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!

On location, freeze-drying cycle support & monitoring for critical processes to mitigate risk

  • 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

Lyophilization Cycle Development/ Optimization/ Transfer

(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

Lyophilization Cycle Problem Solving

(Remote)

  • Cycle Data/Batch report analysis
  • Recipe review
  • Diagnostic testing
  • Alarm settings review & optimization

4 Hour Minimum

Lyophilization Equipment Operator Training Package

(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

User Requirement Specification Development and Consulting

(Remote)

Perform Needs analysis, create and/or review document

Factory Acceptance Testing (FAT) Support

(At Equipment Manufacturers Location)

  • FAT Document Review
  • Act as client’s representative for the FAT
  • Data analysis and cycle oversight

Site Acceptance Testing (SAT)/Installation & Operational Qualification (IQOQ) Support

(At Client’s Location)

  • SAT/IQOQ Document Review
  • Data analysis and cycle oversight

Operator training can be added to this service for best value

Equipment Capability Testing to Establish Design Space

(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

Third Party Service Support

(Remote or On Site)

  • Support HVAC contractor with diagnosing, testing and repair validation

Operator training can be added to this service for best value

Questions?  Need something not described here?  We’d love to hear from you!