Overcoming Common Lyophilization Scale-up Issues
Topics covered in this seminar
- Characterizing your systems (apparatus, containers, product) with a limited number of experiments and a simple procedure
- Utilizing advanced monitoring tools to speed up the system characterisation process
- Examining safe process transfer from one scale to another using either automatic control systems or a predictive modelling approach
- Predicting changes in the design space in different pieces of equipment by means of process model, taking into account model uncertainty and confidence limits
- Evaluating the distribution of product temperature, drying time, and residual water in your batch as a function of equipment design and operating conditions
- Choosing the operating conditions that guarantee the required percentage of success for the product in hand
Presenters: