The AccuSizer FX Nano SIS system is specifically designed to measure protein aggregation. The instrument meets and/or exceeds all requirements described in USP <787> Subvisible Particulate Matter in Therapeutic Protein Injections. The results generated include particle size and concentration from 0.15 – 150 µm – covering the official 10 & 25 µm sizes, but with the sensitivity to investigate the more interesting submicron region.
The new AccuSizer FX Nano SIS system consists of:
• The SIS sampler modified to be able to accurately deliver samples volumes as small as 250 µL
• Two sensors, the LE400 and FX Nano sensor to measure 0.15 – 150 µm
•The 1.6 mm sample probe is placed in the sample vial.
•The SIS syringe sampler draws the sample up through both the LE400 and FX Nano sensors for analysis
•The sample flow can be reversed so that multiple passes of the sample are analyzed in order to increase the number of particles measured to improve statistical validity
•At the end of the measurement cycle the sample is recovered in the original vial
•The AccuSizer software combines all collected data and reports particle count/ mL
This unique system utilizes the most advanced light extinction/scattering sensor technologies available to generate particle size and count data at smaller particle sizes and higher concentrations than any other system available. Size distributions are reported in up to 64 size channels.
Particle count data for IgG with no stress (black), 1 hour (red) and 6 hours (blue) stressed at 37o C