Filtration Equipment Operation and Control
Operate filtration equipment in biopharmaceuticals manufacturing facilities
Type
Domain
Competency Area
Production
Levels
Implement procedures to operate filtration equipment
Set-up filtration equipment and configurations in accordance with equipment set-up procedures
Prepare for filter integrity tests and conduct other pre-checks of equipment and configurations to verify suitability for use
Monitor the filtration process parameters to verify the products acceptability in accordance with Standard Operating Procedures (SOPs)
Adjust the process parameters to ensure constant optimal performance
Notify the authorised personnel when the filtration processes cannot be carried out
Verify conditions and operations of filtration equipment and perform troubleshooting
Determine the filtration process requirements and objectives
Conduct constant pressure and constant flow filtration tests
Use the Vmax and Amin equations to calculate the minimum required filter areas for processes
Create resistance versus throughput curves and fit data to polynomial functions
Calculate the minimum required filter areas for process steps using the Pmax algorithm
Complete log and batch sheets
Change over filters and conduct leak tests to verify integrity
Sterilise equipment after use and dispose biohazard waste
Lead implementation of Standard Operating Procedures (SOPs) for filtration operations
Recommend the proper filter configurations for the processes with appropriate safety factors
Review batch sample testing outcomes to verify product quality and identify defects
Conduct root cause analysis
Mitigate risks associated with identified hazards relating to filtration equipment operations