Technically Unavoidable Particles (TUPs) are always present in excipients. Concern regarding their presence has increased dramatically in recent years due to several US FDA warning letters to pharmaceutical companies, highlighting adverse findings during inspections....
SAXOCON provides microscopic particle count testing in accordance with Method 2 in USP-NF (788). Testing is conducted in our Class N2 clean workspace according to our internal protocols to guarantee the precise identification and measurement of particles that satisfy...
Pharmaceutical and medical device manufacturers need to ensure the safety of the materials used in their products. Particulate contamination is a risk in production facilities. Good Manufacturing Practice (GMP) and proper risk management require the identification of...
Do you use nanomaterials in your production processes, or are they in your final finished product? If so, you are subject to EU regulations that require you to know and document your use of nanomaterials. According to ECHA, products incorporating or consisting of...
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...
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...
