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
In this article Richard Wiens, Director of Strategic Supply & Marketing at Nordion, a sister company of Nelson Labs, talks about the wide use of Cobalt-60 for gamma irradiation in the medical-device and pharmaceutical industries. He also discusses alternative of...
The FDA has reclassified surgical staplers and staples from Class I to Class II devices, requiring them to undergo premarket review. Since they have been reclassified, these devices will now be subject to more stringent regulatory requirements, such as premarket...
This roundtable discussion examines the technological and regulatory factors affecting the third-party testing and analysis services industry. Medical and orthopedic devices are becoming smaller and more complex. Manufacturing technologies are advancing, new materials are frequently being created, and regulations are...
The industry currently is lacking sufficient guidance from regulatory bodies regarding the disinfection requirements for non-patient-contacting, noncritical medical devices or equipment. A more practical disinfection level is needed – one that represents the actual use and probable contamination of these...
There are many options available for Container Closure Integrity (CCI) testing of glass vials and syringes. From traditional probabilistic methods like Dye Immersion (tracer dye) or Bacterial or Microbial Challenge testing, to a variety of deterministic methods like Vacuum Leak,...
