rap.ID launches new particle identifier
shape within 15 seconds, has been launched by German equipment
supplier rap.ID, which believes such technology could solve the
problem of foreign particle contamination in pharmaceutical
products.
The particle finder allows for the first time, to filter particles from suspensions or highly coloured solutions reliably through the filtr.AID technology and to count them quickly using the portable Particle Finder.
With Particle Finder the size and number as well as the shape of airborne or liquid-borne particles of 5 microns or larger can be detected and documented.
The shape and size analyses feature enables the classification of particles and documentation of the particle status of the respective testing solution. The Particle Finder allows data exchange and the identification of Raman or EDX-based particle identification through the (remote) particle analysis at rap.ID. In addition, the Particle Finder software supports particle measuring fully compliant to 21 CFR, Part 11, relevant for the pharmaceutical industry.
Dr Oliver Valet, managing director at rap.ID.Particle Systems, told DrugResearcher.com: "Particle Finder can be generally sold to any industrial/laboratory application where particle number size and shape play a role. This could either be the medical device, chemical and pharmaceutical industry."
Particle detection is based on a scattered light analysis in which a focused laser beam scans the surface on which the particles were located. The scattered light characterises both particle size and properties. You will be able to very quickly determine the number and size of emitted particles, and the particle identification can be automatically engaged.
Light obstruction is the standard method for foreign particulate matter testing. Indeed, membrane counting has several advantages over light obstruction, notably the shape information of the particle and the particles are still available for further investigation.
"Particle counter on the basis of light obstruction need relatively high sample volumes, in the field of biopharmaceuticals our customers are dealing with very expensive samples. The Particle Finder can go down to several hundreds of µl sampling volume," said Valet.
"Another advantage is that particles stay on the membrane once they are isolated and they are available for other investigations like our automated Raman Particle ID or evaluation of the membrane with an SEM system. To identify foreign particles on a routine basis is mandatory in new drugs application files for OINDPs," he added.
The Airborne Particle Explorer detects, counts and identifies particles using Laser Raman- Spectroscopy, which carries out automatic identification of most particles present in ambient air. A laser beam is focused to the micrometer on the particle in which the integrated laser Ramanspectrometer provides the particles' spectrum at high resolution and sensitivity. Preparation of samples is not necessary and all processes run automatically.
The Particle finder can be used for the identification of airborne microcontamination, foreign particles and particle uniformity in inhalers. It will also prove handy for the development of biopharmaceutical drugs, particles, and drug delivery systems, claims rap.ID.
Currently there are about 15 different suppliers of light obstruction particle counters. However there are no suppliers of a reliable membrane counting method. Microscope companies are now emerging in the field of membrane counting but they do not offer an integrated filtration and particle counting system.
Valet said that the state of the particle analysis sector was a very dynamic growing field.
"The authorities, especially the FDA cares a lot about pharmaceutical companies and its lack of ability to perform foreign particulate matter studies or routious particle testing," he said.
"Especially in the fast growing sector of OINDPs, We see the particle analysis sector growing by 25-35 per cent per year."
The system could be delivered 4 weeks after receiving the PO. The system starts at €7500 including software and digital camera. A ready to go mobile system comes together with a pump, filtr.AID equipment, a laptop computer, for under €10000.
