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Aseptic Manufacturing Gains an Ultra-Compact and Faster Liquid Fill-Finish Solution, Boosting Early Stage and Low Volume Production

3P innovation has launched a new generation of their F2V Liquid Fill-Finish technology; an ultra-compact and fully customisable, aseptic filling platform with check-weighing, designed to help customers develop and manufacture new drug products and devices faster and at lower cost.

The technology comes in both single-station and multi-station variants and due to its scalability, offers all the benefits of a fully-automated process in a portable, isolator-ready solution.  Two major advantages that the F2V platform delivers over its competitors are its ultra-compact size and the integration of high-speed check-weighing; 

“Having a small foot-print and low weight means the machine can be installed easily in existing, space-limited isolators, RABs, bio-safety cabinets and down-flow booths, leaving more space for other manufacturing processes and material stock,” explains Simon Strothers, Director at 3P. 

“The high-speed weigh cell means that cycle times can be reduced from several seconds needed for conventional lab-balance weighing to just milli-seconds with the 3P solution, so productivity is significantly higher.  Also, as it is integrated with the machine, it provides for a fully-automated setup and calibration of the pump;  Risk of human error with data recording and drug product handling present with other systems on the market is therefore eliminated.”

Another key advantage of the technology is its flexibility, allowing users to quickly reconfigure to fill a wide range of different container types on the same machine, including syringes, vials, bottles, cartridges and custom containers.  Through the use of simple change parts, a fast and easy change-over can be achieved in a time of less than five minutes.  This is ideal for new devices and custom containers where late-stage changes in design may be necessary. 

The filling and stoppering processes are fully-automated and representative of commercial-scale processes.  This means that users can develop and de-risk the key manufacturing steps for new drugs and devices, safe in the knowledge that the production technology can be ‘scaled-up’ for high-volume manufacture without the need to change or re-validate the process.  Having this capability also helps drug and device development companies to convince their customers and stake-holders to invest further as it demonstrates ‘manufacturing know-how’ and provides sound data and evidence with which to make investment decisions.

Both single-station and multi-station variants are available to suit individual volume demands, enabling users to produce pre-clinical and GMP clinical batches quickly.  F2V can be easily supplied to CMO’s and CDMO’s (Contract (Development) and Manufacturing Organisations) and due to its compact size is ideal for use in existing clean-rooms, aseptic manufacturing suites and containment solutions.

Other key benefits of F2V include:

  • Fully-sealed, stainless steel design that can be used with existing, validated containment and sterilisation protocols (e.g. HPV).
  • Optimised for unidirectional airflow for full cGMP compliance and improved drug safety where high-value and high-criticality drug filling is required.
  • Portable design for easy transportation and re-location to wherever the process is needed.
  • Recipe management, enabling machine settings to be permanently recorded for different product types, allowing rapid recall and set-up for repeat batches. 
  • Easy to use, touch-screen display
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