The EU Falsified Medicine Directive (EUFMD) will require bar codes on even the smallest saleable drug units, and with some experts saying drugmakers are already behind on preparations for the 2018 deadline, three firms have teamed up to offer a new serialisation service.
Glassmaker Schott, quality assurance company Heuft and processing equipment firm GEA have developed a joint solution for the clear traceability of primary packaging, based on a 'glass-coding' principle which marks and traces vials throughout the process chain.
"The primary packaging, meaning the glass vial, is coded by the glass manufacturer [Schott]," explained Stephan Bachmeier, Product Manager at Heuft Systemtechnik. "Each vial is unique and has a unique serial number. For each batch of empty glass vials there is a list of numbers."
He continued, telling us that these vials are inspected within GEA's equipment for freeze-drying within the pharmaceutical production line using Heuft's code-reading technology.
"As the dimensions of the GEA machine are defined, the Heuft system knows in detail which vial is on which position within the freeze-drying machine."
A second inspection occurs following the lyophilisation process:
"All the vials are counted to make sure that really every vial that has entered the process also leaves the machines again. But much more important is, that predefined vials can be rejected from the line for further quality analysis."
The approach is focused on the primary packaging, and not secondary packaging and as such fulfils just one part of the upcoming EU directive.
None of the three firms are 'leading' this project, but rather the service can only work with all parties involved. Bachmeier was unable to divulge any financial details of the collaboration.