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Sterile Filtration for Compressed Air Systems
The need for 100% sterile, bacteria-free compressed air is common to a range of industries as diverse as the applications they serve. Food processing and packaging, aseptic packaging, beverage manufacturing and bottling, brewing, dairying and pharmaceuticals are just some of the industries that require uncompromising compressed air and gas sterility for their processes. Sterile filters must effectively remove and retain all bacteria and viruses as well as other organisms and contaminants.
Sterilization filters are extremely fine filters designed to remove microorganisms. The correct use of sterile filters therefore requires prior filtering and cleaning of the incoming compressed air; air free of oil and water and coarse pollutants. Therefore, it is imperative that the filtration model used uses a tiered approach. Ideally, sanitary industrial filters, including at least a pre-filter and a coalescing filter, should be installed before the final sterile filter. A pre-filter will remove coarse contaminants that would otherwise dramatically shorten the life of filters installed after it. Next in line you need to install a coalescing filter to remove any oil and water in the system. In addition, an activated carbon filter could be installed behind the coalescing filter to remove odors from the air intake. Finally, in typical installations, install a sterilizing filter just before the point of use to prevent infections on the sterile side. Sterile cross contamination is possible in every pipeline, pipe fitting, valve and faucet. The recommended direction of air flow in the filter element is radiation from outside to inside.
Once in-line, the new unit must be sterilized before use to ensure 100% sterility of the working environment. This is where many applications go wrong, as it is often assumed that sterility is already in place. Two methods are recommended for filter sterilization. Almost any use carries the risk of possible increased bacterial growth on the receiver, and possible backgrowth of microbes through the tubing to the sterile filter. Therefore, you need to sterilize each system frequently according to specific conditions. One approach uses hydrogen peroxide, which should not be a problem for the installed filter element. Check with the manufacturer to see if your filter element can be sterilized in this way. When sterilizing with hydrogen peroxide as the active agent, H202 deposits must be drained from the housing before operating the system. Another option for preparing your filter for use involves on-site steam sterilization. Introduce steam into the sterile filter using a bypass inlet line. In this case, use a steam filter to remove coarse contaminants from the compressed steam, ensuring a longer life for the sterile filter element. It is important to note that you must re-sterilize your filter system every time you replace the filter element. It is also recommended that filter systems be re-sterilized after each system shutdown, as bacterial growth can occur in an inactive environment. You must replace the element if your filter reaches the permissible differential pressure of 0.7 bar to 1 bar and if the total steam sterilization cycle of 100 times or 100 hours has been reached.
The manufacturer must construct their sterile filters with elements constructed of stainless steel inner and outer support sleeves to withstand air or gas surges and stainless steel end caps. They must also feature three-dimensional media layering and a 100 percent seamless submicrofiber mesh with 94 percent void volume to support a two-stage depth filtration model. Depth filters must operate at 99.99998% efficiency down to a particle size of 0.01 microns. Element media should also boast zero migrations and zero extractions. Problems can arise if the filter elements contain binders that provide a nutrient medium for microorganisms and thus promote growth. Filter elements must also be chemically, biochemically and biologically neutral and inert and resistant to chemicals and high temperatures. Elements must be resistant to steam or H202 sterilization before use. Properly constructed sterile filters must also have stainless steel housings without slots to ensure 100% sterile filtration of air and gases.
Performance characteristics to look for in a truly effective sterile filter include:
- Ability to withstand sterilization up to 200°C;
- Steam sterilization cycles up to 100 times or 100 hours;
- Suitability for steam sterilization in place of standard or reverse sterilization;
- Guaranteed 100% maintained sterility;
- Resistance to differential pressure of 5 bar;
- Load capacities between 0% and 200% of nominal flow;
- 100% element sealing with double 0-ring construction;
- Microfiber filter media without antifouling binders;
- Finally, both elements and housings should be manufactured with minimum tolerances.
Proper selection, configuration, installation and maintenance are key factors in creating and maintaining a 100% sterile environment for your specific process. All criteria must be met to ensure consistent sterility. Be sure to select the right filters for your system design and develop a maintenance plan that will ensure a sustainable sterile environment for your application.
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