View
217
Download
4
Category
Tags:
Preview:
Citation preview
The project delivery specialists
Presentation on ADC facility concepts- NIBRT, June 2014.
expertise.The project delivery specialists
Agenda
1. PM Group Overview
2. ADC process flow
3. PMG- Dance floor concept
4. PMG’s Standardized Disposable Design Initiative – SDD
5. 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
4
•Biopharmaceuticals•Vaccines•Blood Fractionation•Chemical API•Fill & Finish•Formulation•Oral Solid Dosage•Packaging•Pilot Plants•QA/QC Laboratories•R&D Laboratories•Warehousing
Key Technical strengths
5
• Lean facility design.• Impartial advice.• BiosolveTM modelling.
• Cost of goods (COG) modelling.• Cost / benefit vs stainless.• Disposables strategy document.• Prototyping & 3D modelling.• Automation/MES advice.• Standardised Disposables
Design (SDD). • Can be used as a COG’s tool for
disposables.• Application of the ‘Dance Floor’
concepts - where needed.
SDD
3D
The project delivery specialists
Pall’s ADC process flows
skill.The project delivery specialists
Process Flows
7
100L to 500L scale for in-
market supply
Process Flows
8
The project delivery specialists
Lessons learnt in the Ballroom (The Dance Floor concept)
excellence.The project delivery specialists
The Dance Floor Concept
• Static Totes.• Defined Tubing Paths.• The 3M rule.• No trip Hazards.• Ability to Automate.• Facility engineered to be lean.• Smaller footprint.• Less HVAC costs.
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.
Article ForPharmaceutic
al Engineering Magazine
The project delivery specialists
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)
Parts List sent to vendors for
pricing
Use PMGroup’s Supplier Drawing
Database to choose suitable
part
PM Group 2013
PM Group’s Visio ‘Drag & Drop’ Design
Tool
The project delivery specialists
Can PMG concepts be applied to ADC manufacture ?
excellence.The project delivery specialists
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
Facility design & ADC’s
Reliability and repeatability is paramount from a health/safety and product quality/productivity perspective.
Connectivity and defined tubing routes
Reliability and repeatability is paramount from a health/safety and product quality/productivity perspective.
Automation & remote reliable operation
• 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
CIP and Toxic waste
Questions
Recommended