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
Nelson Labs Europe is pleased to announce that we have recently expanded our ISO17025 accreditation for our healthcare reprocessing services. Reusable medical devices must be properly cleaned, disinfected, and/or sterilized. One of the services that Nelson Labs offers is to...
The following poster was presented at the Extractables & Leachables session of the annual conference of American Society for Mass Spectrometry (ASMS) in Minneapolis. Read the following abstract to learn more. Routine E&L testing of medical devices requires extraction using...
Six steps to assess the situation and determine how to move forward… Each medical device present or coming on the market needs to have a demonstrated biocompatibility to protect users from potential biological risks arising from its intended clinical use....
Understanding the sterility assurance level To understand how steam sterilization processes are validated, it is important to understand some key concepts about sterilization. The purpose of sterilization is to inactivate microbiological contaminants, thereby rendering products sterile[1]. The kinetics of inactivation...
ISO 17664:2017[1] as well as FDA[2] state that if a medical device is intended to be sterilized, at least one validated sterilization method must be specified in the IFU. Consequently, if devices are intended to be steam sterilized, at least...
