Filtration technology plays a very important role in ensuring the sterility of sterile drugs, especially non-terminal drugs. Factors such as the design of the filtration system, filter selection and verification, and parameter control during use all directly affect the reliability and quality of pharmaceuticals. Therefore, the filtration system is not only a key control point in the enterprise’s sterile drug production process, but also the focus of drug production inspection.
We need to realize that just installing a filter without a process-proven filtration process cannot guarantee efficiency and usefulness. . The verification of the filtration process needs to include verification of the bacterial interception ability of the bacterial filtration membrane under simulated filtration process conditions. Typically, we use defective Pseudomonas as the challenge microorganism. Sometimes, pharmaceutical companies will also isolate typical contaminating microorganisms from the production process and conduct microbial challenges.
Bacterial filter membrane can intercept all kinds of phages, small bacteria and particles above 0.02um. Moreover, the pore size of the material is small and the distribution is concentrated, achieving surface filtration to achieve a dust removal efficiency of 99.9%~99.999%. For some extremely fine particles with a diameter of 0.1um-0.3um, it can well prevent fine dust from entering the filter material. It can operate at a continuous operating temperature of 240°C and an instantaneous temperature of 260°C.
Suzhou New Material Technology Co., Ltd. is a company integrating bacterial filtration membrane, ptfe bubble point membrane, polytetrafluoroethylene film, Teflon Long is a fluorine material membrane manufacturer that integrates R&D, production and sales of membranes and membrane-coated filter materials. The company has advanced bacterial filtration membrane production lines, film coating and composite production lines, which are at the domestic advanced level. The company’s products are widely used in various fields. Interested parties can enter the store for consultation and purchase!
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