The primary place where leakage occ

The primary place where leakage occurs is at the membrane material and interface welding, as emphasized in the book Pharmaceutical Equipment and Process Validation. The main reason is improper control of the interface heat sealing temperature and heat sealing time. Low heat sealing temperature setting, short heat sealing time setting, large gap between heat sealing molds, uneven heat transfer caused by dirt on the surface of heat sealing molds, etc. will cause virtual welding at the interface of the soft bag, otherwise, over welding will occur, which will cause leakage. liquid. The secondary leakage occurs at the joint between the interface and the combination 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. It is mentioned in the drug GMP guidelines issued by the Drug Certification Management Center that the integrity of the product seal after filling should be taken as the key point in the verification work for the filling of large-volume injections, which shows the importance of product sealing for injections.