With the new European Medical Devices Regulation (MDR) coming into effect, cleanliness of medical devices continued to gain importance. In our testing laboratory we are seeing more and more inquiries from customers who require a test report on the number and size of foreign particles. Also the material determination of the particles is requested more and more frequently because this result can be used to estimate the risk to the patient.
A particular challenge is the correct analysis of microparticles inside medical glass ampoules. When the vials are opened, glass breakage often occurs, which can introduced 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. For the analysis we set 3D X-ray microscopy and tomographic reconstruction:
Our Accredited Test Laboratory is happy to accept customer orders for this novel analysis method. We also advise customers who are interested in investing in this technology for use in your own laboratory.
