The cleanliness of a pharmaceutical company clean room is determined by the level of contamination that is allowed within the facility. Cleanroom levels are defined by the number of particles present in the air per cubic meter. There are various cleanroom levels, and each level has its unique requirements for air quality.
ISO 14644-1 is a widely used standard for classifying cleanroom levels. It defines cleanroom levels from Class 1 to Class 9, with Class 1 being the cleanest level.
A Class 1 cleanroom is restricted to less than 10 particles per cubic meter, while a Class 9 cleanroom can have up to 35,000 particles per cubic meter. Class 1 cleanrooms are typically used for manufacturing products that require the highest level of cleanliness, such as microchips or pharmaceutical products.
In conclusion, the classification of a pharmaceutical company clean room is critical to ensuring the quality and safety of pharmaceutical products. It is essential to have a thorough understanding of cleanroom classification standards to maintain cleanroom integrity and protect products and processes.
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