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Resources
Scientific resources and analytical context
Explore the published heritage of automated particle Raman analysis and discuss the technical information relevant to your application.
Integrated foreign-particle testing in OINDP
Niemann & Valet
Particle Explorer qualification for DPI foreign-particle counting and identification
Valet & Niemann
Non-destructive identification of particles in pharmaceutical products
Valet & Lankers
The Use of High Throughput Raman Microscopy for the Concurrent Size Determination and Chemical Characterization of Inhalation Particles
Valet et al. · Respiratory Drug Delivery 2010
MDI foreign-particulate Raman method validation according to ICH parameters
Chemical characterization of common foreign particulate contaminants in dry-powder inhalers
Chemically specific API particle-size distributions in nasal sprays: submicron particles to agglomerates
Krapf, Laskina & Valet
Subvisible particle identification in protein-based formulations by Raman spectroscopy
Lankers, Valet & Laskina
Particle identification in parenteral drug raw materials
Lee, Lankers & Valet
A Systematic Approach in the Development of the Morphologically-Directed Raman Spectroscopy Methodology for Characterizing Nasal Suspension Drug Products
Farias et al.
FDA-inspected rap.ID laboratories
Our rap.ID heritage includes FDA-inspected laboratories in Berlin and Princeton, New Jersey, with no Form 483 observations issued in those inspections.
APSys / rap.ID developed an image-first workflow: automated microscopy located candidate particles before selective Raman measurement. Early patents combined detection, sizing and spectroscopic identification, anticipating the workflow later marketed as MDRS.
Historical patent references: DE 199 46 110 C1; PCT/EP00/07937; DE 101 27 537.4; DE 101 27 538.2.
1999 APSys patent record
2001 substrate patent record
Automated particle-identification patent family
The first stainless-steel, touchscreen-controlled prototype was released in 2001. Development now spans more than 25 years and seven instrument generations.
2018 · rap.ID acquired by Unchained Labs, bringing its particle-identification technology and contract services into a larger life-science tools platform.
Current SizeID.bio evidence
Current GramRay i MK3 workflows connect larger particle populations, targeted Raman confirmation, reference comparison and Test-vs.-Reference/Q3 data.
Population-level chemical fingerprints and reference-source comparison
Parenteral and combination-product particle evidence
DeepMorph image-directed candidate targeting
Test-vs.-Reference / Q3 particle-level evidence
Discuss your analysis
Historical rap.ID experience refers to the predecessor companies and laboratories. SizeID.bio is the current particle-analysis offering of mibiC GmbH & Co. KG.