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© Bioproduction Group | www.bio-g.com 
1/23/2014 
Optimizing Maintenance and Calibrations using Real-Time Scheduling 
Jan 23, 2014 
Rick Johnston, Ph.D. - Principal and Founder 
Gary Wright - Senior Account Director, gwright@bio-g.com
© Bioproduction Group | www.bio-g.com 
Bioproduction Group 
Founded in 2007 with an exclusive focus on Biomanufacturing Operations 
Primary goal of improving Quality, Productivity, Flexibility and Operations in Biomanufacturing 
World Class “real time” data collection, modeling, and simulation software 
Technology Assisted 
Knowledge Generation Tool 
Specifically designed for the unique 
needs of Analysts 
Improving Quality, Productivity, Flexibility and Operations at the World’s Largest Biomanufacturers
© Bioproduction Group | www.bio-g.com 
Bioproduction Group is now used by more than 20% of the world’s biomanufacturing capacity*. 
0 
5 
10 
15 
20 
25 
2007 
2008 
2009 
2010 
2011 
2012 
2013 
% of worldwide capacity* 
Year 
1/23/2014 
2 
* As measured by total installed production bioreactor volume.
© Bioproduction Group | www.bio-g.com 
A collection of quotes* 
1/23/2014 
3 
* Collected from 45 Bio-G phone interviews with biopharmaceutical professionals from 16 companies, November 2012. Redacted for privacy. 
Maintenance: “We got the OK, and turned the power off. Turns out that also turned off power to the skid in another part of the facility, that was running a batch. Million dollar mistake.” 
Manufacturing: “Maintenance is always trying to find out when equipment is free… but to be honest we often don’t know exactly ourselves.” 
Manufacturing: “Calibrations? Mark does that. It takes him about a week to find places in the schedule where events will fit. And every time we change our schedule, he re-does his too. Patient man.” 
Maintenance: “I couldn’t count the number of times I’ve gowned up, then found out manufacturing will be using [the equipment] till tomorrow. What a waste of my day.” 
Manufacturing: “We tell our bosses we schedule in SAP, but really? We use Excel for detailed shop-floor scheduling.”
© Bioproduction Group | www.bio-g.com 
Maintenance vs. Manufacturing 
1/23/2014 
4
© Bioproduction Group | www.bio-g.com 
Scheduling Calibrations and Maintenance is difficult 
1/23/2014 
5 
Manufacturing 
Maintenance / Calibrations 
High Visibility 
“Value Added” 
Production Group 
Low Visibility 
“Necessary Evil” 
Support Group
© Bioproduction Group | www.bio-g.com 
Significant delays are introduced by these events* 
1/23/2014 
6 
Manufacturing 
Calibrations 
Maintenance 
Downtime 
Overall fraction of time scheduled for events 
* Bio-G internal data, sourced from representative biopharmaceutical manufacturers. Exact numbers redacted. 
Manufacturing 
Calibrations 
Maintenance 
Downtime 
Delays 
Observed time required for events
© Bioproduction Group | www.bio-g.com 
What causes these delays in maintenance / calibrations? 
Cause 
"Equipment 
unavailable" 
"Manufacturing still in 
process" 
"Maintenance took 
longer than expected" 
"Co-ordination issues" 
"Trained personnel 
not present" 
"Affects other part of 
facility" 
1/23/2014 
7 
More than half of the reasons reported for delays were due to poor scheduling or wrong information 
Other
© Bioproduction Group | www.bio-g.com 
Fundamental problem: two systems are competing for one resource 
CMMS Planning 
1/23/2014 
8 
Computerized Maintenance Management Systems (CMMS) 
Equipment 
Manufacturing Planning 
Manufacturing Systems 
CMMS systems and production systems can’t “see” each other’s schedules
© Bioproduction Group | www.bio-g.com 
For example: SAP* 
1/23/2014 
9 
Plant Maintenance 
Equipment 
Equipment 
Advanced Planning / Optimization 
* Bio-G is an SAP Certified Partner. Bio-G software is validated for use with SAP Systems. 
It is possible to schedule maintenance on a skid at the same time that skid is being used for a process order 
“Start calibration on Chrom Col 1 at 2/1/2014 9:00am” 
“Start downstream Pro-A Cycling on 2/1/2014 12:00am” 
???
© Bioproduction Group | www.bio-g.com 
Need a scheduling “arbiter” that prioritizes the finite resources 
1/23/2014 
10 
Plant Maintenance 
Equipment 
Equipment 
Advanced Planning / Optimization 
“Start calibration on Chrom Col 1 at 2/1/2014 9:00am” 
“Start downstream Pro-A Cycling on 2/1/2014 12:00am” 
Finite Scheduler 
“Start Pro-A on 2/1/2014, then Calibration on 2/5/2014”
© Bioproduction Group | www.bio-g.com 
Two Case Studies 
1.“Simple Use” case study 
–Take a plan (planned and production orders) from SAP and schedule unit operations 
–Take a schedule from a CMMS system and plan calibrations / maintenance 
–Publish that schedule out so it is visible 
2.“Advanced Use” case study 
–Use SAP for high level planning, but “blow out” a plan into detailed production steps with work allocation 
–Incorporate CMMS data (calibrations / maintenance) 
–Allow users to publish and provide feedback on a schedule as it is executed. 
1/23/2014 
11
© Bioproduction Group | www.bio-g.com 
Case Study 1 
•SAP APO used to generate initial planned and production orders with proposed (earliest) start times 
•A CMMS system used to generate equipment maintenance / calibrations events 
•Bio-G’s Real-Time Modeling System used as an ‘arbiter’ to schedule the two 
•Outputs are published to Microsoft Outlook, a video planning board, back to SAP, and to Excel 
1/23/2014 
12 
CMMS Planning 
SAP 
* Bio-G is an SAP Certified Partner. Bio-G software is validated for use with SAP Systems. 
Bio-G Real-Time Modeling System 
Excel (duplicate current output) 
Outlook (calendar) 
TV on shop floor
Demonstration
© Bioproduction Group | www.bio-g.com 
Case Study: Takeaways 
•Allows everyone to see an integrated view of the manufacturing floor 
–Different views for different groups (management, maintenance, upstream, downstream) 
–Incorporates both maintenance / calibrations and production plans while optimally scheduling finite resources 
•System is designed to be implemented in existing enterprise architecture 
–Supports most CMMS systems, SAP, DeltaV / Syncade, Rockwell 
–No databases, “system administrators” or extensive training involved 
–Less than one month setup and deployment (provided) 
–Single person can run the system 
–Can replicate current outputs, or provide “next generation” visualizations like Outlook 
•Supports “bring your own device” (BYOD) 
–provided your corporate email is accessible from your email 
1/23/2014 
14
© Bioproduction Group | www.bio-g.com 
Traditional Scheduling Software only solves half the problem 
1/23/2014 
15 
Planner Creates Schedule 
Published Schedule 
Run Facility Based on Schedule 
“How can planners see and respond quickly to events on the manufacturing floor?”
© Bioproduction Group | www.bio-g.com 
Bio-G’s software is designed to allow real-time reaction to events 
1/23/2014 
16 
Planner Creates Schedule 
Published Schedule 
Run Facility Based on Schedule 
Delays and Rework 
X 
Unexpected Events
© Bioproduction Group | www.bio-g.com 
Create / Update 
Publish 
Execute 
Observe 
Reconcile 
This feedback loop is designed to be familiar to the user and real-time. 
1/23/2014 
17 
Smart Phones 
iPads 
Laptops 
Rockwell / DeltaV / OSISoft PI Historians 
Rockwell / DeltaV / OSISoft PI Historians 
DeltaV + OSISoft PI Historians
© Bioproduction Group | www.bio-g.com 
Case Study 2 
•SAP and CMMS system as before 
•Bio-G’s Real-Time Modeling System includes all of the detailed manufacturing plan (down to detailed steps) 
•Outputs are published to Microsoft Outlook, a video planning board, back to SAP, and to Excel 
•As the schedule executes, Outlook is used to communicate changes back to the schedulers 
1/23/2014 
18 
CMMS Planning 
SAP 
* Bio-G is an SAP Certified Partner. Bio-G software is validated for use with SAP Systems. 
Bio-G Real-Time Modeling System 
Excel (duplicate current output) 
Outlook (calendar) 
TV on shop floor 
Two way integration
Demonstration
© Bioproduction Group | www.bio-g.com 
Case Study: Takeaways 
•Enterprise Ready 
–Can be used by multiple people across the enterprise at the same time 
–What if scenarios, testing 
–User access control and other advanced features 
–No database administrator or IT support required 
•Allows a simple method of reconciling changes to schedules 
–Delays, late starts, notes and other issues communicated to the scheduler in real-time 
–Allows real-time adjustments to the schedule (more than once a day!) 
•System can model all the complexity of biotech 
–Media and buffer prep, transfer panels and valve arrays 
–WFI systems and Labor / shift structures 
–Variability in processing times 
1/23/2014 
20
© Bioproduction Group | www.bio-g.com 
Bio-G’s Technology Evaluation Program 
•First three manufacturers who enroll in program are eligible 
•Bio-G will setup the toolset 
•Includes free 3 month evaluation 
•15 hours of consulting time with a Bio-G Engineer 
–Set up of first model 
–Training and Support to integrate with other data sources 
•Free access to online training materials and the Bio-G wiki / help files 
•Private WebEx demonstration for internal personnel 
•Contact Gary Wright for more information 
–gwright@bio-g.com 
–510-725-9875 
1/23/2014 
21 
RTMS 
Crosswalk
Q&A

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Maintenance and calibrations

  • 1. © Bioproduction Group | www.bio-g.com 1/23/2014 Optimizing Maintenance and Calibrations using Real-Time Scheduling Jan 23, 2014 Rick Johnston, Ph.D. - Principal and Founder Gary Wright - Senior Account Director, gwright@bio-g.com
  • 2. © Bioproduction Group | www.bio-g.com Bioproduction Group Founded in 2007 with an exclusive focus on Biomanufacturing Operations Primary goal of improving Quality, Productivity, Flexibility and Operations in Biomanufacturing World Class “real time” data collection, modeling, and simulation software Technology Assisted Knowledge Generation Tool Specifically designed for the unique needs of Analysts Improving Quality, Productivity, Flexibility and Operations at the World’s Largest Biomanufacturers
  • 3. © Bioproduction Group | www.bio-g.com Bioproduction Group is now used by more than 20% of the world’s biomanufacturing capacity*. 0 5 10 15 20 25 2007 2008 2009 2010 2011 2012 2013 % of worldwide capacity* Year 1/23/2014 2 * As measured by total installed production bioreactor volume.
  • 4. © Bioproduction Group | www.bio-g.com A collection of quotes* 1/23/2014 3 * Collected from 45 Bio-G phone interviews with biopharmaceutical professionals from 16 companies, November 2012. Redacted for privacy. Maintenance: “We got the OK, and turned the power off. Turns out that also turned off power to the skid in another part of the facility, that was running a batch. Million dollar mistake.” Manufacturing: “Maintenance is always trying to find out when equipment is free… but to be honest we often don’t know exactly ourselves.” Manufacturing: “Calibrations? Mark does that. It takes him about a week to find places in the schedule where events will fit. And every time we change our schedule, he re-does his too. Patient man.” Maintenance: “I couldn’t count the number of times I’ve gowned up, then found out manufacturing will be using [the equipment] till tomorrow. What a waste of my day.” Manufacturing: “We tell our bosses we schedule in SAP, but really? We use Excel for detailed shop-floor scheduling.”
  • 5. © Bioproduction Group | www.bio-g.com Maintenance vs. Manufacturing 1/23/2014 4
  • 6. © Bioproduction Group | www.bio-g.com Scheduling Calibrations and Maintenance is difficult 1/23/2014 5 Manufacturing Maintenance / Calibrations High Visibility “Value Added” Production Group Low Visibility “Necessary Evil” Support Group
  • 7. © Bioproduction Group | www.bio-g.com Significant delays are introduced by these events* 1/23/2014 6 Manufacturing Calibrations Maintenance Downtime Overall fraction of time scheduled for events * Bio-G internal data, sourced from representative biopharmaceutical manufacturers. Exact numbers redacted. Manufacturing Calibrations Maintenance Downtime Delays Observed time required for events
  • 8. © Bioproduction Group | www.bio-g.com What causes these delays in maintenance / calibrations? Cause "Equipment unavailable" "Manufacturing still in process" "Maintenance took longer than expected" "Co-ordination issues" "Trained personnel not present" "Affects other part of facility" 1/23/2014 7 More than half of the reasons reported for delays were due to poor scheduling or wrong information Other
  • 9. © Bioproduction Group | www.bio-g.com Fundamental problem: two systems are competing for one resource CMMS Planning 1/23/2014 8 Computerized Maintenance Management Systems (CMMS) Equipment Manufacturing Planning Manufacturing Systems CMMS systems and production systems can’t “see” each other’s schedules
  • 10. © Bioproduction Group | www.bio-g.com For example: SAP* 1/23/2014 9 Plant Maintenance Equipment Equipment Advanced Planning / Optimization * Bio-G is an SAP Certified Partner. Bio-G software is validated for use with SAP Systems. It is possible to schedule maintenance on a skid at the same time that skid is being used for a process order “Start calibration on Chrom Col 1 at 2/1/2014 9:00am” “Start downstream Pro-A Cycling on 2/1/2014 12:00am” ???
  • 11. © Bioproduction Group | www.bio-g.com Need a scheduling “arbiter” that prioritizes the finite resources 1/23/2014 10 Plant Maintenance Equipment Equipment Advanced Planning / Optimization “Start calibration on Chrom Col 1 at 2/1/2014 9:00am” “Start downstream Pro-A Cycling on 2/1/2014 12:00am” Finite Scheduler “Start Pro-A on 2/1/2014, then Calibration on 2/5/2014”
  • 12. © Bioproduction Group | www.bio-g.com Two Case Studies 1.“Simple Use” case study –Take a plan (planned and production orders) from SAP and schedule unit operations –Take a schedule from a CMMS system and plan calibrations / maintenance –Publish that schedule out so it is visible 2.“Advanced Use” case study –Use SAP for high level planning, but “blow out” a plan into detailed production steps with work allocation –Incorporate CMMS data (calibrations / maintenance) –Allow users to publish and provide feedback on a schedule as it is executed. 1/23/2014 11
  • 13. © Bioproduction Group | www.bio-g.com Case Study 1 •SAP APO used to generate initial planned and production orders with proposed (earliest) start times •A CMMS system used to generate equipment maintenance / calibrations events •Bio-G’s Real-Time Modeling System used as an ‘arbiter’ to schedule the two •Outputs are published to Microsoft Outlook, a video planning board, back to SAP, and to Excel 1/23/2014 12 CMMS Planning SAP * Bio-G is an SAP Certified Partner. Bio-G software is validated for use with SAP Systems. Bio-G Real-Time Modeling System Excel (duplicate current output) Outlook (calendar) TV on shop floor
  • 15. © Bioproduction Group | www.bio-g.com Case Study: Takeaways •Allows everyone to see an integrated view of the manufacturing floor –Different views for different groups (management, maintenance, upstream, downstream) –Incorporates both maintenance / calibrations and production plans while optimally scheduling finite resources •System is designed to be implemented in existing enterprise architecture –Supports most CMMS systems, SAP, DeltaV / Syncade, Rockwell –No databases, “system administrators” or extensive training involved –Less than one month setup and deployment (provided) –Single person can run the system –Can replicate current outputs, or provide “next generation” visualizations like Outlook •Supports “bring your own device” (BYOD) –provided your corporate email is accessible from your email 1/23/2014 14
  • 16. © Bioproduction Group | www.bio-g.com Traditional Scheduling Software only solves half the problem 1/23/2014 15 Planner Creates Schedule Published Schedule Run Facility Based on Schedule “How can planners see and respond quickly to events on the manufacturing floor?”
  • 17. © Bioproduction Group | www.bio-g.com Bio-G’s software is designed to allow real-time reaction to events 1/23/2014 16 Planner Creates Schedule Published Schedule Run Facility Based on Schedule Delays and Rework X Unexpected Events
  • 18. © Bioproduction Group | www.bio-g.com Create / Update Publish Execute Observe Reconcile This feedback loop is designed to be familiar to the user and real-time. 1/23/2014 17 Smart Phones iPads Laptops Rockwell / DeltaV / OSISoft PI Historians Rockwell / DeltaV / OSISoft PI Historians DeltaV + OSISoft PI Historians
  • 19. © Bioproduction Group | www.bio-g.com Case Study 2 •SAP and CMMS system as before •Bio-G’s Real-Time Modeling System includes all of the detailed manufacturing plan (down to detailed steps) •Outputs are published to Microsoft Outlook, a video planning board, back to SAP, and to Excel •As the schedule executes, Outlook is used to communicate changes back to the schedulers 1/23/2014 18 CMMS Planning SAP * Bio-G is an SAP Certified Partner. Bio-G software is validated for use with SAP Systems. Bio-G Real-Time Modeling System Excel (duplicate current output) Outlook (calendar) TV on shop floor Two way integration
  • 21. © Bioproduction Group | www.bio-g.com Case Study: Takeaways •Enterprise Ready –Can be used by multiple people across the enterprise at the same time –What if scenarios, testing –User access control and other advanced features –No database administrator or IT support required •Allows a simple method of reconciling changes to schedules –Delays, late starts, notes and other issues communicated to the scheduler in real-time –Allows real-time adjustments to the schedule (more than once a day!) •System can model all the complexity of biotech –Media and buffer prep, transfer panels and valve arrays –WFI systems and Labor / shift structures –Variability in processing times 1/23/2014 20
  • 22. © Bioproduction Group | www.bio-g.com Bio-G’s Technology Evaluation Program •First three manufacturers who enroll in program are eligible •Bio-G will setup the toolset •Includes free 3 month evaluation •15 hours of consulting time with a Bio-G Engineer –Set up of first model –Training and Support to integrate with other data sources •Free access to online training materials and the Bio-G wiki / help files •Private WebEx demonstration for internal personnel •Contact Gary Wright for more information –gwright@bio-g.com –510-725-9875 1/23/2014 21 RTMS Crosswalk
  • 23. Q&A