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
ISO17664:2017[1] notes that disinfection can be carried out concurrently with manual cleaning of a medical device but does not provide any additional guidance. On the other hand, FDA specifies that cleaning steps should be validated separately and independently from disinfection...
The ISO 17664 series[1][2] as well as the FDA guidance for reprocessing medical devices in health care settings[3] specify that processing instructions should include the required quality of any water that is used for preparing solutions or for rinsing. A...
Acceptance criteria for disinfection validations that are outlined in AAMI TIR12:2020[1] specify that depending on the disinfection level either a 3-log or a 6-log reduction of appropriate microorganisms should be achieved. Mathematically one might be inclined to consider a 5.8-log...
Deciding which disinfection level applies to your non-critical device can be tricky. Non-critical devices are defined as devices that will either only contact intact skin but do not penetrate it, or which have no direct patient contact but may become...
ISO 17664[1] specifies that ”where drying is necessary, at least one verified drying method shall be specified.” FDA provides more detailed information on the importance of drying steps following different stages of processing[2] as outlined below. One important merit of...
