Aseptic filling - fully automatic systems

FPC50 filling, stoppering and capping system

Overview

FPC50 filling, stoppering and capping system

FPC50 is a highly flexible aseptic filling system with integrated, full or partial stoppering and crimp capping of vials. It provides a ready-to-use and easy-to-validate filling system for small batch production of vial sizes between 2R and 100H.

Designed for use under laminar air flow or in a restricted access barrier system, the FPC50 is available as a customized solution for integration into an isolator.

Providing fast and easy changeover between batches, the FPC50 handles up to 25 vials per minute and uses a minimum of space in a cleanroom. High filling accuracy prevents costly overfilling.

Filling is done by the integrated, highly accurate peristaltic dispenser, which can give an optimum filling accuracy for volumes from micro-volumes. This feature prevents costly overfilling of expensive liquids. As an option, the unit can do automatic gas purging before, during and after the liquid filling process.

A complete change-over between different liquids, vials or stoppers can be done by the operator within five minutes, without any technical support from outside the cleanroom.

FPC50 can be customized to fit different sizes of trays at the infeed and at the outfeed. The infeed tray can be positioned on the front of the FPC50 or on the left side of the unit.

Features and benefits

  • Single-use fluid path ensures simple cleaning validation
  • First-class documentation and test protocols for FAT, IQ and OQ
  • Software designed and qualified according to GAMP5
  • Universal format parts for stoppers and crimp caps
  • 13 mm and 20 mm stoppers and crimp caps
  • Optional in-line check weighing and customized guarding
  • Optional software to support FDA 21 CFR Part 11
  • Batch report after each production run

Technical summary

Filling volume range 0.1-100 ml
Accuracy±0.5 %
Capacity1500 units/hour
StoppersØ13 mm and 20 mm 
Infeed and outfeed traysWidth/open end min. 200mm/7.9"-max. 305mm/12" 

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

Specifications

Technical specifications

FPC50
Filling volume range 0.1-100 ml
Accuracy±0.5 %
Capacity1500 units/hour
Power supply110/230 VAC, 50/60 Hz 
Power consumptionMax 1200 W 
Air supply/pneumatic connection5 bar clean and dry air 
Interface2 x RS232 serial communication for balance and printer 1 x 24V output signal for nitrogen purge valve 2 x external error for interface with for example a particle counter Communication with RABS (specified by Watson-Marlow Flexicon) 
Weight400 kg
StoppersØ13 mm and 20 mm 
Infeed and outfeed traysWidth/open end min. 200mm/7.9"-max. 305mm/12" 

Dimensions

Materials of construction

MaterialAnodized aluminum, Stainless steel, Stainless steel AISI 316L

Literature

Brochures

  1. FPC50 (EN).pdf
    PDF - 4mb

Datasheet

Videos

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