Glossary
Blow-Fill-Seal (BFS)
A technology that forms a container from thermoplastic resin, fills it with product, and seals it in one continuous automated operation.
Source · EudraLex Volume 4, Annex 1 (2022), §§8.105–8.110 and §11 Glossary
Details
BFS combines forming, filling, and sealing so that the open time is short, but the parison, the filling zone, the high temperatures and complex airflow, and equipment interventions create their own contamination risks. Inspections cite weak airflow visualisation and environmental monitoring, the grade assigned to critical zones, and unverified cutting, trimming, and mould interventions. Check equipment qualification, process and seal validation, APS, airflow video, and environmental trends.
Related sections
Related terms
Source
EudraLex Volume 4, Annex 1 (2022), §§8.105–8.110 and §11 GlossaryGRM Regulatory Glossary
243 GMP terms in one place
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