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