Fluids that would be damaged by heat, irradiation or chemical sterilization, such as drug products, can be sterilized by microfiltration using membrane filters. This method is commonly used for heat labile pharmaceuticals and protein solutions in medical drug processing.
A microfilter with pore size 0.2 µm will usually effectively remove microorganisms In the processing of biologics, viruses must be removed, requiring the use of nanofilters with a smaller pore size (20-50 nm) are used.
Smaller pore sizes lower the flow rate; so, in order to achieve higher total throughput to avoid premature blockage, pre-filters might be used to protect small pore membrane filters. Membranes filters are used in production process are commonly made from materials such as mixed cellulose ester or Polyethersulfone (PES).
The filtration equipment and the filters themselves may be purchased as pre-sterilized disposable units in sealed packaging, or must be sterilized by the user, generally by autoclaving at a temperature that does not damage the fragile filter membranes.
0.2 micron and 0.22 micron filters are indistinguishable. Their performance is the same, only the difference being the designation of their pore size rating. The real measure of filter’s ability to sterilize fluid is passing the test described in ASTM F838-05 Standard.
Basically, if the filter can retain a minimum of 1 x 107 colony forming units (cfu) per cm2 of a challenge bacteria (usually B.diminuta5), then the filter is suitable to use for sterilization.
Even with the contraction of the standard pore size for sterilization, it turns out that simple size selection is not a sufficient method to fully contain all the particles. The irregular and tangled nature of the pores of most membrane filters makes them impossible to directly measure the size of an individual pore; so the bubble point test is used to determine the smallest particle that the filter can sieve out of a fluid.
To ensure proper functioning of the filter, the membrane filters are integrity tested post-use and sometime before use. The non-destructive integrity test assures that the filter is undamaged; and is a regulatory requirement. Typically terminal pharmaceutical sterile filtration is preformed inside a clean room to prevent contamination.
Sterile Filtration Market by Product: Membrane Filters, MCE Membrane Filters, Cellulose Acetate Membrane Filters, PTFE Membrane Filters, PVDF Membrane Filters, Nylon Membrane Filters, PES Membrane Filters, Cartridge & Capsules, Syringe Filters, Bottle-top Vacuum Filters, Filter Funnels & Holders, Filtration Accessories, Other Products
Global Sterile Filtration Market by Application: Bioprocesses, Cell Culture Growth Media, Recombinant Proteins, Buffer Filtration, Bioburden Control, Pharma Drugs, Vaccines, Other Bioprocesses, Fill-finish Process, Large-volume Parenterals, Small-volume Parenterals, Syrups, Utilities Filtration, Pre-Filtration, Virus Filtration, Other Applications
Global Sterile Filtration Market by Membrane Pore Size: 0.22 Microns, 0.45 Microns, 0.1 Microns
Global Sterile Filtration Market by End-Users: Pharmaceutical & Biotechnology Companies, Academic Institutes & Research Laboratories, Food & Beverage Industry, Water Filtration Companies
Global Sterile Filtration Market by Geography: North America, U.S., Canada, Europe, Asia Pacific, and Rest of the World.
North America is expected to account for the largest share in the global sterile filtration market in 2015. Asia Pacific is expected to register the fastest growth in the forecast period.
The Key Players include 3M, General Electric Company, Merck & Co., Inc., Pall Corporation, Parker Hannifin Corp, Porvair Filtration Group, Sartorius Stedim Biotech S.A., Sigma-Aldrich Corporation, Starlab Scientific Co., Ltd., Sterlitech Corporation.
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