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