Unexpected Findings

Unexpected Findings

Are you responsible for the production of pharmaceutical products, such as vaccines? What if you suddenly find something unexpected, some foreign material, or particles, in one of the vials in your production? Sudden unexpected findings of particulate matter in, or in...
3D Printing and Your Health

3D Printing and Your Health

Are you using 3D printers to produce mock-ups or in manufacturing? What kind and how many particles are produced while using a 3D printer? Particles produced during 3D printing pose a health risk. In fact, they are almost as harmful as the exhaust produced by Diesel...
Food Contact Materials

Food Contact Materials

Packaging is not the first thing we think of when we think of food. However, the materials used in food packaging impact the food contained within. So, it is essential to understand the health and safety consequences presented by the food packaging used. Any materials...
Get Ready for EU MDR

Get Ready for EU MDR

The deadline, 26 May 2021, for EU MDR is fast approaching. The Danish Medicines Agency (Lægemiddelstyrelsen) recently published guidance regarding the new regulations and their consequences for both industry and Danish authorities. Read their guidance here (Danish...
Material Readiness

Material Readiness

Whether you are manufacturing medical devices, pharmaceuticals or combination products, you will be using materials. Marketing your products in the EU requires that you ensure the quality and safety of the materials used in your products. Early and robust material...
Surface Characterisation

Surface Characterisation

Surfaces are everywhere, and we constantly come into contact with them. To live in this world means touching surfaces, so we rarely give it any thought. But the things that we manufacture that we come into contact with must be safe. This is true for everything we use...