| cGMP requirement for the Bioprocess Industry |
| WEEK 1 |
WEEK 2 |
Day 1
Media selection
Media preparation
Media sterilization – Fo concept |
Day 1
Optimization of centrifugation and tangential flow filtration for broth clarification / bio molecule separation |
Day 2
Fermentor functional design
Sterilization In Place of fermentor
Sterilization process validation |
Day 2
Cleaning and sanitation of centrifuge and tangential flow filtration systems
Scale up of tangential flow filters |
Day 3
Inoculation of fermentor
Maintaining fermentation parameters
Growth kinetics |
Day 3
Product sterilization by dead end filtration
Cleaning & sterilization of DE filtration systems
Integrity testing of sterilizing grade filters |
Day 4
Scale up / down of fermentation
Optimization of fermentation
Qualification of fermentor |
Day 4
Biopharma facility requirements for production
HVAC system
Black & clean utilities |
Day 5
Harvest and cleaning in Place
Cleaning process validation |
Day 5
Good documentation practices
Visit of the manufacturing center |