During the second half of 2023, the Association for the Advancement of Medical Instrumentation (AAMI) published a new Standard called ANSI/AAMI ST108:2023. The Standard, replacing AAMI TIR34:2014/(R)2021 provides guidance to the medical device processing industry to effectively manage and maintain a water quality level…
It is quite common to hear the terms “validation” and “verification” used interchangeably amongst those of us who work in Food Safety and, up until the publication of ISO 16140-3, there was no globally accepted standard developed to help labs…
United States Pharmacopeia (USP) published a new microbiology test method, USP <60> Tests for Burkholderia cepacia Complex, with an initial effective date of December 1, 2019. This was in response to numerous infections, and subsequent product recalls, linked to BCC species….
Microbial contamination continues to be the leading cause of recalls of drug and cosmetic products, so, understandably, the first reaction to microbial recovery may be one of dread. However, as with most things in life, understanding what to do, and having…
When it comes to food safety, timely confirmation of pathogens like Listeria monocytogenes is crucial for protecting consumers and maintaining the integrity of the food supply chain. However, traditional confirmation methods often take between 3-7 days, leaving food producers uncertain when making…
Is your laboratory testing partner ready for MoCRA? Cosmetics manufacturers around the globe have been busy registering their facilities with the United States Food & Drug Administration (FDA) as required by the Modernization of Cosmetics Regulations Act (MoCRA). Did you know that…
