A Flexicon FP50 tabletop filling and stoppering machine from Watson-Marlow Pumps Group has automated a previously manual process at a Cancer Research UK facility in Hertfordshire. The FP50 is delivering increased speed and reliability into this critical operation, as well as enhanced vial filling accuracy.

The Cancer Research UK Biotherapeutics Development Unit (BDU) was constructed in 2010 at South Mimms near Potters Bar. It is a modern, MHRA licensed, fully cGMP-compliant, 2000 sq metre facility that is engaged in the process development and GMP production of novel Investigational Medicinal Products (IMPs) for phase I clinical trials sponsored by Cancer Research UK.

Recent Challenges

Recent challenges at the BDU included the introduction of an automated filling and stoppering procedure, which was previously performed manually using a dosing pump. This method was very “hands-on” and labour intensive which resulted in a slow process throughput.

This manual procedure was unsatisfactory for such a leading edge facility and a reliable automated vial filling process was required for the delivery of future BDU projects.

Best practice solution

“We wanted a vial filling and stoppering process more in step with our modern facility,” explains Tim Hillyer, Senior Scientific Officer at the BDU. “To help deliver this we set out to source a machine capable of rapid, repeatable filling but without any compromise to process quality and control.”

The answer arrived in the shape of a Flexicon FP50 tabletop filling and stoppering machine from Flexicon Liquid Filling, part of the Watson-Marlow Pumps Group. Capable of filling up to 25 vials a minute (up to 100ml capacity) the system also offers quick and easy change-over between batches.

“As a multi-product facility producing small batch size, high-value IMPs the flexibility offered by the FP50 was ideal for our purposes,” says Mr Hillyer. “Our most recent batches involved not more than a few litres in quantity so having a reliable method for product filling and stoppering enables us to bring new drugs into the clinic in a  controlled and reproducible manner.”

Successful outcome

Today the Flexicon FP50 is used as and when required to fill and stopper biological therapeutic products (solution-form drugs) produced at the BDU.

“Not only is the FP50 quicker than our old manual process by a ratio of several factors, it is also easy to adapt the FP50 for different vial and stopper sizes,” says Mr Hillyer. “An adjustable walking beam transports vials from the feeding turntable to the different working positions (filling needle and stopper plug). Only 2 parts require changing to cater for the entire range of vials and stopper sizes used by the BDU. Furthermore, the pump is very accurate, allowing us to closely control the dose volume going into each vial. Finally the FP50 unit is fully contained within a six-glove isolator allowing us to gas the equipment prior to each product fill using hydrogen peroxide vapour. This containment twinned with the speed and efficiency of the FP50 greatly reduces the chances of batch contamination.”

The technology

The Flexicon FP50 is a universal and aseptic tabletop filling system with integrated full or partial stoppering of rubber stoppers for use in pharmaceutical R&D departments and bio-pharma facilities. All materials and surfaces are designed to meet cGMP standards for aseptic filling, thus providing a ready-to-use validated filling system to carry out clinical trials and small batch production. The filling accuracy of the peristaltic filling system is better than ±1%.

The operator interface is an easy-to-clean touch screen and keypad. The panel is mounted on a separate control box, remote from the filling unit. This allows the control panel to be placed outside the LAF bench or isolator. It is possible to store up to 20 sets of filling parameters as complete working programs.

Ultimately, this makes it well suited to the needs of the Cancer Research BDU, where manufacturing equipment such as the Flexicon FP50 enables the development of processes that are scalable and transferable if a product is licensed to manufacturing partners later in the project.

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