Glossary

Cleanroom Qualification

Also writtencleanroom certification

The overall assessment of whether a classified cleanroom or clean air equipment is fit for its intended use.

Source · EudraLex Volume 4, Annex 1 (2022), §§4.24–4.32 and §11 Glossary

Details

Cleanroom qualification bundles together the performance needed for the intended use — not only particle classification but HEPA integrity, air volume and velocity, pressure differentials, airflow direction, microbial results, and recovery. Inspections cite qualification declared on the basis of the classification test alone, and missing requalification intervals or impact assessment after a change. Look at the qualification protocol and report, the raw data, the drawings, and the history of changes, maintenance, and requalification.

Related sections

EU GMP Annex 1 §§4.24–4.32 EU GMP Annex 15

Related terms

Cleanroom Classification1 caseQualification692 casesAirflow Visualization Study (Smoke Study)

Source

EudraLex Volume 4, Annex 1 (2022), §§4.24–4.32 and §11 Glossary

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