Conversion to PI3 in an FDA Regulated Environment

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Conversion to PI3 in an FDA Regulated Environment

• Michael M. Hutchison
• Manager of Automation
• Biopure Corporation

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Background Information

• Biopharmaceutical batch plant in Cambridge, MA
• VMS PI system installed in 1996
• Small core group of PI users
• Control system troubleshooting
• Process analysis
• Considered an FYI system only

3
Conversion Project Goals

• Transition to new hardware platform
• Documented historical data integrity
• Increased utilization of PI features
• Standardized user interface
• High availability
• Online data capacity of gt 10 years
• User training on system capabilities
• Validated System

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Consultant / Vendor Selection

• High Exposure to OSI PI System Software
• Proficient with Distributed Controls System
  (ABB/Bailey Controls)
• Must be Microsoft Certified System Engineer
  (MCSE)
• Fluent with connectivity applications
• VBA proficiency

Benefit

• Minimized learning curve translates to cost
  savings
• Major asset when defining Rev 2 of project scope
  / timeline

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System Validation Process

• Validation Documentation
• Installation Qualification procedure
• Operation Qualification procedures
• Hardware IQ and OQ testing
• Software OQ testing
• QA / Regulatory Sign-off

Benefit

• PI System data can be used in cGMP environment.
• Documentation for Change Control, Failure
  Analysis, etc.

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Historical Data Integrity

• 2.5 Years of data for 3700 points
• 400 Million data values
• 20 MB of string data
• Documentation
• Random sampling of PI2 data and timestamps
• Permanent CD-R copies of pre- and post-
  conversion data

Benefit

• Original plant data is accurate and available

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Support Applications...

• Event-to-String conversion program
• Reads PI2 Event Log Data into a database
• Formats/Writes data to the appropriate PI3 string
  tag

Benefit
Batch messages accessible via DataLink
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Support Applications

• DCS database compared against PI database
• VBA in Excel, differences reported on a worksheet

Benefit
PI vs. DCS tag consistency report available at
anytime
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PI2 System Hardware

• 1 DEC Alpha 2100, and 1 DEC AlphaStation 255/233
• 1 Home Node and 1 NetNode
• DAT Tape backup system
• Redundant DCS Connections
• Running dual Corporate applications

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PI3 System Hardware

• 2 Dual Pentium II Windows NT machines
• 1 Server and 1 API Node, each with
• 256 MB
• Hardware RAID-5, 4 x 9.3 GB (27 GB usable)
• Dual power supplies
• Connection to Bailey DCS
• CD-RW drive for backups
• Redundant DCS Connections

Benefit
99.99 system availability
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System Architecture

• Automation resource domain
• Trust relationship with master domain
• File and print server
• Redundancy

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PI-Batch

• Created batch units
• Added batches to match manually recorded
  historical batch information
• Physical and logical units

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The Users...

• Range from technicians to scientists
• 31 Trained in 4 hands-on classes
• Time and batch relative trending
• ProcessBook 2.0
• 50 standard displays kept on file server
• BatchView add-in
• Excel 7.0 w/Datalink 1.7

Benefits

• All users see the same information and format as
  DCS consoles.
• Average individual usage increases from 23 to
  76

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VBA Technology Was The Key!

• ActiveX Controls
• StringValue control for batch message display
  in ProcessBook
• OISMessage control performs database lookup of
  text message based on an integer value
• MSForms.Listbox as current phase indicator
• VBA scripts to bind everything

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ProcessBook Displays
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ProcessBook Displays
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Whats in the future?

• PI-API 1.3
• Buffering string tags
• Batch Reports
• DCOM client/server model
• Windows NT Domain Security
• Serialized and traceable
• Alarm Wizards
• Pager and desktop notification

18
Whats in the future?

• Computerized Maintenance Management System (CMMS)
  Integration
• Manufacturing Execution System (MES) Integration
• Batch Record
• Electronically traceable lots
• Process unit costing analysis

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The End