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

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Our work Spans the Full Pharma Spectrum

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•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

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• 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

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100L to 500L scale for in-

market supply

Process Flows

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The project delivery specialists

Lessons learnt in the Ballroom (The Dance Floor concept)

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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

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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

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Can PMG concepts be applied to ADC manufacture ?

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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