单位面积的流速高于已验证的流速过滤压差超过被验证压差过滤时间超过被验证

The flow rate per unit area is higher than the verified flow rate, the <br>filtration pressure difference exceeds the verified pressure difference, the <br>filtration time exceeds the verified time, and the <br>filtration area is unchanged. The <br>filter sterilization condition or the sterilization method is changed. The <br>filter manufacturer changes , The change of the filter production process, or the change of the membrane material or structural composition of the <br>filter, should first evaluate whether the filter manufacturer’s verification documents can cover different applications in actual production. <br>The service life of the gas filter and the frequency of replacement should be verified. <br>Verification should be based on the following considerations: filter integrity, appearance, sterilization times, working temperature, point of use, etc. <br>If the equipment comes with a filter housing (such as fermentation system, liquid distribution system, washing, drying and irrigation equipment, freeze dryer, water system, compressed air system, etc.), the housing should always be used in conjunction with the original equipment and cannot be replaced; At this time, there is no need to perform number management for this type of filter housing. <br>The filter shell shall be established by the material management post of each workshop, "Filter shell receiving and issuing account" F-SOP-03-4-0-014-01 and unified management, each shell shall have a clear code, This code can use the equipment number given by the equipment department. <br>The workshop material management post submits a purchase application according to the work needs of each post, and the workshop director submits it to the manager of the production management department for approval after review. <br>After receiving the filter element from the material management post of the workshop, the "Filter Element Receiving and Issuing Ledger" F-SOP-03-4-0-014-02 should be established according to the name of the filter element. <br>The number of the filter element is the same as the factory number of the filter element (article number, batch number, serial number, etc.). <br>When the filter element (membrane) is distributed to each post, the person in charge of the post should review whether the specifications, accuracy, and materials meet the process requirements. <br>If the filter element is used repeatedly, it is necessary to fill in the "Filter Element Use, Maintenance and Replacement Record" F-SOP-03-4-0-014-03 according to the filter cleaning and maintenance SOP regulations of each workshop.<br>The quality certificate of the filter element (membrane) should be delivered to the workshop statistician for uniform preservation, and the serial number (article number, batch number, serial number, etc.) of the corresponding filter element (membrane) should be indicated on each certificate. <br>The location of the filter should be convenient for its installation, disassembly, testing and other operations. <br>The connection between the filter and the equipment supporting the filter, the ground, the wall, etc. should be firm and reliable. <br>The components of the filter should be tightly joined, well sealed, able to withstand the production operating pressure, and be free of leakage or deformation. <br>Before installing the filter element and membrane, confirm that their specifications, models and appearance meet the requirements.

The flow rate per unit area is higher than the verified flow rate.<br>The filter pressure difference exceeds the verified pressure difference.<br>The filtering time exceeds the verified time.<br>Increase the amount of filtration if the filter area remains the same.<br>Filter sterilization conditions or sterilization methods change.<br>Changes in the filter manufacturer, changes in the filter production process, or changes in the film or structural composition of the filter.<br>The filter manufacturer's validation file should first be evaluated to see if it can already cover different applications in actual production.<br>The service life of the gas filter and the frequency of replacement should be verified.<br>Verification should be considered from the following considerations: filter integrity, appearance, number of sterilizations, temperature of operation, point of use, etc.<br>Equipment comes with filter housing (e.g. fermentation system, distribution system, washing and irrigation equipment, freeze-drying machine, water system, compressed air system, etc.), the housing should always be used with the original equipment, not to replace;<br>Filter housing by the workshop material management post to establish a "filter shell collar, release ledger" F-SOP-03-4-0-014-01 and unified management, each shell shell should have a clear code, this code can use the equipment number given by the equipment department.<br>Workshop material management posts according to the needs of each post work to apply for procurement, workshop director after examination and approval to the production management department manager, materials department after purchase, pick up and issued to each post for use.<br>After receiving the filter element at the workshop material management post, the filter should be established according to the filter name" F-SOP-03-4-014-02.<br>The filter number follows the filter filter factory number (goods number, lot number, serial number, etc.).<br>Filter (membrane) issued to each post, the post responsible person should review the specifications, accuracy, material, etc. in line with the process requirements.<br>Repeated use of filters is required to fill in the "filter use, maintenance and replacement records" F-SOP-03-4-0-014-03 in accordance with the SOP regulations for cleaning and maintenance of each workshop filter.<br>The quality certificate of the filter element (film) shall be handed over to the workshop statistician for unified preservation, and the corresponding filter element (film) number (goods number, lot number, serial number, etc.) shall be indicated on each certificate.<br>The filter should be positioned to facilitate its installation, removal, detection and other operations.<br>The connection between the filter and the equipment, floor, wall, etc. supporting the filter should be secure and reliable.<br>The filter components should be tightly joined, well sealed, able to withstand production operating pressure, and no leakage, deformation.<br>Filter element, membrane installation should confirm its specifications, model, appearance in line with the requirements.

The flow rate per unit area is higher than that verified<br>The filtration pressure difference exceeds the verified pressure difference<br>The filtering time exceeds the verified time<br>Increase the filtration capacity under the condition of constant filtration area<br>Change of filter sterilization conditions or sterilization methods<br>Change of filter material or membrane composition<br>It should first be evaluated whether the filter manufacturer's validation documents already cover different applications in actual production.<br>The service life and replacement frequency of gas filter shall be verified.<br>Verification should be considered from the following aspects: filter integrity, appearance, sterilization times, working temperature, use point, etc.<br>If the equipment has its own filter shell (e.g. fermentation system, liquid preparation system, washing, drying and filling equipment, freeze-drying machine, water system, compressed air system, etc.), the shell should always be used together with the original equipment and should not be replaced; at this time, there is no need to carry out number management on such filter shells.<br>The material management post of each workshop shall establish the "filter shell receiving and distributing standing book" f-sop-03-4-0-014-01 and manage it uniformly. Each shell shell shell should have a clear code, which can use the equipment number given by the equipment department.<br>The workshop material management post shall submit the purchase application according to the work needs of each post. The workshop director shall review the application and submit it to the manager of production management department for approval. After the material department purchases, it shall be collected and distributed to each post for use.<br>After the material management post of the workshop receives the filter element, it shall establish the "filter element collection and distribution account" f-sop-03-4-0-014-02 according to the filter element name.<br>The serial number of filter element follows the factory number of filter element (article number, batch number, serial number, etc.).<br>When the filter element (membrane) is distributed to each post, the person in charge of the post shall check whether the specification, accuracy and material meet the process requirements.<br>If the filter element is used repeatedly, fill in "filter element use, maintenance and replacement record" f-sop-03-4-0-014-03 according to the filter cleaning and maintenance SOP of each workshop.<br>The quality certificate of filter element (membrane) shall be submitted to the workshop statistician for unified preservation, and the corresponding filter element (membrane) number (product number, batch number, serial number, etc.) shall be indicated on each certificate.<br>The filter should be placed at a position convenient for its installation, disassembly, detection and other operations.<br>The connection between the filter and the equipment, floor and wall supporting the filter shall be firm and reliable.<br>All parts of the filter should be tightly connected and well sealed to withstand the production operation pressure without leakage and deformation.<br>The specifications, models and appearance of filter element and membrane shall be confirmed to meet the requirements before installation.<br>