rap. ID identifies particles in new laboratories
laboratory premises to meet the demands of contamination-free
particle identification. The move is in response to the increase in
demand for qualified particle counts and identification in drug
discovery.
On a strategic level, the expansion reflects the trend in the last year that has seen an increase in demand for particle counts and identification through automated Micro Raman Spectroscopy by more than 30 per cent per year.
With the knowledge of particle composition researchers have the ability to look really into processes. The knowledge about the origin of foreign particles allows production managers to change the right parts of processes but also with authorities to show that the foreign particles are harmless, or that their origin is clear and countermeasures are clearly assigned.
"In the new laboratory area we are now in the position to develop and process very demanding methods of particle examination. In the future it will be possible to examine synthetics, solvents and highly potent drugs," said Dr Markus Lankers, head of laboratory.
Rap.ID's service has been available worldwide since 2002 and has proved particularly adept for quick identification of contamination sources, helping to conclude a number of studies on foreign particle pollution in new drugs.
Dr Oliver Valet, managing director for rap.ID Particle Systems, told DrugResearcher.com: "We started the contract testing service nearly 3 years ago just to show the capabilities of our Particle Explorers."
"For the first time it was possible to count and size particles and give a shape and chemical composition analysis. And it grew from the end of 2002 to today from showing to a very reasonable business, which is now about a third of our sales," he added.
Valet said that on the other hand the contract testing also promoted the sales of the equipment, offering customers ready developed and validated methods to start with the analysis immediately after the IQ, OQ and PV procedure.
The new location capacities for contamination-free manufacture of filter elements will be adjusted to new demands generated through the machine sales. The IPW offers conditions for the research and development of new instruments for particle characterisation.
"Fortunately we are dealing with microparticles and we don't need so much space in the lab yet. We have a 30 square metre laboratory for the regular contract testing and a 20 square metre cleanroom where we manufacture our filtr.AID membranes and within we also have the ability to do special ultra clean particle work in a 8 square feet soft wall class 100 cleanroom," Valet added.
The planned ISO 9001 -2000 certification in autumn will complete the expansion of our laboratory capacities.
