ProJect Pharmaceutics GmbH’s Post

Are you sure your stopper is dry enough to be safe enough for your lyophilized drug product's stability? Have you ever experienced increase in residual moisture content in your lyophilized drug product and could not explain why? Do you know the moisture uptake capacities & water release characteristics of your lyo stopper? An increased residual moisture content could be caused by incomplete drying of the stopper after sterilization. Some stoppers feature a higher moisture uptake potential, weaker stopper drying kinetics and lower water release characteristics than others. Some stoppers are simply subjected to an inefficient drying process at the CMO – without anyone noticing. Check out our “check your lyo stopper“ service offering: You do not need to have a project running with us. You do not need to disclose your API nor any other details of your drug product. We simply need the sterilization and drying process protocol for your stoppers as performed at your CMO, and some stoppers (~ 100 pcs). Our experts will conduct a comparative evaluation on your stoppers versus modern state-of-the-art stoppers and carefully evaluate stopper drying kinetics, moisture uptake potential & water release characteristic. If you also want to find out whether you are already using a stopper that safeguards your lyo product, contact us at info@project-pharmaceutics.com. To learn more about our fields of expertise visit: https://lnkd.in/ePm5bWyF #processdevelopment #lyophilization #freezedrying #pharmaceuticalmanufacturing #CRO

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