06.08.17
Adents has successfully installed a fully configurable drug serialization and aggregation software solution on seven packaging lines at four France sites for a pharmaceutical contract manufacturer. With a dozen production sites, the CMO requested short-term implementation to serialize saleable units for four markets – China, South Korea, Brazil and the U.S. – along with the ability to upgrade the installation to pending track & trace mandates in 10 other countries.
Adents serialization solution is compatible with a wide range of equipment to achieve traceability and documentation compliance for current and emerging regulations. The client plans to equip as many as 80 lines to address increased demand as serialization deadlines in America and Europe approach.
For implementation, the CMO established a two-level decision-making organization: a group leadership team to manage procurement and global governance, and serialization project management teams at each site.
The lines being outfitted had a wide array of differing specifications. The company’s packaging operations were diverse, running the spectrum from manual lines producing 40 items per minute to semi-automatic operations of 300 units/min. The CMO was able to leverage existing equipment as much as possible, allowing the company to reduce training and documentation, and simplify support and vendor management.
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. Adents’ software also supports a range of requisite add-on devices from various brands. The CMO chose machines from Domino, Zebra, Keyence, Cognex and Omron vision systems.
The first line was installed in 2.5 months, and each of the other lines was incorporated in less than 6 weeks. The client now provides serialized production services for at least four big pharma companies and has the capacity to address larger demand and expanded customer requirements.
Adents serialization solution is compatible with a wide range of equipment to achieve traceability and documentation compliance for current and emerging regulations. The client plans to equip as many as 80 lines to address increased demand as serialization deadlines in America and Europe approach.
For implementation, the CMO established a two-level decision-making organization: a group leadership team to manage procurement and global governance, and serialization project management teams at each site.
The lines being outfitted had a wide array of differing specifications. The company’s packaging operations were diverse, running the spectrum from manual lines producing 40 items per minute to semi-automatic operations of 300 units/min. The CMO was able to leverage existing equipment as much as possible, allowing the company to reduce training and documentation, and simplify support and vendor management.
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. Adents’ software also supports a range of requisite add-on devices from various brands. The CMO chose machines from Domino, Zebra, Keyence, Cognex and Omron vision systems.
The first line was installed in 2.5 months, and each of the other lines was incorporated in less than 6 weeks. The client now provides serialized production services for at least four big pharma companies and has the capacity to address larger demand and expanded customer requirements.
