Gloveless isolators don’t end interventions. Learn to assess intervention dependency in robotic aseptic filling and when glove ports are justified.
|Articles|June 25, 2021
Terminal Sterilization of Sterile Filtered Products
Author(s)Prince Sterilization Services, LLC
Terminal sterilization of aseptically processed drug products is extremely important for patient safety. As such, it is a regulatory requirement that drug products that can withstand terminal sterilization be terminally sterilized. Overkill type sterilization cycles are not required for a drug manufacturer to make a terminal sterilization claim. Many different time and temperature combinations that are much more product friendly can be used to safely terminally sterilize drug products.
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