Overview
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.
Unparalleled value
- Increased batch consistency between operators
- Zero waste of highly valuable product in batch start up
- Pneumatic free
- No format parts for the entire vial range
- Reduce contamination sources and save time with hand-free initial calibration
- Highly accurate filling of better than ± 1% from 0.2ml up to 100ml
- Up to 2700 vials per hour (45 vials/min)
- No tools and minimal setup between batches
To meet the needs of aseptic fill finish applications, Flexicon provides full turnkey FPC60 solutions for LAF and RABS systems. Integrated isolator solution for the FPC60 are also available through Flexicon in collaboration with our preferred partners.
New advanced features
- Auto reject for minimal operator intervention*
- Independent validation of capping force*
- No vial — no fill sensor prevents miss filling and contamination of the filling environment*
- One-handed open/close pump design for easy change fluid-path in RABS and isolators*
*optional features
Advanced features
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
- GAMP5
- EudraLex Vol 4
- Serialisation ready
Flexible modular design
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 asepticsu 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 |
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Infeed
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- 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
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Filling
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- 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
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Stopper
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- 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
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Capping
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- Optional crimp force sensors with data capture ensures correct and reliable capping
- Format parts: vibrator bowl, chutes and crimping heads. For the crimp caps the same vibrator bowl can normally be applied for both 13mm and 20mm caps
- Chutes in guarding for easy refilling of stoppers and caps
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Reject
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- 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.
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Outfeed
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- 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
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Technical specifications
Vials, stoppers and caps:
- Fill volume: less than 0.2 - 100ml
- Vials: ISO 2R–100H
- Diameter: 14mm - 52mm
- Height: 30mm - 120mm
- Stoppers: 13mm and 20mm injection and lyophilization
- Caps: 13mm and 20mm flip-off or plain aluminum
Infeed/outfeed trays for vials:
- Width infeed tray: 185mm – 360mm
- Width outfeed tray: 180mm – 360mm
- Infeed for pre-sterilised, nested vials is optional
Production capacity:
- Up to 45 vials per minute*
Filling acuracy:
- Peristaltic pump with better than ± 1% accuracy*
Power:
- 200 - 240VAC - 50/60Hz + PE max 20 AMP (consumption max. 3200W)
- External electrical cabinet – 200cm H x 100cm W x 40cm D
*Individual results may vary. Accuracy and capacity depend on
fill volume, inline check weighing, vial size and viscosity