Validation for HVAC cleanrooms & operating rooms
Cleanrooms, production facilities for pharmaceutical products, operation rooms, and LAF cabinets are subject to international legislation of the EU, FDA, and ISO 14644 Annex 1. This entails an obligation of validation and revalidation. Agidens Life Sciences provides custom advice and support.
Course of the project
We set up a qualification protocol in close consultation. This lays down the acceptance criteria together with the measurement methods by which these should be determined. These criteria depend on the validation master plan and the cleanroom design. They are tested in accordance with the applicable guidelines (ISO 14644-1/3). After testing, the client receives a qualification report with conclusions, recommendations, test data, and calibration data from our measuring equipment. If there are any deviations, we will share our ideas for possible solutions.
The structure of our validation report is fully in line with the current ISO standards and complies perfectly with the legal requirements. The annual calibration documentation of our measuring equipment is included in the validation report.
How can we help?
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