Intraoperative margin assessment using X-rays has long been standard in breast cancer treatment in countries such as the USA, China, Japan, and the UK. Although the procedure can significantly reduce the number of repeat surgeries, the technology has been adopted only hesitantly in Germany.
We recently determined for an analytical client whether and to what extent the rubber stopper used to seal a medication bottle generates particles when pierced with a syringe to withdraw the medication. The client was surprised that piercing the stopper can generate particles measuring several hundred micrometers and wanted to statistically investigate the process.
Anyone who has samples tested for cleanliness relies on reliable testing and precise determination and representation of the particles contained. With our Particle Browser, we offer you software for follow-up checks and revisions to verify analysis results and to identify and correct possible measurement errors.
In the Bruker AXS webinar series, our managing director Dr.-Ing. Markus J. Heneka spoke as an expert about the application of 3D X-ray tomography in the pharmaceutical industry. The event was viewed very positively by well over 100 registered participants from all over the world.
A particular challenge is the correct analysis of microparticles inside medical glass ampoules. When the vials are opened, glass breakage often occurs, which can get into the analysis and falsify the result. To solve the problem, our team has developed a new process to non-destructively detect foreign particles in glass ampoules.
It is often surprising for our customers when we find hard mineral particles on their components during technical cleanliness analysis. Customers ask: "How can that be? We didn't find anything in our own cleanliness tests." The contamination of hard minerals is so important, because these particles have an abrasive effect and thus massively damage mechanical systems such as gears and motors.
The determination of the technical cleanliness according to VDA-19.1 or ISO-16232 is now an integral part of quality control and error analysis - because the cleanliness of components is decisive for the quality and error-free function of the product. In addition to particles, filmic contamination poses a problem, as the following example from quality assurance in the manufacture of electric drive systems shows.
Yesterday we had a working visit from the German Accreditation Body (DAkkS), who audited our management system for ISO-17025 accreditation. Monitoring of this type is carried out by the DAkkS at regular intervals, and our processes are put through their paces.
A central requirement in the production of pharmaceutical products is the avoidance of visible foreign particles. Our testing laboratory has developed innovative yet simple methods to reliably quantify foreign particles in pharmaceutical powders.
