The Gene Therapy team at Catalent offers fill/finish process services in our dedicated state-of-the-art development and manufacturing facilities. The fill/finish equipment (Flexicon FPC-50) performs fully automated filling, stoppering, and crimping of up to 4,000 glass or Daikyo Crystal Zenith® vials ranging from 2mL to 100mL. The automated stoppering and capping function is configured to process 13mm and 20mm injection (serum) and lyophilization stoppers.
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 minimizes operator and environmental risk to Critical Quality Attributes (CQAs) of exposed, in-process drug product.
Filling equipment is validated for 2mL to 10mL glass vials. The Flexicon FPC-50 machine and line are fully automated and EU compliant. The entire product path is disposable, including the fill needle. Flexicon peristaltic pumps with a dual fluid path (at the pump head) enable highly accurate fills down below 0.5mL. The components are manufactured according to well-established specifications for biopharma application.