The SPE raman.ID 0.5 inhaler is designed for the fast and reliable identification of Foreign Particulate Matter recovered from inhalable drug products. The particle size ranges from 0.5 - 10 µm. To streamline the Quality by Design approach, in regards to foreign particle control, it is crucial to shorten the analysis time. The system is suited to perform routine enumeration of filter patches in just 5 minutes and Raman identification of single 2 µm. particles in just 1 - 3 seconds each. Cross contamination free particle sampling from inhalers and filtration equipment are available to ensure the collection of a delivered dose from a dry powder inhaler with sufficient low blank values. All the raw data including raw images, analyzed images, particle morphology, particle stitch merging, and spectra are then stored in a “results” file in compliance with 21 CFR Part 11.
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