Improving the Performance of Your Lyophilization System
Agenda: Day Two
VII. Scale Up - From Pilot to Production
- Using the Collapsed Temperature formulation
- Meet the requirements for all clinical applications
- Organize and maintain proper data and documentation
- Address complications that arise from equipment and facility
VIII. Design
- Refrigeration
- Vaccum
- Control systems
- Shelf mechanics
IX. Validation
- Compare Validation vs Optimization
- Formulation
- Freeze Drying Cycle
- Freeze Dryer
X. Buying a New Lyophilizer
- Analysis and Discussion of a URS
Discussion: Analyze and Discuss a URS
XI. Trouble Shooting
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Dealing with:
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Address and decide the proper CAPA
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Proven acceptable range
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Batch related issues
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XII. Meeting Review and Close
Exercise: Examine Key Points from the Past Two Days of Training
Booking Options
This course is available exclusively as an onsite training solution. To discuss a solution that fits your organization's needs, objectives, schedule and budget, contact a PTi Client Solutions Manager at 800-303-8194 or OnSiteSolutions@pti-international.com.