With the Falsified Medicines Directive coming into force in 2019, companies must re-evaluate the efficiency of their production lines to ensure they can cope with the extra demands the directive will place on them.

In July 2011, the EU adopted the Falsified Medicines Directive in a concerted effort to protect patients and consumers from falsified medicines which may contain ingredients of low quality or in the wrong doses; be deliberately and fraudulently mislabeled with respect to their identity or source; or have fake packaging, the wrong ingredients, or low levels of the active ingredients. As you might expect, falsified medicines do not pass through the usual evaluation of quality, safety, and efficacy, which is required for the EU authorization procedure. Because of this, they can be a very real health threat.

The Falsified Medicines Directive doesn’t come into force until February 2019, but EU member states are under an obligation to start implementing the measures laid out in the directive.

Implementing the Falsified Medicines Directive

For pharmaceutical manufacturers, contract packers, and distributors—all those involved in the supply chain—the new directive is momentous. Whilst there have already been requirements for certain information to be included on the packaging, the directive will require organizations to be able to proficiently handle vast amounts of extra data. That data doesn’t just need to be stored and archived, but will need to be applied to medicine packaging and read at high speeds.

Falsified medicines should not be confused with from counterfeit medicines.

• Falsified medicines are drugs that are designed to mimic real medicines.
• Counterfeit medicines are medicines that do not comply with intellectual-property rights or that infringe trademark law.

With the new directive, every individual pack of medicine must be marked with a unique, non-predictive serial number with information that can be read by people and machines. Previously, only data pertaining to the batch was required, but the onus has now changed to each and every individual container. The unique identifier must be placed in a 2D barcode and contain the product code, a serial number, the national reimbursement number (if requested by member states), the batch number, and the expiry date. Each serial number must be registered with a pan European database.

To implement these changes will clearly require considerable IT resource and expertise, including significant investment in software and data handling, which is where much of the current development work has been focused. In order to meet the legal requirements of the directive this is entirely understandable. However, as a business you also have commercial requirements to take into consideration and the directive will have an immediate negative impact here if your physical production facilities are unable to cope with these changes to data demands whilst maintaining line efficiency. You may be well on the way to cracking the IT issues, but if your labelling platform underperforms, the whole system falls apart and your profitability takes a nose dive. If you are one of the many organizations that have yet to make any serious headway in this area, then you need to act swiftly.

Reevaluating Your Production Line

When reevaluating your production line in light of the directive, there are a number of considerations to be made.

The most obvious first step is your printing and vision systems that enable a code to be applied to the label and packaging and read at speed. Not many printing systems currently in operation are expected to be able to make the transition to printing unique, non-serialized codes and at C grade and above. Not only that, but these need to be accurate and operate at high speeds (up to 350 cpm). Your choice of vision system may also have to be changed, depending on the decision of choice of data carrier method.

Even if you have the latest, state-of-the-art printing and vision systems in place, if they operate from a platform that hasn’t been designed to handle the extra requirements placed on it by the directive, it’s all in vain. That’s because at the heart of any pharmaceutical packaging production line is an automated labelling system from which all the other systems operate.

When you add any extra requirements to a labelling system, such as additional printing, it has a direct and immediate impact on line efficiency. Many existing platforms may not be able to handle these extra requirements whilst operating at their existing rate. The control systems, for example, may not be capable of coping with the new level of synchronization required. Certainly the extra printing is likely to have an impact as larger labels may be necessary or even booklet style labels—which have become increasingly popular over the past couple of years. The latter present a particular challenge due to their thickness, potentially affecting the accurate application of the label, forcing the leaflet labels to open up, and sometimes delaminating from the carrier web causing mechanical jamming and additional ongoing maintenance.

This is not to say that all labelling systems are unable to meet these new demands. Instead, manufacturers and contract packers need to look further afield than just the IT challenges presented by the directive and carefully (and closely) analyze their production line efficiency.

Each production line has its own unique challenges, whether it is the need to label a wide variety of containers and/or container sizes, particularly challenging container shapes, or the need for very high labelling speeds. However, there are certain aspects of a labelling system that are always worth investing in and that will help you meet the production challenges brought about by the new directive.

Labelling Systems: What You Need to Know

Labelling systems with a drive roller system, a short and simple label path from the reel unwinder to the applicator plate, and a straight label arm will prove more flexible and efficient. In addition, good access to the label dispensing area should also be considered. Systems that rely on the flag and wrap method of application should be avoided if at all possible. It is much better that the label dispensing is synchronized with the label application to minimize label sagging and ensure the application tolerance is kept to a minimum. A system that is available with infeed and outfeed buffer tables that will allow the rest of the production line to function during the high frequency label reel changes is ideal to maintain line efficiency.

With talk of serialization potentially resulting in up to 10 percent rejection rates in the early days of implementation, the ability to handle label rejection swiftly is essential and something that should also be given serious consideration. There are a number of ways of achieving this, but the traditional method of tracking faulty labels, applying them to a container, then rejecting the container is not ideal when dealing with such large rejection levels. It makes for a lot of additional work to rework those containers and a considerable decrease in line efficiency. Far better to remove the labels before they are applied to a container.

Should the system not receive “good signals” from the scanning devices in use (including bar code reader, missing overprint detector, OCV camera, and 2D matrix code reader), the faulty label is securely removed from the label web prior to application onto the container. These faulty labels are then transferred to a paper roll for batch reconciliation and inspection.

In Conclusion

Change is always difficult and the Falsified Medicines Directive requires a considerable change—a change in the type of data the pharmaceutical industry must provide and the means of handling and storing that data. But this isn’t just an IT issue for the industry. Yes, it’s about creating a unique code for each and every medicine container, but it’s also about physically printing and applying that code to a label whilst maintaining line efficiency. That translates as maintaining line running speeds and keeping rejection rates low—and that’s an engineering challenge!

This article can also be found in the September/October 2016 issue of Pharmaceutical Processing. 

Follow us on Twitter and Facebook for updates on the latest pharmaceutical and biopharmaceutical manufacturing news!