Cognex image-based barcode readers help Bosch in the fight against counterfeit drugs
The pharmaceutical industry is undergoing dramatic changes all around the world. Soon it will no longer be permitted to sell pharmaceutical drugs without clear labeling and verification. Bosch Packaging Technology has come up with a track and trace solution to satisfy this future requirement, using Cognex barcode readers embedded in a test and identification module made by the leading systems integrator AIT Goehner.
In 2004, Germany authorized the sale of drugs via mail order, which, in principle, was a good thing. However, some estimates suggest that over half of the drugs sold over the Internet are counterfeit. One of the reasons for this is that their origin, and therefore their authenticity, cannot currently be verified. This can result in potentially serious consequences for patients requiring vital drugs, for example for heart failure or diabetes. It is therefore no surprise that legislators in much of Europe, the U.S., Brazil, Saudi Arabia and other countries are demanding better anti-counterfeit measures and are turning toward innovative ways to effectively combat the distribution of falsified, ineffective and dangerous drugs.
Upcoming mandatory regulations
These efforts resulted in the adoption of the draft of the Falsified Medicines Directive (Directive 2011/62/EU) in February 2016, which will go into effect in 2019, following a transitional period. Will this mean the end of counterfeit drugs? The directive will require all prescription drugs to carry a serial number that will ensure the pharmaceuticals are traceable throughout the entire supply chain. The use of tamper-evident technology in the form of tamper-proof caps or seals is a second safety measure that will become mandatory at the same time.
In addition to pharmaceutical wholesale and retail operations (such as drugstores, which are able to check the authenticity of products), this new regulation will impact manufacturers, distributors, contract packagers and logistics companies. The industry innovations will allow products and their associated data to be traced via the serialization of individual packaging and aggregated products. In addition to the implementation of Directive 2011/62/EU, drug manufacturers will be required to establish a global strategy for the consistent allocation of serial numbers, to adapt their packaging processes, and to establish new procedures for managing and storing the serial numbers.
Retrofitting packaging lines
Retrofitting or integrating appropriate packaging machines with these new innovations is a fundamental part of the serialization project. Daniel Sanwald, Product Manager at Bosch Packaging Technology, confidently states, "As of 2019, the identification and authenticity of all products sold in drugstores will be able to be verified."
For this reason, thousands of packaging lines across the world will need to be retrofitted with the track and trace capability. Bosch Packaging Technology draws on over 15 years of experience in the Bosch automotive industry, in which the automation and networking of machines, processes and IT systems has been well established. Logic and features have been specifically adapted for pharmaceutical track and trace applications.
Flexibility plays a major role in achieving traceability, since many pharmaceutical manufacturers operate internationally and deliver their products to countries with a multitude of differing labeling requirements. Bosch Packaging Technology also manufactures and commercializes packaging lines throughout the world. As a general rule, and for cost-efficiency, pharmaceutical drug manufacturers use bright stock manufacturing, in which they hold off on labeling and packaging products until just before delivery. Manufacturers thus avoid the accumulation of large stocks of labeled products for specific markets.
Flexibility through modularity
With the machine concept of its CPS series, Bosch Packaging Technology has made an important step toward improving flexibility. Thanks to its modular design, the CPS folding-carton printing and verification system offers functional expansion possibilities, such as the addition of a scale, a labeler and a tamper-evident function. With its small footprint, CPS 0800 (basic model) can print and verify up to 400 folding cartons per minute — that is over six units per second! Adjustable conveyor belts and a tool-free quick-change system allow the cartons to be printed on all sides.
A randomized serial number is allocated using the modular, flexibly scalable CPI serialization software. Thanks to CPI, the serialization process can be managed down to the last aggregate level. This future-proof software can network individual components, packaging lines and even entire production plants. The 1-D or 2-D serial number codes with batch numbers and expiry dates generated with CPI can be printed onto the packaging via inkjet or laser printing. To accommodate various regulations throughout the world, and in anticipation of future market requirements, new coding types may be added at any time.
A camera solution developed by an experienced engineering partner
Once the tracking data has been printed onto the packaging, it is automatically verified by a high-speed camera system. Verifying the authenticity of the data printed during the packaging process is required in real time. Due to the high throughput, this presents a challenge for the camera.
With over 25 years of experience and 20,000 reliably installed systems in a wide range of industries (and thanks to its longstanding partnership with Cognex, the world market leader in machine vision and barcode reading systems), AIT Goehner was chosen as the engineering partner to develop the barcode reading module, consisting of a machine vision camera and lighting system. To meet the demands of Bosch Packaging Technology, the image-processing specialist developed a compact barcode reading unit (V30 LED module) using Cognex solutions. The system includes a module that can be seamlessly integrated into the Bosch control system, and which is optimally suited to the entire CPS machine series. The look and feel have been scrupulously aligned with the Bosch concept.
The In-Sight 5613 vision system is equipped with a Cognex vision camera for ultra-high-speed, high-resolution (1600 x 1200) applications. It is capable of quickly and reliably reading and verifying all common code types and fonts, such as 1-D codes, 2-D Data Matrix codes and plain text. Its industrial interfaces allow for simple integration into the machine control system. With software development kits (SDK), it is possible to fully integrate the Cognex reader’s parameterization software into the system software and to deeply embed it into the user interface (HMI).
Thanks to Cognex's powerful industry-leading algorithm, seven fast-moving, challenging codes can be read with ease. The Cognex vision system can be configured to provide high read rates even in dimly lit factories, in high temperature environments and on fast-moving production lines.
Just like the printing module, the camera module can be quickly and easily set up to read the code from the front, rear or top. With the In-Sight 5613 vision system, all of the relevant test standards are met. Sanwald stresses the significance of the module: "Various projects — for instance in Saudi Arabia — have shown that the Cognex vision system provides significant value. We rely solely on absolutely reliable, high-quality components, which allow us to offer greater performance and robustness. Cognex products are perfectly adapted to our overall system."
AIT Goehner has supplied a large number of ID units in casing machined out of solid aluminum. It has developed an extremely compact premium solution, which meets Bosch Packaging Technology’s strict requirements that have been in place for years. The unit is preconfigured, meaning it is preset and calibrated, and all parameters (such as lighting) have been optimally set and can be seamlessly integrated into the machine control system. In addition to the automated procedures, data can also be manually entered using a Cognex handheld barcode reader.
AIT Goehner was also able to configure the Cognex vision system to read codes on folding cartons with a high-gloss finish. Sanwald concludes, "We have a zero-error record, without a single claim in years. Among other things, this can be attributed to the components used and our very close and excellent collaboration with AIT Goehner."
Cloud-ready for Industry 4.0
One way that data reliability is checked is via mandatory audit trails. This works to ensure that machines can achieve the best encoding quality, reliably control each individual code and attain a very high degree of efficiency. With its comprehensive solution concept, Bosch goes far beyond other track and trace providers, which principally focus on the components and machines themselves. As an Industry 4.0 solution, Bosch's CPI software for track and trace applications is already being used by customers all over the world, thanks to the high-performance Cognex components.