- Single-use fluid path ensures simple cleaning validation
- Universal format parts for stoppers and crimp caps
- 13mm and 20mm stoppers and crimp caps
- Optional in-line check weighing
- Optional customized guarding
- Software designed and qualified according to GAMP5.
- Optional software to support FDA 21 CFR Part 11
- Batch report after each production run
- First class documentation and test protocols for FAT, IQ and OQ
The FPC50 is a highly flexible aseptic filling system with integrated, full or partial stoppering and crimp capping of vials. It provides 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 laminar air flow or in a restricted access barrier system. The FPC50 can be also supplied as a customised solution for integration into an isolator.
Providing fast and easy changeover between batches, the FPC50 handles up to 25 vials per minute and uses a minimum of space in a cleanroom. High filling accuracy prevents costly overfilling (±0.5% >1ml and ±1% >0.2ml is achievable).
Filling is done by the integrated, highly accurate peristaltic dispenser, which can give an optimum filling accuracy for volumes from less than 0.2ml to 100ml. This feature prevents costly overfilling of expensive liquids. As an option, the unit can do automatic gas purging before, during and after the liquid filling process.
A complete change-over between different liquids, vials or stoppers can be done by the operator within five minutes, without any technical support from outside the clean room. The FPC50 can be customized to fit different sizes of trays at the infeed and at the outfeed. The infeed tray can also be positioned on the front of the FPC50 or on the left side of the unit.
Shipment of sample vials/bottles/stoppers/inserters/caps to Flexicon
To comply with a promised delivery date for customized filling and capping equipment or in order for us to complete a detailed quotation, please download and complete the Sample Shipping Note form, and mail it to firstname.lastname@example.org and enclose in the shipment of samples.
Download Sample Shipping Note