The SPE raman.ID 0.5 biopharmaceuticals is designed to quickly identify particles and agglomerates recovered from biopharmaceutical intrinsic particles. The standard particle size ranges from 1 - 10 µm. Measurement of smaller particles than 1 µm is possible, down to 0.3 µm, using integrated illumination and further calibration procedures.
The biopharmaceutical industry creates highly sensitive and complex products, therefore it is crucial to shorten analysis time to streamline the development of the most advanced biopharmaceutical drugs. The system is suited to perform both enumeration and particle size distribution of filter patches in just 5 minutes and Raman identification of single 0.5 µm particles in just 1 - 3 seconds each.
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The speed of this process enables the equiment to conduct silicone protein interaction studies or other formulation stability related investigations. Measuring and identifying nano particles is now as easy as a touch of a button. All raw data including raw images, analyzed images, particle morphology, particle stitch merging, and spectra are stored in a “results” file in compliance with 21 CFR Part 11.
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