gPROMS FormulatedProducts® lyophilization process models allow for efficient design and operational enhancements for drying heat sensitive products at low temperature.
Advanced models, validated against process data, enable users to reduce experimentation and comprehensively explore the design space for freeze drying cycles with a view of ensuring process robustness.
gPROMS FormulatedProducts models allow for the transfer and optimization of freeze drying processes between different equipment and scales while significantly reducing process downtime.
- Primary drying
- Secondary drying
- Sublimation of pure water
- Drug degradation
- Process scale-up
- Single vial and vial packing approaches
- Capability to manage process inhomogeneities
Applications and benefits
- Modern, user-friendly software allowing robust simulations, parameter estimation, graphical outputs, sensitivity analysis and optimization. No coding is required by user.
- Straightforward workflow for process development and sequential evaluation of key adjustable parameters of the models: heat transfer coefficient and mass transfer coefficient
- Practical methodology for process transfer and scale-up or scale-down, modification and optimization
- Single vial and vial packing approaches with separate models for sublimation of pure water from a single vial or packing of vials. The models allow fast evaluation apparent heat transfer coefficients at critical locations on a shelf
- Explore process design and decision space tosystematically analyse the impact of process conditions on operation using Global System Analysis tool
Scale-up from lab-scale to large-scale freeze drying cycles
The diagram below is a gPROMS FormulatedProducts workflow that enables faster tech transfer and optimization with reduced experimentation for lyophilization processes.