All stages of biopharmaceutical production rely on efficient and dependable membrane air, gas, and exhaust filtration to safeguard important drug quality features and, ultimately, patient safety. During the process, such as exhaust gas from storage tanks or bioreactors, compressed gas filtering, and high temperature or high oxidation conditions, sterilization-grade air filters can safeguard biopharmaceutical products from microbial or particle contamination. Non-sterile filters can help non-critical applications reduce their bioburden.
Alfa Chemistry has built an air filtration product line that meets the demanding quality standards of all biopharmaceutical applications, based on its filtering experience. From testing to cGMP conditions, high-quality hydrophobic membranes in several scalable configurations can suit air filtering needs. To satisfy the requirements of stainless steel and disposable processes, our air filtration solutions include several filter elements and filter capsules.
Various Product Applications
It's critical to examine not just the filter type and size when selecting an air filtration system, but also the process operating circumstances, such as sterilizing procedures, temperature, regulatory requirements, and integrity testing needs.
1. Stainless Steel Filtration for Air and Gas Sterilization
The highest level of sterility assurance is required in many applications in essential biotechnology processes. Filter inert compressed gas and provide ventilation and filtering for storage tanks and bioreactors using sterilization-grade air filters.
- Products to Consider:
PTFE sterilization grade membrane filter cartridges and capsules have been designed specifically for use as air filters, with high strength and long life, and are suitable for nitrogen protection or compressed gas applications in stainless steel bioreactors, as well as filling operations at temperatures below 60 °C. The sterile-grade filter membrane is hydrophobic and chemically inert, and it meets the requirements of international standards for the elimination of microorganisms. In liquid, the film is removed at a rate of 0.2 µm, while in dry gas, it is removed at a rate of 0.003 µm.
2. Filtration of Sterile Air in Disposable Systems
Gamma radiation stabilized filters are required for disposable bioreactors, biocontainers, and filling processes. Filters compatible with and confirmed to be sterilized by gamma up to 50 kGy should be used by users who require this type of filter sterilization.
- Products to Consider:
The high particle capacity of PVDF sterilized membrane air filter cartridges and capsules has been validated by gamma irradiation, and they can be utilized in disposable systems.
3. High Temperature, Ozone Water Discharge, and Oxygen-enriched Applications
A specific filter element is required for sterilization grade filtering in high temperature, ozone water discharge, or oxygen-enriched air applications.
Exhaust filter on the storage tank: To create a sterile barrier and free movement for air in and out of the tank top space, an exhaust filter must be fitted on the water for the injection storage tank.
Ozone water tank: Since ozone is only weakly soluble in water, it will escape as gas and collect in the tank's headspace and vent filter. Ozone is a powerful oxidant, as is its breakdown product oxygen. As a result, the filter should be resistant to oxidation and has been tested in water with an ozone concentration of up to 100 ppb at 40 °C.
Oxygen-enriched air and pure oxygen in cell culture applications: High-strength broths with increased biomass are being used to boost the productivity of mammalian and microbial cell culture applications, resulting in higher product yields. A high oxygen demand will result from these circumstances. As a result, the sterile air filters on the bioreactor's input and exit will be exposed to a highly oxidizing environment, potentially resulting in filter damage, particularly during protracted fermentation. As a result, air filters for these applications must be developed and tested to withstand exposure to both oxygen-enriched and pure oxygen.
- Products to Consider:
The PTFE sterilization grade membrane filter element is designed for sterile air filtration in high oxidation applications such as oxygen-enriched bioreactors or process steps with a temperature greater than 60 °C, such as autoclaves, fermentation inlet air, and so on. For a long period, the improved filter element has been demonstrated to work in high temperature or high oxidizing situations.
4. Bioburden Reduction
Non-sterile filters can be used to filter the air in non-critical ventilation and gas applications when high flow rates and little bioburden are required.
- Products to Consider:
Through an optimized membrane combined with a high filtration area per 254 mm (10 inches) filter element, the PFA membrane gas filter element provides the highest level of bioburden reduction and high flow rate.
5. Protection of Sterilizing-grade Filters in Air and Gas Applications
Pre-filters may help reduce the frequency with which more specialized membrane air filters are replaced in particular processes (such as sterile-grade filters).
- Products to Consider:
A patented tapered hole polypropylene depth medium is used in all polypropylene filter capsules and filter components, and there are many distinct forms to choose from. It's ideal for fine particle and pre-filtration applications where purity, dependability, and cost-effectiveness are critical.