The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
Sterilization modalities and medical device packaging are deeply interdependent decisions that should be evaluated together from the earliest stages of product development. This white paper examines how ethylene oxide and radiation sterilization processes can influence sterile barrier system performance. Join...
Biocompatibility is often treated as a milestone, a box to check on the path to regulatory approval. In reality, it is the cumulative outcome of hundreds of decisions made long before a device ever reaches a test lab. Every choice...
In this article Bryce Telford and Logan Luke discuss the unique considerations, such as sterilization and packaging, to chart a course for regulatory approval of 3D-printed devices. Read the Article in ODT Learn more about the authors.
Container closure integrity, which is verified by container closure integrity testing (CCIT), is critical to ensure the sterility of drug products. Physical, chemical, and biological assessments must be carried out to make sure components are compatible and fit for use....
