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Serialization to meet Turkey’s requirements

A massive serialization project is completed in an impossibly tight timeframe by taking a modular approach across 24 packaging lines and by assembling a tight-knit team.

INBOUND CARTONS. As cartons visible in the lower right corner are conveyed into a case packer, a camera reads all 100 unique car
INBOUND CARTONS. As cartons visible in the lower right corner are conveyed into a case packer, a camera reads all 100 unique car

On January 1, 2012, Turkey became the first country in the world to implement comprehensive legislation regarding traceability for 100% of the medicines sold in its territory.

This article describes the installation of Antares Tracking System (ATS), an advanced traceability solution from Antares Vision, at the largest pharmaceutical manufacturing plant and the biggest distribution center in all of Turkey, both of which are owned by a major multinational pharmaceutical company. These two projects were carried out in parallel and coordinated with each other. Their size, timing of implementation, and successful results have made them a benchmark of the marketplace.

At the manufacturing plant, the scope is indeed impressive: 24 lines on which all major pharmaceutical formats (capsules, tablets, liquids, etc.) are handled. Many of the lines are highly automated, involving bundlers, shrink wrappers, case packers, robotics, and so on. But on some lines, casing and palletizing are done by hand. Production is typically carried out in two shifts, six days a week, and it leads to the production of more than 150 million units of use (i.e., primary packages such as bottles or cartons) per year.

The distribution center, on the other hand, is delivering more than 120 million units of use per year. It averages out to about 80,000 drug shipments per month, or 2,666 per day, that go to hospitals, pharmacies, clinics, etc. But spikes in the number of drug shipments are not at all uncommon, so that in some cases there might be as many as 4,000 shipments per day.

On top of all the built-in complexity and size of the projects, there was an extremely tight deadline that had to be met. The pharmaceutical company’s purchase order was placed only seven months before Turkey’s 2012 deadline took effect. This meant that the project managers at Antares had to make a number of decisions to guarantee the deployment in time. Among these was the decision to introduce as many ready-to-plug-in modules into the lines as possible. Integrated into these modules are a number of devices, including cameras, hand-held scanners, HMIs, thermal-transfer or ink-jet printers, labelers, and reject mechanisms. If each of these devices had been installed on the packaging lines separately, productivity would have been seriously curtailed. By taking the modular approach, all the devices in a module could be fully tested away from the actual customer production lines, and then the complete module could be installed in several hours.

Module categories
These ready-to-plug-in modules come in five categories that can best be seen at the bottom of Figure 1. In each category, a number of models offering varying capabilities are available. But essentially, the serialization modules are for marking unique codes on primary containers. Bundling modules are for aggregating multiple units of use in a bundle that gets a parent number; the same bundle aggregation station can be configured in one of three ways depending on whether the customer wants to have bundles scanned from the top, from the leading edge, or from the right or left side. Case packing modules are for aggregating multiple bundles with a parent number that goes on a case. And palletizing modules are for aggregating multiple cases with a parent number that goes on a pallet. These four module categories are found in the pharmaceutical company’s manufacturing plant. The packing station module, on the other hand, is more typically used for re-aggregation and decommissioning of containers in the Distribution Center when, for example, a previously created case or pallet needs to be opened in order to modify its contents prior to shipment to a customer. As for the mobile terminals shown in Figure 1, these are used throughout the customer’s operations for a variety of scanning, verifying, and data entry tasks.

Figure 1 also shows how the plant floor production lines are networked with the software systems that are essential to the ATS concept. At the top of the heap, unique codes are generated at the Plant ERP Level. When the ERP allocates a work order, the intervals of the unique codes needed for that work order are communicated to the Antares GTS software that, in turn, generates the full range of codes. Running on a remote server, the GTS is the heart of the overall ATS concept. It sends unique codes to the Antares MTS software, which is designed to control a single packaging line. MTS accesses the proper production information, including serialized codes, from GTS and configures all the devices in the packaging line. This is how thermal-transfer printers, for example, know which unique codes to print on cartons or bottles. MTS also captures production data and code status from devices on the packaging line during production and communicates it to GTS in real time so that statistics, serialized codes, and audit trails can be made accessible to the Plant ERP. Access to GTS is managed through the security levels required by the 21 CFR Part 11 rules, so only authorized operators can access it.

Communication with regulatory agencies is essential in a serialization implementation, and this is where the Antares Notification Tracking System comes in. This software is designed to manage all the communications—inbound and outbound—with the Ministry of Health or Regulatory Agencies in general. Based on a modular structure, it can easily be adapted to future requirements and regulations. According to the chosen configuration, it may be activated manually or can automatically start communications when each work order is completed.

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INTRODUCING! The Latest Trends for Life Sciences at PACK EXPO Southeast