DuoVIAL LACR Modification - Visual Inspection, Process Optimisation & Quality Assurance
DuoVIAL LACR Modification - Visual Inspection, Process Optimisation & Quality Assurance
批准号:
10062481
负责人:
金额:
$1.7万
依托单位:
依托单位国家:
英国
项目类别:
Collaborative R&D
财政年份:
2023
资助国家:
英国
项目状态:
已结题
起止时间:
2023 至 --
中文摘要
DuoVIAL是一种独特的专利药品一级包装系统,能够更安全、更简单、更高效地复溶冻干生物制剂,包括疫苗和诊断试剂。该系统旨在分别保护、混合和交付产品、医疗保健专业人员、患者和地球,在材料利用方面更具成本效益、更紧凑和效率,同时由可回收的玻璃和铝材料组成。先进的激光技术现在已经发展到足以使这种解决方案在技术上可行,以及非常可扩展,以实现商业优势。在全球医疗保健领域取得最大影响的最终应用是冻干疫苗,通过冷链运输到发展中市场。产品优势同样适用于其他高价值领域,包括诊断、益生菌、伤口护理和医疗器械。这些激光技术的应用典型地已经被优化用于平面屏幕电子显示器,例如移动的电话、硅晶片。更具挑战性的是激光环形切割环(LACR)工艺的应用和优化,该工艺适用于DuoVIAL固有的复杂3D形状,具有相对显著的可变性和公差。主要目标是确保在重构配方中的单个美学圆盘的一致的“清洁-切割”激活。为了保证当前产品的质量并使DuoVIAL应用能够扩展到更具挑战性和监管的医疗保健市场,需要开发新的计量和视觉检测系统,该系统可以在线定量测量半透明的μm LACR特征,质量成本,或者说质量成本的缺乏,是浪费原材料,降低生产效率,降低产品质量和无法利用的市场机会。投资于研发以支持质量保证和优化流程,对于确保在全球市场上的竞争优势以及能够继续创新和向市场推出新产品并挑战现状至关重要。
英文摘要
DuoVIAL is a unique, patented, pharmaceutical primary packaging system, enabling safer, easier and more efficient reconstitution of lyophilised biological formulations, including vaccines and diagnostic reagents. Designed to Protect, Mix & Deliver, respectively the product, healthcare professionals, patients and the planet, the system is more cost effective, more compact and efficient in its' materials utilisation, whilst consisting of recyclable glass and aluminium materials. Advanced laser technologies have now evolved sufficiently to make this solution technically viable, as well as exceptionally scalable to enable commercial advantages. The ultimate application, achieving the greatest impact within global healthcare, is for lyophilised vaccines, shipped via the cold chain to developing markets.The product advantages can equally be applied to other high-value sectors, including Diagnostics, Probiotics, Wound Care and Medical Devices. Application of these laser technologies has typically been optimised for flat screen electronic displays, e.g. mobile phones, silicon wafers. Significantly more challenging is the application and optimisation of the Lasered Annular Cleave Ring (LACR) process applicable to DuoVIAL's inherently complex 3D form, having relatively significant variability and tolerances. The primary objective is to ensure the consistent 'clean-cleave' activation of a single aesthetic disc within the reconstituted formulation.Underpinning the quality assurance of current product and enabling DuoVIAL applications to expand into more challenging and regulated healthcare markets requires the development of New Metrology & Vision Inspection Systems, which can quantifiably measure, semi-transparent, µm LACR features, inline, on 100% of components and feedback into the high speed LACR process, resulting in optimised laser processing parameters.The cost of quality, or rather the lack thereof is, wasted raw materials, reduced production efficiencies, lower quality products and market opportunities unable to be exploited. Investing in R&D to underpin quality assurance and optimised processes is critical to ensuring competitive advantage in a global market, as well as being able to continue to innovate and introduce new products to market and challenge the status quo.
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