Sterilization and Quality System Consulting LLC
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Ethylene Oxide Sterilization
Radiation Sterilization
Moist Heat and Dry Heat Sterilization Validation
Aseptic Processing - Sterile Filtration
Product and Package Shelf - Life / Stability
Microbiology and Product Biocompatibility
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Aseptic processing - sterile filtration validation services
Media Fill - Process simulation validation studies
Aseptic Environmental Monitoring Requirements and Metrics for Grades A, B, C, D - ISO Class 5, 7 environments
Process Risk Assessments
(SIP) Steam in Place, Sterilize in Place process development, validation, routine monitoring and troubleshooting
Bulk Liquid sterilization validation, reactor
equivalency approaches and validation,
Sterility Testing requirements
Sterile Filter validation and integrity testing
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