New Flexicon PF7+ pump provides no-waste solution for critical aseptic filling
Watson-Marlow Fluid Technology Group (WMFTG) launches the new Flexicon PF7+ intuitive peristaltic filling pump to provide a no-waste solution and 21 CFR compliance for critical aseptic final fill applications. The PF7+ builds on Flexicon’s extensive expertise in peristaltic filling to ensure high value products such as ATMPs, vaccines, and cell and gene therapies are protected from contamination and damage to viability.
Reducing waste of high value products
The new final fill pump offers zero waste start-up and 100% in-process weight checking when connected to a third-party balance, meaning more liquid can be used for viable product and less valuable product is wasted. In order to ensure accuracy in fill volumes, the PF7+ is set up with dynamic recalibration to automatically adjust if a series of consecutive fills deviates too far from the fill target. The PF7+ can also check the weight of individual fills and uses colour fill tolerance to indicate if the fill is within the acceptance criteria for easy vial rejection.
Improved traceability for audit confidence
With its higher levels of product and production repeatability, the PF7+ offers electronic batch reporting via Ethernet or USB and live audit trails via Ethernet for improved process traceability. This remote connection also removes the need to enter the cleanroom, reducing risk of contamination. The PF7+’s compliance with 21 CFR part 11 provides the necessary assurance, essential for regulatory approvals.
Confidence in cleanliness and safety
The new PF7+ is available with the QC14 pumphead which features a hollow core rotor and removable tray to further improve cleanability. A recessed locking lever and secure tube design enables single handed tube loading operation while ensuring that tubing is loaded correctly. The removable tray includes a safety switch for added safety, as well as a guard switch that becomes active only when both parts are securely in place. The pumphead is factory calibrated and designed without the need for adjustments over the life of the pump. Confidence in the PF7+ pump’s operating capabilities is further assured with critical IQ/OQ documentation and a 5-year warranty.
Easy to use
The pump’s simple set-up and reduced user interaction combined with easy to clean surfaces, an ergonomic design and clear and intuitive display facilitate its use, even when gowned up in cleanroom environments. The addition of a USB keyboard further improves user experience and reduces risk of error, with the capability to define recipe parameters to improve repeatability.
These additional capabilities are based on Flexicon’s extensive industry experience and designed to reduce waste, minimise contamination risk and improve user experience. This provides an accurate and reliable final fill pump for sensitive fluids in GMP production, to optimise high value fill processes.