Glossary
Lyophilization (Freeze-drying)
Also writtenlyophilisation
A physicochemical drying process that removes water or solvent from a product by subliming it from the frozen state.
Source · EudraLex Volume 4, Annex 1 (2022), §§8.117–8.126 and §11 Glossary
Details
In sterile freeze-drying the product is exposed from filling until full stoppering, so protection during transfer, loading, in the chamber, and for partially stoppered vials matters. Inspections cite inadequate treatment of loading patterns, leak testing, sterilisation, hold times, manual interventions, and assessment of the product impact when the process fails. Check cycle validation, chamber sterilisation and leak testing, loading diagrams, transfer and intervention records, and CCI data.
Related sections
Related terms
Source
EudraLex Volume 4, Annex 1 (2022), §§8.117–8.126 and §11 GlossaryGRM Regulatory Glossary
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