Level 1 - is a quick visual characterization allows a quick sorting into the different types of particulate defects. Grouping defects according to USP <1790> requires training and thorough knowledge about the particles physical behavior. We show an approach to characterize visible particles in situ by imaging the particle inside the container.
Level 2 - microscopic identification (applied to representative Level 1 groups (e.g., light or dark particle, light or dark fibers. or for particles found during manual AQL inspection). Rapid characterization to specific material categories.
Level 3 - spectral or other fingerprint ID methods used for initial library set-up and then applied, as required, during deviations or investigations. Methods include FTIR, Raman, LIBS, SEM/EDS and mass spectrometry.
With these high quality in-situ images and thorough spectroscopic information the defect library is populated and training sets can be put together as well to train operators in the life-cycle concept outlined in the USP <1790>.
TRUST in rap.ID's 15 year experience in thorough particulate matter investigations for parenteral drug products. We are trained on Roy Cherris's visible inspection life-cycle approach: