Automation Aspects of PAT Installation w Case Study

1
Automation Aspects of PAT Installation w/ Case
Study

• Pete Miilu, Pfizer
• Marc Surprenant, Pfizer

2
Intro/Background

• Automation and Control Strategy
• Levels of Automation
• Process Monitoring
• Instrument monitors the process to determine when
  the end point is met
• Monitoring and Analysis of data
• Process Control
• Instrument monitors and adjusts the process based
  on results
• Full implementation of PAT
• Ultimate Goal is Real Time Release
• Integration with Distributed Control System
• Communication
• Hardwired Input / Output
• Serial
• Ethernet (OPC)
• Recipe Management
• Data Retention

3
Data Strategy

• Several aspects to consider
• Who are the users?
• Operators for process control decisions
• Require go/no-go decision bytes
• Require limited data trending KB
• Engineers for process improvement
• Require results data KB
• Require trending capabilities MB
• Lab personnel for instrument maintenance and
  calibration
• Require raw and spectral data GB
• Require trending capabilities MB
• Data retention
• Different for each type of data?
• Important for long-term supportability when
  dealing with frequent samples of high-data-volume
  assays
• Limited retention for raw data can be justified
  using calibration and maintenance procedures
  which meet requirements for demonstrating
  instrument performance

4
Case Study Background

• Operational Setting
• Batch Solvent Recovery Distillation Process
• Recovered solvent quality verified with manual
  sampling and analysis using process lab
• In process lab analysis results obtained in one
  to two hours
• During lab analysis distillate is directed to a
  slop tank until quality is verified
• Manual sampling does not allow distillate
  collection at the time it meets specification

5
Case Study Background

• PAT Solution
• Continuous sampling and analysis required
• Achieved by implementing an on-line gas
  chromatograph on the distillate stream
• On-line GC capable of collecting and reporting
  composition of the distillate every four to eight
  minutes (near real time)

6
GMP Classification of System

• Direct vs. Indirect vs. No Impact
• Ultimately this decision is based on the way that
  Operations intends to use the information
  produced by the system
• CQA provides standard tools for determining
  classification
• Case Study
• Classified as an Indirect Impact system because
  the system is not used to demonstrate compliance
  with any registered parameters or attributes
• Downstream direct impact systems ensure
  compliance with registered parameters
• Benefits of Indirect Impact Classification
• Allows commissioning-only approach to testing
• Lower project long-term support costs
• Opportunity costs
• If/when the business finds that the system is
  capable of replacing the registered downstream
  assays, then a system qualification must be
  performed, in addition to a process validation.

7
Ta Da! The Final Incarnation
8
Implementation

• Qualified
• Direct Impact Systems Critical Components
• Product contact piping and pump
• Analytical Instrument
• Critical software functions
• DCS Interface
• DCS Recipe Control
• Vendor Software critical functions
• Methods of Analysis
• Commissioned only
• PC Hardware
• Data Historian Interface
• Challenges
• Breadth of teams background and experience with
  CQ
• Agreeing on System/Component Impact Assessments
• Assigning ownership of support responsibilities
• OPC network security
• Assigning ownership of components during project

9
DCS to Instrument Integration
10
Epilogue

• Experiencing issues with calibration drift
  instrument/analytical support are working to
  resolve
• Relying on both PAT and backup control strategy
• Expect fully operational and reliable system by
  EOY2008