Microbiological Updates to 11137-1:2025 – Demonstrating Stability in Bioburden Numbers and Types
The previous version of ISO 11137-1 contained a requirement that manufacturers of products with low bioburden counts...
The previous version of ISO 11137-1 contained a requirement that manufacturers of products with low bioburden counts...
In recent years, concerns have been raised regarding the lack of understanding of bioburden (both numbers and...
In this podcast from Nelson Labs, business leaders who recently returned from the AAMI standards week meetings...
Moist-heat sterilization is a commonly used and widely accepted process in pharmaceutical manufacturing. Given its critical role,...
Ensuring sterility and sterility assurance is crucial in the pharmaceutical industry, as the lack of these can...
This webinar will delve into various aspects of a sterility assurance program for pharmaceutical products, emphasizing its...
In the realm of bioburden, sterilization, and environmental testing, national and international standards play a crucial role...
This webinar will focus on the evaluation of microbiological and environmental monitoring data, highlighting what constitutes significant...
Sterility assurance for pharmaceutical products is of paramount importance, encompassing numerous aspects beyond the actual sterilization cycle...
3D-printed orthopedic medical devices have gained significant attention due to their potential for enhanced biocompatibility, customizability, and...