Since most manufacturers aim primarily for compliance, there is little incentive to learn more about the formation or introduction of particles present in compliant formulations. For example, under USP <788>, sub-visible particle testing is typically done in a lab away from the line where visual inspections are conducted for visible particles. Vials may be rejected from either test, but are not often evaluated together using orthogonal methods to determine what particles are triggering the rejections. Concern is focused on effectively rejecting off-spec vials rather than on identifying the type of particle detected and understanding why it is present.

由于大多数制造商主要致力于合规性，因此几乎没有动力去了解合规配方中存在的颗粒的形成或引入。 例如，在USP <788>下，亚可见颗粒测试通常在远离对可见颗粒进行目视检查线的实验室中进行。 可以从任一测试中拒绝小瓶，但是通常不使用正交方法一起评估小瓶以确定哪些颗粒触发不可接受条件。 关注的重点是有效地拒绝不合格的样品瓶，而不是确定检测到的颗粒类型并理解其存在的原因。

The situation faced
面临的情况

According to Berdovich, this mind set is changing. “Most of my customers want to know more about their products than compliance requires, such as particle shape - it’s invaluable in case problems arise later in formulation - but you can’t find out much more if you’re using laser scatter or light obscuration devices,” he says.

根据Berdovich的说法，客户的这种心态正在发生变化。 “我的大多数客户都希望了解他们的产品，而不仅是合规要求，例如颗粒形状 - 如果在配方中出现问题，这是非常宝贵的 - 但如果您使用激光散射法或光阻法，您就无法发现更多“他说。

The problem came to a head during another test that required measuring particles in a liquid or gel formed on a membrane. Since the particle shape deformed in minutes, the analysis need ed to be done quickly. Manual micros copy proved far too slow. Moreover, the particles deformed when filtered and squeezed between the glass slides. “We were bumping up against a wall and thought there was no way to do this,” says Berdovich.

在另一个需要测量膜上形成的液体或凝胶中的颗粒的测试中，又一个问题出现了。 由于颗粒形状在几分钟内变形，因此需要快速完成分析。 手动微拷贝证明太慢了。 此外，颗粒在过滤并在载玻片之间挤压时变形。 “我们碰到了一堵墙，并认为没有办法做到这一点，” Berdovich说。

Then he read in a trade magazine about new instrumentation called the FlowCAM^®, an imaging particle analysis system that automatically detects the presence of particles and microorganisms in a sample, including transparent, semi transparent and sub-visible particles. 

然后他在一本行业杂志上阅读了一种名为FlowCAM^®的新仪器，这是一种颗粒成像分析系统，可自动检测样品中颗粒和微生物的存在，包括透明，半透明和亚可见颗粒。

The instrument’s software package does typical spreadsheet analysis operations on particle data while presenting the results visually as images- as opposed to tabular representation. It incorporates statistical pattern recognition for particle characterization, a big improvement over simple value filtering.

该仪器的软件不仅对颗粒数据进行典型的电子表格分析，同时又以图像形式呈现结果 - 而不仅仅是表格。 它结合了用于粒子颗粒表征的统计模式识别，这是对简单值过滤的重大改进。

Not relying on scatter
不依赖于分散

Rather than rely on light scatter, the FlowCAM’s imaging technology captures a high-resolution, digital image of each individual particle passing in front of its flow cell. Imaging thousands of particles in seconds, it measures each one based on its actual image to yield data based on particle shape, size and transparency.

FlowCAM的成像技术不是依赖光散射，而是捕获通过流动池前方的每个粒子的高分辨率数字图像。 在几秒钟内成像数千个颗粒，它根据其实际图像测量每个颗粒，根据粒子形状，大小和透明度产生数据。

Clicking an image or touching the image on screen reveals the measurement data, which may be graphed several different ways depending on how the data needs to be visualized and the types of particles targeted.

单击图像或触摸屏幕上的图像会显示测量数据，这些数据可能会以几种不同的方式表达，具体取决于数据需要如何显示以及所针对的颗粒类型。