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FEATURE MACHINE BUILDING, FRAMEWORKS & SAFETY


sponsored by


Facing challenges in its filling/capping suite, Advaxia


Biologics turned to the Flexicon FPC60 vial


filler, which helped the company achieve


greater operational efficiency. Here we take a look at the system’s design


A RECIPE FOR SUCCESS IN FILLING & CAPPING


batches and included the Flexicon PF6 peristaltic filler and Flexfeed 20 semi-automatic vial feeding system. The caps were placed manually before being crimped by the Flexseal 10 capping machine and installed on the benchtop under a Laminar Air Flow control system. It was realised, however, that investment in


A


new automatic filling/capping operations would provide multiple benefits to their process, including batch reporting and zero waste. To maintain the highest level of quality, the


challenge for Advaxia Biologics has been to train and maintain operator skill levels, as they are responsible for much of the entire filling process, including a critical step of final filtration of the pharmaceutical drug product. Reducing operator input in the critical process, as well as through recipe drive auto-adjustments, would help address this challenge.


A COLLABORATION Working in collaboration, Flexicon and Franz Ziel developed a new solution. An FPC60 filling/capping system was integrated with environmental barrier technology to ensure both product and operators were fully protected and the platform met all regulatory requirements. Advaxia Biologics works with two sizes of


Stevanato Group EZ-Fill vials, in pre-sterilised ready-to-use vial trays for automatic loading. The fill volumes fall within a variable range between less than 1ml and 5ml. With the previous filling system, the batch sizes ranged up to 1000 vials – the new FPC60 machine and suite means the company is now able to offer around 5000 vials. To maintain aseptic conditions during filling


and capping of a product particularly susceptible to external contamination, or considered


14 DESIGN SOLUTIONS APRIL 2023


t Advaxia Biologics, a leader in GMP compliant contract manufacturing, the vial filling configuration was focused on small


bio-hazardous to operators, a closed Restricted Access Barrier System (cRABS) or isolator provides the highest level of protection. The FPC60 automatic filling and capping machine is equipped with fully electric systems and does not require compressed air, saving Advaxia Biologics time and cost in installing a new compressed air line compliant with the Class A environment. In addition, the No Touch Transfer compliant de-bagging system ensures that vial trays are unwrapped and introduced into the critical filling area without human contact, while maintaining the required levels of safety and sterility at good production speeds. Of further interest, its remote Human-Machine


Interface enables recipe and user creation from outside the cleanroom. Once in the cleanroom, recipes simply need to be recalled and the machine fully adjusts itself based on the recipe parameters, increasing repeatability and reducing risk.


IMPROVEMENTS Not only does the new system reduce contamination sources from critical processes, while also providing greater repeatability, greater quality assurance and high levels of traceability, but it has reduced the number of operators required to fill a batch. Traceability of the entire filling process


takes place through software that controls all automated systems and keeps track of batch records and audit trails. Reducing rejection rate and zero waste start-up means vials filled during priming and calibration are viable. According to Branislav Mitrovic, Flexicon’s


sales manager, significant challenges had to be overcome in the Factory Acceptance Testing (FAT) process for Advaxia’s FPC60 at the end of 2020, due to the Covid-19 pandemic. He said: “Since it was not possible to travel


around the world at the time the FPC60 was set up, it was necessary to perform the final FAT for the system remotely, using Advaxia’s vials, caps and tear-off caps. We perform the same tests according to FAT protocol documentation, regardless of whether the FAT is performed with the customer present, or remotely. Remote execution of FPC60 FAT typically takes four to five days (eight hours per day) and requires concentration, teamwork and commitment. “Advaxia Biologics had previously used a


Flexicon system, so the move to a much higher volume automated filling/capping system is a perfect example of known and reliable upscaling technology. It was a moment of great satisfaction when the test was successfully completed and the Advaxia Biologics FPC60 was ready to be shipped to Rome."


Flexicon www.wmfts.com/en/brands/flexicon/


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