Filtration Equipment Operation and Control

Operate filtration equipment in biopharmaceuticals manufacturing facilities



Competency Area



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