The standard outlines how to measure physical parameters in cleanrooms, such as airflow, pressure, and particle levels. It is primarily used by industries requiring high levels of environmental control, including pharmaceuticals, microelectronics, and aerospace. Key Testing Procedures
Understanding the nuances of the 2021 edition—which harmonizes the globally accepted revised methodology—is vital for facility managers, HVAC engineers, and quality assurance teams in the pharmaceutical, semiconductor, medical device, and aerospace sectors. What is ISO 14644-3:2021? iso 146443pdf 2021
| Annex | Title | Key Content | | :--- | :--- | :--- | | | Airborne Particle Count Test Method | Detailed procedures for measuring airborne particle concentrations using optical particle counters (OPCs), including sampling locations, volumes, and data interpretation | | Annex B (normative) | Installed Filter System Leakage Test | Comprehensive protocol for leak testing HEPA/ULPA filters using either photometer or light-scattering airborne particle counter (LSAPC) methods | | Annex C (normative) | Containment Leak Test | Methodology for verifying the integrity of containment systems handling hazardous materials, including glove ports, transfer systems, and barrier isolators | The standard outlines how to measure physical parameters
| Industry Sector | Typical Application | | :--- | :--- | | | Aseptic processing facilities; sterile product manufacturing under GMP requirements | | Medical Device Manufacturing | Cleanroom validation for implantable and sterile devices | | Semiconductor & Electronics | Ultraclean environments for wafer fabrication | | Aerospace | Assembly of precision components and optical systems | | Hospital Pharmacies | Compounding aseptic isolators (CAI/CACI) | | Food & Beverage | Aseptic filling lines and high-care areas | | Research Laboratories | Controlled environments for sensitive research activities | What is ISO 14644-3:2021