Cleanroom Certification and Testing
EOC1 offers certification and testing of controlled environments and cleanrooms. Depending on the use of the cleanroom, EOC1 can provide testing to meet ISO and IEST standards and methodology. EOC1 is experienced in USP compliance for Sterile Compounding Facilities and utilizes the CETA CAG Guide: CAG-003-2006 Sterile Compounding Facilities.
Cleanrooms are controlled environments that utilize HEPA filter air, airflow and room design criteria to manage pollutants or quality of air. ISO-14644 is an International standard that replaced the federal standard FS209E in 2001. These standards set classes for cleanliness based on particulate levels. ISO- 14644 has 9 classes with ISO Class 9 being the dirtiest and ISO Class 1 being the cleanest. Other specifications can be set for air movement, differential pressure and air change rates. The U.S. Pharmacopeia’s USP Chapter 797 dictates the ISO Class and room specifications of Sterile Compounding Facilities.
Cleanrooms can unidirectional or non-unidirectional (turbulent) airflow. Depending on the customer requirements, testing would generally include the following tests:
- Particle Counts (to establish ISO-Class)
- Airflow Volumes
- Room Differential Pressure
- Air Exchange Rates
- HEPA Leak Testing
- Smoke Visualization