FP50
Filling and stoppering for small batch production. No costly overfilling – fill accuracy better than ±0.5 %.
Aseptic filling - fully automatic systems
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Built around our highly accurate peristaltic filler, the FPC60 is a uniquely configurable small batch aseptic fill/finish system with a wide variety of modules designed to work together to provide the ultimate filling solution. The FPC60 system can be designed and built with a choice of optional solutions allowing adaptation of each stage of the fill/finish process including vial infeed, filling, stoppering, capping, auto-reject and product outfeed.
Flexicon has an excellent record in working to meet short and reliable delivery times. With more than 30 years of experience, Flexicon provides seamless FAT, and IQ/OQ tests all working towards avoiding costly project delays.
To meet the needs of aseptic fill/finish applications, Flexicon provides full turnkey FPC60 solutions for LAF and RABS systems. An Integrated isolator solution for the FPC60 is also available through Flexicon in collaboration with our preferred partners.
Filling volume range | 0.2-100 ml |
Accuracy | up to ±0.5 % |
Capacity | 1500 units/hour |
Stoppers | ISO standard or Lyo, 13 mm and 20 mm |
Infeed and outfeed trays | Width infeed tray: 185mm – 360mm, Width outfeed tray: 180mm – 360mm, Infeed for pre-sterilized, adaptiQ + EZfill RTU vials in trays is optional |
Technical Summary table lists features available within the range. See ‘Specifications’ tab for model specific information.
FPC60 | |
Filling volume range | 0.2-100 ml |
Accuracy | up to ±0.5 % |
Capacity | 1500 units/hour |
Power supply | 200 V to 240 V AC, 50/60 Hz |
Power consumption | Max 3200 W |
Weight | 1800 kg |
Vial Size | ISO 8362 2R - 100H, 2 mL - 100 mL CZ vials |
Stoppers | ISO standard or Lyo, 13 mm and 20 mm |
Infeed and outfeed trays | Width infeed tray: 185mm – 360mm, Width outfeed tray: 180mm – 360mm, Infeed for pre-sterilized, adaptiQ + EZfill RTU vials in trays is optional |
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
Full regulatory compliant and designed for future regulation
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
Guarding/environment control
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 |
Filling and stoppering for small batch production. No costly overfilling – fill accuracy better than ±0.5 %.
Aseptic filling - fully automatic systems
Uniquely configurable fill/finish system. Innovative design with a wide variety of options to suit all requirements.
Aseptic filling - fully automatic systems
Tubing for accurate filling with excellent dispensing accuracy ± 0.5 %. Eight sizes available.
Single-use assemblies
WMArchitectTM fill/finish single-use assemblies safeguard your therapeutic during the filling process with a wide range of sterility-assured assembly configurations.
Single-use assemblies
Fully-automatic systems for production. Highly accurate filling of volumes from less than 0.2 ml to more than 250 ml.
Aseptic filling - fully automatic systems
Filling and stoppering for small batch production. No costly overfilling – fill accuracy better than ±0.5 %.
Aseptic filling - fully automatic systems
Highly flexible aseptic filling system with integrated, full or partial stoppering and capping of vials.
Aseptic filling - fully automatic systems
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