Process Monitoring
Precise control and measurement of life sustaining solutions.
Our particle characterization solutions enable customers to perform particle size analysis both in the laboratory and online, in real-time, directly in the fluid stream process. AccuSizer® SPOS systems and Nicomp® Nano DLS/ZLS systems are well-suited for a variety of life science applications such as USP tests, formulation, quality control testing, and more.
The importance of particle monitoring is more crucial than ever. Life-sustaining solutions depend on high quality control and standards for efficacy. Companies manufacturing parenteral drugs and ophthalmic solutions need to test for subvisible particulates using a liquid particle counter. Parenteral drugs must be tested according to USP <788> or <787> for therapeutic proteins. The globule size of lipid injectable emulsions is tested per USP <729> for both the mean size and the percent >5 µm (PFAT5). Ophthalmic solutions are tested following USP <789>.
Our AccuSizer® system is the most advanced liquid particle counter used for these tests, providing the highest specifications and sophisticated automation. Our unique single particle optical sizing (SPOS) sensors have the widest dynamic range-reporting results to the smaller sizes useful for differentiating stable protein formulations. Low sample volumes, push/pull mixing, and sample recovery facilitate protein testing using a minimal sample amount. An autosampler and microplate analyzer can automate the measurements, proving high throughput capability.
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