At the end of the installation and before being put into operation, each Clean Room must be validated, i.e., it must pass stringent checks that demonstrate compliance with all the reference standards.
Phamm offers the Cleanroom certification service both as the final step of the project leading to the Turnkey Cleanroom, and as a separate service for existing Cleanrooms.
At the end of each validation process, the test report is issued, which allows the commissioning.
Validation and certification process
Our specialized technicians, thanks to instruments subjected to scrupulous and periodic calibration, carry out careful checks of the parameters specified in the design phase and issue a test report which establishes compliance with the regulations:
What are the certifications for Clean Rooms
Through the certification process, parameters such as temperature, humidity, pressure, degree of cleanliness (dust particles in one m³ of air) are checked.
It is also verified that the class of contamination, air speed, pressures and flow rates correspond to those required by the project.
Once this operation has been completed, our specialized technicians issue a test report in compliance with the UNI EN ISO 14644 standard: the Clean Room is ready to be immediately put into operation.
Our certifications are:
During the design phase, the regulatory obligations regarding air quality in the workplace and re-emission in the environment are respected, ensuring systems that comply with the requirements of ISO standards, UNI and the current regulations CEI and CEE ATEX and specific standards IE RP-006, US Federal Standard 209E, ISO 14644-1, US GMPs and EEC GMPs.
The main reference standard is UNI EN ISO 14644, an international standard that collects all the regulations relating to the Clean Rooms. This directive also defines and regulates the control tests to be carried out during the validation process to allow the use of the Clean Room.
Other regulations also remain of reference, such as the Federal Standard in the USA and the Good Manufacturing Practice (GMP) for the pharmaceutical sector.