Embedded Micro-optic Security Features for Pharma and Other Applications

根据世界卫生组织的报告，估计世界上10%至15%的药物供应是假冒的，2017年，国际刑警组织缉获了2500万种非法和假冒药物。非法供应假冒医疗用品，特别是在公共卫生危机期间，可能是灾难性的。因此，世界各地的医疗保健当局制定了法规来打击假药的供应（例如，欧洲授权法规（EU）2016/161，美国伪造指令DSCSA或ISO标准21976：2018）。这些法规制定了一个唯一的标识符序列和一个用于验证药品包装的任何篡改的设备。为了遵守这些法规，过去几年来，全球各地已经开发了复杂的序列化和跟踪/追溯系统，为每个包装分配一个唯一的标识符。然而，篡改证据特征的可用性仅限于安全印刷的“无效”标签、全息图和定制包装密封（例如，NHS药品的不干胶标签上有横切口，在剥离时会破坏标签），但这些措施仅适用于外包装。在发展中国家，药品以“松散”形式出售（作为一条中的单个片剂），除非对每个泡罩/条包装实施假冒措施，否则上述规定意义不大！保护每一个“平板电脑”免受伪造的最佳方法是在制造过程中在每个泡罩/条形包装中嵌入一个“易于识别但无法复制”的安全功能。遗憾的是，现有的防伪特征，如全息图、菲涅耳透镜、衍射特征等，由于表面浮雕图案的效果被填满而无法嵌入。该项目旨在将目前仅用于高面额纸币的固有安全“易于识别和无法复制”、明显、动态、防伪和防篡改特征（例如，英国50英镑和100美元纸币）首次以成本效益的方式进入制药行业。Optrical已经解决了开发这种技术用于外部/非消费应用的一些关键挑战。在这个项目中，我们的目标是开发工业规模生产这种可嵌入薄膜的完整工艺，并测试符合医疗行业需求的健康安全/制药产品原型。

As per the WHO report it is estimated that 10 to 15% of the world's drug supply is counterfeit and in 2017, 25.0 million illicit and counterfeit drugs were seized by Interpol. Illicit supply of counterfeit medical items specially during a public health crisis can be catastrophic. Healthcare authorities worldwide have therefore developed regulations to counter the supply of fake drugs (e.g., European Delegated Regulation (EU) 2016/161, US falsification directive DSCSA or ISO standard 21976:2018). These regulations make a unique identifier sequence AND a device for the verification of any tampering essential for pharma packaging.To comply with these regulations, sophisticated serialisation and track/ trace systems have been developed globally over the past few years by assigning each pack a unique identifier. The availability of Tamper evidence features is however limited to security printed "Void" labels, holograms and custom package seals (e.g., NHS drugs are dispensed with self-adhesive labels with cross-cuts which break the label while peeling off), these measures however only apply to external packaging.In developing countries where medicines are sold "loose" (as individual tablets from a strip) unless the counterfeit measures are implemented on every blister/ strip pack, above regulations are of little significance! The best way of protecting every "tablet" from counterfeiting would be to embed an "easy to recognise but impossible to replicate" security feature in each blister/ strip pack during their manufacturing. Unfortunately, existing security feature like holograms, Fresnel lenses, diffractive features cannot be embedded as surface relief pattern responsible for the effect gets filled up.This project aims to bring inherently secure "easy to recognise and impossible to replicate", overt, dynamic, anti-counterfeit and tamper-evident features currently used only in high denomination currency notes (e.g., UK £50 and US $100 notes) first-time to pharma industry cost-effectively. Optrical has addressed some of the key challenges in developing this technology for external/ non-consumption applications.In this project we aim to develop the complete process for the production of such embeddable films on industrial scale and test the prototype for health safe/ pharma compliant product suiting the demands of medical industry.