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Plasma separation filtration

Plasma separation filtration

Human blood plasma contains many valuable therapeutic proteins, such as albumin, various immunoglobulins, factor VIII, fibrinogen, and other proteins. The process of extracting and purifying these proteins is called plasma fractionation. Plasma fractionation is achieved through a series of extractions and purifications of these proteins.

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Eye drop filtration solution

Eye drop filtration solution

Ophthalmic preparations, from contact lens cleaning and storage solutions to rinsing solutions in ophthalmic surgery and eye treatment products, must meet stringent regulatory requirements and product specifications. The majority of most eye drops are composed of water. In addition, there may be salts such as sodium chloride, preservatives, petroleum jelly used in the production of ointments, and gel polymers used as lubricants. Heat-sensitive ophthalmic solutions can be sterilized by filtration or by adding sterilizing components to pre-sterilized bulk solutions.

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Small-volume parenteral (SVP) injection

Small-volume parenteral (SVP) injection

Small-volume parenterals (SVPs) encompass a variety of conventional and bioengineered drugs. These drugs are typically packaged in vials (less than 20ml), pre-filled syringes, and ampoules, or are formulated as lyophilized powders. Many SVPs require sterility because of their lack of thermal stability.

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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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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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