Visual inspection is an FDA-required part of drug manufacturing in order to ensure the finished product is practically free of visible particles.
Blow-Fill-Seal is known for its very low particle generation, both visible and sub-visible.
Ironically, although BFS produces fewer particles than traditional glass filling lines, particulate inspection can be more difficult in BFS. This is because the polymer containers are more opaque than glass vials.
Before filling and finishing your drug product in BFS, please consult your local regulatory agency on approved visual inspection for BFS, and see if the excellent record of BFS for 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.
