Serialization: Coding and Marking is Paramount to Readiness

Thierry Protas
Global Pharma Director
Videojet Technologies

This article looks at the key role coding and marking systems play in serialization and how best to achieve consistent, reliable results in order to achieve compliance with ever stringent regulations

With serialization deadlines fast approaching, a staggering amount of pharmaceutical manufacturers and contract packagers are not fully prepared to meet the stringent requirements for compliance. A number of reports have been commissioned to identify the extent of this issue, with the consensus being reached that some 30 to 40 percent of European pharma companies are not compliant with the Falsified Medicines Directive (FMD) and some 50 to 60 percent of US companies not compliant with the Drug Supply Chain Security Act (DSCSA).

This begs the question: why are approximately one third of companies not ready for these major legislative changes? There are a number of reasons, not least the fact that implementing serialization is a complex cross -functional project. Many departments must coordinate effectively, from production, IT and Marketing to Engineering and Quality, and often a steering committee is required to coordinate activities. To implement such a major change over several lines, or in many instances across multiple plants , is a slow process. This has been exacerbated by end users requesting help from track and trace providers with increasingly short deadlines - creating a bottleneck for the skilled resources available.

This does not mean that pharmaceutical manufacturers should stand still on the issue, as there are many elements that can be addressed that must be implemented regardless. One critical aspect that can be considered and implemented ahead of time is the way in which products are coded and marked on the production line - an operational aspect on which effective serialization hinges.

Coding and marking is essential

Given the complexity of a serialization project, coding and marking solutions can sometimes be assumed to be a minor player on the stage. However, although printing operations may appear on the surface to be a simple element, they are crucial to the success of a serialization project.

Without a camera-readable code, all further process steps cannot be carried out and therefore serialization fails. If a printer is not capable of producing camera-readable serialization codes reliably, invalid printed packages need be reworked manually or, worse, codes become unreadable at some point along the supply chain and the invalid packages are not allowed to be released to the market. This can have harmful consequences for patients' health and can lead to costly losses in terms of sales revenue. Proven code quality is therefore the cornerstone of every successful serialization project.

In the case of prescription drugs that fall under serialization legislation, the vast majority are packaged using folding cartons. This means that companies looking for effective coding and marking solutions must find the optimum combination of coder to carton substrate in order to achieve high quality, consistently readable codes.

Achieving the ultimate combination of code to carton

With countless variations of folding cartons available, manufacturers and contract packagers seldom use the same packaging across the board. Code quality, therefore, is mutually dependent on the coding technology, ink type and carton type. Through the identification of challenges faced by the market and the reaction of experts with practical solutions, it is now possible for pharmaceutical companies to take advantage of a joint service provided by Videojet and an independent foundation that effectively ensures the best possible combination of code to carton. This can significantly reduce the risk of issues deriving from inferior code quality, such as scanning issues and ultimately wastage as a result.

A number of factors can influence the longevity of a code, depending on how that code has been applied to the packaging material. In the pharmaceutical industry, thermal inkjet (TIJ) or laser technologies are often preferred for code application. Laser technology provides fast, permanent marks that are ideal for high throughput applications. They use virtually no consumables and offer very high uptime advantages. Thermal inkjet (TIJ) is by far the most common application in the pharmaceutical industry. It is easy to implement and maintain and offers superior print quality with clean, no -mess operation and solid-state electronics requiring no controller maintenance. TIJ printers allow for more complex coding options and the ability to print linear bar codes, alternate fonts, logos, and 2-dimensional codes such as GS1 DataMatrix and QR codes.

When evaluating code clarity it is critical to assess the resistance of colors under the influence of light - particularly sunlight with high UV levels, and also how codes cope with abrasion - either on production lines, in transit or in the pharmacy store itself. Water resistance too is a key element, as condensation can often form in pharmaceutical manufacturing environments, particularly in cold chains. All of these elements can be stringently tested under laboratory conditions to ensure the best possible combination is recommended in terms of coder technology and inks if required .

Connectivity and data management

The way in which a system interacts with the production line must also be taken firmly into consideration, alongside the need for that system to be easy to integrate and to handle serialization data effectively. The ability to purchase and implement serialization-ready solutions makes this a very straightforward process where coding and marking is concerned, and the benefits are wide ranging.

Asynchronous communications is a good example of intelligent data management and how coding and marking systems can integrate with the flow of information. Advanced software allows the printer to send unsolicited information to the line control system, providing the dual benefits of active notification of a printer event and reduced network traffic. As a result, faster notifications can be achieved, which increases potential throughput on the line.

Buffer management, too, is a key area of consideration. Serialization solutions vary in their requirements for printer memory, therefore printers must be configurable to print unbuffered - where variable data is received and printed one record at a time - and buffered, where many records are sent to the printer at once but printed only once each. When using a buffer, an unexpected line stoppage can result in unused codes unless an intelligent coding device can communicate which numbers are still available for use. This is especially relevant in countries where manufacturers may have to purchase serial numbers, enabling manufacturers to reclaim unused codes and ultimately safeguard against wastage.

Finally, by utilizing Unicode encoding technology, over 1m characters can be encoded, unlocking access to a huge range of global languages. This is vital as, given the global markets served by the pharmaceutical industry, manufacturers need to have the capability to represent an extensive number of characters across Arabic, Cyrillic and pan-Asian languages.

In all instances, ensure your coding and marking provider is able to offer full Installation Qualification (IQ) and Operational Qualification (OQ) packages. This will guarantee that the systems installed are not only set up according to your specific parameters, but are also able to deliver what is expected on an operational level.

Working with expert partners

Pharmaceutical companies who align themselves with an expert coding and marking provider can often reap the benefits of the relationships that company has with OEMs and Track & Trace providers. As coding and marking is such an integral element of serialization, there is often a reliance on these suppliers for the successful completion of projects, therefore certain elements of a project can sometimes be expedited. Videojet, through its commitment to its customers and ongoing relationships, constantly supports its partners to help them through the implementation phase, bringing to the table elements such as the testing facility for code assurance and other elements of advanced technical support. In addition, given the broad reach of pharmaceutical companies and their often global operations, the company's pharmaceutical experts - whether they be sales engineers or technical support specialists - are available worldwide to cover international serialization projects.

Pharmaceutical companies do not have a choice where compliance is concerned - outside of losing business as a result of lack of preparedness. Take steps today, engage with expert partners, and reap the rewards through operational preparedness.