Scalable Acoustic Microscopy for Pharmaceutical Applications

适用于制药应用的可扩展声学显微镜

• 批准号: 522773-2017
• 负责人: Sylvestre, Julien
• 金额: $ 1.82万
• 依托单位: Université de Sherbrooke
• 依托单位国家: 加拿大
• 项目类别: Engage Grants Program
• 财政年份: 2017
• 资助国家: 加拿大
• 起止时间: 2017-01-01 至 2018-12-31
• 项目状态: 已结题
• 来源: https://www.nserc-crsng.gc.ca/ase-oro/Details-Detailles_eng.asp?id=639529
• 关键词: Scalable; Acoustic; Microscopy; Pharmaceutical; Applications

Various containers, such as glass vials and plastic bags, are used in large quantities by the pharmaceuticalindustry to manufacture and distribute sterile products. Structural weaknesses or defects in these containers cancompromise the integrity of the pharmaceutical products. When detected during the manufacturing phase,compromised products have to be discarded and result in significant monetary losses. When they goundetected, compromised products jeopardize patient safety. As a result, manufacturers of pharmaceuticalproducts and suppliers of glass or plastic containers invest significant efforts to control the quality of containersand packaged products, before, during and after the manufacturing process. Many of the most important classesof defects are difficult to detect with conventional methods, such as optical inspection. Examples includehairline cracks or voids in the walls of glass vials, voids in plastic bag seals, glass vial walls or plastic bags thatare too thin, and small glass particles mixed with the pharmaceutical product inside glass vials. The industry istherefore looking for other inspection technologies that could provide quality information which is orthogonalto what is provided by optical methods, to better detect hard-to-find defects. The main research challenges to beaddressed through the project therefore include the use of quality control technologies for pharmaceuticalcontainers based on acoustic microscopy, which have high sensitivity to defects, low false positive rates, andwhich are fast enough for high-volume manufacturing.

制药行业大量使用玻璃瓶和塑料袋等各种容器来制造和分销无菌产品。这些容器的结构弱点或缺陷可能会损害药品的完整性。当在制造阶段发现问题时，受损产品必须被丢弃，并导致重大的金钱损失。当它们未被检测到时，受损产品就会危及患者的安全。因此，药品制造商和玻璃或塑料容器供应商投入大量精力来控制制造过程之前、期间和之后的容器和包装产品的质量。许多最重要的缺陷类别很难用传统方法（例如光学检查）检测到。例子包括玻璃小瓶壁上的细裂纹或空隙、塑料袋密封件中的空隙、玻璃小瓶壁或太薄的塑料袋，以及玻璃小瓶内与药品混合的小玻璃颗粒。因此，业界正在寻找其他检测技术，能够提供与光学方法提供的信息正交的质量信息，以更好地检测难以发现的缺陷。因此，该项目要解决的主要研究挑战包括使用基于声学显微镜的药物容器质量控制技术，该技术对缺陷具有高敏感性，误报率低，并且速度足够快，适合大批量生产。