This document discusses concurrent engineering and its advantages over traditional sequential engineering approaches. Concurrent engineering involves simultaneous engineering activities that lead to higher quality designs and more efficient processes. Benefits include reduced time to market, ensuring design goals are met, and lower costs. Traditional approaches where different groups work sequentially have resulted in delays, scope changes, and integration issues. The document provides examples of pharmaceutical projects that experienced challenges due to the traditional approach and advocates for concurrent engineering best practices where process and automation are designed together. This leads to robust systems designed to meet business objectives and enables flexibility.

1. Concurrent
Engineering –
Breaking down
the silos
Gilad Langer and EJ Alston

2. Agenda
Introduction
• What is Concurrent or Integrated Engineering?
• What are the benefits
Engineering in Pharma – the traditional approach
• Examples
Concurrent Engineering Best Practice
• Examples
Concurrent Engineering In Practice
• Examples
• Advantages
• Value

3. Concurrent Engineering / Integrated Engineering
• The process of Designs “tossed over the wall”
are inherently wasteful and risky
• Concurrent Engineering - simultaneous
engineering activities leading to a higher quality
design and a more effective engineering process.

4. What are the benefits?
• Effectively Achieve Design Goals
• Reduction in time to market
• Right first time
• Cost of quality
• Enhanced Productivity
• Earlier discoveries of design problems
• More efficient C&Q
• Decrease Design and Development Time
• Products & process that match customer’s
needs, in less time and at a reduced cost

5. A bit of historical perspective…
Concurrent Engineering
• 1988
• Aero & Defence
…
QbD by FDA
• 2006
QbD
• 1992
• Automotive
CIM
• 1993
• Auto, A&D, Ship
…
Integrated Engineering
• 2017
• Pharma

6. THE TRADITIONAL APPROACH
6

7. Disadvantages of the traditional approach
7
• The process vendor sends the completed process design to the automation vendor – this makes
integration difficult
• Automation system design becomes a matter of “this is possible – this is not possible”
• Small changes in the process design can have huge consequences for the automation system –
leads to scope changes/change orders and ultimately delays
• You miss any chances of identifying process steps which may prove to be redundant
• Discussions focus on scope changes rather than on functionality
• Things get lost in translation between the process people and the automation people
• No one takes ownership of solving the problem – both the process vendor and automation vendor
are doing their jobs

8. Example Brownfield Fill Finish Facility
• $120 mill. Fill Finish Facility under a consent decree with GMP fill and finish suites and packaging
• Equipment and facility designed by one company with installation, electrical, and automation
managed by other companies.
• Design delivered on time but automation programing 3 months delayed
• Document review cycles executed 6 times due to changes
• Executed multiple change orders increase project cost

9. Melted Instrumentation and Tubing
• Instrumentation installed and positioned
after design, FAT acceptance, and skid
installation
• Several valve operational failures due to
melted pneumatic control tubing during SIP
• Damaged instrumentation due to close
proximity to piping during SIP
• Damaged electrical conduit due to close
proximity to piping during SIP

10. Design and Automation Interface Issues
• Automation programing reworked due to
misalignment between process description, valve
matrix, automation scope, and process
development
• Automation scope did not match user
requirement specifications and required additional
work
• Skid design not aligned with automation and
instrumentation requirements for program
functionality causing additional work
• Functional specifications and valve matrix
required several updates to align process design
and automation requirements

11. Example: Greenfield Fill Finish Facility
• $500 mill. Fill Finish Facility with GMP fill and finish suites, utility plant, central warehouse
• Different companies for Process Design, Architect, Automation Design & Integration, and G.C.
• 1+ year delay
• Design review cycle from 2 to 5+ (still not enough)
• 30% new scope in automation due to “unfinished” process and HVAC design

12. No room to mount actuator
• Process specified instruments
• Automation design purchased instruments
• Installed by G.C.

13. WFI Loop Sanitization Cycle – all or nothing

14. Best practice example
Novo Nordisk DAPI US
14
Facility design + operating model
• Overall aspiration
• Operating principles
• Manufacturing processes
• Business processes
• Organisational structure
• Roles and responsibilities
• Competence/capacity requirements
• Quality system setup
• IT system alignment
• SOP development programme
• Recruitment programme
• Training programme
• Communication programme
Client contact: Morten Nielsen, head of DAPI-US

15. Elements of Pharma Facility Design – The key
Design framework should focus on the product attributes and the process
• unit operations required for manufacturing the product and the risks
• introduced by implementing the right technology
PROCESS
• Product produced
– Logical operating
units (LOUs)
• Equipment
– Steel and Single-use
• Input materials
INFRASTRUCTURE
• Control system
– Procedures/SOP’
– Computer systems
– Operating and
maintenance systems
– Documentation
• People
– Personal discipline
– Qualification/training
FACILITY
• Layout - flow
• Environment
• Utility systems
PROCESS
INFRASTRUCTUREFACILITY

16. Process and automation designed concurrently
to support each other
16
PROCESS AND AUTOMATION
• Complete understanding of process, equipment,
regulatory requirements, and support activities
(e.g., sampling)
• Complete understanding of software and
hardware requirements to support the defined
process
• Utilize pharmaceutical heritage to deliver a
comprehensive solution (Just works vs. works
even when there is human error)
PROCESS
INFRASTRUCTUREFACILITY

17. Our Front-End/CD Roadmap (OurModel)
17

18. What are the real business objectives?
18
Agile manufacturing Effective documentation Process capability Supply chain reliability Operational excellence
Flexibility Compliance Quality Volumes Competitiveness
New product intro Stable production volumes Patent expiry
Time
Recipe/
workflow
execution
Batch
reporting and
verification
AutomationandITcapabilities
Business
objectives
Enterprise
resource
planning
Scheduling
Unit control
Product and
process
definition
Electronic log
books
Batch control
Transport
control
Review by
exception
Manufacturing
intelligence
Quality
monitoring
Data collection
Laboratory
data
management
Quality test
workflow
execution
Calibration
management
Maintenance
management

19. 19

20. Advantages
20
• Ensures risk free design and implementation of automation and IT
• Leads to better and more robust design – the system is more effective and meets design objectives
• Facilitates a leaner process as it enables parallel design of process and automation system, which
optimises the project and the time schedule
• Enables optimisation of the process during the design phase
• Allows for automation input to process design, which creates room for optimisation and control
strategy – “have you thought about …”
• Allows for process input to automation design (what can we do to achieve seamless manufacturing?)
• Supports flexibility, agility and GMP readiness – all documentation is more homogenous – test
documentation for process and automation is the same
• Facilitates concurrent engineering – flexible manufacturing systems (FMS)

21. Value to the customer
21
• Transform automation solution from “just automating the process” to a complete system solution that
enables flexibility, agility and is “future proof”
• Design driven by business objectives
• Eliminate isolated and subjective technology decision
• Clear cost/benefit for solution elements
• Roadmap for solution elements not in initial scope
• Enable “informed” decisions during design and implementation phases using enterprise architecture
• Organisational alignment around common architecture
• Enterprise system touchpoints and integration
• Third party automation solution and equipment suppliers

22. Thank you
For further information please contact
EJ Alston
Director, Engineering
edal@nne.com
919-338-3160
Gilad Langer
Director, Automation & MIS
gidl@nne.com
415-405-6743