additives | Anticounterfeiting Right: Fluorescent
dyes are used in this
Actinoptycus
cell marker from Polysecure as a supplementary security feature
regulators have instituted requirements for systems that assign a serial number to each single-unit package or device to prevent counterfeiting or diversion by tracking the item through the supply chain. In the EU, the Falsified Medicines Directive of 2011 requires barcodes on packages and new responsibilities for the supply chain. In the US, laws to prevent counterfeiting were passed in November 2013 for pharmaceutical drugs and in September 2013 for medical devices. The US Drug Supply Chain Security Act will be phased in over ten years and will eventually require item-level traceability. Some classes of medical devices are now required by the US Food and Drug Administration (FDA) to have a Unique Device Identifier (UDI) as a label on the device and the device package, and other classes will be required over the next several years. More information about the FDA’s UDI scheme can be found here. The UDI data will go into FDA’s Global Unique Device Identifica- tion Database (GUDID). Other countries also have UDI requirements, and a
Global Harmonisation Task Force led by the European Commission adopted a guidance document, the Unique Device Identification (UDI) System for Medical Devices in September 2011 to encourage an internationally coordinated approach. Innovations designed to meet these regulatory
Below: German electrical equipment producer Obo Bettermann has been using marker technology from Polyse- cure since 2013
requirements are finding use in other industries. “Demand for our supply chain solutions has exploded as the need for enterprise serialisation, track and trace, authentication and regulatory compliance expands in adjacent markets such as food and beverage, retail and consumer products,” says Bob DeJean, CEO of Systech International. The key is unique identification that can prove a product is authentic. In September 2015, Systech launched UniSecure, which generates a unique identifi- cation signature from an existing print mark or data carrier, such as a barcode. That unique signature is then stored in the Cloud, and the product can be tracked and
authenticated at any point using a mobile app. “Counterfeiters are becoming increasingly sophisti-
cated, allowing them to easily defeat current anti-coun- terfeiting technologies,” according to DeJean. “UniSe- cure capitalises on unique characteristics that occur with all printers. No two labels or printed data carriers are identical. Printing is dynamic and affected by numerous environmental and other factors that combine to produce small-scale variations or ‘noise’ in printed marks. These microscopic variations are random, unique and at a scale beyond the controllable resolution of printers – meaning they cannot be intentionally duplicated. It’s as unique as a fingerprint or a snowflake. It can’t be duplicated, so it can’t be counterfeited. You simply cannot reverse-engineer the random vibration of a production line or the humidity in a factory on a given day; it can’t be done.” UniSecure captures these microscopic variations,
detecting specific measurable patterns, and generates an inherent, covert security feature from existing print marks. Anywhere in the supply chain, a product can be scanned and matched to its “UniSignature” to prove its authenticity. Today, the technology is being used to identify labels (for example bar codes and QR codes), but it can also be used on packages such as blister packs, and possibly with an identifying mark directly on plastic or other parts such as medical devices or electronic headphones, says Darryl Brown, vice-presi- dent of global strategic marketing at Systech. He adds that advantages of the technology include immediate authentication at the inspection point using an inexpen- sive software application tool.
Additive identifiers Several types of additives can be used as covert anticounterfeiting technologies and Compounding World discussed these in some detail in its November 2014 edition. Covert technologies that can be identified in the field with inexpensive light-based devices include pigments that fluoresce under ultraviolet light and addi- tives that convert infrared to visible light. Some
52 COMPOUNDING WORLD | December 2015
www.compoundingworld.com
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