- Rossix has optimised its process by using a peristaltic filler of the PF series and a FlexFeed30 tabletop bottle handling and capping system from Flexicon Liquid Filling, a Watson-Marlow Fluid Technology Solutions company
- Filling accuracy and consistency in cap torque results in an excellent cost of ownership when handling a wide range of bottles, fill volumes and screw caps
- Since adopting Flexicon systems, productivity has increased and risk of batch variations has been minimised
Investing in two Flexicon filling and capping units has transformed Rossix’s small-scale production, to ensure optimum filling accuracy and consistent screw capping within a compact space.
Rossix, which was established in 2000, develops and manufactures chromogenic kits and assay reagents for haemostasis research, diagnostics (one product that is for haemophilia diagnosis), and quality control. The Sweden-based company is also an OEM supplier of reagents, serving its clients with customised solutions.
Rossix started to use a PF series tabletop peristaltic filling machine in 2016 and Flexfeed 30 (FF30) tabletop bottle handling and capping machine in 2018 to optimise its production process. Rossix has not experienced any breakdowns in over seven years of using the two modular units from Flexicon Liquid Filling, a Watson-Marlow Fluid Technology Solutions (WMFTS) company, for accurate dispensing of buffers and reagents into screw cap bottles.
Per Rosén, Rossix CEO, said: “Before we bought the PF series pump, we filled at another company’s facility, and we wanted to bring the filling process in-house, to have control over our own production.
“We don’t fill every day. When we fill the bottles intended for lyophilisation, a batch size is typically 1,500 bottles which is too large for manual filling but too small to require a high-capacity filling and capping system.
“Combining Flexicon’s PF series with the compatible FF30 gave us a solution with a smaller footprint so we can operate from a bench top in our compact filling and capping room, and also avoid within-batch and between-batch variations associated with manual filling and cap screwing.”
Consistent cap torque
The FF30 is a bottle handling and capping machine for bottles up to 50 mm in diameter. In combination with the PF series, liquids can be filled automatically in volumes from less than 0.2 ml to approximately 100 ml.
Per Rosén, Rossix CEO, said: “Switching from manual screw capping, the most important thing was that we got a more consistent cap torque. We once failed a batch because we had one person that simply tightened the caps too tight. Also, when we relied on the manual tightening of the caps it was not good for the workers’ fingers.
“The Flexicon system prevents leaking bottles and ensures we have consistent capping for product quality and stability. We have two kinds of screw caps that require slightly different torque settings and it’s simple to change between the two with the FF30.”
The unique design of the Flexicon peristaltic fillers, along with sets of recommended filling parameters and Accusil silicone tubing, are ideal for filling within the pharmaceutical, diagnostics and biotechnology industries, particularly when handling shear sensitive or costly liquids. The product is only in contact with USP Class VI validated fluid path components, manufactured in an ISO 14644-1 Class 7 environment.
No costly overfilling
The PF series is designed for flexible small batch filling applications and can fill from less than 0.2 ml up to more than 250 ml. A filling accuracy better than +/-0.5% is achievable for most volumes.
Flexicon’s consistent filling accuracy and reliability means Rossix has avoided costly overfilling of expensive liquids, and no unexpected production stops have happened.
Per Rosén, Rossix CEO, said: “We fill from 0.8 mL to 2 mL for lyophilisation and from 6 mL to 100 mL with liquid reagents/buffers so the flexibility is good for us. We can use the system for all our products within that range and avoid having a lot of different types of equipment. When we do the filling of reagents for lyophilisation, it’s important to have a high filling accuracy. If the bottles have different volumes dispensed before the lyophilisation process and the customer subsequently reconstitutes them to the target volume, then you will have different concentrations and you might get different analytical results because of variations in the potency in the bottles.
“We also dispense some liquids that are quite expensive. Due to the accuracy of the pump, we can guarantee a minimum fill volume and also save money because there’s marginal overfilling.
“Assuming that we needed maintenance or repair of the equipment during a batch, then we would have to fill manually with a pipette and that’s not something we could do for a long time, so it’s important we don’t have to stop production. The peristaltic filler and the FF30 have never broken down or failed.”
Youssef Elsharabasy, Sales Manager – Biopharm – Sweden, said: “Several FF30 bottle handling units and capping units are in operation in Sweden and hundreds are installed around the globe. Historically most of them have been supplied together with a PF6 peristaltic filler. However, after around 20 years within our product range, the PF6 has been replaced by the upgraded PF7/PF7+ which is even more user friendly in terms of ergonomics, cleanability and user interface. It fills just as accurately as Flexicon peristaltic dispensers have always been renowned for. The PF7+ also provides flexible and state of the art batch reporting.
“Should users of FF30/PF6 or PF7 have a need for further automation of their filling and screw capping process, then they would typically take a closer look at the fully automatic FMB210, also developed and manufactured by Flexicon Liquid Filling.
“WMFTS is a total solution provider having developed, manufactured and also tested not only the peristaltic pumps, but also the fluid paths. WMFTS provides excellent products for liquid filling and also suggests recommended filling parameters for a wide range of fill volumes. WMFTS is widely seen as a provider of plug-and-play filling and capping equipment, making the time from installation to actual production very short.”
