FPC50 Filling, Stoppering and Capping System
Flexicon Aseptic aLiquid Filling
Industrial equipment
FPC50 is a highly flexible aseptic filling system with integrated, full or partial stoppering and option of roller or crimp capping of vials. It is a ready-to-use and easy-to-validate filling system for small batch production of vial sizes between 2R and 100H.
Designed for use under the laminar air flow (LAF) or in the restricted access barrier system (RABS) the FPC50 is available as a customized solution for integration into an isolator.
Providing fast and easy changeover between the batches, the FPC50 handles up to 25 vials per minute and uses a minimum of space.
Filling is carried out by the integrated, highly accurate peristaltic dispenser which ensures optimal filling accuracy down to microdosing. This feature prevents overfilling of expensive medicines and results in optimization of your production costs. As an option, the unit can perform automatic purging before, during and after the liquid filling process.
The operator can completely reconfigure the system to work with different liquids, vials or stoppers within five minutes without any external technical support.
The FPC50 can be adapted to different sizes of trays at the inlet and outlet. The feed tray can also be positioned at the front of the FPC50 or on the left side of the unit.
FPC50 Filling, Stoppering and Capping System
About the Product
The Flexicon FPC50 is a fully automatic Fill & Finish system that integrates high-precision filling, partial or full stoppering, and vial capping into a single compact platform. It is designed for small- and medium-scale production of sterile pharmaceuticals, vaccines, diagnostic reagents, and biopharmaceutical products.
At the heart of the system is a high-precision peristaltic filling unit, delivering filling accuracy of up to ±0.5% across volumes from 0.1 to 100 mL. A single-use aseptic fluid path eliminates the risk of cross-contamination between production batches while significantly simplifying cleaning and validation procedures.
The FPC50 performs the complete vial processing cycle automatically, including filling, partial or full stopper insertion, and either roller crimping or press-on aluminum cap sealing. Optional nitrogen flushing before, during, and after filling helps protect oxygen-sensitive products and supports demanding aseptic manufacturing processes.
Designed for operation under LAF cabinets, within RABS, or inside isolators, the FPC50 offers exceptional production flexibility. Universal change parts enable conversion between different vial, stopper, and cap formats in less than five minutes, minimizing changeover time and maximizing manufacturing efficiency.
Clinical & Pilot Production
Manufacture of clinical trial batches, process validation, and pilot-scale production with rapid product changeovers and minimal downtime.
Injectable Drug Manufacturing
Aseptic filling, stoppering, and aluminum cap sealing of sterile injectable solutions with high dosing accuracy and fully automated vial handling.
Contract Manufacturing
Flexible Fill & Finish operations for multiple pharmaceutical products, enabling fast format changeovers and efficient small-batch production for contract manufacturing organizations (CMOs).
Biopharmaceutical Manufacturing
Aseptic filling of vaccines, monoclonal antibodies, protein therapeutics, and other sensitive biopharmaceutical products in small- and medium-scale production.
Applications
FPC50 Filling, Stoppering and Capping System
Use of replacement disposable hoses for fluid supply and a peristaltic pump for easy cleaning and prevention of cross-contamination
Full qualification and validation support
Fast system changeover with no additional structural parts for different types of vials and universal components for stoppers and crimp/roller caps
In Process Control (IPC) with optional in-line check weighing
FDA 21 CFR Part 11 compliant
Full batch reports
ISO 8362 Compliance management (regulation of shape, sizes and capacity, as well as performance requirements for glass vials intended for medical use)
Prepared for restricted access barrier systems (RABS)
FPC50 Filling, Stoppering and Capping System
Specifications
Filling Volume Range
0,1–100 ml
0,1–100 ml
Accuracy
up to ±0,5%
up to ±0,5%
Maximum Capacity
1500 units/hour
1500 units/hour
Stoppers
ISO standard or lyophilized, 13 mm and 20 mm
ISO standard or lyophilized, 13 mm and 20 mm
Width/open end of inlet and outlet trays
min. 200 mm/7,9”, max. 305 mm/12”
min. 200 mm/7,9”, max. 305 mm/12”
Additional Resources
Operating Manuals
Specifications
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