Common questions related to sterilizing filters and purchase precautions

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pharmaceutical art articles] Network sterile filtration is an important link in the pharmaceutical manufacturing process, it needs to complete the deviceWherein the sterilization filteris mounted in a front end of the vacuum device, the main purpose of simple primary filter bacteria, germs, fungi and the like, to prevent the brightest "gas" cross-infectionsterilization filter before the selection, the user issues need to understand and control devices, such as device pressure, temperature, material selection filter sterilization problemson the use of pressure, the low pressure will depend on the strength of the film, the structure of the filter, the filter material used, the geometry, temperature of the filter medium, and other factorsDenotes the art, in general, the use of a sterilizing filter pressure limit is 0.2-0.3MpaWhen using the cartridge, the starting pressure difference should be about 0.02Mpa, the filter cake layer thus produced is more sparse, the filtration process, the pressure drop increase more slowly, help extend the life of the filtertemperature generally depends on the material of the membrane, i.emembrane for aggressive heat resistance and membrane filtration media, CN-CA membrane long-term use temperature of 50 ℃, nylon-6 film of 60 ℃, PVDF film 80 ℃selection filter material needs to be treated according to the difference between the different solventsIn contrast, material selection filter is a simple single solvent, the solvent will have to be carefully multicomponent membrane material and in the choice of filter, by a solubility parameter may be selected from a crude method, then authentication by experimentFurther, the problem in terms of the cartridge disinfection, sterilization step is a routine operation, the filter comprises a common disinfection three kinds of steam sterilization, hot water and chemicalsWherein the selected note steam sterilization saturated steam, one can reliably kill bacteria, two temperature is adjusted by controlling the pressureFor steam sterilization hydrophobic frit it is relatively simple, but especially the hydrophilic filter membrane material can not high Q filter, the method of operation is essentialaddition to understanding the problems described above since the sterilization filter, the user when selecting sterilizing filter suppliers requires caution Sterilization filter guide mentions that "drug manufacturers in the choice of sterilization filter supplier, should be reviewed to verify documents and quality certificates provided by the supplier, make sure the filters are sterilizing grade filter Drug manufacturers should the sterilization filter manufacturers to be managed as a supplier, such as files or audit the factory site audit, signed agreements and quality control protocols and other product changes "
Therefore, in order to control production risks, the user needs for sterilization filter supplier risk assessment to determine the supplier's management strategy based on the assessment results In addition, the need for a scientific and rational management of suppliers sterilizing filter, in order to ensure production quality and safety of medicines art further remind the user to use the device in the process control environment should be noted that the equipment and operation, and by controlling the production environment sterilizing filter feedstock will affect the control of the filter quality example, in the film production or the production of the filter device, without good quality can affect the control performance of the filter Further, the cleanliness of the filter in a production environment, such as particles, dust and the like cross-contamination of different materials, if not effectively controlled, but also will affect the cleanliness of the finished filter, and cause contamination of the product stock solution.