Identification of Parameter Variables in the ISO 11607 Sealing Process

In the production of sterile packaging materials for medical use, in addition to materials selection, the heat-sealing process can directly affect the outcomes of packaging materials tests and the maintenance of the sterile barrier system. Control of the following factors during production will determine the performance of the heat-sealing process.

Temperature

The sealing temperature should be appropriate to the selected materials. This temperature should allow melting of the sealant layer without deforming the surface due to overheating or cause the paper fibers to curl as a result of excessive tension.   

Pressure

Higher pressure can increase tension, while a lower pressure may result in poor sealing (low tension). This does not mean that the higher the tension, the better the results. Excessive tension from high pressure will cause paper fibers to curl when tearing off.   

Speed (Sealing Time) 

The faster the speed, the higher the yield. However, a shorter sealing time may also increase the risk of under-tension. Conversely, the longer the sealing time, the better the bonding performance of the sealing will be. But this slows production and may cause excessive tension. Therefore, a balanced approach is needed.   

Control and Management

Sealing performance is all about having appropriate controls to maintain stable sealing and is a manifestation of the manufacturer’s technical capacity.