Werfen reduces fill-finish time by approximately 40% with Flexicon units

Werfen has reduced its fill-finish time by approximately 40% with the help of a Flexicon FlexFeed 30 (FF30) semi-automatic tabletop bottle-handling and capping machine at its facility in Dartmouth, Nova Scotia.

The company uses the FF30 alongside a PF6 peristaltic filler with Accusil tubing from Flexicon Liquid Filling, part of Watson-Marlow Fluid Technology Solutions, in the production of its vialed blood banking reagents. Werfen has recently upgraded their system, replacing the PF6 with the newer PF7 peristaltic filler model.

Werfen specialises in diagnostics for haemostasis, acute care, transfusion, autoimmunity, and transplant. Its product line is comprised of in vitro diagnostic systems, reagents, information management and service solutions used to diagnose and guide treatment of thrombotic and bleeding disorders.

All of Werfen’s vialed blood banking reagents are filled and capped using the FF30 in 10 mL and 5mL vials which includes Anti A, Anti-B, Anti-A,B, Anti-D (IgM+IgG), Anti- C, Anti-c, Anti-E, Anti-e, Anti-IgG, Anti-IgG+C3d, Anit-C3d, Anti-Mia, Diluent Control, and Anti-A1 Lectin. These reagents are used to detect antigens and antibodies for blood transfusions, bone marrow transplants, and organ transplantation.

A single semi-automated FF30 ensures consistent cap torque control while processing between 200 and 10,000 vials per day. Werfen has relied on the FF30 system since 2019, operating one unit at a time with a second unit added to their inventory as a backup. The two units are now being used interchangeably to effectively balance operational wear between the units.

Before using the FF30, Werfen manually capped its vials. The process now involves two operators: one performing filling and capping, and the second providing support and verification.

Dean Langley, Manager, Facility & Engineering at Werfen in Nova Scotia, said: “Since installing the FF30 into our filling process, we have seen the fill process time decrease by approximately 40%. This shortening of the process time not only prevents expensive overtime, but reduces the fatigue and stress on the operators. It has also effectively eliminated any repetitive stress injuries that would occasionally occur with the manual process.

“Before using the FF30 and PF6 system, we used solely the PF6 and the capping/filling process was manual. By including the FF30 in the process a 10,000 vials job time was decreased from 12 or 13 hours to 6 to 7 hours.”

Low maintenance and accuracy are crucial for Werfen in its filling and capping processing.

Dean Langley, Manager, Facility & Engineering at Werfen in Nova Scotia, said: “Beyond cleaning there is little maintenance for either the FF30 or the PF6. We verified the FF30 screwdriver and dispenser once a year, but there are seldom significant issues. The calibration procedure for the dispenser is quick and easy. We use the same dropper and vial configuration for all our vials, but we have an alternative configuration that only requires a swap of the dropper attachment on the screwdriver that is as quick as swapping a bit in an impact driver.

“The cost of a breakdown of a filling capping machine could be significant depending on the nature of the deficiency. A deficiency could result in leaking product and rejection/rework at the QC stage or more impactful, if the product was released, a replacement of product for customers or a full recall which has significant regulatory implications.

“For our process, accuracy is very important.  We do not want to under deliver to the customer, but we also do not want to over deliver as that is money wasted. At the extreme end, if the vial actually overflowed, the job has to be halted and the entire area cleaned, costing not only the value of the wasted product but the time of the employees performing the filling operation.

“Any issue or question with the equipment has been quickly and thoroughly addressed by the excellent support personnel from Watson-Marlow and Flexicon. We have had nothing but a positive experience with the Flexicon equipment.”

In over six years of using the FF30, Werfen has not experienced any disruptive and costly breakdowns.
 
Anouk Leblanc, Technical Account Manager, Life Science at Watson-Marlow Canada, said: “Werfen runs preventative maintenance every two years and because they take such good care of the equipment, they have never had any issues with the Flexicon FF30 and PF6. They don’t have any downtime in their production and with two operators they can manage 10,000 vials in a regular 8-hour day so the FF30 is like a fully automated system with the numbers it does. This reliability helps Werfen with its continuous biomanufacturing. The simplicity of the system means it’s easy to train operators how to use it.” 

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