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
Choosing a detergent will depend on a combination of three considerations: the device materials, the users, and the cleaning procedure. Reprocessing instructions When selecting a detergent, it is important that the label claim of the cleaning agent you wish to...
It is D-day, or the Day of Application (DoA) for the Medical Device Regulation (MDR) EU 2017/745. Years of hard work have preceded this date to prepare for this new regulation. The key message of the MDR is to minimize...
FDA’s guidance on reprocessing re-usable medical devices[1] indicates that in addition to reprocessing instructions that allow for thorough cleaning, an appropriate microbicidal process should be in place. Which terminal processing step should be included will depend on the device’s potential...
Before looking into the validation requirements of thermal disinfection, let’s first go a bit more into what thermal disinfection is and why you should consider having a thermal disinfection procedure in place. What is thermal disinfection? Thermal disinfection is defined...
ISO17664:2017 provides guidance on this issue and states that “At least one validated automated cleaning method (which may include a validated manual cleaning method as part of the automated cleaning validation) shall be specified unless the medical device cannot withstand...
