How Automation Helps to Enhance Aseptic Filling Processes

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TURCK GmbH

Glatt Ingenieurtechnik GmbH

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Romaco Pharmatechnik GmbH

Aseptic Liquid Filling for a Wide Range of Applications

The Macofar VF can fill bottles and vials with diametre of 14 to 68 mm and height of 35 to 140 mm. The fill volume is between a fraction of a millilitre and 250 mm. Moving at medium-high speed, the sterile filling machine has a maximum output of 24,000 vials per hour. In addition to processing pharmaceutical liquids, the plant is also used for handling lyophilised products. There are three different filling systems available: a volumetric pump system, a mass flow filling system and peristaltic pumps.

If required, the machine can be fully integrated into the Romaco Macofar aseptic line configuration. In this case, the vials to be filled are initially fed to a washing machine before passing through a depyrogenation tunnel, where they are sterilised using hot air at up to 3400C. After the aseptic filling and stoppering using rubber stoppers, the vials can optionally be lyophilised before receiving a final seal using an aluminium cap.

No Turbulences Around Open Vials

The Macofar liquid filler can optionally be equipped with isolator or with Restricted Access Barrier Systems (RABS). Both technologies capitalise on the flow principles of modern air conditioning technology. Laminar flow systems can be installed in both the classic clean room environment and the interior of the machine. The cleaning effect is achieved with an air preparation facility, which steers sterile air from above into the critical zone. Due to the prevailing pressure conditions, a vertical flow of air is generated, thus protecting the processing area.

How to Avoid Air Swirls in Sterile Filling

Uni-directional flow of air prevents turbulences in the open-vial area. Swirling air in the sterile zone must always be avoided, as it inhibits product protection. At the same time, turbulences cannot be completely eliminated because they are a physical consequence of any mechanical movement. The interior of the Macofar VF is therefore designed so that the high distance between the machine bottom plate and the passing vials avoids turbulences in the vials’ area.

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