乐动体育登录乔迪实验室是世界领先的authoriti之一es in the field of medical device analytical chemistry and laboratory testing. It is a deceptively broad field of analysis, comprising routine physical testing and complex product deformulation, alongside contamination and failure investigations. Each of these analytical requirements can be subdivided into varying technological branches and areas of application. At Jordi Labs, we must work closely with clients to understand the unique manufacturing, storage, and operating conditions of distinct products to provide a reliable medical device analytical chemistry service with both quantitative and qualitative results.
我们对医疗装置分析化学的整体方法最好用我们的可萃取和浸润物（E＆L）测试的方法来体现。这是一个多步骤的过程，在该过程中，我们的化学家从头开始设计一项定制研究。有关设备的组成和使用条件的背景信息可为E＆L研究的途径提供信息。这包括确定样品选择和提取条件以及必要的分析技术。
通常使用多种分析技术的布置来检测，识别和量化医疗设备中的E＆L污染物。这样可以确保对最严格的质量控制（QC）措施进行医疗设备分析化学。
静脉内医疗设备在整个制造和存储中都符合严格的标准，以减轻进入患者血管系统的污染物的风险。部署后，可以释放出生物医学设备表面或饱和的不良颗粒和残留物。如果它们在足够低的浓度水平下包含小的无毒颗粒，则可能是无关紧要的。可以通过测量医疗设备的整体颗粒负荷来照亮这种行为。
The total particulate load of biomedical devices such as catheters, guidewires, and stents does not elaborate on particle shape or size and provides little information regarding a contaminant’s elemental composition. It is subsequently an imperfect assessment of the potential health risks associated with patient contamination, such as blood vessel occlusion and toxic exposure.
确定颗粒和残基的可接受限制应在污染物本身的鲁棒表征之前。这是使用高级分析工具（例如扫描电子显微镜）以及能量色散X射线（SEM-EDX）分析和傅立叶变换红外（FTIR）显微镜进行的。
概述SEM-EDX和FTIR显微镜
SEM-EDX vastly exceeds the resolving power of traditional microscopy with potential magnifications of up to 50,000x. This rapidly generates three-dimensional surface maps to detect and observe topographical variations that may be characteristic of contaminant elements.
SEM-EDX显微镜还配备了光学检测器，该光学检测器获取样品分散的基本特征X射线。颗粒和残基不仅可以通过分辨率为1000 - 3000份（ppm）检测到，而且可以识别并追溯到原点。FTIR显微镜通常用于使用斑点大小至10微米（µm）的红外光源来检测和识别较小的杂质。
Jordi Labs的颗粒物和残留分析乐动体育登录
乐动体育登录乔迪实验室是全球领先的专家之一颗粒和残留分析用于制药和生命科学应用。我们使用SEM-EDX，FTIR显微镜和其他设备提供量身定制的分析研究，以支持医疗设备领域的质量控制和质量保证。
