Clean Room Certification
Once installed but before being used, each Clean Room must be validated, meaning that it must pass strict tests that demonstrate it complies with all the relevant standards.
Galvani offers a Clean Room certification service both as the final stage of a project to create a new Turnkey Clean Room, or as a stand-alone service for existing Clean Rooms.
Once the validation process is complete, a test report is issued and the room can be used.
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Clean Room Certification
Once installed but before being used, each Clean Room must be validated, meaning that it must pass strict tests that demonstrate it complies with all the relevant standards.
Galvani offers a Clean Room certification service both as the final stage of a project to create a new Turnkey Clean Room, or as a stand-alone service for existing Clean Rooms.
Once the validation process is complete, a test report is issued and the room can be used.
Validation and certification process
Our specialist technicians carry out thorough checks on the parameters established during the planning and design stage using carefully calibrated tools, and issue a test report confirming compliance with the relevant regulations.
- The area is prepared
- Parameters are measured
- Certification is issued
What are the certifications for Clean Rooms
Through the certification process, parameters such as temperature, humidity, pressure, level of cleanliness (dust particles in one m³ of air) are checked. It is also ascertained that the contamination class, air-movement speed, pressure levels and flow rate correspond to those required.
Once this step is complete, our specialist technicians issue a test report, in compliance with the ISO 14644 standard, and the Clean Room is ready to be used straight away.
Validation and certification
With regard to the final verification process, the terms “validation” and “certification” are often used almost interchangeably. In fact, the ISO 14644 standard stipulates that, after production is complete, parameters are checked—the validation stage—before a test report is issued. This document is what guarantees that a Clean Room is compliant and enables it to be used. Legislation does not require additional certifications.
Relevant standards
ISO 14644, an international standard that sets out all the regulations relating to Clean Rooms, is the main applicable standard. This directive also stipulates and regulates the tests that need to be carried out during the validation process before the Clean Room can be used.
Other relevant standards include the American Federal Standard and the Good Manufacturing Practice (GMP) system for the pharmaceutical sector.
Unique
for 6 reasons
Choosing Galvani means choosing a partner who, thanks to their know-how and expertise, can provide you with an effective, customised, certified and ready-to-use Clean Room. Offering a Turnkey service, we are experts in planning, designing, directly manufacturing, validating and installing Clean Rooms.
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Decades of experience in contamination-free environments
Components manufactured directly
Solutions tailored to the customer
Delivered on time
Continued investment in innovation, research and development
Quotes issued quickly
Decades of experience in contamination-free environments
Components manufactured directly
Delivered on time
Solutions tailored to the customer
Continued investment in innovation, research and development
Quotes issued quickly
Sectors and uses
Thanks to our extensive experience in the Clean Room sector, we are able to produce bespoke solutions for any process, sector or application.
If you cannot see your sector listed below, contact us for a bespoke Clean Room.
