How to be fast
Modular engineering Concept
Ole Baekgaard, NNE Pharmaplan
January 15, 2008
Agenda
• Modular Engineering Concept
•
•
•
•
Project break down structure
Engineering in parallel
Project Concept definition
Project Control
• Questions & answers
Customer challenges
• Products must be launched as fast as possible.
• Engineering Challenges
• Squeeze the Engineering, Construction & Validation Time Schedules.
R&D process:
Clinic I
Clinic II
Clinic III
Approval
Production:
Pilot Plant
Launch Plant
Design Construction/IQ/OQ PQ/PV
Time squeeze
Commercial production
How to be fast
• You can only work faster to a certain extent and
the costs rise exponentially
How to be fast
• An alternative approach is to break the project into a
structure of de-coupled, physical, functional modules:
• Which can be handled in parallel throughout the project.
• For which concepts for all major project activities can be
established and then repeated module by module.
• Which can be used for a high resolution project control.
control
• Keywords being: Structure,
Structure Parallelism,
Parallelism Concepts &
Project control.
control
We call it Modular Engineering
M
M
Modular Engineering is a system we use for a
structured break down of a physical plant into
function related objects - also called modules.
Module - Definition
Plant
Building Modules
Process Modules
40X 2T
Area Modules
Equipment Modules (Units)
Components
Structure, Parallelism, Concepts,
Project control
Modular Document Structure
Structure, Parallelism, Concepts,
Project control
Break down Structure
• The structure must remain unchanged through the entire
project
• Communication regarding control, technical changes, etc,
will be more effective as individual modules can be
addressed.
• Activities: Installation, tie-in, FAT/SAT, C&Q should also
be arranged in this structure.
• Documentation: Status lists, GMP and all other kinds of
checklists, specifications, must follow this common
structure.
Structure, Parallelism, Concepts,
Project control
Timesaving benefits by working in parallel
• Being able to construct the buildings and the equipment
(as modules) at the same time on different locations,
contrary to the traditional way of finishing the building
and then constructing the equipment inside the building.
Traditional
Building
Equipment
Modular
Building
Install.
Equipment
Structure, Parallelism, Concepts,
Project control
Timesaving benefits by working in parallel
• Being able to commission and qualify a major part of the
equipment in parallel AND/OR without dependencies to
adjacent, upstream and downstream equipment.
• Or even being able to do qualification activities, such as
IQ, off site.
Structure, Parallelism, Concepts,
Project control
Project concept definition
Major time savings and risk reduction:
• Using one example module, to define concepts for all
major project activities
• Negotiating for approval with relevant parties (end-user,
QA, etc), in advance and then copy those concepts to all
modules.
• Especially, it is advantageous to make a complete mockup qualification of a module, which can then be used as an
example by everyone in the project and for training of new
project members
Structure, Parallelism, Concepts,
Project control
• Complete process functions
• Modules should constitute a complete, ‘independent’, decoupled
process function:
• To keep complexity inside modules and not across boundaries
• To be able to keep the entire design and construction of a
module within a project group or sub-supplier.
• To be able to test the module without adjacent module being
present.
• To be able to test the module off site.
Structure, Parallelism, Concepts,
Project control
De-Coupling
DISTRUBUTION & SERVICE SYSTEMS
Structure, Parallelism, Concepts,
Project control
Similar or master/variant modules
Project 1
Standardisation within project
Standardisation across projects
Project 2
Structure, Parallelism, Concepts,
Project control
Modules must keep their definition
C&Q
CD
DD
BD
Con.
HO
Structure, Parallelism, Concepts,
Project control
Major risk reduction:
• Being able to apply a high resolution project control (that
is apply control on module level) on
‰ Time & Finance.
• As the control focuses on small (compared to the total)
uniform modules, it will be more reliable, and statements
such as “we are almost on schedule” will be replaced by
“we are on schedule, except for module X which is
behind and module Y which is ahead”
• As the modules will be more or less similar to modules in
other projects, benchmarking, module to module, will be
more accurate
Fast Track supported by
3D Modular Engineering
Fill & Finished example
Filling line
Filling
Filling line
Filling line
Formulation
Formulation
Wash & Sterilisation
St
eri
lis
ati
on
eq
u
ipm
en
t
The modular functions combined as
one production unit
Modular approach also supports
upgrades
Formulation area had to be
in FDA compliance
Modules can be used in renovation
projects
Visual Configuration is another way to speed
up projects in the front end design
Amplification
Seed Train
5000L perfusion
Harvest
UF
Capture
DSP Column
UF
DSP Column
Virus filtration
UF/DF
Freze drying
Visual Configuration in the CD fase
Modularization without compromising
work environment and aesthetic results
Questions ?