Cycle Development - Case Study.
The attached presentation analyzes the optimization process for a production cycle, highlighting initial issues like crumbly cake appearance and fogging. The optimization aimed to increase yield, improve cake appearance, and enable automatic visual inspection. The process involved thermal analysis and freeze-drying cycle design. Post-optimization, defects were eliminated, and production yield increased, allowing for automated visual inspection.
Cycle Development Case Study
GEA Lyophil GmbH, Huerth, Germany
▪ Crumbly cake appearance is partly accepted ▪ Slight cake travelling
Status before optimization
2
„Faulty Vials“
▪ Crumbly cake appearance ▪ Heavy cake travelling ▪ Fogging ▪ Sublimation on shoulder, neck and stopper
„Optimal Vials“
Cycle Development - Case Study
Reason for Optimization Targets
3
Increase production yield
Higher % of vials within the specification
Enable automatic visual inspection
Optimize cake appearance
Avoid cake travelling
Cycle Development - Case Study
Heating curve close-up without annealing
Heating curve close-up after annealing
Cycle Optimization Procedure
4
DSC measurements: Thermal analysis and characterization of the product
▪ Determination of freezing and melting points
▪ Glass transitions
▪ Crystallization events
Cycle Development - Case Study
Cycle Optimization Procedure
5
Design of a freeze-drying cycle based on the results of the product characterization
▪ Spontaneous vs. controlled nucleation
▪ Annealing yes/no?
▪ Shelf temperature & chamber pressure during PD & SD
Cycle Development - Case Study
Status After optimization
6
▪ No defects after unloading
▪ No fogging or dusting
▪ Product evenly distributed on the bottom due to hydrophobic coating and low filling volume.
Cycle Development - Case Study
Status After optimization
7
▪ No defects after unloading
▪ No fogging or dusting
▪ Product evenly distributed on the bottom due to hydrophobic coating and low filling volume.
Benefits
▪ Increase production yield -> less vials which are „out of specification“
▪ Substitute manual visual inspection with automated visual inspection
Cycle Development - Case Study
Status After optimization Conclusion
8
„GEA´s cycle improvement alongside the change of our primary packaging material increase our product yield and enabled us to automize our visual inspection.“
▪Vice President Production
Cycle Development - Case Study
GEA.com
Standardabschnitt Folie 1: Cycle Development Folie 2: Status before optimization Folie 3: Reason for Optimization Folie 4: Cycle Optimization Folie 5: Cycle Optimization Folie 6: Status After optimization Folie 7: Status After optimization Folie 8: Status After optimization Folie 9