Labelling to meet FMD needs

Innovative label formats are increasingly used to deliver information and provide protection through the use of security technologies and tamper-evident features. Malcolm Waugh, Group Commercial Director, Essentra, explains the multiple benefits that labels can deliver

Brand protection, anti-counterfeit or tamper evidence can be achieved in many ways

Stringent regulation ensures that patients are given comprehensive information about the medicines they are taking. This can require the provision of significant amounts of text, which has traditionally been produced on leaflets, in some cases requiring secondary packaging to ensure that these are carried with the medicine. In certain circumstances, leaflet labels are replacing a classic leaflet where a manufacturer can pack the product without a carton. Multiple innovative label formats for this type of product include LabelXtra and Peel and Read labels.

LabelXtra incorporates an information leaflet, secured to the printed base label by laminating. Labels can be printed with up to eight colours plus Braille to match branding and artwork requirements. Peel and Read is a standard label with multiple layers that can be printed on either side. This can consist of up to three layers and is able to incorporate a large quantity of information that would usually require the inclusion of a leaflet. Labels are available on either a paper or polypropylene substrate, with a deadened lift area for opening. They can be sequentially numbered on the reverse of the liner and can also carry Braille on the top layer to further boost the functionality.

LabelXtra leaflet label secures a leaflet to the label via lamination

Tamper Evident labels play an important role in ensuring product security. Special seals can provide a clear indication that tampering has occurred and can protect both the end-user and the manufacturer from potentially harmful interference. There are several ways to incorporate effective tamper evidence on labels according to the features required. Security slits and clever die-cutting ensure destruction of the label upon any attempts to remove it and provide robust tamper evidence.

Specially developed frangible materials can be used that break up immediately on attempted removal, making it obvious where tampering has been attempted. Void release labels have an adhesive construction that releases a portion of the adhesive layer onto the carrier in the form of a void message, pattern or total release of the substrate from the adhesive layer. The nature of the label construction makes it impossible to re-seal the labels without clear evidence of tampering being apparent.

Hidden Hologram labels work in a similar manner to void release labels, revealing a hologram that gives clear evidence of any attempts at removal or opening and adds an extra layer of authentication. The holographic feature remains hidden until removal is attempted and is impossible to replace or re-use once removed. These labels are available in an ultra-clear format or as printed labels with a security print option and are perfect for use as a tamper evident seal for cartons.

Tamper evident resealable labels combine tamper evidence with the ability to reclose the packaging and keep the contents fresh. Ease of use is designed into these labels, with finger lift areas for simple removal and an adhesive designed to stick securely time after time. Labels can be supplied in a variety of shapes, sizes and materials to suit each pack type, with top quality printing enabling complicated designs and images to be carried on labels.

Holographic tapes, foils and labels offer a range of different security features

Delivering tamper evidence combined with labels’ ability to carry authentication technologies make them an ideal carrier not just to meet the demands of legislation, such as the Falsified Medicines Directive, but also to deliver anticounterfeit solutions for brand owners. From an authentication perspective, labels can offer a wide range of opportunities that other packaging components cannot. Advances in materials, printing and process technology enable the development of a wide range of label types, which can be used to authenticate pharma products.

With a wide variety of fine design techniques created by specialist security software, Essentra can build bespoke overt and covert security solutions to banknote standards into brand protection label requirements. Overt or first level authentication of security print features can be made by the consumer or agent without equipment; however, further detail can be examined under magnification, either in the field with suitable viewing devices or in the laboratory.

Due to the need for specialist equipment, materials and technical knowledge, these origination techniques are extremely difficult to copy. Furthermore, access to inks specifically formulated for this technology is required and must be used in conjunction with skilled printing techniques to produce print high in definition and with reliable quality. Solutions include: Microtext and logo print, engraved images, relief images, warp grids, variable line width, guilloche designs, crystal patterns and special rasters.

Essentra’s range of tamper evident seals provide a clear indication that tampering has occurred

Essentra has been supplying secure hologram labels to a number of customers for many years for brand protection purposes. Secure holograms are supplied on a variety of self-adhesive substrates and are available as either stock or bespoke holographic designs. To further enhance the security of the hologram a variety of features can be included in the design. There are three levels of security features and the hologram can be built up using a combination of these features depending on the level of security required:

  • Public Recognition Features, which can be seen by anyone viewing the hologram.
  • Inspector or trained user features, which are not instantly recognisable but can be identified by somebody with knowledge of holography or widely available equipment.
  • Forensic Features, which require specialist equipment to identify them.

These features can be deployed individually or in combination to create a highly secure solution. Security inks incorporated into labels and other packaging products enable a range of security printed features to be provided. The range of inks includes UV fluorescent inks, colour shift inks, infra-red inks and Essentra’s Patron taggant system for a layered security approach.

The images printed with a UV ink are visible only under an ultra violet (UV) light. Images and text can be printed in a variety of UV colours including blue, yellow, green and red. Manufacturers including Essentra have access to UV inks that respond to different frequencies of UV light. Depending on the formulation of the ink, investigators will need to use either a long- or short-wave UV light. More complex designs can be further validated using a magnifying lens or microscope to examine the detailed features and sophisticated print.

Colour shift inks appear as two or more distinct colours when viewed from different viewing angles. Such features can be seen on many banknotes and are easily verified by tilting the item carrying the colour-shift in order that the different colours can be seen; for example, red once tilted becomes gold. Different colour combinations are available and both strong opaque and subtle transparent effects can be created to complement the existing design of the document or product.

IRWatermark is a special infra-red ink that is designed to be extremely secure. Unlike many other infra-red inks, this one is invisible to the naked eye under normal lighting conditions, so completely covert, making it easy to overlook during forgery attempts. The ink requires a bespoke reader to detect and view it, as it does not emit light in the visible spectrum.

The Patron taggant authentication solution provides customers with a covert security system for on-site or in-field applications. The technology is able reliably to identify and distinguish genuine products from counterfeits. At the heart of the Patron system is a transparent taggant ink that can, as an option, be chemically engineered to provide a unique signature. The technology can reliably identify and distinguish genuine products from counterfeits. This sophisticated marker is for all practical purposes undetectable and can only be authenticated using a bespoke Patron reading device.

Essentra’s experienced technical support ensures the right adhesive is selected for permanence, repositionability and tamper evidence. The company meets specific customer application needs with specialist processes such as Braille printing, extra security slitting and over-laminating to prevent product contamination and the innovative label formats offer quick and simple implementation on existing packaging lines with high production speeds.

IRWatermark is a registered trademark of Essentra.

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