The is the global benchmark for cleanrooms and associated controlled environments. It defines the requirements and best practices for designing, operating, and maintaining controlled spaces where airborne particles and other contaminants must be kept within strict limits. The series is structured into multiple parts, each addressing a specific aspect of cleanroom management:
The series operates as a modular collection of parts, each addressing a specific aspect of cleanroom technology. The most fundamental part, , defines cleanroom classes (ISO Class 1 through ISO Class 9) based on the concentration of airborne particles permitted per cubic meter of air. This classification system provides the foundation for all other parts of the standard.
: Verifies that HEPA or ULPA filters are installed correctly without pinhole leaks or bypasses in the frames. iso 146443pdf 2021
This part of the ISO 14644 series covers the following:
Clause B.7 ("Installed filter system leakage test") was updated for better clarity and efficiency, removing some of the complexity found in the 2005 edition. The is the global benchmark for cleanrooms and
These standards are critical for industries like pharmaceuticals, biotechnology, and electronics to ensure contamination control. Key Performance Tests in ISO 14644-3
Guidance on classifying air cleanliness by particle concentration was removed from this part and consolidated into ISO 14644-1 . The most fundamental part, , defines cleanroom classes
The facility is functioning normally with its full complement of personnel. Core Testing Methodologies
Whether you’re in pharma, biotech, medical devices, or microelectronics – this standard helps ensure compliance with GMP, EU GMP Annex 1, and FDA expectations.
Cleanroom design is a critical aspect of contamination control. A well-designed cleanroom can help minimize contamination risks and ensure product quality. ISO 14644-3:2021 provides guidelines for cleanroom design, including: