Paragon’s Fill-Finish process service offers a dedicated state-of-the-art facility designed for Phase I/II clinical drug product. The fill-finish equipment (Flexicon FPC-50) performs fully automated filling, plugging, and crimping of up to 2500 glass vials ranging from 2mL to 100mL. The automated stoppering and capping function is configured to process 13mm and 20mm injection (serum) and lyophilization plugs. The filling equipment product contact surfaces are engineered as single-use disposable and the ready-to-use container closure components are purchased pre-processed. Filling operations take place within a restricted access barrier system (RABS) which minimize operator and environmental risk to Critical Quality Attributes (CQAs) of exposed, in process drug product.
The filler is validated for 2mL to 10mL glass vials. The Flexicon FPC-50 machine and line is fully automated and EU compliant. Entire product path is disposable, including the fill needle. Flexicon peristaltic pump with a dual fluid path (at the pump head) – enables highly accurate fills down below 0.5mL. Components are from Gibraltar Labs and West Pharmaceuticals using their ready-to-use technologies (vials, stoppers, caps come washed/sterilized ready for immediate use). Components are manufactured according to well-established specifications for biopharma application.