What is BS EN ISO 14644-2:2015

BS EN ISO 14644-2:2015 is an international standard that focuses on the classification of air cleanliness in cleanrooms and associated controlled environments. It provides guidelines for defining the requirements and protocols necessary to achieve and maintain the desired level of cleanliness. This standard is crucial for industries such as pharmaceuticals, biotechnology, healthcare, electronics, and aerospace, where maintaining a controlled environment with minimal particle contamination is critical.

Importance of Compliance

Compliance with BS EN ISO 14644-2:2015 ensures that cleanrooms meet specific cleanliness levels and operate within defined parameters. It takes into account factors such as airborne particles, air velocity, room pressurization, temperature, humidity, and lighting. Adhering to this standard guarantees that products manufactured or processes performed within cleanroom environments are not jeopardized by contaminants, thereby increasing overall quality, reliability, and safety.

Classification System

BS EN ISO 14644-2:2015 employs a classification system based on the number of particles present in the air. The standard uses particle size limits and counts to categorize the cleanliness level of cleanrooms. There are nine classes of air cleanliness defined in this standard, ranging from ISO Class 1 (highest cleanliness) to ISO Class 9 (lowest cleanliness). Each class specifies the maximum allowable concentration of airborne particles per cubic meter at specified particle sizes.

Testing and Monitoring

Regular testing and monitoring are essential to ensure compliance with BS EN ISO 14644-2:2015. Airborne particulate sampling and microbial monitoring are commonly performed to assess the cleanroom environment. Sampling methods, locations, and frequencies are determined by the standard, ensuring consistent and reliable results. Furthermore, the standard also covers topics such as cleanroom operational procedures, maintenance, and documentation requirements to facilitate effective monitoring and control.