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?

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• Individual recipes for major unit operations

• Examples:

Chromatography

Media Prep

Virus Filtration UF/DF

Buffer PrepProduction

Bioreactor

Case Study 1: Automating Solution Prep

Case Study 1: Automating Solution Prep

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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

Case Study 2: Generic and Flexible Recipes

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• 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?

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• 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

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• 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

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• 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

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• Recipe formula creation

– Excel tool being developed to enable anyone to generate

formulas

– Easy to use• Built-in error checking

• Limit allowable entries

Summary

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• 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

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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