Bioreactor Operation and Control
Operate bioreactors in biopharmaceuticals manufacturing facilities
Type
Domain
Competency Area
Production
Levels
Implement procedures for operating bioreactors
Set up bioreactors and single-use bioreactor bags by calibrating and installing pH probe, Dissolved Oxygen (DO) probe, and inlet and exit gas filters
Load culture medium into bioreactors
Test agitation and aeration, temperature controller and pH controller
Sterilise bioreactors, equipment, feed containers and reagent solutions before and after use
Perform bioreactor inoculation
Notify the authorised personnel where bioreactor operations cannot be carried out
Extract samples from bioreactors to measure cell density, viability and concentration
Carry out culture harvesting and dispose of sterilised biohazard wasters
Prepare bioreactors for next culture operations
Complete log and batch sheets
Verify conditions and operations of bioreactors and perform troubleshooting
Identify the cell culture process requirements and objectives
Implement Standard Operating Procedures (SOPs) for bioreactor operations
Inspect and verify the conditions and operations of bioreactor components
Oversee bioreactor preparation and start-up
Conduct root cause analysis
Oversee and direct changes to critical parameters to adjust or restore bioreactors to optimal functioning
Review batch sample testing outcomes to verify product quality
Identify defects or faults in equipment parts or operations
Mitigate risks associated with identified hazards relating to bioreactor operations