Automated inspection of lyophilized products was in its infancy in the 1990’s, but has become widely accepted in the 21st century. With advances in computers, cameras and machine learning, many of the initial challenges have been overcome, making automated inspection suitable for many lyophilized products. Following the established guidance for qualification and validation of automated liquid inspection machines, while paying attention to some of the key differences with lyophilized products, provides a robust process to ensure proper automated inspection of lyophilized products. Jeff Najarian is an Associate Director of Vaccine Manufacturing Engineering at Merck & Co., Inc., having started there in 1998 after graduating from the University of Virginia. He is well versed in the end-to-end lifecycle of lyophilized product inspection machines, having supported a dozen of them since 2003. It was not until the past year that he finally branched away from lyo inspection and began to develop deeper knowledge of the lyophilization process itself.
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