Tamper evident upgrade for Track & Trace

Counterfeiting is a growing threat to patients and the pharmaceutical industry alike. To reduce or even eliminate this risk, the safety of the pharma 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.

CPS1900TE	CPS

The European Union’s Directive 2011/62/EU requires the implementation of uniquely coded, serialised 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 finalised 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 serialisation

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, serialisation is the method used for tracing pharma 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 serialisation 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 steering components. 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 optimisation in the pharma industry for quite some time. These solutions can be customised 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 serialisation 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.

Datamatrix

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 pharma industry, the Track & Trace system is suited for all current and future market requirements in the pharma, food, and cosmetic industries like the serialisation of blisters, vials, folding cartons and pallets.

In addition to printing and 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, labeller 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 serialisation of folding cartons in the pharma 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 labeller

Bosch has now introduced an upgraded CPS including a tamper evident labeller. 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 labeller 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 labelling 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.

Contact Details:
Daniel Sanwald
Bosch Packaging Technology
Tel: +49 711 811 57319
Email: [email protected]