This webinar focuses on regulations for stability testing such as ISO 11607-1:2019 and EU MDR:2019 Section 4.5 and ASTM F1980-16 and the requirements and best practices for performance and stability testing. The presenter stresses the importance of always preparing a worst-case sterilization whether you are doing performance testing or stability testing and that the stability testing shall demonstrate the SBS maintains integrity over time, until the point of use. The presenter also reviews the importance of accelerated and real-time aging and the accelerated aging factor formulas.