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...
Nelson Laboratories, Inc. Alpa Patel, senior scientist in healthcare reprocessing, presented at the annual American Association of Tissue Banks (AATB) meeting last month on the topic of Equipment Cleaning and Disinfection Validations, something she calls, “the tissue industry’s compliance challenge.”...
Department Scientist-Healthcare Reprocessing I recently attended the 10th Annual FDA and Changing Paradigm for HCT/P Regulation Conference, with my colleague Wendy Wangsgard, Department Scientist, Bioburden. We presented topics of interest that have surfaced the validation realm, in addition to learning...
On April 14-16, 2014, I attended the Association for the Advancement of Medical Instrumentation (AAMI) semi-annual Sterilization Standards Meeting. These Association meetings, and the standards discussed during them, have a major impact on medical device manufacturers, testing facilities, HCF managers,...
Agenda: Emily Mitzel will present on reusable medical device cleaning, disinfection and sterilization validations at the 2014 MD&M West Conference. Emily is a Laboratory Manager at Nelson Laboratories in Salt Lake City, Utah. Her presentation will include: Standards that govern...
