LyoNavigator Services
LyoNavigator’s standard service offerings are described below. If you have a need that does not fit neatly into one of these services, please contact us and we can let you know if we can help, or we’ll tap our lyophilization network to try to introduce you to someone who can!
- Recipe robustness review and testing
- System testing prior to cycle execution
- Cycle oversight through completion
- Written report/summary provided within 7 days of service
Remote prep and follow-up up to 4 hours
Travel & expenses charged separately
Operator training can be added to this service for best value
(Remote or On Site)
- Support when transferring cycles between different lyophilizers
- Knowledgeable assistance in developing robust and optimized cycles
- Review and recommend Alarm settings
If on site, travel & expenses to be charged separately
4 Hour Minimum
Operator training can be added to this service for best value
(Remote)
- Cycle Data/Batch report analysis
- Recipe review
- Diagnostic testing
- Alarm settings review & optimization
4 Hour Minimum
(Remote via Microsoft Teams and/or On Site)
- Basic Theory of Freeze-Drying (2 hours)
Practical, equipment based training to lay the foundation for successful lyophilization - Principles of Lyophilizer Design (1 hour)
Introduction of design and components and their impact on system performance - GLP for Freeze-Drying (1 hour)
Best practices to ensure consistency, repeatability and batch uniformity - Software Training (90 min)
- Process Analytical Tools & Endpoint Determination Methods for Freeze-Drying (1 hour)
Current technologies and their benefits - Problem Solving using Batch Reports and Cycle Data (1 hour)
- Understanding and Determining Equipment Capability Limits (1 hour)
Slides and recorded trainings provided at course completion.
Includes quizzes and cycle troubleshooting exercises
(Remote)
Perform Needs analysis, create and/or review document
(At Equipment Manufacturers Location)
- FAT Document Review
- Act as client’s representative for the FAT
- Data analysis and cycle oversight
(At Client’s Location)
- SAT/IQOQ Document Review
- Data analysis and cycle oversight
Operator training can be added to this service for best value
(On Site)
- Provide testing protocols
- Optional Test Execution
- Data analysis
- Written report/summary provided within 7 days of service
Operator training can be added to this service for best value
(Remote or On Site)
- Support HVAC contractor with diagnosing, testing and repair validation
Operator training can be added to this service for best value