adsorption research-simple is not simple
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adsorptionrefers to the process by which certain components in the medium to be filtered adhere to the filter membrane (or filter), which may affect the components and concentration of the medium to be filtered.
filters includeFilter Membranes, Housing and Support Materials.Flow rate, filtration time, concentration of media to be filtered, concentration of preservative, temperatureandpHand other factors may affect the adsorption effect.
For some filtration processes with relatively high adsorption but still acceptable, it can be used before final filling.buffer tank, thereby reducing the effect of adsorption on product concentration. In the process development process, adsorption tests are usually carried out at the time of the small test, and then inconfirmed in scale-up production. These tests can also be used to establish possiblepretreatment process(e. g. buffer rinse, soak),operating parametersormembrane material.
inbacteria reduction filtrationandpre-filtrationprocess, and the 2018 SFDA Verification Center issued the "Guidelines for Aseptic Filtration Technology and Application" requiring:"shall verify that the bacteria reduction filter does not have a negative impact on the drug solution. The verification of the bacteria reduction filtration process can be used as part of the product process verification. …… The verification of the bacteria reduction filtration process should include chemical compatibility, extractables/leachate and adsorption, etc."
in the case of adsorption studies, there is a common classpreservatives. In many pharmaceutical processes, preservatives are added to prevent or destroy the growth of microorganisms, and preservatives are easily adsorbed by filters and related materials, which may lead to reduced or loss of preservative effect.
preservatives are commonly used.Benzalkonium Chloride (BAK)is often used as a model preservative because it has both hydrophobic and electrostatic properties. Many research experiments show that the adsorption of BAK by the filter membrane is related tofilter membraneandthe physical and chemical properties of BAK itselfrelated. Usually from the existing filter membrane material screening and testing, can find relatively low adsorption.Filter element material; in addition, formulation-related factors, suchavoid the use of salts, and process-related factors suchPretreatment of filtration membranes, the loss of BAK can be further reduced. If an active substance is present in a particular formulation, the interaction between BAK and the active substance should also be evaluated and there may beBAK and active substances.
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