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The price of unforeseen interactions can be steep, including potential product launch delays, as well as possible product recalls in the case of a combination product experiencing functional or safety challenges post-launch.1 As a component of a combination product in constant contact with the biologic drug, the plunger stopper plays a critical role in determining the combination products exposure to extractables and leachables

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For instance, various metal-based nanoparticles, such as Zn and Ag, produce ROS by causing initial membrane damage 162,163

In addition, we specify the expected measurement noise assuming a log-normal distribution with constant standard deviation for each measured target