Hebei Hankai 25x38x7 oil seal
In addition to the materials used, the design of high temperature shaft seals is also crucial for their performance. The seal must effectively block the passage of fluids or gases through the interface between the moving shaft and stationary housing. This requires precise engineering to ensure a tight fit and proper sealing under varying temperature and pressure conditions.
high temperature shaft seals


Moreover, real-time stability studies are conducted under recommended storage conditions. These long-term studies are essential as they help to validate the findings from accelerated studies, providing a comprehensive understanding of how the API will function during its intended shelf life. The data obtained from these stability tests inform pharmaceutical manufacturers about necessary measures for handling, packaging, and labeling, ensuring that the needs of regulatory agencies, such as the FDA or EMA, are met.
The complexity of regulatory requirements cannot be overstated. Companies must navigate an intricate web of local and international regulations, which vary significantly from one jurisdiction to another. This complexity can pose challenges for API manufacturers, particularly smaller firms that may lack the resources to ensure compliance with multiple regulatory frameworks.
active pharmaceutical ingredient industry
