A premier, fully configurable drug serialisation and aggregation software solution from Adents was successfully installed on seven packaging lines at four France sites for a top European pharmaceutical contract manufacturer.
With a dozen production sites, the CMO requested short-term implementation to serialise saleable units for four markets – China, South Korea, Brazil and the U.S. – along with the ability to upgrade the installation to embrace pending track & trace mandates in 10 other countries.
Adents serialisation solution is hardware agnostic, meaning it is compatible with a wide range of equipment. This was a key selling point for the CMO, which 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: a group leadership team to manage procurement and global governance, and serialisation project management teams at each site. Here, the Adents solution, by its nature, helped make for a smooth incorporation; an ideal “standardised software” approach, Adents is extremely flexible, scalable, and quick to deploy because its configuration takes place completely 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 nearly any pharmaceutical manufacturer 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.
Here again, the hardware-agnostic Adents solution made implementation far more manageable than it could have been. The CMO was able to leverage existing equipment as much as possible, allowing the company to optimise its project budget, reduce training and documentation, and simplify support and vendor management.
Of note, five lines were already equipped with H2M and Seidenader modules, so the remaining two lines that required additional equipment were outfitted with new H2M modules for continuity’s sake. Adents’ software solution also supports a wide range of requisite add-on devices from a broad array of brands; the CMO chose machines from Domino, Zebra, Keyence, Cognex and Omron vision systems with the reassurance that, via the Adents software, all would work well together to form a comprehensive serialisation solution.
The first line was installed in 2.5 months, much of which comprised arrival and installation time for the aforementioned new equipment. The remaining steps included:
• Documentation (project quality plan, functional analysis, protocols): 1 month
• Set-up and qualification by machine builder (FAT & SAT): 2 weeks
• Set-up in client plant by Adents (configuration and installation): 1 week
• Qualification in Adents office (FAT): 1 week
• Qualification in client plant (SAT): 1 week
Each of the other lines was incorporated in less than six weeks. A rework station was set up on each line as well. Because a comprehensive FAT was performed by Adents upfront, line downtime was reduced to a maximum of one week for new qualification (SAT/IQ/OQ/PQ), significantly minimizing the impact on production capabilities.
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.