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One of the most challenging parts of the project was ‘creating a solution that identified the features of each individual component without slowing down the process,’ according to PCI’s Ray Hook, director, global serialisation. And while this did present variability challenges at the beginning of the project, Hook notes that PCI found an ‘optimal solution to address that real- world variability,’ settling on a solution ‘that is very robust’. Through considerable time spent in engineering analysis and proof-of-concept challenge testing, we were able to leverage combinations of critical text and colour to establish a basis of validated parameters by which the system could ensure the presence of each component. Variability, however, continued to provide an ever present challenge in establishing parameters. Green and yellow were two key distinguishing features for identifying the 20- and 22-gauge needles. Due to printing variability from the sourced components, the distinction between yellow and green was found to be particularly difficult. In the end, using colour with other key attributes allowed the system to deliver a robust solution. Once the key elements of the vision systems were fool-proofed, the remaining architecture of the line engineering elements needed to be established. With modest product volume requirements, full automation was not the optimal solution. The line ultimately blended human activities with automated elements, all governed by inline automated inspections at each critical milestone of the build. This included fully automated WFI syringe assembly, beginning with
sterile glass barrels and adding components such as finger flange, syringe labels, plunger rods and protective packaging. The WFI is paired with the labelled active drug product lyophilised vial, and the kit is then fitted out with the remaining components. At every step of this complex build, the vision system ensures the proper fit, placement, and correctness of each critical component. Once a kit is complete in its contents, anti-counterfeiting tamper stickers are added to provide additional security. Kits are then serialised with market specific requirements, vision inspected, and further aggregated to the case and pallet.
Marc Luebbing, PCI business unit manager, added: “Working closely with our customer ‘at the table’ meant we could develop a package design that was elegant and intuitive for the care-giver delivering the medicine, but also incorporated all the key elements for our packaging system to deliver with a high degree of confidence. The project called on resources across many functional groups and teams and yielded a great solution for everyone concerned.”
The key to automated inspection systems is to provide inspection criteria that can be validated to assure robustness and reliability.
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