Integrity Redefined. presented by Carole Langlois, Segement Marketing Manager, Traditional Vaccines Edit

Integrity failures within single-use commercial manufacturing may increase regulatory concerns, drug availability and costs, or worse, impacting patient safety. Regulatory bodies considered liquid leak and microbial ingress mechanisms in correlation with integrity testing methods as a must have. Our understanding about the correlation between microbial ingress and liquid leaks, the Maximum Allowable Leakage Limit and the impact of process conditions makes our developments for proven integrity unique. Still, product robustness is one of the main factors when we are talking about proven integrity. Therefore we integrated a multi-level quality risk management strategy for our production processes. By this, we can guarantee a leak detection from ninety six to hundred percent depending on the needed quality level. Additionally to our in-house integrity testing we developed systems for risk minimization at point of use. This demonstrates how we are building the foundations for end-to-end single-use manufacturing.