The contract manufacturing organisation (CMO) had 12 production sites and requested short-term implementation to serialise saleable units for four markets — China, South Korea, Brazil and the US — along with the ability to upgrade the installation to embrace pending track and trace mandates in 10 other countries.
Adents serialisation solution is hardware agnostic, which means it is compatible with a wide range of equipment. This was key for the manufacturer, who plans to equip as many as 80 lines to address increased demand, as serialisation deadlines in America and Europe approach.
The Adents serialisation and aggregation suite enables companies to achieve traceability and documentation compliance easily, addressing both current and emerging regulations while also minimising impact on production processes and productivity.
For implementation the CMO established a two level decision making organisation, with a group leadership team managing procurement and global governance, and serialisation project management teams at each site.
The Adents solution was smoothly incorporated because it is flexible, scalable, and quick to deploy with its configuration taking place at the site level, making per-line configuration unnecessary.
In its effort to realise a workable, forward thinking serialisation solution, the CMO faced a challenge that most pharmaceutical manufacturers its size would face: the lines being outfitted had a wide array of differing specifications.
The large company’s packaging operations were unsurprisingly diverse, running the spectrum from manual lines producing 40 items per minute to semi-automatic operations churning out 300 units/min.
The first line was installed in 2.5 months, including arrival and installation time for the new equipment. Each of the other lines was incorporated in less than 6 weeks. A rework station was set up on each line as well.
In all, seven lines were installed at four different sites in France for this CMO, with ten different packaging formats enabled on a single line. The client now provides serialised production services for at least four big pharmaceutical companies and has the capacity to address larger demand and a variety of expanded customer requirements.