Hilton Vienna Park
Vienna, Austria
Hilton Vienna Park
Vienna, Austria
Register today for the next ISPE Aseptic Conference and join us during the session moderated by Stevanato Group!
Tuesday, March 12th - from 11.45 am to 12.15 pm.
Moderator: Keith Weseli - Site Quality Project Director, Stevanato Group
“Steam sterilization of stoppers. The biological validation of a worst-case load: how to assess the risk of an incorrect biological validation and mitigate it with the right approach.”
A theoretical perspective and the practical example of a load. How to sterilize and validate a heat stable load: the cycle, how the cycle may have an impact on the biological result of a validation procedure. The choice of the right biological indicator and the rationale behind the validation approach chosen. An overview of Rules, Standards about sterilizing a not heat sensitive load and the impact of the load on the choice of the biological validation procedure.
We are glad to announce that Keith Weseli will be a Committee Member of the 2024 ISPE Aseptic Conference, bringing his vast expertise to this edition.