Flexicon delivers repeatability and flexibility in Rossix’s small batch filling and capping process
Since adopting Flexicon systems, productivity has increased and risk of batch variations has been...
Case Study
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Developed for accurate and reliable filling of sensitive fluids in GMP production and cleanroom environments, the PF7 range of benchtop filling machines offer a reliable, flexible and scalable filling solution.
With only the inner bore of the single-use tubing coming into contact with the fluid, Flexicon benchtop filling machines remove the potential of cross contamination.
Flexicon’s high-quality fillers are the perfect centrepiece for your final filling process. The PF7 range’s intelligent user interface, regulatory validation and simple operation combine to safeguard and drive efficiencies to your filling process. Developed through decades of engineering experiences, the PF7 benchtop filling machine range from Flexicon provides the perfect solution that can grow as you enhance, scale-up and look to introduce levels of automations your final fill/finish process.
Paired with our Accusil tubing and WMArchitect fill/finish, Flexicon benchtop filling machines provide an optimised filling performance while gently transferring product without affecting viability or quality.
Choosing the right product for your filling process |
PF7+ |
PF7 |
Precision filling from micro-volumes |
✔ |
✔ |
Repeatable filling accuracies of better than ± 0.5% to prevent costly over filling |
✔ |
✔ |
No foaming, splashing or dripping between fills |
✔ |
✔ |
User-programmable ‘recipes’ where users can define filling recipe parameters |
✔ |
✔ |
Connects to a range of balances and printers for error-free calibration and batch reporting to help compliance to GMP and regulatory demands |
✔ |
✔ |
Easy-to-clean surfaces with no entrapment areas, and an ergonomic design for operation on the bench or in isolators and LAF units |
✔ |
✔ |
Clear and intuitive colour display with large keypad for easy use when gowned up in cleanroom environments |
✔ |
✔ |
21 CFR part 11 compliance |
✔ |
|
eBatch Reports via USB or EtherNet |
✔ |
|
USB keyboard |
✔ |
|
Zero waste start-up |
✔ |
|
100% in-process weigh checking |
✔ |
|
Dynamic recalibration |
✔ |
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Colour fill tolerance indicators |
✔ |
|
Accuracy | Better than ±0.5 % |
Technical Summary table lists features available within the range. See ‘Specifications’ tab for model specific information.
Performance | ||
---|---|---|
Fill volume / ml | Bore / mm (in) | Typical fill time / s |
0.2 | 0.5 (1/50) | 0.75 |
1.0 | 0.8 (1/32) | 1.10 |
1.4 | 1.2 (3/64) | 0.75 |
1.8 | 1.6 (1/16) | 0.60 |
8.0 | 3.2 (1/8) | 0.70 |
15.0 | 4.8 (3/16) | 0.80 |
24.0 | 6.0 (6/25) | 0.80 |
50.0 | 8.0 (5/16) | 0.80 |
PF7+ | PF7 | |
---|---|---|
Accuracy | Better than ±0.5 % | Better than ±0.5 % |
Ingress Protection | IP32, NEMA 2 | IP32, NEMA 2 |
Operating temperature range | 5 °C to 40 °C | 5 °C to 40 °C |
Operating temperature range | 41 °F to 104 °F | 41 °F to 104 °F |
Speed control ratio | 570:1 | 370:1 |
Humidity | (Non-condensing) 80 % up to 31 °C (88 °F) decreasing linearly to 50 % at 40 °C (104 °F) | (Non-condensing) 80 % up to 31 °C (88 °F) decreasing linearly to 50 % at 40 °C (104 °F) |
Noise | <70db (A) at 1m | <70db (A) at 1m |
Standards | CAN/CSA C22.2 No 61010-1, CE, cETLus, UL 61010-1 | |
Power supply | 50/60 Hz, Filtered 100 V to 120 V/200 V to 240 V, Single-phase | |
Power consumption | 140 VA | 140 VA |
Weight | 12.5 kg | 12.5 kg |
Weight | 27.6 lbs | 27.6 lbs |
Full load current | <0.6 A at 230 V, <1.25 A at 115 V | <0.6 A at 230 V, <1.25 A at 115 V |
Fuse rating | 2.5 amps | 2.5 amps |
Accessories | Foot switch, filling stand, Advanced filling kit (AFK) | Foot switch, filling stand, Advanced filling kit (AFK) |
Compatible tubing size | 0.5 to 8.0 mm ID | 0.5 to 8.0 mm ID |
Rear panel | |
---|---|
Feature | Description |
1 | USB 2.0 |
2 | M12 connectors |
3 | RJ45 10/100 Mbps(For export capability from pump only, not control use. Not designed for use with EtherNet/IP™. Not designed for use with PROFINET) |
4 | Voltage selector |
5 | Power switch |
6 | Power supply socket |
Rear panel | |
---|---|
Feature | Description |
1 | USB 2.0 |
2 | M12 connectors |
3 | Voltage selector |
4 | Power switch |
5 | Power supply socket |
Casework | ABS plastic, Anodised aluminium |
Keypad/HMI | Polycarbonate (PC), Polyester |
Pumphead roller assembly | Stainless steel 316 |
Tube bridge | Anodised aluminium EN AW-5754 |
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:
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.
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.
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 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.
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.
The PF7 comes with a five year warranty. IQ/OQ documentation and execution available on request to assist with process validation.
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.
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.
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.
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.
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:
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.
Compatible with Schott vials
Pump product codes | |
---|---|
Description | Partcode |
PF7+ Peristaltic Filler | 91-068-14X* |
PF7/PF7+ Foot Pedal Switch | 88-210-040 |
PF7+ Filling Stand | 88-200-200 |
PF7+ IQOQ Protocol for 1 unit | 74-156-440 |
PF7+ IQOQ Execution | 74-156-441 |
PF7+ IQOQ Additional units | 74-156-442 |
PF7/QC14 | 91-060-14X |
PF7/QC12 | 91-060-00X |
PF7 Filling Stand | 81-100-200 |
PF7 IQOQ Protocol | 74-156-443 |
PF7 IQOQ Execution | 74-156-444 |
FlexFeed 15 | 92-160-300 |
FlexFeed 20 | 92-170-100 |
FlexFeed 30 | Contact local sales office |
Advanced Filling Kit (up to 30R vials) | 88-208-00X* |
Advanced Filling Kit (50R-100R vials) | 88-208-22X* |
Wireless Cleanroom Keyboard | 88-100-001 |
Field replaceable parts | |
QC14 pumphead for PF7+/PF7 | 87-068-000 |
QC14 tubebridge for PF7+/PF7 | 87-068-047 |
QC14 complete tubelock set | 87-068-500 |
QC14 replacement access tray | 87-068-055 |
Weigh pan set for Advanced Filling Kit | 87-208-001 |
*Plug options | |
---|---|
U: | UK mains plug |
E: | EU mains plug |
A: | American mains plug |
K: | Australia mains plug |
R: | Argentina mains plug |
C: | Swiss mains plug |
D: | India/South Africa mains plug |
B: | Brazilian mains plug |
J: | Israel mains plug |
Accusil platinum-cured tube ordering codes | |||
---|---|---|---|
Bore / mm (in) | Wall / mm (in) | Length / m (ft) | Part code |
0.5 (1/50) | 1.6 (1/16) | 10 (32.8) | 84-103-005 |
150 (492.1) | 84-104-005 | ||
0.8 (1/32) | 1.6 (1/16) | 10 (32.8) | 84-103-008 |
150 (492.1) | 84-104-008 | ||
1.2 (3/64) | 1.6 (1/16) | 10 (32.8) | 84-103-012 |
150 (492.1) | 84-104-012 | ||
1.6 (1/16) | 1.6 (1/16) | 10 (32.8) | 84-103-016 |
150 (492.1) | 84-104-016 | ||
3.2 (1/8) | 1.8 (1/14) | 10 (32.8) | 84-103-032 |
150 (492.1) | 84-104-032 | ||
4.8 (3/16) | 2.0 (10/127) | 10 (32.8) | 84-103-048 |
125 (410.1) | 84-104-048 | ||
6.0 (6/25) | 2.1 (10/127) | 10 (32.8) | 84-103-060 |
90 (290.3) | 84-104-060 | ||
8.0 (5/16) | 2.2 (2/23) | 10 (32.8) | 84-103-080 |
65 (213.2) | 84-104-080 |
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Highly flexible solution for filling and capping of bottles. Handles screw, pipette or other caps with a special shape.
Aseptic filling - semi-automatic handling
Highly flexible solution for filling with no format parts for different vials/bottles up to 78 mm diameter.
Aseptic filling - semi-automatic handling
Filing and capping accessories including stands, weights, tube manifolds, Y-connectors and a range of filling nozzles.
Fluid path - accessories
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Single-use assemblies
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Aseptic filling - benchtop fillers
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