780-SIS: Particle Size and USP-788 in the same instrument

780-SIS: Particle Size and USP-788 in the same instrument

The FDA requires all manufacturers of injectable fluids to test their products for particle contamination that if present can render the fluids dangerous for human consumption.

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. 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. 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.

A quick software adjustment...

 

 

 

 

 

Now you have 512 channels of resolution as seen in here.  With 512 channels you can do this...

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.