Select Page
Updated ISO 10993-17:2023 Standard

Updated ISO 10993-17:2023 Standard

The ISO 10993 standard series covers the biological evaluation of medical devices. Part 17 of this series addresses the toxicological risk of chemical constituents resulting from the chemical characterization of medical devices. In its first major revision in 20...
New FDA NDSRI Guidelines

New FDA NDSRI Guidelines

The Food and Drug Administration (FDA) is updating its guidance regarding Nitrosamine Drug Substance-Related Impurities (NDSRIs). With this update, the FDA acknowledges the leading scientific research by introducing a novel framework for determining the Acceptable...
New ECHA Chemicals Enforcement Project

New ECHA Chemicals Enforcement Project

The European Chemical Agency (ECHA) is launching a project to check the compliance of products sold online with REACH and CLP requirements. Currently, chemical products sold online are largely non-compliant. Starting in 2025, ECHA inspectors will check products sold...
Particulate Contamination

Particulate Contamination

Particulate contamination is a risk in pharmaceutical production facilities. Good Manufacturing Practice (GMP) and proper risk management requires identifying root causes and evaluating what impact a particulate matter finding has on product safety. Understanding the...
Nitrosamine Contamination

Nitrosamine Contamination

As a pharmaceutical manufacturer, you need to know whether your products contain nitrosamine impurities and, if so, whether they are below the thresholds established by various regulatory agencies. Nitrosamine impurities can be introduced at any stage in the supply...
ISO 10993-17 Development

ISO 10993-17 Development

We are very proud that our CTO, Carsten Senholt, has a central role in the international writing group developing ISO 10993-17, which was recently submitted as a final draft. The ISO 10993 series is a suite of standards covering the biological evaluation of medical...