A cleanroom is a controlled environment specially designed and maintained to minimize and control contamination, such as dust, particles, microbes, fungie and chemical vapors. These environments are used in various industries, including manufacturing, pharmaceuticals, electronics, aerospace, and healthcare, where maintaining a high level of cleanliness and product integrity is crucial. Cleanrooms are essential for industries where even tiny particles or microorganisms can have a significant impact on the quality and safety of the products being produced.
Cleanrooms are classified based on the level of cleanliness they can maintain, as defined by specific standards. The classification of a cleanroom is typically determined by the maximum allowable concentration of airborne particles within a specified size range per cubic meter of air. The most widely recognized cleanroom classification standard is the ISO 14644 standard. This standard classifies cleanrooms into different classes, ranging from ISO 1 (the cleanest) to ISO 9 (the least clean). The Federal Standard 209E, once widely used, has been replaced by ISO 14644 in recent years.
Here are the ISO cleanroom classes and their corresponding particle count limits:
1. ISO Class 1: This is the highest cleanliness level, with extremely low particle counts. It is typically used in advanced semiconductor manufacturing, nanotechnology, and other highly sensitive processes.
2. ISO Class 2: This class is suitable for applications like semiconductor manufacturing, biotechnology, and aerospace, where strict contamination control is essential.
3. ISO Class 3: Commonly found in pharmaceutical manufacturing, electronics assembly, and medical device production, Class 3 cleanrooms offer a controlled environment with relatively low particle counts.
4. ISO Class 4: These cleanrooms are used in applications such as research laboratories, optics, and some aerospace manufacturing processes.
5. ISO Class 5: Often referred to as a "mini-environment," Class 5 cleanrooms are found in pharmaceutical compounding, food processing, and general manufacturing where a high level of cleanliness is needed.
6. ISO Class 6: These cleanrooms are suitable for applications like medical device assembly, food packaging, and optics manufacturing.
7. ISO Class 7: Class 7 cleanrooms are common in industries like pharmaceuticals, where precision is required but not to the extent of more critical applications.
8. ISO Class 8: This is the lowest class that is typically considered a cleanroom. It is used in industries like textile manufacturing, automotive, and some general assembly processes.
9. ISO Class 9: ISO Class 9 cleanrooms are not technically "cleanrooms" but are instead considered controlled environments. They are suitable for applications where general cleanliness is important, but not critical.
To maintain the required cleanliness levels, cleanrooms are equipped with various technologies, including high-efficiency particulate air (HEPA) and ultra-low penetration air (ULPA) filters, air handling systems, specialized gowning protocols, and rigorous cleaning and monitoring processes. These measures help to ensure that products produced within cleanrooms meet stringent quality and safety standards. Cleanroom design and operation are critical to a wide range of industries, contributing to the production of reliable, high-quality products and research outcomes.