Critical Process Parameters and Critical Quality Attributes in Sterile Product Manufacturing


Stage: Mixing

CPP

  • Tank type
  • Tank temperature
  • Homogenizer speed
  • Product temperature
  • Feeding speed


CQA

  • Appearance
  • Assay
  • pH
  • Particle size
  • Impurity


Stage: Aseptic Filtering

CPP

  • Filter type
  • Filter integrity test (pre & post)
  • Solution viscosity
  • Filtration speed


CQA

  • Sterility
  • Assay
  • pH
  • Particle size
  • Viscosity
  • Impurity


Stage: Filling and Sealing

CPP

  • LAF air flow speed
  • Tunnel passing speed and temperature
  • Filling needle features
  • Stopper sealing 
  • Ampule closing


CQA

  • Appearance
  • Sterility
  • Assay
  • Endotoxin limit
  • pH
  • Content Uniformity


Stage: Sterilization by Autoclave

CPP

  • Vapor pressure
  • Vapor temperature
  • Internal Air Pressure
  • Load method


CQA

  • Appearance
  • Sterility
  • Assay
  • Endotoxin limit
  • pH
  • Content Uniformity
  • Impurity



Related Posts