Live eLearning - PDA 203.1 Technical Report No. 48: Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance

Steam sterilization is a crucial process to sterile and aseptic operations in the pharmaceutical and biotech industries. Assuring that steam sterilizers are designed, specified and qualified with the appropriate loads and cycles is a core quality system contributing to those sterile and aseptic operations. This training course will provide greater clarity in those steps, such as specification and design, and will ensure successful and cost-effective qualification and validation.

This is a comprehensive training course to understand sterilization processes using steam, designing the right steam sterilizer for particular applications, developing the load and cycle for those applications, performing qualification to demonstrate that the design and development were robust, and providing ongoing process controls to maintain the qualified state.

1. Discuss sterilization models and how to calculate lethal rate
2. Develop a robust user requirements document for steam sterilizers
3. Test for steam quality and the importance of dryness fraction and value
4. Design sterilization cycles appropriate for loads such as porous, hard goods and liquid
5. Qualify steam sterilizers