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.
Testo finto finto finto testo testo
Testo finto finto finto testo testo
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.
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Analysis
Analysis
The Clean Room journey
At Galvani, we believe in paying close attention to every single detail. This is why we scrupulously follow every step involved in creating the Clean Room, from analysis to validation, as well as subsequent periodic maintenance.Get in touch for more information
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.
Validation report
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.
Relevant standards
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.
Unique
for 6 reasons
Offering an all-inclusive, turnkey service, we are experts in planning, designing, directly manufacturing, validating and installing Clean Rooms. Choosing Galvani means choosing a partner who understands your needs and can provide you with effective, customised, certified and ready-to-use solutions.
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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
Different solutions
for different sectors
Knowledge is limited if you do not branch out. At Galvani, we bring our know-how and expertise to different fields, allowing us to find the best solution for any need. Discover the solutions we have come up with for each different sector, or ask us for one tailored to your business.
