Revolutionary Colour Change Technology Offers Solutions for Reliable Tamperproof Codings in Pharmaceutical Sector

Datalase Ltd, the leading laser reactive colour change materials company is proving invaluable to the pharmaceutical industry, particularly in America which has seen in recent years, Congress and the Food and Drug Administration (FDA) working on several legislative measures designed to address weaknesses in the U.S. drug supply chain. This is primarily in response to the fungal meningitis outbreak linked to unsanitary conditions at a compounding pharmacy in Autumn of 2012 as well as concerns regarding counterfeit, falsified, substandard and dangerous prescription medication.The Drug Supply Chain Security Act (one of the two independent acts within The Drug Quality and Security Act) requires the FDA to create and implement a national track-and-trace system by which manufacturers must affix product identifiers (bar codes) that are either human-readable or machine-readable to each package or homogenous case of a pharmaceutical product intended to be introduced into the supply chain.

Datalase Ltd has developed a broad portfolio of products which enable laser coding of virtually any substrate. This range of unique patent protected materials are integrated into water based, solvent based, oil based or UV curable coatings and applied via a broad range of printing processes, including flexography, gravure, pad and screen.

Coding with a low energy laser results in an irreversible colour-change from white or clear to black, or clear to white, enabling printing of high contrast text, graphics, barcodes and QR codes.

The coatings can be successfully activated beneath barrier layers such as laminates, waxes or varnishes without compromising the integrity, providing a secure, indelible, tamper resistant code that is integral to the product or packaging.

With Datalase® colour change technology, high resolution track and trace codes can be added to individual products, leaflets and packaging, as well as outer cases. CO2 lasers are used at much lower energy levels than required for ablation and cause no structural damage to the substrate. As Datalase technology can create either black or white coding on any colour background there is no longer the need for the dark or white coloured block previously needed to ablate the date / batch information allowing for more “aesthetically pleasing” product packaging that complies with global standards and guidelines.

E-pedigree solutions are becoming the key choice for repeated tracking on every package, bundle, case and pallet. In fact, California e-pedigree legislation requires that 50 percent of pharmaceuticals shipped to the states starting in 2015 be tracked down to the individual bottle level.

E-pedigree consists of an electronic record of each transaction resulting in a change in ownership of the drug from the initial sale by the manufacturer through wholesalers and distributors and pharmacies until final sale to the consumer.

GS1, an independent organisation also sets standards for reliable identification of products operating in multiple business sectors including pharmaceutical over 150 countries.

Track and trace is intended to be followed throughout the medical institution to ensure that each patient receives the correct drug in the correct dosage at the correct time.

Bar codes and identification technologies in hospitals are very important. There are huge patient safety benefits drawn from positively identifying patients.” Steven Gore, Department of Health

Pharmaceutical manufacturers are addressing track and trace by implementing serialisation solutions that affix a unique and traceable serial number to every package, bundle, case and pallet. This serial number is read many times by both human and robotic interaction as the product moves from manufacturer to consumer and, each time, an entry is made in a database to document the chain of custody. This means that the coding system used must be of good quality enabling it to be read by a variety of different scanners. It needs to be durable and not easily smudged or wiped off by detergents or alcohol based cleaners often used in medical establishments.

Recently one of the global leaders in healthcare products had an issue with one of their injectable lines. They were using hot stamp to place lot and expiration information on a poly label. The problem was the hot stamp method of coding did not provide enough flexibility to easily change variable information that was specific to each batch. There was also a limited amount of space on the label to code all the variable data needed to print and the label was not robust enough to withstand the solvents the medical professionals come in contact with which lead to smudged, unreadable codes.

Datalase provided a solution in the form of a UV cured Datalase Prime ink spot, flexo printed on the injectable poly label along with a 10w scanning laser. The laser activating the DataLase colour change technology provided the flexibility of printing high quality variable information in a small space and because the DataLase ink was beneath a laminate structure, the black code was resistant to rub and solvents thus providing reliable, secure and tamperproof coding.

Not only suitable for track and trace applications, QR coding offers E-marketing opportunities for targeting and customer profiling.

Colour change technology from Datalase Ltd also provides variable template turning capability which is particularly interesting to pharmaceutical and food companies who, in some cases, produce many variables on a standard label. For example, different dosage or nutritional values on the same type of product. These labels can now be run from one standard template and the variable information printed at late stage reducing the amount of stock keeping units (SKU’s) and delivering a substantial cost and time saving. This also provides the flexibility for late stage marketing offers and provides an easy route to customer interaction.

Laser technology provides a clean environment with no risk of ink spills, no need for high extraction and reduced down time.

Russell Hill, the Technical Innovation Manager from major US label manufacturer 3C Packaging states, “We have been working with Datalase for several years and are impressed by the capabilities of this technology. We have developed our own systematic way of printing Datalase coating to ensure A & B rated OCR vision system (optical character registration) and can confidently say that barcode and QR codes printed by us using Datalase technology will be easily read. This system provides the best solution for brand owners, marketing and the environment”

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For more information contact Datalase Ltd             T: +44(0)151 4239360

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