Coating & Particulate Testing

Acute and chronic particulate testing is required for most intravascular devices to mitigate potential health risks for patients. Additionally, coating integrity and durability are commonly evaluated for drug-eluting stents. Element’s心血管设备测试专家根据领先的行业标准和指导文件对涂料和微粒进行检查。

涂层完整性和微粒脱落可能会影响患者的安全性，但也会影响设备的疗效和治疗效果，例如药物洗脱支架。尽管一些制造商制定了自己的标准或使用USP788中规定的标准，但监管机构并未对颗粒物设定接受限值。

Minimizing particulates and increasing coating lubricity can be two competing requirements, which presents challenges for device manufacturers. Our experts evaluate coatings and particulates intending to bring safe and reliable products to market.

FDA guidance for coating & particulate testing

除了行业标准外，还有一些FDA指导文件与血管内设备相关，其中包括涂层检查和微粒测试的建议。例如，“冠状动脉、外周血管和神经血管导丝——性能测试和推荐标签”是一份指导文件草案，其中有关于涂层完整性、微粒评估和模拟使用的章节。

指导文件“非临床工程试验和血管内支架及相关输送系统的推荐标签”也包含关于涂层完整性和微粒评估的基线和模拟使用试验的有用信息。

Coating integrity

Coating integrity inspections focus on detailed characterization of the device’s coated surfaces for defects, anomalies, or artifacts. Unintended delamination, flaking, webbing, or degradation may impact the device’s clinical performance and should be characterized. FDA guidance documents listed above recommend inspections on the finished product that has been subject to all manufacturing processes, including sterilization.

Inspections for coating integrity are recommended for baseline and simulated use conditions. For simulated use coating integrity assessments, devices are tracked through a tortuous path fixture that mimics challenging in vivo physiologic and anatomic conditions that the device might encounter during use, and they are then expanded in air or in an aqueous solution.

作为可接受涂层完整性讨论的一部分，需要记录观察到的缺陷数量和大小，测试报告应包括用于量化缺陷的方法的详细信息。计算每单位面积的总缺陷数量，测量代表性和最坏情况下的缺陷区域也可包括在内。

微粒测试

There are two main types of particulate evaluation: acute and chronic particulate testing. Acute particulate testing is related to the particulate matter released during simulated delivery and deployment of a device. Chronic particulates measurement takes place over a specified length of time that mimics the lifetime use of the device.

急性微粒试验

FDA guidance documents and existing standards focus on acute particulate testing, outlining the assessment of particulates through either light obscuration or filtration/microscopy methods. Each method has its advantages and limitations. The light obscuration method has higher throughput but can only quantify particulates and categorize them by size. In contrast, the filtration/microscopy method can quantify particulates as well as identify them by color, shape, or composition. We employ the filtration/microscopy method that offers more flexibility in the evaluations requested by device manufacturers.

我们的生物可吸收支架的急性微粒试验article gives a more in-depth look at the baseline and simulated use testing of particulates generated from enzymatic or hydrolytic degradation.

慢性微粒测试

我们通过将颗粒计数模块与我们的支架移植测试系统集成，并使用模拟血管的个性化流量回路、流量计和过滤器来执行慢性颗粒测试。我们的流动回路设计将流动顺应性影响降至最低，从而保持疲劳试验的生理径向应变。

模拟容器的过滤器按预先确定的间隔取样，以便在长期疲劳试验中分析微粒。由于我们拥有内部过滤/显微镜功能，我们可以在耐久性测试运行期间快速进行这些检查。

For more information about our coating and particulate testing for intravascular devices, or to request a quote,contact us今天。