Aseptic filling - fully automatic systems

FPC60 fully automatic fill/finish system

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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

Prepared for barrier systems in accordance with Annex 1
Minimise contamination risk with no operator intervention and automatic setup
Highly accurate, precision filling from volumes of 0.2-100 ml at up to ±0.5 %
Decrease downtime, increase uptime with no tools and minimal setup between batches
Zero waste start up and no format parts for the entire vial range
Full audit trail of operator changes
Remote digital access and separate services cabinet

Technical summary

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 ‘Technical specifications’ tab for model specific information.

Specifications

Technical specifications

	FPC60
Filling volume range	0.2-100 ml
Accuracy	up to ±0.5 %
Capacity	1500 units/hour
Power supply	200 to 240 VAC, 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

FPC60 dimensions

Literature

Datasheet

FPC60 datasheet (US).pdf
PDF - 714.1kb

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
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 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