PF7+ peristaltic filling machine

PF7+

Advancements in bioprocessing through increasingly complex ATMPs and vaccines means that adopting smarter technologies into your final fill/finish process today is vital. With the increased complexity of cell line and gene therapies, Flexicon’s expertise in peristaltic filling ensures your high value product is protected from contamination and damage to viability.

Developed for critical aseptic final fill applications, PF7+ is an intuitive peristaltic filling pump. Our expert engineers have innovated to provide a no-waste solution, meaning more of your liquid can be used for viable product. Together with higher levels of product and production repeatability, PF7+ requires less operator interaction and simple set-up. When connected to the advanced filling kit  the PF7+ provides:

• Zero waste start-up
• 100% in-process weigh checking
• Dynamic recalibration
• Colour fill tolerance indicators

Enhancing the performance of your critical process

PF7+ is the ideal pump for every stage of your process development, from research and development, clinical trials and small batch production. With improved process traceability through electronic batch reporting and live audit trails via Ethernet, PF7+ removes the need to enter the cleanroom and provides access to a full audit trail with ease.

We have enhanced security through three user levels with unique permission, auto timeout locking and batch user password sign-off capabilities. 

• 21 CFR part 11 compliance
• eBatch Reports via EtherNet and removable USB
• USB keyboard

Improved cleanability, ergonomics and safety with the QC14 pumphead

For ultimate cleanability, the QC14 pumphead (available on both PF7+ and PF7) features a hollow core and removable tray, allowing easy access for cleaning. The recessed locking leaver and secure tube bridge design affords users with single-handed tube loading operation while ensuring the tubing is loaded correctly.

• Hollow core rotor design
• Removable tray for easy cleaning
• Autoclavable and gamma-irradiatable tube locks and tray
• Additional safety sensors for removable parts
• Ergonomic single lever design

For added safety the removable tray and tube bridge are fitted with safety switches that prevent operation of the pump unless both parts are securely in place. A redesigned tube bridge brings added drop protection for the critical track fingers. The pump has been factory calibrated and designed without the need for adjustment over the life of the pump.

PF7

PF7 is a flexible, reliable and versatile peristaltic filling machine. Developed to protect your valuable product in GMP production environments, PF7 provides a dependable, high-quality solution.

PF7 is the result of 30 years of industry-focused experience. PF7 is simple to operate, highly flexible whilst reducing the risk of errors and comes with Flexicon’s trademark precision. With an intuitive user interface, error-free calibration and batch reporting, PF7 helps to ensure GMP and regulatory compliance.

• Precision filling from micro-volumes
• Repeatable filling accuracies of better than ± 0.5% to prevent costly overfilling
• No foaming, splashing or dripping between fills
• Simple, powerful user interface
• Designed for single-use fluid paths

Fast single-use fluid path changeover

Changing the fluid path can be achieved in less than a minute. The closed fluid path removes any risk of cross contamination, making the PF7 ideal for aseptic filling. Optimised for filling accuracy with Accusil tubing, the PF7 is designed to work with single-use fluid paths such as asepticsu.

Reliable and secure

The PF7 comes with a five year warranty. IQ/OQ documentation and execution available on request to assist with process validation.

Simple, powerful user interface

Large keys and a clear, colour display aids operation while working in gloves or behind glass within a RABS or LAF unit. The PF7 comes programmed with recommended filling parameters based on Flexicon’s 30-years of experience. Users can also set custom filling parameters of their own for optimum accuracy.

Integration into automated filling solutions

The PF7 will connect to a variety of bottle handling systems such as the FlexFeed 15, 20, and 30, or third-party systems. A range of accessories are available including footswitches for remote operation.

Improved cleanability, ergonomics and safety with the QC14 pumphead

For ultimate cleanability, the QC14 pumphead (available on both PF7+ and PF7) features a hollow core and removable tray, allowing easy access for cleaning. The recessed locking leaver and secure tube bridge design affords users with single-handed tube loading operation while ensuring the tubing is loaded correctly.

• Hollow core rotor design
• Removable tray for easy cleaning
• Autoclavable and gamma-irradiatable tube locks and tray
• Additional safety sensors for removable parts
• Ergonomic single lever design

For added safety the removable tray and tube bridge are fitted with safety switches that prevent operation of the pump unless both parts are securely in place. A redesigned tube bridge brings added drop protection for the critical track fingers. The pump has been factory calibrated and designed without the need for adjustment over the life of the pump.

Advanced Filling Kit

For a complete filling solution, Flexicon has worked with precision instrument specialists Mettler Toledo to develop a PF7+ advanced filling kit. Optimised and validated to eliminate compatibility risk, the advanced filling kit enables the PF7+ features of:

• Zero waste start up
• 100% in-process weight checking 
• Dynamic recalibration 
• Improved weighing accuracy 

To ensure filling repeatability, the PF7+ advanced filling kit includes a Mettler Toledo analytical balance with wind guarding and an integrated, adjustable nozzle holder. The kit also includes a set of custom weigh pans that allow for faster weight stabilisation in areas with laminar air flow and ensure proper repeatable positioning of the vial under the nozzle. The design gives extra protection to the weigh cell from accidental spillage.

The custom weigh pans accommodate a range of vial sizes including ISO standards up to 30R. 50R and 100R are additionally available.