SPE raman.ID 0.5 inhaler

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 Quality by Design, in regards to foreign particle control, it is crucial to shorten 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. Dry powder inhalers and filtration equipment undergo cross-contamination free -particle sampling to confirm sufficient low blank values recovered from a delivered dose. 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.

The SPE 0.5 Inhaler applies Quality by Design principles into OINDP. The SPE 0.5 Inhaler combines various modern technologies to detect the material composition of foreign particles ranging from 2 µm and larger in accordance with ISO 9001:2008 and GAMP V guidelines, with optional IQ, OQ, PQ documentation equipment qualification, and Process Analytical Technology (PAT) implementation. Full sample enumeration takes just 4 minutes. The automated image recognition and interpretation, Raman spectroscopy, and data reports in compliance with 21 CFR Part 11 require no sample preparation or in depth knowledge from staff.