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
Understanding the importance of TIR17 for medical device manufacturers: TIR17 has evolved over the years to be a necessary resource for device manufacturers, says Wendy Wangsgard, Nelson Labs. Read the Full Story in Medical Plastics News
What medical device manufacturers need to know about the recent changes to the ISO bioburden standard. Read the Full Story in Medical Device Outsourcing
Most national and international standards regarding bioburden, sterilization, or environmental testing refer to establishing alert and action levels to assist in demonstrating continued control over a process or product. The standards sometime include guidance on evaluating the data but seldom...
