Optical Density Value and Ratio as Novel Indexes for Nanoemulsion Sterile Filtration Process Control or Characterization.

Sterile filtration is an effective method to remove any microorganisms present during nanoemulsion preparation. However, it lacks effective control parameters. Here, we established a simple and rapid approach for the process control of nanoemulsion sterile filtration by utilizing optical density detection as a process control parameter. During sterile filtration, the optical density or optical density ratio of the filtrate were continuously monitored to explore the correlation between optical density and the emulsion content and the change in the optical density ratio before and after sterile filtration. In the emulsion stability test, the optical density ratio was determined. A good correlation was obtained between the optical density and the nanoemulsion content during sterile filtration, thereby reducing sterile filtration loss. The optical density ratio changed significantly after sterile filtration, indicating that it could be used as a process control parameter to monitor leakage during emulsion sterile filtration. The optical density ratio can be a characterization index for stability monitoring as it is more sensitive than particle size detection and more convenient than large particle detection. These parameters may be used for sterile filtration process control and as an index for nanoemulsion characterization. This approach overcomes the limitations of existing nanoemulsion characterization methods.