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In today’s dynamic regulatory and supply chain landscape, more medical device and pharmaceutical manufacturers are exploring changes to their sterilization methods. These shifts are often driven by growing environmental concerns, evolving regulatory expectations, and...

New Approach Methodologies (NAMs)—ranging from in vitro assays to computational models—offer promising alternatives to traditional animal testing. However, their widespread adoption hinges on confidence in their predictive power. Integrating diverse data sources such...

Pyrogen testing is conducted in vivo to detect the presence of various endotoxins and other fever-inducing substances. While bacterial endotoxin testing (BET) can be performed in vitro, it is limited to detecting only bacterial endotoxins. Pyrogen testing, on the...