Integrity Assurance for SUS: End-User Perspective

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Presented by

Charlotte Masy, Project Manager in global support GSK vaccinés and Donald Young, Sr. Product Manager at Thermo Fisher Scienti

About this talk

Single Use technologies are more and more used close to final product leading to increase concern related to integrity. In this article we would like to share supportive data affecting integrity. Defect mode analysis has allowed us to build a risk assessment and a strategy on integrity. This strategy is very important for critical applications when single use are used after last sterile filtration or in process no sterile filtration is possible. Several case studies supporting our approach will be shared showing the importance of addressing integrity in the context of use and taking all technical aspect into consideration. Finally, we will also present data analyzing the effect of such a strategy on lowering defect occurrence .

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