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Lyophilization is a common method for stabilizing parenteral drugs with poor solution stability. Ensure the success and stability of your lyophilized products by knowing how to evaluate your stopper options and choose the right container-closure system.
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Despite the durability of glass used, breakage of vials is occasionally encountered during lyophilization. Learn how controlling freezing rates, utilizing specialized vials, and employing optimized stoppering techniques can tip the scales in favor of preservation.
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Understanding where the product may fail allows our development scientists to design formulations and processes with meaningful operational ranges supported by robust data. This document outlines our approach to process development for lyophilized products.
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A key limiting factor in any freeze dryer is a phenomenon known as “choked flow.” Here, we observe two experimental methods for determining choked flow: the minimum controllable pressure method and the choke point method.
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Ensuring the vacuum integrity of freeze dryers used in the manufacture of sterile pharmaceutical products is critical for Good Manufacturing Practice (GMP) operations. Explore our innovative approach to establishing leak rate acceptance criteria.
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