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

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

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Presenters:

Marc Hogreve
Senior Engineer Integrity Testing

Marc Hogreve has been working for Sartorius since 2006, where he is today Senior Engineer for Integrity Testing Solutions. He earned his engineering degree at the “University of Applied Sciences and Arts” in Goettingen. Marc started his career as project leader in the field of development for lab equipment for cell culture and microbiology. As of 2011, he has been working as an engineer for integrity testing solutions with a focus on single-use systems for fluid management. As a subject matter expert in that area he is working on Sartorius’ global single-use system integrity strategy. As an active member of task forces in BPSA and PDA and leader of two new ASTM standards on “Integrity Assurance and Testing of Single-Use Systems” he is supporting the creation of standards, technical reports and best practices for the proven integrity of single-use systems.

Carole Langlois,
Marketing Manager, Traditional Vaccines

Carole Langlois started her career in 1996 with Abbott Laboratories in Chicago, US. In 1998, she joined Sartorius Stedim Biotech in Aubagne, France where she is today Marketing Manager – Traditional vaccines. Carole has 20 years of experience in the Pharmaceutical and Biopharmaceutical industries and has been involved in many industrial projects for the integration of single-use systems (SUS) in Form, Fill & Finish processes. As of 2012, she has been working on the container closure integrity strategy for SUS. Carole is a member of the PDA, the BPSA and the ASTM E55 task force for the integrity assurance of SUS. Carole Langlois holds a Biotechnology university degree from Polytech Marseille and an Executive Master of Business Administration (MBA) from Kedge Business School Marseille.

About this event:

June 12, 2019

11 am EDT | 8 am PDT |
5 pm CEST

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.