Aseptic filling - fully automatic systems

FPC50 filling, stoppering and capping system

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Overview

FPC50 filling, stoppering and capping system

FPC50 is a highly flexible aseptic filling system with integrated, full or partial stoppering and option of roller or crimp closure for vial capping. 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 customised 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 customised 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 and peristaltic pump for simple cleaning validation and no cross contamination
Full qualification and validation support
Faster changeover time with no format parts for vials and universal format parts for stoppers and crimp/roller caps
In Process Control (IPC) with optional in-line check weighing
FDA 21 CFR Part 11 compliant
Full batch reports
Compatible with ISO8362 components
Prepared for barrier systems (RABS) in accordance with Annex 1

Technical summary

Filling volume range	0.1-100 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/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	up to ±0.5 %
Capacity	1500 units/hour
Power supply	110/230 VAC, 220 to 240 V AC, 50/60 Hz
Power consumption	Max 1200 W
Air supply/pneumatic connection	6 bar (87 psi) to ISO 8573-1 2010 [1:4:2]
Air consumption	Max 100 L/min
Interface	1 x 24 V output signal for gas purge valve; 2 x external interface for e.g. particle counter; Integration with RABS
Weight	400 kg
Vial Size	ISO 8362 2R - 100H
Stoppers	ISO standard or Lyo, 13 mm and 20 mm
Infeed and outfeed trays	Width/open end min. 200mm/7.9"-max. 305mm/12"