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检测机构使用流动成像显微镜来表征蛋白质聚集体(三)

2020.4.08

More than 30 different properties, including length, width, diameter, volume and aspect ratio, as well as advanced morphological types such as circle fit, elongation, perimeter and roughness are measured. Each image is saved with its corresponding measurement data for review, analysis and sharing online or by email.

通过测量了30多种不同的特性,包括长度,宽度,直径,体积和纵横比,以及先进的形态类型,如圆形拟合,伸长率,周长和粗糙度。 每个图像都保存有相应的测量数据,以便在线或通过电子邮件进行查看,分析和共享。

“You can get more information from the FlowCAM, says Berdovich.

Berdovich说,您可以从FlowCAM获得更多信息。

From the advent
FlowCAM_Imaging_Particle_Analysis_reveals_and_differentiates_individual_particles,_droplets,_bubbles_lo-res从出现

Now that he and his analytical staff have more than three years of experience running analyses on the instrument, he says, “Going to the FlowCAM with a particle problem is just the best feeling in the world because it turns data into useful information a customer can use to solve a problem.”

现在,他和他的分析人员在仪器上运行分析已有三年多的经验,他说,“带有颗粒问题地去使用FlowCAM只是世界上最好的感觉,因为它可以将数据变成有用的信息,可以帮助客户解决问题。“

For one application, FlowCAM measures the coverage of coatings on medical devices. If the coating process is insufficient, particles may be released that could affect the patient. “These types of particles simply can’t be effectively characterized by anything but a FlowCAM, says Berdovich.

对于一种应用,FlowCAM可测量医疗设备上涂层的覆盖范围。 如果涂覆过程不充分,可能会释放可能影响患者的颗粒。 Berdovich说:“除了FlowCAM之外,这些类型的颗粒根本无法有效地表征。”

Similarly, the FlowCAM may be used to optimize microencapsulation processes by looking at the shell layer around individual particles.

类似地,FlowCAM可用于通过观察单个颗粒周围的壳层来优化微囊化过程。

The ability to automatically differentiate one type particle from another, such as a globular protein aggregate from a curly fiber, round oil droplet or air bubble, also proves useful. Foreign matter, such as silicone oil droplets, for example, may come into contact with a sample from a rubber stopper. To a light obscuration device, these opaque oil droplets are counted just as if they were a protein or any other particle, since no distinction from one to the other may be made. This artificially increases the total particle count and may trigger destruction of an entire batch of quality product for failing to meet specifications.

自动区分一种粒子与另一种粒子的能力,例如来自卷曲纤维,圆形油滴或气泡的球状蛋白质聚集体,也证明是有用的。 例如,诸如硅油滴的异物可能与来自橡胶塞的样品接触。 对于光阻法仪器,这些不透明的油滴就像它们是蛋白质或任何其他颗粒一样被计数,因为可以不对它们进行区分。 这会人为地增加总颗粒数,并且可能触发破坏整批优质产品而不符合规范。

While microscopic membrane analysis can verify that these droplets are not discrete, it cannot sufficiently characterize their concentration, since they pass through the membrane. This can be troublesome because the concentration is typically needed to solve a problem.

虽然膜式显微镜分析可以证实这些液滴不是离散的,但由于它们穿过膜,因此不能充分表征它们的浓度。 这可能很麻烦,因为说明浓度来解决问题。

To the outcome
结果


In contrast, the FlowCAM images each individual oil droplet and the total count of droplets - or of any other type particle - may then be characterized as an isolated population, or even removed from the total particle count. Again, you just can’t do this with anything but a FlowCAM. The data tells a lot,” Berdovich adds.

相比之下,FlowCAM对每个单独的油滴成像,并且液滴或任何其他类型颗粒的总数可以被表征为分离的群体,或甚至从总颗粒计数中去除。 再说一次,除了FlowCAM之外你不能做任何事情。 数据说明了很多,“Berdovich补充道。

The lab has provided several customers with FlowCAM data for sub mission to the FDA. “When you’re submitting data to the FDA, you want to understand the issues and you don’t want any doubt about the accuracy, Berdovich says. “I feel very confident in the FlowCAM because it helps us look under every rock when solving a problem, and it has also opened a lot of doors for us.”

该实验室为几个客户提供了FlowCAM数据,用于FDA的子任务。 Berdovich说:“当您向FDA提交数据时,您希望了解这些问题,而且您不希望对准确性产生任何疑问。” “我对FlowCAM非常有信心,因为它帮助我们在解决问题时能够看到每一个颗粒,它也为我们打开了很多大门。”

Since adding the FlowCAM, Berdovich has substantially increased his laboratory services customer base among medical device and pharmaceutical product manufacturers. Growth triggered a facility expansion, with an added dean room and staff. “With the FlowCAM and our knowledge base, we can take on applications that other labs won’t,” says Berdovich.

自配置FlowCAM以来,Berdovich已大幅增加其医疗设备和医药产品制造商的实验室服务客户群。 增长引发了设施扩建,增加了管理和工作人员。 “通过FlowCAM和我们的知识库,我们可以接受其他实验室所不具备的应用程序,”Berdovich说。

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