美国食品药品管理局FDA要求所有注射液检测他们的产品以防止不溶性的污染颗粒对人体食用方面带来危险。
This is codified in the USP<788> test which lays out the protocol for testing injectable fluids for contamination of particles greater than 10 micron and 25 microns in size. There are a variety of offerings in the market for devices that can perform the USP-788 Light Obscuration test. It requires a light obscuration sensor, multi-channel analyzer, and a simple syringe pump system to move liquid through the sensor.
美国药典USP< 788 >明文阐述了检测注射液中大于10微米和25微米的不溶性微粒。目前市场上有各种各样的可以完成USP 788所需的光阻法检测仪器。它需要一个光阻传感器、多通道分析仪,以及一个简单的将液体推送到传感器的注射泵系统。
Particle Sizing Systems offers the Accusizer 780 SIS Syringe Injection Sampler for this application. But the 780 SIS is more than a contamination tester for USP-788. It might be the most versatile Syringe System available with the ability to perform high resolution particle size measurements over a range of 0.5 to 400 microns.
美国PSS粒度仪公司提供了一款AccuSizer 780 SIS 来专门应用于检测不溶性微粒。780SIS 不仅仅只具备符合USP 788检测不溶性微粒的功能,同时它型的注射进样系统可以在0.5微米至400微米的范围内完成高分辨率的粒度检测。
Even measurements made for USP-788 can be converted from two channels to 512 independent size channels. Typical USP-788 data can be seen. The graphical display consists of two channels, >10 microns and > 25 microns.
AccuSizer 780SIS 甚至可以在适于USP<788>的基础上从两个到512个独立通道自由转换。从标准的USP <788>数据可以看出。下图显示包含了两个数据通道,分别是> 10微米和> 25微米。
trong>A quick software adjustment…
软件快速调整
Now you have 512 channels of resolution as seen in here. With 512 channels you can do this…
现在只要你拥有512个高清通道,你可以得到更多数据。
This figure contains a mixture of polystyrene latex spheres of different sizes.
So the Accusizer 780 SIS Syringe Injection System can provide dual capabilities, saving space and money, and SPOS when used for particle sizing, provides unparalleled resolution and a true particle size distribution.
上图包含了不同粒径大小的聚苯乙烯乳胶球混合物。
所以Accusizer 780 SIS能够给你提供双重功能,节省空间与,SPOS 单颗粒光学传感技术来检测粒度,可以得到的分辨率和一个真实的粒度分布。