- Simplicity of operation: minimal intervention required with recipe driven, auto adjust settings and interface designed for highest possible user experience
- Dynamic prime and calibration: means no waste of highly valuable filling material*
- Hands-free initial calibration reduces time and potential source of contamination and errors
- Innovative design with a wide variety of options to suit all requirements
- Highly advanced data management and retrieval: SQL server database; ease of integration with MeSH systems; single sign on; remote control via web tools
- Batch reporting and data control fully compliant with 21 CFR Part 11
- Highly accurate filling from less than 0.2ml up to 100ml
- New advanced technologies: independent validation of capping force with auto reject; no vial, no fill sensors; no use of pneumatics; easy, one-handed tube loading for simple integration of single-use fluid paths
About the FPC60
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 providing 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. Working closely with the customer, the FPC60 is designed with every operation tailored to the individual customer’s requirements.
- The FPC60’s innovative design offers a wide variety of modular based configurations that can be built to suit almost every small batch fill/finish application.
- The FPC60 can be designed and built specific to your detailed specifications and requirements. Flexicon has an excellent record in working to short and reliable delivery times and providing seamless FAT and IQ/OQ tests all working towards avoiding costly project delays.
Capable of handling vial sizes between 2R and 100H, the FPC60’s unique servo driven auto adjustment allows for less tools and setup between batches. When supplied with in-line check weighing, the FPC60 offers unique dynamic prime, no intervention initial calibration and dynamic recalibration, meaning every vial, from first to last, is confirmed to be within specification. With throughput of up to 30 vials per minute, and options for automatic segregation of rejects; speed is optimised while keeping downtime to an absolute minimum.
The FPC60 is built to fit a small footprint with machine guarding as standard, and the integration of Laminar Airflow, Restricted Access Barrier Systems or Isolators available. Flexicon have an excellent record in working to short and reliable delivery times and providing seamless FAT and IQ/OQ tests all working towards avoiding costly project delays.
- The FPC60 is designed for users looking for production flexibility. The entire fluid path is designed for single-use, making cleaning validation extremely simple, and allowing for fast changeover between types of liquids.
- The new horizontally mounted pumphead allows easy, one-handed interaction and fast fluid path changover.
- When supplied with in-line check weighing, the FPC60 offers unique dynamic prime, no intervention initial calibration and dynamic recalibration, meaning every vial, from first to last, is confimred to be within specification.
Contact your local sales engineer for more information.
* requires in-line check weighing
Advanced data management
Highly advanced data management
The FPC60’s user interface is intuitive and easy to understand. Using a secure internet based tool, the FPC60 allows remote operation (director supervisory) from outside a cleanroom or distant location. With each batch recorded in full compliance with 21 CFR Part 11 this is ideal for contract filling and development applications.
The all-new interface uses intuitive design with quick reference icons to identify key operations; guiding users to what they need. The highly advanced data management system is SQL Server based and is fully accessible from any web device.
- The FPC60’s revolutionary new features include the option for an independent validation of capping force used during the capping process. If the capping force is slightly less/more than specified, the vial is automatically placed in the reject station for further inspection.
FPC60 is highly modular. When ordering a machine, options for each module can be selected to meet your specific demands and requirements.
|Module name ||Module description
- Loading of vials into the machine from a removable tray on the front or left side of the machine. Infeed can be designed for customer specific tray sizes or infeed needs.
- Loading of vials into the machine from nested trays from the front or left side.
- A round table aligns the vials and moves them to the first position of the walking beam.
- Walking beam with automatic adjustment of guide rails, transports vials from the infeed to the different work stations. Thus, no format parts are required for the entire vial range between 2R and 100H.
- Liquid filling by the use of a horizontally mounted stainless steel (AISI 316L) or aluminum peristaltic pump.
- Bottom up filling where filling nozzle raises along with fluid surface.
- Sensor detecting that there is a vial standing upright under filling nozzle.
- Balance for in-line check weighing with dynamic prime, hands-free initial calibration and in-batch dynamic calibration saves time and ensure no loss of costly product
- IQ/OQ protocols and test—Fluid path assemblies or components suitable for accurate filling of a wide range of fill volumes
- Gas filling before and after liquid filling
- Format parts for stoppers consist only of a vibrator bowl, chutes, jaws and pistons. The vibrator bowl for the stoppers can be applied for both 13mm and 20mm injection and lyophilization stoppers.
- Chutes in guarding for easy refilling of stoppers
- Format parts for crimp caps consist of a vibrator bowl, chutes and crimping heads. For the crimp caps the same vibrator bowl can normally be applied for both 13mm and 20mm caps.
- Crimp head with pressure cell that verifies crimp force with data capture
- Chutes in guarding for easy refilling of stoppers and caps
- Reject station transfers out of tolerance vials from the vial track down to the reject tray
- Collection of filled vials takes place on a removable tray. Removal of filled vials can be done without stopping production
- Extended outfeed for removable trays or connection to a conveyor belt
- FPC60 comes with a guarding to protect both operator and product.
- Guarding extended to an existing LAF unit in ceiling.
- Open RABS with integrated LAF.
- Machine cabinet modified for integration into closed RABS or isolator from preferred partners.
- Probe for particle counter near open vials.
- Interlocks on guarding
- Glove ports and light curtain in guarding
- Guarding between capping, stoppering and filling stations with “mouse holes” for vial transfer
Vials, stoppers and caps:
- 2R–100H vials with diameter from 16mm to 52mm
- 13mm and 20mm injection and lyophilization stoppers
- 13mm and 20mm flip-off aluminum caps and/or plain aluminum caps Dimensions according to ISO8362
- From less than 0.2ml to 100ml
Infeed/outfeed trays for vials:
- Width infeed tray: 185mm – 360mm
- Width outfeed tray: 180mm – 360mm
- Infeed for pre-sterilized, nested vials is optional
- Up to 31 vials per minute for 1ml fill in a 6R vial (without in-line check weighing)
- Up to 26 vials per minute for 1ml fill in a 6R vial (100% in-line check weighing)
- Capacity with or without check weighing will depend on fill volume and vial size
- Better than 1% at constant suction level and a viscosity like water
- 200 – 240VAC – 50/60Hz + PE max 20 AMP.
- The power supply must be protected by an ELCB / HPFI type B relay for use with frequency converters (30mA) in accordance with the applicable national safety regulations.
- Max. 3200W (excluding LAF)
- Ambient temperature: +5C - +40C
- Ambient humidity: Max 90% RH at +20C, Max 50% RH at +40C
- AISI304, AIS316L, anodized aluminum, polycarbonate, PTFE, PEEK, PETP, PEHD. Stopper contact parts all in AISI316L and PTFE.
Minimum Server Requirements:
- Internet information server 8.0
- SQL server 2005 express
- SQL Server Reporting Services 2008
- Hardware requirements (CPU, RAM, HDD etc.) must for fill specification for the installed servers.
A preinstalled server can be supplied with FPC60 as an option.
Weight: 400kg - 600kg