Combining process monitoring using online analysers, together with solid process engineering principles and advanced process modelling techniques will enable processes to be actively controlled in order to compensate for minor input variations (eg. raw materials) so that the specifications for the final product will be closer to the ideal target.

Using process models to identify the process conditions that highlite products which perform best in subsequent processes will enable the whole production process to be targeted towards the performance of the final dose rather than just optimising each unit operation individually. GEA Pharma Systems wide scope gives it a unique perspective on the complete process.

Freeze Drying Cycle with Thermodynamic Lyophilization Control

GEA Lyophil has developed TLC as an in-line, non-invasive method of:

• Monitoring the primary (main) drying
• Determining the end of the main drying
• Monitoring the secondary drying
• Determining the end of the secondary drying

TLC enables a dynamic control of the drying process: minor variations – e.g. of the raw product or the filling height of the vials – will be identified and the process will be adjusted accordingly.

Advantages:

• Applicable for all freeze dryers
• Ideal for sterile processing
• Ideal with automatic loading and unloading systems
• Ideal when isolator technology is used
• No need for mechanical modifications at the lyophilizer
• No risk of contamination
• Reproducible measurements
• Direct & accurate lyophilization monitoring and control
• Monitoring of the complete batch during the whole drying process
• Enables optimization of the freeze drying process cycle
• No influence on the product by short measuring times
• Process data easy to scale-up
• Delivers comprehensive data for better process understanding