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Large-volume injection process

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

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.

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Culture medium

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.

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