Joydeep Ganguly and Real-time Bioprocess Monitoring and Control
"It isn't enough to have a more sophisticated way of telling you that you have a product that is crappy...that's not PAT.
PAT is about consistently creating product that is NOT crappy."
CBER monitors the biologicals industry.
Talecris is a newly-formed company that inherited the assets of Bayer's plasma business.
Automation needs to be put in where it is needed, Ganguly says.
What is the automation pyramid?
---Batch Control and Reporting-------
---Historian, Sequencing---------------------
-------------Monitoring, Alarming-------------------
------------------------Batch Control-----------------------
^
Field devices(sensors, actuators, and local control)
If you work with PAT concepts you can get far better quality.
As an industry we are very good at finding out what went wrong after we lose a batch. What we need to do is get as good with keeping batches from going bad.
Don't start PAT too big.
Here's a case study, Talecris' Water For Injection (WFI) system
---an online PAT monitoring and automation case study
Before PAT:
Individual skid basis
no historians or local historians with different formats
look and feel widely different between skids
no handshake between skids
manual actuators,local gauges, bench process
After PAT:
Batch control and reporting for entire process
Central data access, one format
local or central control, same look and feel
communication accross skids,
connected and operated by the control system
The bandwidth of PAT includes:
--Monitoring via inline analytics
--collection of data
--analysis and correlation of data (continuous and batch)
--control and mitigative actions in place
We decided to start small...instead of trying to do the entire plant we just decided to do the WFI system...
Before:
WFI used 45% of the time in the process
Request by production to use the WFI system
Call QC, take sample from the distribution line
Ensure no other user wants WFI
Check TOC, conductivity and Temperature
Water released at risk
If water experiences high TOC in the interim, the batch is lost
After:
Communication at systems level
Production control system communicates with Utilities control system
online TOC, conductivity, and temperature on utilities control system confirms WFI good
online totalizer verifies usage
messages back and forth logged
realtime quality assurance, valves to production close on "bad" WFI
correlation on information online
entire gamut of PAT deployed
PAT is not, according to the FDA, implementation of process analyzers.
What we got from WFI case study:
Real time quality assurance
WFI management electronic
electronic reporting allows for 'realtime' release of WFI
Implemented and fully validated with 1+ yerar of peroation experience
Reduced manual sampling
Bottom line: $500,000 per year, not including cost of batches saved ($3-4 million a year)
So very simple can have a huge increase for the bottom line.
