Chromatography Equipment Operation and Control
Operate chromatography systems in biopharmaceuticals manufacturing facilities
Type
Domain
Competency Area
Production
Levels
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