The process layout of the API production workshop is crucial to the normal production and product quality of the workshop. The article analyzes the characteristics, layout principles and factors affecting the layout of API workshops, and focuses on the dimensions, number of layers, layer height and material flow forms of API workshops that are widely […]

After decades of research and development efforts, the biopharmaceutical industry has achieved rapid development, but oral biologics technology is still far away from everyone’s vision. Today, biologics are often administered in a healthcare facility (by IV, or subcutaneously), rather than by the patient at home.   The term “biopharmaceuticals” is generally understood as complex macromolecules,

01 According to the requirements of the EU decision tree, if it cannot be sterilized at 121°C for 15 minutes, the residual probability method with F0≥8 can be selected. Excuse me, if the product can be sterilized at 121°C for 12 minutes, can you not choose 121°C for 10 minutes? Similarly, if it can reach