Presentation on ADC facility concepts- NIBRT, June 2014.

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

2. Agenda • 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 • Facility design • Connectivity and routing • Remote operation • 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

4. 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

5. Key Technical strengths • 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

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

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

8. Process Flows

9. 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. 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.

11. 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 Use PMGroup’s Supplier Drawing Database to choose suitable part Process Flow Diagram (PFD) Parts List sent to vendors for pricing PM Group’s Visio ‘Drag & Drop’ Design Tool PM Group 2013

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

16. 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

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

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

19. 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

20. Questions