1. The project delivery specialists Presentation on ADC facility concepts- NIBRT, June 2014. expertise. The project delivery specialists

2. 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

3. 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

4. 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

5. Key Technical strengths 5 Lean facility design. Impartial advice. Biosolve TM 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

6. The project delivery specialists Pall’s ADC process flows skill. The project delivery specialists

7. Process Flows 7 100L to 500L scale for in- market supply

8. Process Flows 8

9. The project delivery specialists Lessons learnt in the Ballroom (The Dance Floor concept) excellence. The project delivery specialists

10. 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 For Pharmaceutical Engineering Magazine

11. The project delivery specialists PMG’s Standardized Disposable Design Initiative - SDD excellence. The project delivery specialists

12. 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 ’

13. 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,

14. 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

15. The project delivery specialists Can PMG concepts be applied to ADC manufacture ? excellence. The project delivery specialists

16. 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

17. Reliability and repeatability is paramount from a health/safety and product quality/productivity perspective. Connectivity and defined tubing routes

18. Reliability and repeatability is paramount from a health/safety and product quality/productivity perspective. Automation & remote reliable operation

19. 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

20. Questions