A CleanRoom, also known as a controlled environment, is a specialized space designed to maintain low levels of environmental pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors. Cleanrooms are essential in industries where even the smallest contamination can compromise product quality, such as pharmaceuticals, biotechnology, and Semiconductor manufacturing.
CleanRoom Classification Standards
Cleanrooms are classified based on their cleanliness levels, which are determined by the number of particles present in the air. Two prominent classification systems exist: the now-obsolete United States Federal Standard 209E and the international ISO 14644 standard. While the Federal Standard categorizes cleanrooms into classes (like Class 10, Class 100, etc.), the ISO standard uses a similar but distinct classification, ranging from ISO1 (the cleanest) to ISO9.
The cleanliness level of a modular cleanroom is typically denoted in terms of the maximum allowable number of particles (measured in micrometers) per cubic meter of air. Generally, a lower number indicates a higher cleanliness level.
Focus on ISO 7 Cleanroom
An ISO7 cleanroom corresponds to the standard originally derived from the Federal Standard 209E. In an ISO7 cleanroom, the maximum allowable number of particles measuring 0.5 micrometers (μm) is 35,000 per cubic foot (ft³). While this level of cleanliness is relatively stringent, it is not the highest level achievable in cleanroom standards.
In addition to monitoring 0.5 μm particles, other particle sizes must also be filtered according to specific cleanliness standards. This requirement ensures that all potential contaminants are kept at bay, allowing for a controlled environment conducive to sensitive processes.
When it comes to airflow in an ISO7 cleanroom, a turbulent airflow pattern is typically sufficient. The use of Fan Filter Units (FFUs) is common, although they do not need to be fully distributed throughout the area, provided that the cleanroom maintains the necessary air change rates to meet cleanliness specifications.
a ISO 7 cleanroom, as defined by ISO standards, plays a crucial role in various industries that require strict contamination control. With specific limits on particle counts and a focus on maintaining a controlled environment, ISO 7 Cleanrooms ensure that sensitive processes can occur without the risk of contamination. Despite not being the highest level of cleanliness available, ISO7 is still a critical standard for many applications and is instrumental in maintaining product integrity and quality.