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| Sterility Assurance Development of a site or Corporate Sterility Assurance Program Sterilization (Component, In-process, and Terminal Sterilization) - Training on Sterilization Requirements
- Training on Sterilization Calculations
- Training on Sterilization Science
- Assist with Biological Indicators, selection, use, procedures, heat resistance, D-values, z-values and F-values
- Development of Sterilization Models
- Component and Terminal Sterilization Cycle Design
- Sterilization Validation and Qualification
- Development of Qualification Protocols
- Optimization of Sterilization Programs
- Training on sterilization
- Assessment of sterilization programs
- Troubleshooting sterilization processes, sterility failures, product complaints
- Oven and Tunnel Depyrogenation Cycle Design
- Correlation of Theoretical Depyrogenation and Actual Depyrogenation
- Depyrogenation Validation and Qualification
- Development of Qualification Protocols
- Optimization of Depyrogenation Programs
- Training on depyrogenation
- Assessment of depyrogenation programs
- Environmental Monitoring
- Personnel Monitoring
- Cleaning Validation
- Environmental Surveys
- Facility assessment
- Evaluation of contract manufacturing facilities
- Review of processes
- Review of facility design and renovations
- Review of manufacturing deviations, non-compliances, and other investigations
- Validation of equipment, e.g., sterilizers, tunnels, fillers, packaging equipment
- In-house training of professional staff in aseptic processing
- Development of environmental monitoring programs
- Assessment of environmental monitoring programs
- Conversion of processes from aseptic to terminal sterilization
- Benchmarking against other facilities/companies
- Development, or assessment of qualification and validation processes
- Resolution of FD483 and other regulatory compliance issues
- Isolation Technology
- Validation of Sterility Testing Isolators
- Microbial monitoring in isolator systems
- Validation of microbial sampling system
- Interventions
- Process simulation Study design
- Media Fill Failure Analysis
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