Cleanroom Testing Validation and Certification
Cleanroom testing, validation, and certification are essential processes in ensuring that cleanrooms meet the required standards for cleanliness and environmental conditions. Cleanrooms are controlled environments used in various industries, such as pharmaceuticals, biotechnology, electronics manufacturing, aerospace, and healthcare area like clinical laboratory rooms, OT rooms, clean room, and Isolation rooms, where even small particulate or microbial contamination can have significant consequences.
Design and Construction
The cleanroom testing validation is designed and constructed to meet specific cleanliness and environmental requirements based on the intended use. The design factors like airflow, filtration, materials, and personnel traffic to control contamination.
Installation Qualification
This initial step involves verifying that the cleanroom has been installed correctly according to the approved design and specifications. It includes checking equipment installation, utility connections, and compliance with building codes and regulations.
Filter Integrity Testing
Filters within the cleanroom, such as High-Efficiency Particulate Air (HEPA) or Ultra-Low Penetration Air (ULPA) filters, are tested to verify their efficiency and integrity.
Certification and documentation
Once the cleanroom passes all required tests, it is certified, and comprehensive documentation is provided. The certification indicates that the cleanroom meets the specified standards and is suitable for its intended use.
Operational Qualification
During this phase, the cleanroom's functionality and performance are tested and verified. Airflow patterns, temperature, humidity, pressure differentials, and filtration efficiency are assessed to ensure they meet the required standards.
Particle Count testing
Particle count testing is conducted using particle counters to measure airborne particulate levels within the cleanroom. The number and size distribution of particles are recorded and compared to specified cleanliness standards, such as ISO 14644.
Temperature and Humidity meter
Temperature and humidity distribution throughout the cleanroom are mapped to ensure uniformity and compliance with specified ranges.
Periodic Recertification
Cleanrooms typically require regular recertification, which includes repeating some of the tests and inspections at defined intervals to ensure ongoing compliance with cleanliness and environmental requirements. We also provide cleanroom consultancy services for all your queries.
