Do medical products sealing leakage sealing reason analysis can be written:
1, packaging materials: the inner layer of the heat sealing layer of material selection is not appropriate - according to the contents of the packaging and packaging the use of different environments, should be selected to adapt to the packaging materials. Such as liquid, powder drugs, need to heat sterilization drugs, etc., if the inner layer of heat sealing layer material selection is not appropriate, it is easy to lead to the bag sealing is not tight, easy to rupture the seal, leakage and other issues.
2, improper control of the thermal process: If the thermal process of improper control of the thermal parameters, or thermal equipment itself has defects, it is easy to lead to the sealing of the bag sealing failure, excessive or poor thermal phenomena, resulting in the sealing of broken bags, leakage and other issues. Verified by heat sealing strength, sealing performance (negative pressure method), bursting pressure and other tests.
For example: the strength of heat sealing is about 10N/15mm, the strength of heat sealing is low, and the specimens are broken at the root of heat sealing; sealing performance (negative pressure method) test, the bag rupture at -25.5 ?KPa, and along the root of heat sealing rupture. Therefore, the excessive heat sealing of the bag is the main cause of the broken bag problem.
Medical product sealing considerations
Aseptic packaging sealing process validation, first of all, should form a process validation team to ensure that the process validation work. The members of the confirmation team are generally from the R & D, production, quality control, purchasing and other departments of the staff. Confirmation team should develop process confirmation program and according to the program to complete the process confirmation work.
Through the "people, machines, materials, methods, environment and testing" and other aspects of bacterial endotoxin control in the prescribed range, to ensure that "sterile" medical blister packaging. When sealing, the three elements (time, pressure, temperature) need to be adjusted to find the right sealing parameters. After heat sealing, the sealing effect can be verified by visualizing the adhesive transfer, testing the peeling strength, bursting test and penetration test, etc. to check the integrity of the product sealing.