Flexible Automation Design: Considerations for a New Manufacturing Facility
Ryan Hogan, Scientist I, Manufacturing Sciences and TechnologyBioProcess International West 2017 28February2017
Agenda
2
• Automation Strategy
• Recipe Strategy
• Case Study 1
• Case Study 2
• Takeaways
• Lessons Learned
Frederick Manufacturing Center (FMC) B633
3
• 2011 ISPE Facility of the Year
Awards Overall Winner
• Automation packages from each
skid vendor
• Recipe driven control
– Not fully implemented
across all areas
Frederick Manufacturing Center (FMC) B636
4
• New automation
• Single automation vendor
• Recipe driven control
– full integration
Why Use a New Automation Platform?
5
• Class-based coding
– Simpler to implement
– Less code to manage in future
• Opportunity to improve upon B633 capabilities
– Elimination of many manually controlled activities
Types of Control
6
• Controls can be fully manual, fully automatic, or in between
Fully Manual
Control
Fully Automatic
Control
Operator does everything Computer does everything
Shift the
balance
towards
automatic
control
Automation Strategy
7
• Full S88 implementation
– Standard for batch process control
• Key principles:
– Separate recipe from equipment control
– Ensures recipe code remains separate from equipment code
– Equipment programming accounts for full range of capabilities
– Specific product recipe does not limit equipment control
Recipe Strategy:Design Considerations
8
• Identify and segregate process from
equipment parameters
– Recipe parameters change based
on formula (process inputs)
– Equipment specific parameters fixed
for unit
Process
parameterEquipment
parameter
Unit
Vessel
pressure,
min/max level
pH, target volume, DO
Recipe Strategy:How Many Recipes are Needed?
9
• Individual recipes for major unit operations
• Examples:
Chromatography
Media Prep
Virus Filtration UF/DF
Buffer PrepProduction
Bioreactor
Case Study 1: Automating Solution Prep
11
Manual, sequential
running of phases
Recipe runs phases with
operator prompting
WFI
adds
Mixing
Set
alarms
Load
recipe• Time consuming
• Opportunity for errors
• Complex batch records• Built in quality checks
• Faster
• Reduced errors
• Simple batch records
Case Study 2: Generic and Flexible Recipes
13
• Single, generic recipe for each major unit operation
• Multi-product
• Processing sequence options built into structure
• Formula sheet is completed for each product
How Does This Approach Help?
14
• Results worth the investment
– Expected significant reduction in tech transfer time• Limit amount of testing needed prior to GMP processing
• Error reduction
– Dramatic reduction in batch record documentation• Less complexity = less opportunity for errors
• Operator can focus more on process monitoring rather than
manual entries
How to Make This Approach Successful
15
• Plan appropriately
– Large time investment upfront• Time savings for each new tech transfer
• Identify key stakeholders
– Process expert involvement is critical• Early involvement is key
– Expose supporting team members to automation
Lessons Learned
16
• Strategically deploy Subject Matter Experts
– Broad team with different capabilities
– Determine most effective way for individuals to contribute• Area-specific SMEs
• Automation/batch record integration
• Develop future support model for automation
– Transition from contract to site-based support
• Create simple tools to enable future success
– Generation of recipe formulas is not easy!• Need to make this simpler
Tools for Future Success
17
• Recipe formula creation
– Excel tool being developed to enable anyone to generate
formulas
– Easy to use• Built-in error checking
• Limit allowable entries
Summary
18
• We have a flexible, multi-product design
• This strategy was strategically selected and is robust
• We expect significant benefits from this design
– Reduction in tech transfer time
– Reduction in errors
• We have learned throughout this process
– Must create easy to use tools that can be used by anyone
– Continue to look for simplification opportunities
Confidentiality Notice
This file is private and may contain confidential and proprietary information. If you have received this file in error, please notify us and remove
it from your system and note that you must not copy, distribute or take any action in reliance on it. Any unauthorized use or disclosure of the
contents of this file is not permitted and may be unlawful. AstraZeneca PLC, 2 Kingdom Street, London, W2 6BD, UK, T: +44(0)20 7604 8000,
F: +44 (0)20 7604 8151, www.astrazeneca.com
19
Acknowledgments
MS&T:
• Jose Vallejos
• Joseph Neal
• Jared Wells
MFG:
• Brian Stamper
• Nathan Shatto
• Nigel DePeiza
F&E:
• Greg Navolio
• Zach VanDerWerker
• Ricardo Diaz
• Bryce Stewart
• Matt AbboudGlobal Engineering
• Scott Birth
• Steve Granger
• John Finch
• Tim Frame
Executive Sponsors
• Doug Scott
• Stephen Hill
QA:
• John Krincek
• Aneta Grbovic