Product Robustness, Integrity Testing Science and Technologies for Enhanced Process Integrity and Patient Safety

This webcast features: Carole Langlois, Marketing Manager, Traditional Vaccines, and Marc Hogreve, Senior Engineer Integrity Testing, at Sartorius Stedim Biotech

With the expansion of Single Use Systems (SUS) in all process steps of commercial manufacturing, integrity failure can significantly impact drug safety, availability and costs. Consequently, there is an increasing industry scrutiny on single-use container closure integrity (SU CCI), raising the need to develop good science behind liquid leakage and microbial ingress and appropriate physical integrity testing technologies.

The presenters will first review the emerging industry associations’ initiatives and introduce an integrated quality by design, material science and process control approach as the prerequisite to SU CCI. The presentation will then describe how applying good science help determine the maximum allowable leakage limit (MALL) under which no product leakage and no bacteria ingress occur with SUS under various fluids and process conditions. The understanding of liquid leakage and bacteria ingress mechanisms also enables to validate robust liquid leak tests and microbial aerosol challenge that both are correlated to the detection limits of physical integrity testing methods.

The presenters will conclude with the development of highly sensitive deterministic integrity testing technologies such as gas tracer detection and pressure decay able to detect the MALL determined during the scientific study. Helium based Supplier Integrity Test (SIT) for instance is able to control the finished products with a detection limit of 2µm and is correlated to both liquid leakage and microbial ingress under all tested process conditions.

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