There are many applications for sterile filtration, including the preparation of media containing infectious agents
In the pharmaceutical industry, sterile
filtration is used to prevent microbial contamination. By providing a reliable,
safe, and effective way to ensure product manufacturing, the process reduces
the risk of microbial contamination in patients. Multiple vendors offer an
extensive range of products and formats for a wide range of applications. In
any pharmaceutical operation, it is the most important filtration process.
The US
Food and Drug Administration (US FDA) and the United States Pharmacopoeia (USP)
define sterile
filtration as producing sterile effluent with nominal ratings of 0.2 m
and 0.22 m, respectively. The goal of a sterile filtration step is to remove
any viable microorganisms from the bulk product.
For sterile filtration, what type of filtration is used?
Microporous
filtration effectively prevents contamination and maintains sterility.
Biological contaminants such as bacteria, mold, and yeast are removed by
filtration through a membrane with a pore size of 0.2 microns or smaller.
What is the purpose of filter sterilization?
Filtration allows
organisms to be excluded based on their size. There are many different types of
filtration techniques, but membrane filtration is used to sterilize a system.
Membrane filtration traps contaminants on the membrane's surface that are
larger than the pore size.
Sterile filtration is used in a variety of applications, including the preparation of media containing or without serum. Cell culture, reagents, or solutions containing sensitive components that may degrade when exposed to autoclave temperatures, filtering supplements, samples, buffers, and post-fermentation broths can all benefit from the process.
The benefits of sterile filters over non-sterile filters make them the preferred choice for upstream and downstream processing in the pharmaceutical and biopharmaceutical industries, as well as in the food and beverage industry. For optimal filtration of liquids and gases, sterile filters are available in a variety of formats, including syringes, cartridges, capsules, and disposable sterile filter systems. Non-sterile filters are used for general filtration and sample purification. In comparison to non-sterile filters, sterile filters are more effective at removing all microorganisms and particles from liquids and gases. Furthermore, with complete ready-to-use units, sterile filters reduce the risk of contamination.
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