NEW PUMP PROVIDES NO-WASTE SOLUTION FOR CRITICAL ASEPTIC FILLING

WATSON-MARLOW FLUID Technology Group ( WMFTG) new Flexicon PF7+ intuitive peristaltic filling pump provides 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, states the manufacturer.

Bioprocessing needs are becoming increasingly complex with the development of novel biological therapies, so adopting smarter technologies for final fill processes is vital. The PF7+ extends the established capabilities of the ‘industry-leading’ PF7, making it the ideal pump for every stage of biopharmaceutical therapy development, from research and development to clinical trials and small batch production, says WMFTG.

REDUCING WASTE OF HIGH VALUE PRODUCTS

The new final fill pump offers zero waste start-up and 100 percent 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.

These additional features build on the existing capabilities of the PF7 to allow for precision filling from as low as 0.2ml and repeatable filling accuracies of better than ±0.5 percent. With gentle pumping action that eliminates foaming, splashing or dripping, costly overfilling is prevented.

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

Flexicon pumps use peristaltic technology to remove the risk of potential cross contamination. Only the inner bore of the pump’s tubing comes into contact with the fluid, and the low shear, gentle pumping action ensures the product is transferred efficiently without compromising viability or quality.

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 five-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.