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Large-volume injection process
Large volume parenteral (LVP) refers to single-unit doses exceeding 50ml. Prefiltration is used to remove particulate matter to prolong the life of the final (sterilizing) filter. The final filter is used to reduce bioburden or for sterile filtration prior to terminal sterilization. LVP volumes typically range from tens of thousands of liters, with multiple filling lines potentially operating simultaneously.
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Public system water use
Pharmaceutical grade water refers to the water supply commonly used in process systems such as washing machines, autoclaves, or WFI systems. Due to the great variability in source water quality, only a suitable filtration system can ensure efficient, safe, and successful production.
Culture medium
Cells used to produce therapeutic proteins require a precise nutrient balance to support their proliferation and growth. These nutrients are provided by a medium that must be sterile. Terminal sterilization should ensure the removal of bacteria and mycoplasma from media containing animal-derived components. The medium is then stored in fermenters or bioreactors after batch preparation and sterile filtration. Pre-filters are used to remove most particulate and colloidal contaminants from the medium to prolong the life of the final sterilizing filter.
Maximum operating temperature of filter membranes made from different materials
Concentrated separation membrane knowledge - microfiltration, ultrafiltration, nanofiltration and reverse osmosis
A membrane is a material with selective separation function. The process of using membrane selective separation to separate, purify, and concentrate different components of a liquid is called membrane separation. It differs from traditional filtration because membranes can separate at the molecular level, and this process is a physical process that does not require phase change or the addition of additives. The pore size of the membrane is usually in the micrometer range. According to its pore size (also known as molecular weight cut-off), membranes can be divided into microfiltration membranes, ultrafiltration membranes, nanofiltration membranes, and reverse osmosis membranes. According to the material, they can be divided into inorganic membranes and organic membranes. Inorganic membranes are mainly ceramic membranes and metal membranes, which have lower filtration accuracy and selectivity. Organic membranes are made of polymer materials such as cellulose acetate, aromatic polyamide, polyethersulfone, and polyfluoropolymers. In cross-flow membrane processes, the separation and retention performance of various membranes depends on the pore size and molecular weight cut-off of the membrane. The following figure briefly illustrates five different membrane separation processes: (The reflected arrow indicates that the substance cannot pass through the membrane and is retained):
EPJPUSP Pharmacopoeia requirements for purified water
Water quality design