​​​​​​​​Sterilization and Quality System Consulting LLC

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