A Virtual Future

Packaging and labelling play a vital role in the pharmaceutical industry. Labelling provides pharmaceutical companies the opportunity to incorporate anticounterfeiting and brand identification measures on products. It is also a necessity since FDA and the EU introduced legislation governing pharmaceutical labelling.

The increasing importance of pharmaceutical labelling has forced companies to look for suitable label materials that feature all of the information required by regulation, and include branding and anticounterfeiting measures. In addition, the labels must not take up too much space on the packaging and, most importantly, not be expensive.

Labelling legislation

February 2004 saw FDA launch the final version of rule 21 CFR Parts 201, 606 and 610. These regulations aim to reduce the number of medication errors in hospitals and healthcare environments through stricter pharmaceutical packaging and labelling control.

The rule, part 201, requires that human drug and biological product labels include linear barcodes containing the national drug code (NDC) number. Additionally, hospitals are required to use medication administrations recording (MAR) systems (patient drug regimen in a computerized database) so that healthcare professionals can verify that the right drug, dose and route of administration is given to the right patient at the right time. The NDC number also enables the industry to track the drug throughout the manufacturing process.

National drug code

In addition, EU Directive 2001/20/EC, which was implemented in May 2004, applies to the way in which clinical trials involving human subjects are conducted within the European Community. One of its objectives is to impose regulations on the labelling of clinical trials supplies. These rules require investigational products to be labelled with increasing amounts of information such as

• sponsor, clinical research organization (CRO) or investigator contact details

• pharmaceutical dosage form

• quantity of dosage units

• Route of administration

• the name/identifier, strength/potency and batch/code number in open trials.

Adding to the ruling's complexity, the labelled information should be printed in the language of the country where the product is to be used. Furthermore, the information should appear on both the immediate container (such as a blister pack) and outer packaging (e.g., outer carton). The need to include so much information on a label presents a significant challenge to the pharmaceutical company, both in terms of label size and practicality, and cost.

Labelling solutions

Various types of labels have been employed to attempt to address the challenges outlined above. Traditionally, pressure sensitive adhesive labels have been the preferred choice, however these require a time-consuming process of printing and then being applied (often manually) to the packaging. This presents the problem of continuous stop/starting on the production line, which, in turn, has cost implications.

Key points

Print-and-apply. The combination of information levels and limited packaging space on which a label is applied means that print-and-apply labels are starting to fall short. The label can also be peeled off the packaging at any stage during production.

Counterfeiters use a wide range of methods to get their products into the supply chain. One of the principle ways is by removing the labelling and replacing it with false data; for example, expired drugs are relabelled and resold. Print-and-apply labels also fall short where 'parallel packaging' occurs — when drugs destined for one country are repackaged to be sold in another and so need to be in a different language. Counterfeiters tamper with the labelling, often by complete replacement, and sell on at a much higher price than would be the case in the original destination country.

One solution would be to create a labelling system by which the destination language and all variable data are indelibly formed directly within the packaging material. More information could be incorporated with this method without being confined to a small label.

Colour change technology. Colour change technology is a novel solution that can be used in a wide range of applications, including 'virtual' labelling. The technique eradicates the need to use adhesive labels on inner and outer pack materials by incorporating a laser responsive coating (a 'virtual label') into packaging materials such as cartons, cases and overwraps.

Integrating high quality virtual labels into the base material or printing process is simple. The colour change chemistry is incorporated into, or coated onto, the substrate during its manufacture. Alternatively, the converter can introduce the laser responsive chemistry by either a patch printing or flood coating process, as the solution is compatible with the majority of printing and coating processes. The resulting laser responsive surface becomes an integral part of the packaging and, unlike conventional labels, will not peel or fall off. Then, on the packaging line high reliability, low power CO₂ lasers rapidly produce images such as barcodes, graphics and instructions for use (often in multiple languages) directly onto the pretreated surface.

Information can be spread over a larger area because the virtual label is integrated into the design of the packaging. Manufacturers can, therefore, include more text, barcodes and graphics on the packaging. Additionally, the resultant image can be embedded beneath an overlaminate or shrinkfilm making it resistant to abrasion and tamperproof, thereby providing an extra defence against counterfeiters.

Virtual labels eliminate the need for troublesome transfer ribbons or inkjet fluids, which are inherent with traditional labelling technologies. Colour change technology makes it possible to create a label that incorporates a wide range of information and encoding capabilities, and remains secure throughout the life cycle of the package — this is not viable with conventional adhesive labels. By removing the need for the additional consumables, virtual labels offer manufacturers considerable cost savings.

The virtual labelling process uses very low power laser light at high speed, which provides a number of substantial advantages compared with other commercially available methods, including

• low emission

• high throughput

• improved quality

• increased productivity

• compliance with environmental regulations.

The contrast and image clarity benefit from the laser imaging process, as an extremely small spot size laser beam is used. If the virtual label requires a barcode for product tracking, then the fine laser beam provides a precise code with no line-width 'spreading'. A distinguishing feature of this technology is the ability to produce extremely high-resolution images.

Virtual labelling provides a means of information printing that uses a change of colour in the substrate on the application of laser energy on which the printing is to appear, rather than transfer ribbons or fluids. The chemistry offers a viable alternative to traditional printing and labelling methods by abolishing the problems associated with the apparatus (i.e., ribbons, fluids, solvents, maintenance, unreliability etc.), which are particularly undesirable for sensitive pharmaceutical products.

Applications

A German diagnostic device company is moving beyond production trials to implementation with a virtual labelling application. Switching to virtual labelling replaces thermal-transfer print-and-apply labels. The company employs two levels of virtual labelling — one for inner blister packs containing syringes or ampoules, and another on secondary cartons. The blisters are flood-coated with the laser responsive material and laser-marked with alphanumeric product name, expiration data, and traceability information. This is done immediately after sealing the blisters.

The blister packs are then packed into a 58 cm² paperboard carton with product identification and barcode printed by the colour change technique while the carton is stationary. Information that was printed on a label is now coded directly on the carton into a white area that matches the previous label's dimensions.

Because the new technique eliminates consumables, the customer can enjoy significant overall cost savings.

Conclusion

In an industry that faces increasing cost pressures and regulatory compliance, pharmaceutical companies have been striving for a new labelling technique that satisfies all requirements. Virtual labelling is a viable solution to today's challenges, offering a system that deters counterfeiters, increases productivity, is cheaper than traditional technologies and enables a high volume of data to be displayed clearly on the packaging.

Andrew Jackson is applications marketing manager at Sherwood Technology Ltd, UK.