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Single Particle Explorer Enhances Sub-Visible Particulate Detection
West Analytical Services, LLC is pleased to announce that it has completed testing on a new single particle explorer instrument, the Hound™ particle identification platform from Unchained Labs, helping to enhance the scientific team’s ability to detect and identify particulate in drug products and components. The instrument combines microscopy, Raman and Laser-Induced Breakdown Spectroscopy (LIBS) to identify visible and sub-visible particles by their chemical footprint, which is then referenced to a customizable database for identification.
Using a gold-coated filter to provide high contrast, the Hound platform combines both identification and analysis into a single-step process that is done automatically. Using chemical and elemental identification, the instrument counts particulate, and determines shape, size and color within the sample – helping scientists to identify issues that may impact the drug product or component.
“We anticipate that use of the Hound particle identification platform will help West’s customers quickly identify any particulate that may be causing issue with the drug product, helping to avoid drug failures or recalls,” said John Rech, manager, particle tech, lab. “It’s an excellent tool to identify and investigate particulate that is observed during USP <788> and <790> testing to ensure that the drug product meets regulatory guidelines.”
Additional applications for the Hound platform include:
- Chemical specific particle sizing for nasal, topical and dry powder formulations
- Identification of foreign particulate and visible protein aggregation - ISO 4407-2002 fluid contamination determination
- ISO 8871-3 measuring particle release from stoppers
The new capabilities can aid customers when testing during Phase I, II and III of development, and provide a new offering as part of West’s Integrated Solutions Program. The Program offers packages of products and testing aligned with the phases of drug development to help customers Simplify the Journey™ to market.
For more information about the single particle explorer or any of West Analytical Services’ testing capabilities, click here.
Hound™ is a trademark of Unchained Labs.