Adsorption Test

  1. The process by which certain components in the medium to be filtered adhere to the filter may affect the composition and concentration of the medium to be filtered. (Interpretation: The purpose of the adsorption experiment is to investigate whether the filter membrane or filter element will take away the key components in the liquid medicine, thereby affecting the quality of the final product.)
  2. Adsorptive materials in a filter include membrane, housing and support materials. Factors such as flow rate, filtration time, concentration of the medium to be filtered, preservative concentration, temperature and pH value may affect the adsorption effect. (Interpretation: Usually, the adsorption experiment is usually divided into two stages. The first stage is to confirm the degree of adsorption of the filter to the medium by reducing the scale in the laboratory, and the second stage is to further confirm on the enlarged or production scale.) Laboratory scale down flow chart.
  3. Based on product integrity testing: Wetting media for post-service integrity testing of filters should be specified.
  4. If the wetting medium used is liquid medicine, the verification of product-related integrity standards should be carried out to support the determination of the standards.
  5.  A scale-down study at laboratory scale is the first part of the product integrity test. The second part is to periodically monitor the product bubble point or the trend of the product diffusion flow under actual process conditions as part of the validation.
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