Leading pharmaceutical outsourcing services provider PCI Pharma Services (PCI) has announced the release of a published white paper detailing Domino’s study, which analyses potential leachability of ink from coding technologies used in pharmaceutical serialisation activities.
The study was executed to ensure no migration into drug product contained within HDPE bottles with directly applied codes. Domino is an industry leader in coding and printing technologies operating in more than 120 countries worldwide, and one of the key providers of coding technologies to PCI across its global supply network.
The white paper details PCI’s joint development with Domino to analyse potential leachability of coding inks used in the application of serialised codes directly on HDPE bottles.
In the process of aggregation in serialisation technologies, particularly for high speed bottling lines, it is common industry practice to utilise a second “helper” code, often applied to the bottom of the bottle.
Those helper codes are then digitally married to serialised codes applied to labels on the side of the bottle and assist in line-of-sight verification in the commissioning and aggregation process.
The process of aggregation establishes a parent-child relationship with the unit of sale and its ancillary packaging, providing numerous benefits in the supply chain. The leachability study was commissioned to ensure proper usage of Domino-supplied inks and compliance with industry requirements in the prevention of ink migration and potential to affect drug product.
The study analyaes several ink types, including both visible black inks as well as invisible fluorescent ink used with ultraviolet (UV) inspection technologies.
PCI’s Ray Hook, Global Serialisation Manager, commented: “We collaborated with Domino on this study because of their expertise and global capability for applications like this.”
“As we have progressed our serialisation strategy across our global supply network, it was critical that we identified methods that ensured product safety and security for our clients and the patients using these medicines. Domino provided us with the assurance that we were following industry best practices as we further developed our capability with large scale aggregation activity.”
The study was a key precursor in PCI’s serialisation preparation activities. In February this year, PCI announced a significant capital investment in serialization capability expansion.
The multimillion dollar investment effectively triples PCI’s serialisation capacity in advance of US and EU deadline requirements, with more than 80 installations across PCI’s global supply network.
PCI has been providing commercially Serialized drug product to domestic and emerging markets for more than 5 years and is well positioned to support global strategic serialization and anticounterfeiting initiatives for its clients.
For more information or to download the Domino whitepaper, click here.