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.
Features and Benefits
FPC50 Filling, Stoppering and Capping System
Full qualification and validation support
In Process Control (IPC) with optional in-line check weighing
Prepared for restricted access barrier systems (RABS)
ISO 8362 Compliance management (regulation of shape, sizes and capacity, as well as performance requirements for glass vials intended for medical use)
Full batch reports
FDA 21 CFR Part 11 compliant
Fast system changeover with no additional structural parts for different types of vials and universal components for stoppers and crimp/roller caps
Use of replacement disposable hoses for fluid supply and a peristaltic pump for easy cleaning and prevention of cross-contamination
Specifications
FPC50 Filling, Stoppering and Capping System
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”
Stoppers
ISO standard or lyophilized, 13 mm and 20 mm
ISO standard or lyophilized, 13 mm and 20 mm
Maximum Capacity
1500 units/hour
1500 units/hour
Filling Volume Range
0,1–100 ml
0,1–100 ml
Accuracy
up to ±0,5%
up to ±0,5%
Mon-Fri: 09.00 - 18.00
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