The purpose of a cleanroom is to control environmental factors such as: temperature, humidity differential pressure, sound, vibration, and other process-related specifications.
Validation and certification of your cleanroom ensures that the installation meets all ISO 14644-1 requirements. Before operations of your installed cleanroom begin, the cleanroom must be validated to ensure the following:
- Design: Certify that the Design is Consistent and Fit for its Intended Purpose
- Installation: The Equipment and Components Installed Meet All User Requirement Specifications (URS)
- Operation: The Equipment, Facility and Environment Operate Consistently Within a Range of Conditions
- Performance: The Equipment, Facility and Environment Work Together Seamlessly as a System to Produce the Desired Outcome
- Monitor and Control: The Equipment, Facility and Environment Created Meets All Regulatory Requirements Around Ongoing Cleanroom Monitoring, Including ISO 14644-2