Embedded Micro-optic Security Features for Pharma and Other Applications

根据世卫组织的报告，据估计，全球10%至15%的药品供应是假药，2017年，国际刑警组织查获了2500万枚非法和假药。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打击假药供应的法规(例如，欧洲授权条例(EU)2016年/161号、美国造假指令DSCSA或国际标准化组织标准21976：2018年)。这些规定使唯一的标识序列和用于验证任何篡改对药品包装至关重要的设备。为了遵守这些规定，在过去几年中，通过为每个包装分配唯一的标识，全球开发了复杂的序列化和跟踪/跟踪系统。然而，篡改证据功能的可用性仅限于安全打印的“无效”标签、全息图和定制包装封条(例如，NHS药品免去了带有横切的自动粘合标签，在剥离时会破坏标签)，然而，这些措施仅适用于外包装。在发展中国家，药品销售“松散”(作为单独的片剂从条上)，除非在每个泡罩/条包装上实施假冒措施，否则上述法规意义不大！保护每一台“平板电脑”免受假冒的最好方法是在制造过程中在每个泡罩/条形包装中嵌入一个“易于识别但不可能复制”的安全功能。不幸的是，现有的安全特征，如全息图，菲涅尔透镜，衍射特征无法嵌入负责效果的表面浮雕图案被填充。该项目旨在将固有的安全、公开、动态、防伪和明显篡改的特征首次引入制药业，这些特征目前仅用于高面额纸币(例如英国GB 50和美国100美元纸币)。Optrical已经解决了为外部/非消费应用开发这项技术的一些关键挑战。在这个项目中，我们的目标是开发工业规模的此类可嵌入薄膜的完整生产工艺，并测试符合医疗行业需求的健康安全/药物兼容产品的原型。

As per the WHO report it is estimated that 10 to 15% of the world's drug supply is counterfeit and in 2017, 25million 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.