How to select the filter element of the sterilizing filter?
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Author : indrofiltermachine.com
Update time : 2020-08-17 17:57:59
How to select the filter element of the sterilizing filter?
BACTERICIDAL filtration is a very important sterilization method in pharmaceutical production, and it is even the only means of removing microorganisms from products for injections that are not ultimately sterilized. For Pharmaceutical Manufacturers, the first consideration should be given to how to choose the filter element of the sterilization filter.
Filter elements should be selected on the basis of the following principles：
(1) There shall be no adsorption between the filter material of the filter cartridge and the components to be filtered, the filter material shall not release substances in the components to be filtered, nor shall there be fiber shedding, that is, there shall be good compatibility between the two.
(2) The integrity of the filter cartridge can be accurately tested, such as using bubble point, one-way flow test, etc.
(3) The filter material of the selected sterilizing filter cartridge can be subjected to steam sterilization at 121 °C, and the microbial retention test is qualified. The selection of suitable filter in the production process is usually carried out through a series of small-scale membrane test, through the pilot-scale experiment of the capsule filter cartridge, to determine the best type of filter suitable for the production process.
In order to increase the load of the terminal membrane filter and reduce the cost, the filter combination is often optimized in biopharmaceutical industry by adding a deep layer filter and a surface filter before membrane filtration. Because Titanium Rod can play the role of clarification filter, its low cost, often selected as a large filter capacity of deep filter, aperture can choose 10µm, 5µm or 3µm. The cost of the surface filter is low. Before membrane filtration, the surface filter plays the role of pre-filtration. Generally, PES or polypropylene material is used, and the pore size can be 0.6µm, 0.45µm or 0.2µm. The final filtration of the membrane filter cartridge is more expensive, the maximum rejection rate of the general use of membrane filter cartridge to achieve the final filtering effect, the mostly used is PES filter media, micron rating size selected is 0.2µm or 0.1µm.
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