Glossary

Form-Fill-Seal (FFS)

An automated technology that forms a container from packaging film, fills it with product, and seals it in a continuous operation.

Source · EudraLex Volume 4, Annex 1 (2022), §§8.96–8.104 and §11 Glossary

Details

Because FFS relies on the continuity of forming, filling, and sealing, the film specification, the sealing parameters, and integrity control matter to product protection. Inspections cite inadequate treatment of worst cases at start-up, stoppage, splices, and roll changes, and insufficient seal inspection and trending of critical process parameters. Look at material specifications, equipment and process validation, seal integrity testing, batch records, and deviations.

Related sections

Related terms

Source

EudraLex Volume 4, Annex 1 (2022), §§8.96–8.104 and §11 Glossary

GRM Regulatory Glossary

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