2022The science The behind the integrity of single-use system: InvInvestigating estigating liquid leak and micrand microbial ingrobial ingress mechanisms ess ttoo determine the maximum allowable leakage limit

2022The science The behind the integrity of single-use system: InvInvestigating estigating liquid leak and micrand microbial ingrobial ingress mechanisms ess ttoo determine the maximum allowable leakage limit
Integrity is a critical guality attribute of our single-use systems as an integrity breach can have dramatic impacts on patientsafety, operator safety or drug availability. Growing industry scrutiny of single-use system integrity (SUSl) is raising the needto develop good science behind reliable determination of liquid leakage and microbial ingress, as well as the appropriatephysical integrity testing technologies. The results of the experiments performed to understand the mechanisms of liquidleakage and microbial ingress of SUSl are presented. A relation between liquid leakage and microbial ingress mechanismsin single- use plastic containers are confirmed. Microbial ingress testing by the aerosolization and the liquid leakage test areused to determine the maximum allowable leakage limit (MALL). Statistical analvsis indicated the probability of MALL at acertain defect size for each system.
With additional experiments a correlation between a certain defect size and the corresponding gas flow rate is found. TheMALL defined as a gas flow rate will link to a physical integrity testing system.The methods provide an accurate way of predicting ingress, increasing safety down the line for drug manufacturers andpatients alike.