正如《制药设备和工艺验证》一书中所强调的，渗漏主要发生在膜材料和界面焊

As highlighted in the book "Pharmaceutical Equipment and Process Validation", leakage occurs mainly at membrane materials and interface welds. The main reason is improper control of interface heat sealing temperature and heat sealing time. The heat sealing temperature setting is low, the heat sealing time is set short, the heat sealing mold gap is large, and the surface of the heat sealing mold is dirty, which leads to uneven heat transfer, etc. It will cause false welding at the interface of the soft bag, otherwise there will be over-welding and leakage. The second key point of leakage is at the connection between the interface and the combined cover. The leakage here is mainly due to the heating element being used for a long time, and the heating element is oxidized, resulting in excessive heat loss. In the "Drug GMP Guidelines" issued by the Drug Certification Management Center, it is mentioned that for the filling of large-volume injections, the integrity of the product seal after filling should be the focus of the verification work, which shows the importance of product sealing for injections.

As emphasized in the book "Pharmaceutical Equipment and Process Validation", leakage mainly occurs at the membrane material and interface welding points. The main reason is improper control of interface heat sealing temperature and heat sealing time. The setting of the heat sealing temperature is low, the setting of the heat sealing time is short, the gap between the heat sealing molds is large, and the surface of the heat sealing molds is dirty, resulting in uneven heat transfer. It can cause false soldering of the soft bag interface, otherwise it may cause over soldering and cause leakage. The second key point of leakage is at the connection between the interface and the combination cover. The leakage here is mainly due to the prolonged use of the heating element, which is oxidized, resulting in excessive heat loss. In the "GMP Guidelines for Drugs" released by the Drug Certification Management Center, it is mentioned that for the filling of large volume injections, the integrity of the product seal after filling should be the focus of verification work, indicating the importance of sealing injection products.

As emphasized in the book "Pharmaceutical Equipment and Process Verification", leakage mainly occurs at the joint of membrane materials and interfaces. The main reason is improper control of interface heat sealing temperature and time. Low sealing temperature setting, short sealing time setting, large sealing die gap, dirty sealing die surface leading to uneven heat transfer, etc. It will lead to virtual welding of the soft bag interface, otherwise there will be over-welding and leakage. The second key point of leakage is at the joint between the interface and the combined cover. The leakage here is mainly due to the long service time of the heating element and the oxidation of the heating element, resulting in excessive heat loss. In the GMP Guide issued by the Drug Certification Management Center, it is mentioned that for the filling of large-capacity injections, the integrity of product sealing after filling should be the focus of verification, which shows the importance of product sealing for injection.