Using Charles River Celsis® ATP-bioluminescence detection, Novartis has successfully validated a direct inoculation rapid sterility assay, reducing the time-to-result to only seven days. Join Dr. David Roesti of Novartis as he discusses the validation of this method and its non-inferiority to compendial testing. He will also present examples of validation criteria, including the statistical analysis and ways to optimize the limit of detection.


  • David Roesti, PhD, Technical Steward, Microbiology, Manufacturing Science & Technology, Novartis Pharma Schweiz AG