FPC60 fully automatic fill/finish system

When supplied with in-line check weighing, the FPC60 offers unique dynamic prime, no intervention initial calibration and dynamic recalibration, meaning no waste in the batch start up process and confirmation every vial, from first to last, is filled within specification.

The all-new interface uses intuitive design with quick reference icons to identify key operations; guiding users to what they need. The FPC60 has an advanced data management system based on a SQL server platform and is fully accessible from any web device.

Advanced user interface via remote access web tools

• Real-time supervisory oversight
• Batch data retrieval
• Recipe creation

Full regulatory compliant and designed for future regulation

• 21 CFR part 11
• EudraLex Vol 4
• Serialisation ready

FPC60 is highly modular. When ordering a machine, options for each module can be selected to meet your specific demands and requirements.
Flexicon peristaltic filling combined with WMArchitct fill/finish single-use technology reduces risk with no cross-contamination, no line cleaning, rapid product change-over and simplified validation.

Index

• Automatically adjusting walking beam transports vials from the infeed to the different work stations
• No format parts are required for the entire vial range

Guarding/environment control

• Standard guarding to protect both operator and product included
• Solutions for extended guarding to an existing LAF unit in ceiling
• Open RABS with complete integrated LAF solution from Flexicon
• Machine cabinet modified for integration into closed RABS or isolator from preferred partners
• Viable and non-viable particle monitor solutions available
• Interlocks on guarding to prevent accidental opening during production
• Optional glove ports with light curtain safety barrier
• Risk of contamination reduced through internal guarding partitions with ‘mouse-hole’ transfer prevents particulate from entering the filling area

Module name	Module description
Infeed	Loading of vials into the machine from a removable or nest tray Customised solutions to meet most customer needs available on request A buffering turntable aligns the vials and moves them to the starting position of the walking beam
Filling	Peristaltic pump solutions with easy operation and high accuracy Bottom up filling where filling nozzle raises along with fluid surface Vial position sensors, prevents miss filling and contamination of the filling environment 100% in-line check weigh with dynamic prime, hands-free initial calibration and in-batch dynamic calibration Vial gas purging before and after liquid filling
Stopper	Format parts: vibrator bowl, chutes, jaws and pistons The vibrator bowl accomodates both 13mm and 20mm injection and lyophilization stoppers Optional chutes in guarding for easy refilling of stoppers
Capping	Option of Roller or Crimp Closure: Optional crimp or roller force sensors with data capture ensures correct and reliable capping Format parts: vibrator bowl, chutes and crimping heads or roller disks. For the crimp caps the same vibrator bowl can normally be applied for both 13mm and 20mm caps.  For the roller closure the same vibrator bowl can normally be applied for both 13mm and 20mm caps. Chutes in guarding for easy refilling of stoppers and caps for both crimp and roller closure options
Reject	Automatic reject station transfers out of tolerance vials from the vial track down to the reject tray, based upon information relayed from any of the modules.
Outfeed	Vials collect on removable tray Removal of filled vials can be done without stopping production Customisable options for extended trays and conveyors available on request