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Together with Other Partners, Turck Korea has Implemented a Serialization and Identification System for Pharmaceutical Products

Use Cases | von Hans Turck | 27. Juni 2016
The RFID Bulk Reading Machine can identify up to 500 individual tags inside the boxes simultaneously. The RFID Bulk Reading Machine can identify up to 500 individual tags inside the boxes simultaneously. BILD: Turck

Together with other partners, Turck Korea has implemented a complete system – from the production plant right through to the dispatch warehouse

Counterfeit pharmaceutical products present health authorities and competition regulators with a great number of problems. For this reason, in future the entire production and sales chain of pharmaceutical products will be made fully transparent. Together with other partners, Turck Korea introduced this process, known as serialization, for pharmaceutical manufacturer, Daewon Pharm Co. Ltd. The cloud-based solution records the drugs from the production stage right through to storage in the dispatch warehouse.

Written by Frank Rohn, Vice President, sales process automation at Turck

Frank RohnFrank Rohn According to the WHO, one percent of all pharmaceutical products in Western Europe are counterfeit. Whilst this may not sound too dramatic, it means that in Germany alone around seven million out of 700 million drug packages are counterfeit. The situation is even more serious worldwide. Depending on the country, the proportion of counterfeit medicine varies from nine to 41 percent. This is a lucrative business for counterfeiters. A profit margin of up to 700 percent is an attractive proposition for criminals.

A worldwide search is currently in progress for ways to put a stop to the counterfeiting of pharmaceutical products. Besides the financial loss (€50 billion a year in Germany alone), counterfeit drugs can seriously damage the health of consumers. The aim of the search is to implement an end-to-end serialization of pharmaceutical products within the large economic area. Serialization means here the identification of all salable packs of medicine using serial numbers across the entire production chain. To automate the identification of the serial numbers, these are not only printed in plain text, but are also affixed as barcodes, data matrix, or RFID codes depending on the packaging unit.

Serialization in the EU by 2019

This complete serialization has to be introduced in the EU by 2019. It must be possible to identify all drug packaging without any uncertainty. Furthermore, this has to be possible at any point along the manufacturing and distribution chain. As soon as the medicine is placed in the first packaging unit (primary packaging), such as a blister pack, it is assigned to a manufacturer and a batch. This identification must also be possible in larger packaging units such as for wholesalers or logistics providers, as well as finally in the drug store.

Each packaging unit must be identifiable – from the blister and the conventional drug package (secondary packaging) which can be bought in the drug store, to bundles of several packages (tertiary packaging), right up to the complete carton or even an entire pallet of pharmaceutical products. This kind of system is relatively complex. Several interfaces between the different systems are required, and all read and write devices must be able to access the same database – in real time. For this reason, the EU is supposedly postponing the introduction date of mandatory serialization.

The pilot project initially comprised the development and construction of a total of ten bulk reading Machines and seven labeling machines.The pilot project initially comprised the development and construction of a total of ten bulk reading Machines and seven labeling machines.

Serialization pilot project

Turck Korea, together with other partners, have developed a solution for Daewon Pharm, the South Korean pharmaceutical manufacturer, which could also set a precedent in Europe. The pilot project is an excellent example of automated serialization for pharmaceutical products. This involves a lot more than the actual identification with barcodes or RFID tags: the data not only has to be available in the system at individual points but also over a network, which in the final expansion stage runs through the entire production and distribution chain. Serialization here is implemented right up to the storing of the drugs in the Daewon warehouse. In a final expansion stage, it is also possible for wholesalers and each individual drug store to be incorporated in the system and the data cloud. Besides Turck, strong partners were involved in the pilot project, who offered their experience with the parent IT infrastructure and the data connection to ERP and MES systems.

The customer

Daewon Pharm Co. Ltd. was founded as far back as 1958. Today the company has a number of stateof- the-art production plants where it manufactures around 150 different products. With around 700 employees, Daewon has a turnover of approximately 137 million Euros.

The project partners

The main contract partner in the project was the biotechnology and pharmaceutical company Hamni, which made a major contribution in terms of knowhow and experience gained from the implementation of its own RFID system. Using RFID, Hamni revolutionized its distribution system, which also enabled an expansion of the company in the US market. Its subsidiary Hamni IT in particular had already gained relevant experience through the “Keidas” supply chain management system, which it had developed itself and which provided a basis for the Daewon pilot project. The software can record all production management operations – from the start of production, to packaging, shipment, and goods reception, right through to the sale of products. All data for this is not stored locally but is kept available and up-to-date via a data cloud for all members at every point in the production and distribution chain.

Other project partners were involved here. South Korea Telecom (SKT) provided the data cloud. The company is certified with the ISO 27001 IT security standard, and guarantees that the cloud services are reliable as well as manipulation proof and failsafe. Agathon, the consultancy firm, supported the project partners in the validation of the computer system.

Turck Korea completed the automation part of the project, in which the company developed and built complete machines which print, affix, check and read the necessary codes and tags on different packaging units. These machines communicate in turn with the Keidas system, where they provide information on the production and packaging process.

Integrated labeling machine for RFID/2D serialization

A labeling machine that is integrated into the production process is provided at the beginning of production in the Daewon plants. Here the drug packages are provided with an RFID tag on which is written the appropriate serial number. The boxes are also provided with a 2D code and plain text print containing the same information. The correct operation of the RFID tags is checked directly in the machine and tags are discarded if necessary. The print quality of the data matrix codes and the OCR marking is also checked. Turck developed a RFID bulk reading machine for the project and provided it with some products from its own portfolio: besides the inductive sensors, cordsets, power supply units, VT250-HMI controllers and BL20 fieldbus gateways, the installation also included some products from Banner Engineering, Turck‘s optical sensor partner, such as photoelectric sensors and emergency buttons, as well as cameras and vision sensors.

Hamni/Turck RFID bulk reading machine

Before they are stored, the individual packs of medicine have to be combined into larger units, but still must remain identifiable in order to ensure the end-to-end tracing of the individual packs. For this Turck has developed and built the RFID bulk reading machine in collaboration with Hamni. It uses RFID to identify all packs contained in a carton even when it is closed. RFID provides a major benefit compared to barcode technology here: in bulk reading mode, RFID can read the entire contents of a carton – up to 500 individual tags. For this the packer simply places the carton into the opening of the machine. The read operation starts automatically. A total of ten RFID antennas detect all the tags in the carton. One antenna moves inside the machine in order to exclude any duplicate readings or unread packs. Following the identification stage, the machine initiates the printing of a barcode and serial number label, which is stuck onto the outside of the carton for further identification and shipment.

Turck built both a manual version of the machine, in which employees place the cartons in the opening, as well as a conveyor belt version, in which the cartons move into the machine on a conveyor and are transported further for palletizing after identification. The compact machine is just 1.6 meters high and is very mobile.

Identification by fork lift truck

The identification of multiple cartons on a pallet is then implemented using RFID tags. The data is allocated completely automatically. All read devices are connected to computers via Ethernet connections, which can always access the real-time data of the pharmaceutical products via the central data cloud. This end-to-end identification goes right through to the shipment to the drug store and the sale of the products to the customer.

The strength of the solution is based on the combination of the latest RFID technology with the powerful optical sensor and camera technology. Both technologies, optical identification via barcode and data matrix codes or OCR text recognition and RFID, have their strengths. The performance and process reliability of the system solution for Daewon Pharma is based on the clever combination of both identification systems. The centralization of all data in one place excludes the possibility of data synchronization errors and the other disadvantages of an asynchronous solution.

The identification

If you compare the costs of RFID and data matrix identification superficially, RFID is around ten times more expensive if you only take the costs for tags and label printing into consideration.

But, as the pilot project has clearly proven, RFID is the cheaper version with respect to an overall view of all costs (total cost of ownership), including labor costs, and equipment. The benefits of RFID are clearly in the speed and reliability of the processes: identification is not only faster, but as many as 500 tags can be read simultaneously without having to unpack the carton – optically based processes are only able to read a maximum of 200 tags simultaneously and require line of sight in all cases. However, as most recipients at the end of a logistics chain, i.e. the drug stores, do not have an RFID reading device, optical identification is used as well.

Customers benefit from project experience

The pilot project enabled Turck to gain considerable experience in the serialization of pharmaceutical products. The know-how acquired with fully automated machines in particular, and with regard to the specific requirements of the pharmaceutical sector, as well as the handling of projects of this magnitude in collaboration with several partners is of particular value to both Turck and its customers. Ten subsequent projects followed in Korea alone, and discussions are in progress concerning similar projects in Europe, America and Asia.

Letzte Änderung am Dienstag, 25 Oktober 2016 16:01
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