Visual inspection is an FDA-required part of drug manufacturing in order to ensure the quality of a filled drug container.
Blow-Fill-Seal is known for its very low particle generation, both visible and sub-visible.
Before fill and finishing your drug product in BFS, please consult your local regulatory agency on approved visual inspection for BFS, and see if its excellent record of low particle generation allows your manufacturing line to meet a lower inspection threshold standard.
If you would like information on guidance the FDA has given ApiJect regarding our inline visual inspection process for BFS containers to be used in an injectable format, please contact us.
