According to Bosch experts, the need for serialisation technology will continue to grow over the coming years to fight the counterfeit drug industry. Stricter drug packaging guidelines are already being implemented in countries throughout the world. In Saudi Arabia, drug packaging must be equipped with a data matrix code step by step, followed by serial numbers by 2016. In Brazil, individual batches must be serialised as of 2015 (obligatory from 2016). The U.S. Food and Drug Administration (FDA) is aiming to implement a standardised identification for all prescription drugs in the form of a 2D data matrix code in a step-by-step approach until the end of 2023. The European Union’s Falsified Medicines Directive 2011/62/EU stipulates coded packaging with a 2D data matrix code and a unique serial number for nearly all prescription drugs, most likely from the first quarter of 2018.
As a consequence, drug manufacturers require safer and more flexible solutions. Bosch Packaging Technology is preparing pharmaceutical manufacturers now for the anticipated regulatory requirements worldwide by expanding its portfolio for the serialisation of pharmaceutical packaging.
Daniel Sanwald, product manager at Bosch Packaging Technology, explained, “With our serialisation concept, we offer customers more than just a machine. Bosch offers the complete package, which also includes the corresponding IT.”
The first and major upgrade is connecting machine and software. The CPS (Carton Printing System) forms the basis of all serialisation solutions from Bosch. Depending on customer requirements, the system prints 1D or 2D data matrix codes on up to 400 folding cartons per minute, and with the recent upgrade of its camera system, both codes may now be checked on different carton qualities even more reliably. If the contrast and readability of the data matrix codes do not conform with the required level of quality, the products are automatically sorted out. The machine is easy to operate from the front, so that mechanical components are easily and quickly accessible in case of format changes. An optimised threading of the labelling tape reduces downtime of the CPS 1900 to a minimum.
The CPS systems may be connected to both machine software and company IT in a multi-level process to ensure that serial numbers are attributed reliably. This is an adaptation of the proven automation technology from its automotive sector.
“This experience enables us to offer our customers IT solutions that not only process the entire order management; they also control both import and export of the serial numbers,” Sanwald noted.
Depending on country and guideline, the numbers are either allocated centrally or generated by the company. Contract manufacturers in turn receive the numbers from their clients. Bosch’s IT system is equipped for all three cases. The Bosch machines may also be flexibly combined with systems from other IT providers. The concept has further advantages for production companies: production parameters and data of all packaging lines are clearly visible at all times.
“For instance, in the case of unforeseen events like downtime or modification, capacities are automatically re-planned. The connection of our machines with the corresponding IT offers companies a new production foresight,” Sanwald commented.
The modular design of the CPS system provides additional safety. For example, a weighing module inspects the weight of each folding carton individually. Existing machines may also be equipped with a Tamper Evident module. The labeller applies additional safety seals across the side flap of the folding carton, to provide optimum protection against manipulation. Sensor systems carry out safe and reproducible checks of seal presence and correct application. The machine and all applications, such as the camera, are operated via a single HMI (Human Machine Interface). The operator has a uniform look and feel, does not need to switch between different HMIs and the central audit trail is made considerably easier.
