What is EN ISO 14644-7:2012?

EN ISO 14644-7:2012 is an international standard that specifically addresses requirements for cleanliness in cleanrooms and controlled environments. Cleanrooms are critical in industries such as pharmaceuticals, healthcare, electronics manufacturing, and aerospace, where maintaining a controlled environment free from contaminants is essential for the quality and safety of products.

Scope and Purpose

The purpose of EN ISO 14644-7:2012 is to provide standardized guidelines and procedures for evaluating the cleanliness level of surfaces, particularly those that cannot be easily accessed or cleaned. Often referred to as "cleanliness by states," it aims to categorize and quantify the level of particle contamination on these inaccessible surfaces using statistical methods.

These guidelines are important because they help ensure that proper cleaning and maintenance procedures are followed, minimizing the risk of product contamination, maintaining the effectiveness of cleanrooms, and ensuring compliance with regulations and industry standards.

Key Requirements and Measurements

EN ISO 14644-7:2012 specifies how to evaluate the cleanliness level of surfaces by measuring the particles deposited on them. The standard focuses on non-accessible surfaces because they are more prone to accumulating particles over time. It provides detailed instructions on how to sample, handle, transport, and analyze these surface samples.

The standard also introduces two classifications for surface cleanliness evaluation:

1. Classification by Particle Area Concentration: This measurement quantifies the number of particles deposited on a defined area of the surface using particle counting techniques. The results are typically expressed as a class ranging from 1 to 9, with class 1 being the cleanest and class 9 being the least clean.

2. Classification by Particle Number Concentration: This measurement quantifies the number of particles per unit volume of air that are deposited on a surface. The results are again expressed as classes ranging from 1 to 9, with class 1 indicating the lowest particle concentration and class 9 indicating the highest.

Conclusion

EN ISO 14644-7:2012 plays a crucial role in ensuring the cleanliness and quality of controlled environments such as cleanrooms. By providing standardized guidelines and procedures for evaluating the cleanliness of non-accessible surfaces, it helps industries maintain compliance with regulations, minimize product contamination risks, and ensure the effectiveness of cleanroom operations.

Adhering to the requirements and measurements outlined in this standard can significantly contribute to the overall success and reliability of industries that heavily rely on cleanrooms for their operations.