Aseptic filling - fully automatic systems

FPC60 fully automatic fill/finish system

Overview

FPC60 uniquely configurable fill/finish system

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.

Features and benefits

  • Reduce contamination sources and save time with hand-free initial calibration
  • Highly accurate filling of better than ± 1 % from 0.2 ml up to 100 ml
  • Pneumatic free with no format parts for the entire vial range
  • Zero waste of highly valuable product in batch start up
  • Increased batch consistency between operators
  • No tools and minimal setup between batches
  • Up to 2700 vials per hour (45 vials/min)
  • Unparalleled value

Technical summary

Filling volume range 0.2-100 ml
Accuracy± 1.0 %
Capacity2700 units/hour
Infeed and outfeed traysWidth infeed tray: 185mm – 360mm, Width outfeed tray: 180mm – 360mm, Infeed for pre-sterilised, nested vials is optional 

Technical Summary table lists features available within the range. See ‘Technical specifications’ tab for model specific information.

Specifications

Technical specifications

FPC60
Filling volume range 0.2-100 ml
Accuracy± 1.0 %
Capacity2700 units/hour
Power supply200-240 VAC, 50/60 Hz 
Power consumptionMax 3200 W 
Infeed and outfeed traysWidth infeed tray: 185mm – 360mm, Width outfeed tray: 180mm – 360mm, Infeed for pre-sterilized, nested vials is optional 

Dimensions

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
  • Serialization ready

Flexible modular design

Flexicon FPC60 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 nameModule description
Infeed
Infeed icon
Loading of vials into the machine from a removable or nest tray

Customized 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
Filling icon
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
Stopper icon
Format parts: vibrator bowl, chutes, jaws and pistons

The vibrator bowl accommodates both 13mm and 20mm injection and lyophilization stoppers

Optional chutes in guarding for easy refilling of stoppers
Capping
Capping icon
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
Reject
Reject icon
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
Outfeed icon
Vials collect on removable tray

Removal of filled vials can be done without stopping production

Customizable options for extended trays and conveyors available on request

Videos

Recommended Products

  1. Accusil tubing

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    Tubing for accurate filling with excellent dispensing accuracy ± 0.5 %. Eight sizes available.

    Single-use assemblies

Related Products

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  2. FP50

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  3. FPC50

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