As the need to limit medication errors and tackle counterfeiters becomes more complex, so do the tools required to protect the drugs in question. Control and Tjoapack outline why their technology addresses this
The pharmaceutical industry is facing one of its toughest challenges yet. Pressure from government bodies, industry and the public to improve the integrity of the medicines supply chain - driven by a desire to tackle the escalating threats counterfeit medicines pose - is prompting businesses to seek out more robust systems that offer greater value to both the manufacturer and the end user.
It is not just a matter of attaching a code to a pack or box of pharmaceutical medicines but ensuring that the movement of drugs through the supply chain can be traced from the point of manufacture to the point of use.
The European Federation of Pharmaceutical Industries and Association (EFPIA) is one of a number of bodies to outline recommendations aimed at improving track and trace technology. It has stated that the integrity of the current medicines supply chain continues to fracture due to the different coding solutions being implemented in the different EU member states.1 In response to this situation, EFPIA has called for a 2-D Data Matrix bar code system to be introduced across the European supply chain.2
new level of coding
Data Matrix, like radio-frequency identification (RFID) technology, acts as a data carrier system but has the advantage of being smaller and having greater data capacity. It is this Data Matrix technology that has been behind the development of a new track and trace system created through a collaboration between the UK-based Domino Group, its German division called Control, and Dutch pharmaceutical packaging specialist Tjoapack.
Control's expertise lies in developing computer software that manages the packing and coding process and which is currently in operation in more than 70 pharmaceutical production lines. This, when combined with Domino Printing Sciences" knowledge of coding and marking technologies and Tjoapack's business as a contract packager of solid oral drugs, has led to the development of a system that aims to meet the serialisation and legislative needs of the pharmaceutical industry.
The collaborative team claims to have the world's first truly integrated pharmaceutical line with six levels of packaging identification. The coding and marking system provides mass serialisation and aggregation all the way from blister strip and pouch level to carton, case and pallets.
the unit dose
Once a pharmaceutical item has been fed through the production chain, a unique Data Matrix code and human readable text is printed onto each blister pouch - allowing manufacturers to specify greater levels of product information.
Currently, the human readable text or alpha numeric code, as it is also known, has been tested and can contain up to four lines of information. Data includes the expiry date, lot number, the Global Trade Item Number (GTIN), the National Pharmaceutical Product Code and unique serial number.
While there is no current legal requirement to code individual doses, according to Tjoapack ceo Dr Eric Tjoa, being able to print and record to this standard helps to provide greater product authentication at each level in the supply chain.
These codes play their part in authenticating and validating the movement of the pharmaceutical drug along the supply chain. The individual Data Matrix codes on the blisterpacks are read, checked for content and the information is recorded onto a database, once it has been verified. Multiple reads can be pulled off the computer, analysed, checked and either passed or rejected at line speed on individual blister pouches.
This information can then be aggregated to item level pack, whether a single blister or multiple blisters are being inserted. Any unread, misread or unknown codes will be rejected and that information recorded in line with pharmaceutical regulation compliance. There is also a synchronisation process that can be used to detect any type of manual intervention that has occured to the system.
carton identification
Before blister pouches are packed, their information must be verified. A carton code is generated by Control software and then printed using Domino's S200 laser, to form a Data Matrix and human readable text. The carton and blister code aggregates are recorded and at that stage cartons with faulty codes are rejected.
Verification of the carton's content is also achieved by check weighing. Product that does not meet the required specification is rejected. The rest are stacked, bundled and the contents of all carton codes are read and checked against the aggregation of bundles to cases prior to being boxed. Cartons that have been taken off the line can be read also using a handheld scanner.
At the end of the production line when products are boxed, case labels are generated; hybrid labels that use RFID, EAN 128 barcodes, human readable text or Data Matrix can be used. At this stage, all RFID and bar codes on case labels are read and checked. Continuous case label scanning is also implemented to identify any manual intervention that could have taken place during the packing process. At this stage packing of the cartons will be supervised.
Final checks are conducted at the pallet identification stage, where the contents of all RFID case labels are read and checked during the process of stretch-wrapping the boxes. It is important that the information here is consistent with the load on the pallet.
flexibility
One of the benefits of this new track and trace system is its flexibility. The Control software is a client-server application with local decision-making held at the client and with enterprise business logic held at the server level. The agnostic nature of Control's hardware technology means that it can be retrofitted to onto other existing lines.
The system has been designed in such a way that there is seamless integration with existing software systems, allowing ERP, MES and Warehouse Management Systems (WMS) to be used as well. These features allow the technology to dovetail with a range of systems used by the pharmaceutical manufacturing community to improve on supply chain transparency and minimise potential drug errors. The company is currently developing a further interface to SAP AII, which will give businesses the capability to integrate all automated communication and sensing devices.
Domino, Control and Tjoapack began their partnership under the EU Bridge WP6 Track and Trace trial two-and-a- half years ago. Its aim, as part of the initiative, was to address those very challenges associated with medication errors, the threat of counterfeit medicines, patient safety and supply chain inefficiency.
A key aspect of the project was its ability to deal with mass serialisation - the process of tracking and tracing the product using four items of data: product code, the serial number, the batch number and the expiry date. This is something that has been realised in the development of the new system.
partnership
It is from there that the MeditraQ Centre of Excellence in Boskoop in the Netherlands was established and the track and trace system developed to feature the new Control software.
Its existence gives all three companies involved the opportunity to showcase their track and trace technology in a working pharmaceutical packaging plant that is fully operational and validated to global and national standards. The whole system has been retrofitted onto an existing production line that runs daily batches of product for some of the major pharmaceutical companies within Tjoapack's existing customers base. As Tjoa puts it: "The Centre of Excellence is a knowledge centre where ideas can be tested in a real production environment."
But the true test of its success will be in the implementation of this technology and its ability to respond to the ever-growing challenges facing the pharmaceutical industry.
References
1. The European Federation of Pharmaceutical Industries and Association, Position paper: Identification and Coding of Pharmaceutical Products in Europe, November 2006; 2:1-5
2. The European Federation of Pharmaceutical Industries and Association, Position paper: Identification and Coding of Pharmaceutical Products in Europe, November 2006; 4:1-5