Printed, verified and sealed – Bosch Anticounterfeiting solutions for future market requirements
Counterfeiting is a growing threat to patients and the pharmaceutical industry alike. Figures differ depending on the geographical region: While industrialized nations are estimated to “only” have one percent of counterfeit pharmaceuticals on the market, developing countries must fight between 10 and 50 percent. To reduce or even eliminate this risk, the safety of the pharmaceutical supply chain is of utmost importance. With its CPS Track & Trace solution, Bosch Packaging Technology has already contributed its share. This technology has now been upgraded by a Tamper Evident module.
Fake medicines which contain the wrong active ingredients or none at all can have fatal consequences for patients. Counterfeit drugs are responsible for approximately 2,000 deaths worldwide per day. For pharmaceutical manufacturers, counterfeits result in severe damage to their reputation and in high expenses. Growing sales volumes of Internet pharmacies are one reason for the rise of fake drugs. Production outsourcing and longer supply chains also provide more opportunities for counterfeit pharmaceuticals to enter the market. And still, many go undetected.
Throughout the world, initiatives and authorities are currently working on guidance and legislations for a standardized traceability and protection process of pharmaceutical products. The American Food and Drug Administration (FDA) recommends a standardized numerical identification of prescription drug packages. California’s e-Pedigree is due to be implemented in different steps between January 2015 and July 2017. It will also focus on full traceability of prescription drugs on package level.
The European Union’s Directive 2011/62/EU requires the implementation of uniquely coded, serialized packs for almost all prescription drugs. At the same time, the EU demands for a second layer of security, that is tamper-proof closures. The “unique identifier” will be determined in delegated acts, of which the first was published in November 2011. The paper has been submitted for public consultation. Stakeholders were asked to comment on the document until the end of April 2012. The adoption of the finalized document is scheduled for 2014. Its aim, amongst others, is the definition of the characteristics and technical specifications of the unique identifier.
Authentication, tamper-evidence and serialization
A multi-layer approach is obviously the safest option. The technologies available in the market can be divided into three different categories: authentication, tamper-evidence and serialization. Authentication is provided either by overt, covert or forensic methods. They are used to identify a product or package as an original and to rule out counterfeits. Tamper Evident features clearly indicate whether a package has been previously opened or tampered with. Finally, serialization is the method used for tracing pharmaceuticals throughout the supply chain. A serial number is attributed to the package and is recorded in a database, where it can be verified at any time.
Beneficial knowledge transfer between industries
A Track & Trace system is a mass serialization solution that prints a unique identifying code onto each product after it has been packaged. Tracking and tracing systems have been successfully applied in the automobile industry for many years, in particular for security-relevant parts such as brakes and navigations. At this point, Bosch Packaging Technology had a competitive advantage because the company could benefit from knowledge transfer between Bosch’s automotive field and the packaging division. Meanwhile, Bosch Packaging Technology has been implementing solutions for traceability and process optimization in the pharmaceutical industry for quite some time. These solutions can be customized to individual needs, allowing Bosch to offer a wide range of technologies from basic mark and verify systems to complex tracking and tracing for complete packaging lines.
Most flexible concept for different global requirements
The CPS (Carton Printing & Verifying System) is a stand-alone solution and the most flexible serialization system on the market. Due to its small dimensions, the CPS module can easily be incorporated into any existing or new packaging process, thereby ensuring that print quality and production speed are maintained with minimal impact on the overall production output.
With its four flexible feed and outfeed belts, the CPS system can be integrated into all upstream and downstream machines of a line. After the tracking data is printed onto the package, it is automatically verified by the camera system, which reads each printed digit (OCR/OCV). Although CPS has been developed specifically for the fast, high-quality printing of folding cartons in the pharmaceutical industry, the Track & Trace system is suited for all current and future market requirements in the pharmaceutical, food, and cosmetic industries like the serialization of blisters, vials, folding cartons and pallets. In addition to Printing & Verifying, the modular and scalable concept allows for the development of a complete system including a central control unit based on functional features such as checkweigher, labeler and Tamper Evident. In order to meet the market requirements and legal standards (such as Californian e-Pedigree, ITS Turkey and EDPS China) for marking and serialization of folding cartons in the pharmaceutical industry worldwide, CPS can be updated and equipped with various software systems any time. The software is divided into line processing and line administration. The latter serves as interface between the line and all established higher level systems.
CPS with integrated Tamper Evident labeler at Achema
At Achema 2012, Bosch displayed its upgraded CPS including a Tamper Evident labeler. A maximum of 250 cartons per minute can be printed and verified at a length of approximately 2,000 millimeters. The carton can be marked on each side both from the top and from below. Customary transparent and Tamper Evident seals can be provided at both flaps of the folding carton. The labels are usually verified by use of a camera system. With the new CPS 1900TE, verification of standard clear labels can be accomplished with a sensor. This reduces the complexity of the process and enables easier handling. In order to eliminate the customer’s need to purchase an additional machine, this system is available with a labeler or checkweigher, or with a combination of both.
The flexibility of the system also applies to the machines that are already installed. On the CPS module, several labeling and weighing options can be added at a later stage. Any existing type of CPS system can be upgraded with the Tamper Evident module, using a retrofit kit. To keep change-over times short, the system provides tool-free format change. Therefore the system can achieve high overall equipment effectiveness (OEE). The change positions are reproducible by digital displays at spindle adjustment and scales at linear adjustment. Format positions are saved in a Human Machine Interface (HMI) format list where they can be displayed or printed any time.
All over the world, guidelines and legislations are currently being developed to combat the growing threat of counterfeit medicine. Overall product traceability plays an important role in all these endeavors. With the new Tamper Evident module, Bosch upgrades its Track & Trace system to the next level. Moreover, it accomplishes the requisites of the new European Directive for a combination of traceability, Tamper Evidence and serialization.