Presentation on ADC facility concepts- NIBRT, June 2014.
expertise.
The project delivery specialists
Agenda
1.
2.
3.
4.
5.
PM Group Overview
ADC process flow
PMG- Dance floor concept
PMG’s Standardized Disposable Design Initiative – SDD
How to apply PMG concepts to ADC manufacture
1.
Facility design
2.
Connectivity and routing
3.
Remote operation
4.
Handling of toxic waste
The Project Delivery Specialists
You can rely on our team
of 2,100+ people to deliver
your project successfully
•Integrated
Design and Construction
firm
•Proven track record since 1973
•Employee-owned company
•Revenue over €300 million
•18 offices worldwide
•Projects in 30 countries
3
Our work Spans the Full Pharma Spectrum
•Biopharmaceuticals
•Vaccines
•Blood
Fractionation
•Chemical API
•Fill & Finish
•Formulation
•Oral Solid Dosage
•Packaging
•Pilot Plants
•QA/QC Laboratories
•R&D Laboratories
•Warehousing
4
Key Technical strengths
• Lean facility design.
• Impartial advice.
• BiosolveTM modelling.
• Cost of goods (COG) modelling.
•
•
•
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•
Cost / benefit vs stainless.
Disposables strategy document.
Prototyping & 3D modelling.
Automation/MES advice.
Standardised Disposables
Design (SDD).
SDD
• Can be used as a COG’s tool for
disposables.
• Application of the ‘Dance Floor’
concepts - where needed.
3D
5
Pall’s ADC process flows
skill.
The project delivery specialists
Process Flows
100L to 500L
scale for inmarket supply
7
Process Flows
8
Lessons learnt in the Ballroom (The Dance Floor concept)
excellence.
The project delivery specialists
The Dance Floor Concept
•
•
•
•
•
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Static Totes.
Defined Tubing Paths.
The 3M rule.
No trip Hazards.
Ability to Automate.
Facility engineered to be lean.
Smaller footprint.
Less HVAC costs.
Article For
Pharmaceutical
Engineering
Magazine
Note:- Ballrooms concepts are suited for clinical facilities, where
flexibility is key. However the Dance Floors concepts are more suited to
in-market supply, where reliability and efficiency are paramount.
PMG’s Standardized Disposable Design Initiative - SDD
excellence.
The project delivery specialists
End User Advantages of SDD
“Standardisation of disposables is what the
industry has being ‘crying out for’ for years.
The benefits in terms of interconnectivity
between items from different suppliers,
simplification of dual sourcing of materials and
reduction in prototype lead times will be
significant”.
Declan O’Sullivan
Area manager
Pfizer Grange Castle
Suppliers ‘on-board’
High level benefits of SDD Initiative
Interconnectivity between
different vendors,
Speeds up plant design,
Standardizes parts,
Multiple vendor selection,
‘Like for like’ comparisons,
Increased security of supply,
Disposable Design Strategy Flow Chart
PM Group Standardised Disposables Design
Process
Flow Diagram
(PFD)
PM Group 2013
PM Group’s
Visio ‘Drag &
Drop’ Design
Tool
Use PMGroup’s
Supplier Drawing
Database to
choose suitable
part
Parts List sent
to vendors for
pricing
Can PMG concepts be applied to ADC manufacture ?
excellence.
The project delivery specialists
Facility design & ADC’s
Rapid prototyping & 3D modelling
•Fit the facility round the process, rather than the process into the
facility
•Media/buffer on the other side of the wall
Connectivity and defined tubing routes
Reliability and repeatability is paramount from a health/safety
and product quality/productivity perspective.
Automation & remote reliable operation
Reliability and repeatability is paramount from a health/safety
and product quality/productivity perspective.
CIP and Toxic waste
•
•
The cleaning solution & the CIP system will be contaminated with toxic
compounds and need to be contained.
Single use systems can
• Remain contained during disassembly
• Do not need to be CIPed
• Can be incinerated without opening
• Provide more reliable operator protection
• Need less maintenance & prep for maintenance
Questions