Services & Solutions

• Process Development
  • Project managment
  • Documentation
  • Training
  • Reprocess
  • Reuse
     
• Process Validation
  • IQ/OQ/PQ format
  • Sterilization cycle validation
  • Sterile package sealing
  • Injection molding
  • Clean room qualification
    
    
• Process Improvement
  • Problem solving
  • Efficiency / yield Improvement
  • Reduce scrap
  • Identify bottleneck
  • Scale up
  • Equipment improvement
    
    
• Calibration and PM
   
• Inspection Strategies
  • In process vs. finished
  • Sampling plans
  • Continuous improvement
  • Sterility
  • Bio-indicator
  • Particle monitoring
     
• Material qualification and management

  • Biocompatibility testing
  • Traceability
  • Inventory control
  • Purchasing specification
  • JIT (just in time) planning
  • Supplier qualification
     
• Analyses
  • Process flow
    
  • DOE
  • Root cause
  • CpK
  • 6 sigma