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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
Depyrogenation 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
Cleanroom Qualification Environmental Monitoring Personnel Monitoring Cleaning Validation Environmental Surveys
Aseptic Processing 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
Media Fills
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