Validating a Clean Room
To ensure that it is usable and compliant with regulations, the validation process is required for every Clean Room. The advantage of choosing Galvani is having one partner who takes care of every step involved in Clean Room manufacturing, including validation. The end result is a Turnkey Clean Room that is ready to be used.
Using sophisticated measuring tools, our specialist technicians check the parameters established during the planning and design stage, including contamination class, air-movement speed, pressure levels and flow rates.
Once complete, a test report is issued, certifying that all the design and regulatory criteria have been adhered to.
The Clean Room is then ready to use straight away.
This is the quality Galvani provides: maximum efficiency and safety in one turnkey product.
What is meant by Clean Room Validation?
The Clean Room validation process involves checking the minimum parameters required by the relevant regulations, i.e. temperature, humidity, pressure and level of cleanliness (dust particles per m³ of air). In addition, checks on parameters requested by the client (e.g. for certain processes) can be carried out.
Our own highly trained teams carry out all the tests using sophisticated measuring tools, which are regularly maintained and calibrated to exacting standards.
The validation service is also available uponrequest by the client, either periodically or on a one-off basis if necessary.
Clean Rooms that pass all the checks on parameters established during the planning and design stage receive a Validation Report upon completion. This document certifies that the Clean Room complies with the ISO14644 standard and satisfies the project requirements. In addition, clients can request validation reports for existing Clean Rooms.
The ISO 14644 standard, which must be adhered to in every aspect, regulates the validation process.
The standard also specifies, in detail, the conditions in which parameter-inspection tests must be carried out and the methods of testing.
Other relevant standards include the American Federal Standard and the Good Manufacturing Practice (GMP) system for the pharmaceutical sector.
Once all the tests have been passed, we will issue a validation report.
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