Run your Light Obscuration data for USP requirements, and simultaneously validate with images.
SCARBOROUGH, Maine (PRWEB) July 09, 2020
Yokogawa Fluid Imaging Technologies, of Scarborough Maine announced today the release of its newest FlowCam with a fully integrated light obscuration module. By combining industry-standard light obscuration technology required for USP compliance with digital images from proven Flow Imaging Microscopy (FIM) technology, the new FlowCam + LO will soon become the preferred instrument in biopharma labs worldwide.
Measuring and monitoring particulate matter present in injectable drugs is extremely important to companies involved in formulation development, manufacturing, and packaging. Adverse effects caused by protein aggregates and extrinsic particles in these drugs have been well documented over the years. The risks range from reduced efficacy to significant immunogenic responses. Historically, companies have had to rely upon multiple lab instruments to perform analysis of biologics: light obscuration, plus another method like manual microscopy or flow imaging, due to limitations of LO technology. Now there is an option to get FDA-mandated LO results and flow imaging morphology information from a single instrument.
In the FlowCam + LO, a single sample passes continuously through two flow cells. The first uses FlowCam technology to capture digital images of particles ranging from 1µm – 1mm, and the second uses light obscuration to provide data necessary for USP compliance. Those already using flow imaging microscopy will reduce sample volumes and bench time by combining two instruments and two steps into one.
"Users who are new to flow imaging can now obtain images and morphological data that allow them to interpret the light obscuration data and show them what’s underneath the curve, including revealing transparent and translucent protein particles that may have been missed by light obscuration instruments" says Kent Peterson, CEO.
- Correlate light obscuration data with flow imaging microscopy.
- Reconcile data from a single sample, and a single run with two different technologies.
- Save time and sample quantities by using a single instrument.
- Obtain full particle characterization and improved sample throughput time in a single step.
Yokogawa Fluid Imaging Technologies, Inc. manufactures the FlowCam imaging and analysis family of instruments which now encompasses 7 models engineered to analyze particles and organisms ranging in size from 300 nm to 5 mm. The paired intelligent software, VisualSpreadsheet®, utilizes image recognition technology and measures 40+ morphological parameters including biovolume, coloration, shape, and size to classify microscopic particles in a fluid medium.