Chromatography Equipment Operation and Control

Operate chromatography systems in biopharmaceuticals manufacturing facilities



Competency Area



Implement procedures to operate chromatography equipment

Implement pre-checks on the chromatography equipment status, performance and safety

Prepare chromatography equipment and media in accordance with Standard Operating Procedures (SOPs)

Perform packing and operations of process scale chromatography columns

Measure performance of packed chromatography columns

Unpack media from chromatography process equipment

Verify media and assembly integrity

Perform qualitative and quantitative analyses using chromatography and spectroscopy techniques

Calculate the required resin volume with safety factors for chromatography processes based on lab-based process development data

Complete log and batch sheets

Sterilise equipment after use and dispose biohazard waste

Verify conditions and operations of chromatography equipment and perform troubleshooting

Identify the critical chromatography process parameters for the chosen resin type

Prepare protocols or flow charts detailing the various steps in the chromatography operations

Implement Standard Operating Procedures (SOPs) for chromatography operations

Oversee and direct changes to critical parameters to adjust or restore chromatography equipment to optimal functioning

Identify root cause of issues and problems

Analyse column packing results

Identify defects or faults in equipment parts or operations

Conduct root cause analysis

Mitigate risks associated with identified hazards relating to chromatography operations

Review batch sample testing outcomes to verify product quality