“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.