Rapid Particle Systems has introduced the latest generation of its particle identification devices with the Advanced Single Particle Explorer.
The company said that the combination of sampling, fully automated image analysis and Raman spectroscopy makes for fast and precise measurement of size, count, and shape of more than 10,000 particles from 5um 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.
The statistically relevant analysis made possible by these capabilities facilitates the search for potential contamination source.
Background particle presence that may be a normal non-hazardous part of the manufacturing process can be filtered out, while other potential contaminants are detected and isolated.
Rapid Particle Systems claimed a conventional laboratory needs about a week to chemically identify the 20-40 largest contaminating particles once they receive samples.
The Advanced Single Particle Explorer is said to deliver the same results in 25 minutes.
It takes just three minutes to filter the sample using the Filtraid membrane, load it into the machine, select the analysis mode, and push start.
Equipped with autofocus and automatic particle recognition, the device delivers complete particle size distribution analysis in one 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 the company's 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 minutes.
The team at Rapid has validated the system for multiple applications and is standing by with integrated labour for further method development and validation, or for feasibility studies.
Users of Rapid's technology mostly work in the pharmaceutical industry toward development and quality assurance for injectables, nasal sprays, and inhalants, or are medical implant manufacturers.
In addition, clients in the automobile industry have found it useful in improving the production of electronic components and fuel-injection systems, as well as in streamlining quality assurance.
