乐动体育登录Jordi Labs是世界领先的医疗器械分析化学和实验室检测领域的主导权力之一。乐动ldsportsa它是一种谨慎的广泛的分析领域，包括常规物理测试和复杂的产品变形，以及污染和失败调查。这些分析要求中的每一个都可以细分为不同的技术分支和应用领域。在Jo乐动体育登录rdi Labs，我们必须与客户密切合作，了解独特的产品的独特制造，存储和操作条件，以提供可靠的医疗器械分析化学服务，具有定量和定性结果。
Our holistic approach to medical device analytical chemistry is best exemplified by our approach to extractables and leachables (E&L) testing. This is a multi-step process in which our chemists design a bespoke study from the ground up. Background information regarding the composition and usage conditions of the device informs the E&L study’s pathway. This includes determining the sample selection and extraction conditions, alongside the necessary analytical techniques.
An arrangement of multiple analytical technologies is typically used to detect, identify, and quantify E&L contaminants in medical devices. This ensures medical device analytical chemistry is carried out to the most rigorous quality control (QC) measures.
Intravenous medical devices are held to exacting standards throughout manufacture and storage to mitigate the risk of contaminants entering a patient’s vascular system. Undesirable particulates and residues that have accumulated or saturated the surfaces of biomedical devices can be released into a patient’s body when deployed. These may be inconsequential if they comprise small, non-toxic particles at sufficiently low concentration levels. This behavior may be illuminated by measuring the overall particulate load of medical devices.
生物医学装置的总颗粒载量如导管，导丝和支架不会在颗粒形状或尺寸上阐述，并且提供关于污染物的元素组成的很少的信息。随后随后对与患者污染相关的潜在健康风险的不完美评估，例如血管闭塞和毒性暴露。
Determining acceptable limits for particulates and residues should be preceded by robust characterizations of the contaminant itself. This is routinely carried out using advanced analytical tools such as scanning electron microscopy coupled with energy dispersive x-ray (SEM-EDX) analysis and Fourier transform infrared (FTIR) microscopy.
Outlining SEM-EDX and FTIR Microscopy
SEM-EDX大大超过传统显微镜的分辨率，具有高达50,000倍的潜在放大率。这迅速产生三维表面图以检测和观察可能是污染元件特征的地形变化。
SEM-EDX microscopes are also equipped with an optical detector that acquires the elementally-characteristic x-rays dispersed by the sample. Particulates and residues can not only be detected with a resolution of 1000 – 3000 parts per million (ppm) but can be identified and traced back to a source of origin. FTIR microscopy is typically used to detect and identify smaller impurities using an infrared light source with a spot size as small as 10 micrometers (µm).
Particulates and Residue Analysis with Jordi Labs
Jordi Labs is one of the world’s leading experts inparticulates and residue analysisfor pharmaceutical and life science applications. We provide tailor-made analytical studies using SEM-EDX, FTIR microscopy, and additional devices to support quality control and quality assurance in the medical devices sector.
Please feel free tocontact usdirectly with any questions about our analytical tools or our experience inbiomedical device applications.
