Requirements for sterile production - depyrogenation of primary packaging materials

High standards of purity must be maintained in the production of pharmaceuticals. Biopharmaceuticals in particular, which, contrary to regulatory guidelines, cannot be sterilized in the final vessel, must be prepared from absolutely pure ingredients under aseptic conditions. Pyrogens are a highly complex group of impurities that can sometimes cause severe adverse reactions when administered to the bloodstream. Therefore, reliable depyrogenation of the primary packaging material is critical to the biopharmaceutical manufacturing process. But how do you know when the primary packaging material has been successfully depyrogenated? Download our whitepaper to find out more details.