Scalable Acoustic Microscopy for Pharmaceutical Applications

制药行业大量使用各种容器，如玻璃瓶和塑料袋来生产和分发无菌产品。这些容器的结构缺陷或缺陷可能危及药品的完整性。当在制造阶段发现时，受损的产品必须被丢弃，并导致重大的经济损失。一旦被发现，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在生产过程之前、期间和之后投入大量精力来控制容器和包装产品的质量。许多最重要的缺陷是很难用传统的方法检测出来的，比如光学检测。例子包括玻璃小瓶壁上的发际裂纹或空洞，塑料袋密封中的空洞，玻璃小瓶壁或塑料袋太薄，以及玻璃小瓶内的小玻璃颗粒与药品混合。因此，该行业正在寻找其他检测技术，可以提供与光学方法提供的正交质量信息，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基于声学显微镜的药品容器的质量控制技术的使用，这种技术对缺陷具有高灵敏度，假阳性率低，并且速度足够快，可以进行大批量生产。

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.