Foreign Particulate Matter in Orally Inhaled and Nasal Drug Products

OINDP particle characterization for DPI, MDI, nasal spray, and inhalation product development

OINDP particle characterization for DPI, MDI, nasal spray, and inhalation product development.

Foreign particulate matter in orally inhaled and nasal drug products is not only a particle-counting problem. During development, residual particles need to be understood: what they are, where they may come from, and whether they point to formulation, device, material, manufacturing, packaging, or handling risks.

SizeID.bio supports OINDP development teams with DeepMorph-guided particle screening and targeted Raman confirmation. After matrix removal, we characterize residual foreign-particle populations by size, morphology, chemical identity, and likely source — helping teams define relevant CQAs, understand particle risks, and build stronger control strategies.

Identify foreign matter and recurring patterns early—before they enter production. Support supplier qualification, incoming inspection, and risk-based controls.
Monitor microbes and particulates together. Reveal biofilm-related shifts, corrosion signatures, polymer residues, and other contributors that simple counts can miss.
Explain excursions across cleanroom zones by differentiating typical contributors (skin, fibers, equipment wear, packaging residues) and highlighting emerging patterns.
Detect drift, equipment wear, cleaning issues, and process-related shifts through particle population changes and material attribution.
Quantify contributions from silicone, rubber, polymers, glass, and steel—supporting component risk assessments and investigation narratives.
Contextualize reject trends and long-term changes by tying "what is seen" to "what it is," enabling targeted remediation and comparability arguments.