µm||≥0.5µm||≥1µm||≥5 µm|
US FED Standard 209E Maximum Number of Particles Permitted/ft³ for Class 1,000 Cleanrooms
(ISO 14644-1 Equivalent ISO 6)
|≥0.1 µm||≥0.2 µm||≥0.3 µm||≥0.5µm||≥5 µm|
Gowning Protocol and Procedures for Class 1,000 Cleanrooms
To maintain the ISO 6 cleanliness classification, cleanrooms implement gowning protocols to prevent contamination from people and clothing. Required gowning attire for Class 1,000 cleanrooms typically includes coveralls, hoods and shoe covers/booties made from non-woven materials. Gloves are also worn to protect sterilized surfaces from contamination.
In addition to gowning requirements, air showers and pass-through chambers are typically incorporated into the design of an ISO 6 cleanroom to prevent contaminants from entering the environment. Specific gowning protocols for Class 1,000 cleanrooms can vary based on the industry and application. It is critical that you work with a cleanroom consultant to determine what preventative measures are necessary for your specific application.
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