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 that establishes compliance with the regulations
Upon completion of installation and before being put into operation, each Cleanroom must undergo validation, that is, it must pass stringent inspections demonstrating compliance with all relevant regulations.
Phamm offers the Cleanroom certification service both as the final step in the project leading to the Turnkey Cleanroom, and as an untied service, for existing Cleanrooms.
At the end of each validation process, an acceptance report is issued, which allows for commissioning.
Regulatory requirements regarding air quality in working environments and re-entry into the environment are met during the design phase, ensuring systems meet the requirements of ISO, UNI and current CEI and EEC ATEX standards and specific standards IE RP-006, US Federal Standard 209E, ISO 14644-1, US GMPs and EEC GMPs.
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 checked that contamination class, air velocity, pressures and flow rates correspond to those required by the project.
When this is finished, our specialized technicians issue a test report in accordance with UNI EN ISO 14644: the Clean Room is ready to be put into operation immediately.
The main reference standard is UNI EN ISO 14644, an international standard that brings together all regulations related to Cleanrooms. This directive also defines and regulates the control tests to be carried out during the validation process to allow the use of the Cleanroom.
Other regulations, such as the Federal Standard in the U.S. and Good Manufacturing Practice (GMP) for the pharmaceutical sector, also remain of reference.
