Fully-automated Particle Recognition through Image Analysis and Chemical Classification with Raman Spectroscopy for Particles Larger than 10µm.

Berlin – February 3rd, 2008 rap.ID Particle Systems is proud to introduce the latest generation of its particle identification devices with the new Advanced Single Particle Explorer. The combination of sampling, fully-automated image analysis, and Raman spectroscopy makes for unbeatably fast and precise measurement of size, count, and shape of over 10,000 particles from 5µm and up. With these results, particles are subsequently selected for identification. The user can identify around 400 particles an hour and begin determining potential contaminant sources in just a few gestures and with minimal training.

The statistically relevant analysis made possible by these capabilities facilitates the search for potential contamination sources. Background particle presence that may be a normal non-hazardous part of the manufacturing process can be filtered out while, other potential contaminats are quickly isolated and detected.

A conventional lab needs about a week to chemically identify the 20-40 largest contaminating particles once they receive your samples. That’s a long time and it can cost up to 4000EUR. The new Advanced Single Particle Explorer delivers the same results in 25 minutes. Workeres need only take 3 minutes to filtrate the sample using the patented filtr.AID Membrane, load it into the machine, select the analysis mode, and hit start. Equipped with autofocus and automatic particle recognition, the device delivers complete particle size distribution analysis in 1 minute.

Spectroscopic parameters (exposure and laser intensity) are determined by the system itself and the material composition is determined through comparison with the integrated database. Afterwards, the result is combined with the raw data (particle images, image recognition and material classification, spectra) in a 21 CFR Part 11 compliance document. A four-fold sample changer for routine studies is included.

Validation of the system’s IQ, OQ, and PQ with delivery standards and particle norms is undertaken by our worldwide qualified service partners and takes only a half a day. The user is able to check calibration of the instrument to these standards in just a few minutes.

The expert team at rap.ID has validated the system for multiple applications and is standing by with integrated labor for further method development and validation, or for feasabilty studies. Users of rap.ID’s technology are mostly working in the pharmaceutical industry toward development and quality assurance for injectables, nasal sprays, and inhalants, or are medical implant manufacturers, although many clients in the automobile industry have also found it indispensable in improving their production of electronic components and fuel injection systems as well as in streamlining quality assurance.



rap.ID Particle Systems GmbH
Koepenicker Str.325/Haus 40
12555 Berlin
Phone: +49 (0)30 - 6576 34-40
Fax: +49 (0)30 - 6576 34-41