Innovative Design and Fast Trach Project Implementation

8/13/2019 Innovative Design and Fast Trach Project Implementation

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ISPE Nordic 1

Innovative Design &Innovative Design &

Fast Track Project ImplementationFast Track Project Implementation

JanJan LiljaLilja Director Director

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2ISPE NordicPharmaceutical BiotechnologyMiddle East

AgendaAgenda

n Case Study: Turn-Key supply of a Modular Aseptic

Manufacturing Facility in 17 months

n Conclusions






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The Modular ConceptThe Modular Concept – – An EnablingAn Enabling

TechnologyTechnologynModular design and fabrication

The term Modular is a wide-ranging concept. In this case it meansturn-key supply of complete facilities including all installations,

designed, built and IQ:ed off site.




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The Modular ConceptThe Modular Concept – – An EnablingAn Enabling

TechnologyTechnologyn The modular approach is today used for fast track, flexible

and predictable turn-key project delivery

- Global process-oriented design solutions (cGMP)

- Customized standardization

- Integrated validation approach from start of conceptual design

- Off-site construction with higher productivity and predictability

- Fabrication takes place in parallel with permitting and ground-

breaking work

- Same experienced fabrication team independent of final location

- Allows for full installation and testing off-site






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The Value of Fast Project ImplementationThe Value of Fast Project Implementation

Conventional Project

Fast Track Project


Fast Track Project

Fast Track Project


Fast Track Project


Fast Track Project

Less risk at decision point- Clinical trials results

- More info about market conditions

- Better developed process

Efficient use of financial resources

Same Completion Date with Later Start

Same Start with Earlier Completion Date

Faster-to-Market

Earlier return on investment

Less use of resources Defined/known process






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TheThe Modular Modular ConceptConcept – – A FlexibleA Flexible

TechnologyTechnology

n Future expansion

Phased investment with minimal down-time (Baxter)

n Technology Transfer

From Center of Excellence to local market

Product transfer between identical facilities

n Moving the facility

Re-sale (Sweden to Grindeks, Latvia), (Vagos, Estonia to BMS,Moscow)

Re-location (twice within Sweden, Astra Zeneca)

Installation of long lead equipment at vendor s workshop (AstraZeneca, Genentech)






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MovingMoving thethe facilityfacility

n Cost of relocation

Estimated cost for relocation isabout 10-15% of the initialinvestment (manufacturing

building including process,clean utility and HVACequipment and systems)

n Time schedule for relocation

Estimated time required for

relocation is about 4-8 monthsincluding disassembly,transport, reassembly andrequalification (IQ/OQ)






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Case Study: TurnCase Study: Turn--key supply of a Modular key supply of a Modular

Aseptic Manufacturing FacilityAseptic Manufacturing Facility






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The CompanyThe Company’’s Project Requirementss Project Requirements

n The investment should relieve demands on existing facilities andavoid potential delays/shutdown of operations

n Design to higher seismic importance (2,5 in California, SanFrancisco)

n Design for 1 batch fill every 24 hours

n Install and start 1 pc 28 sqm lyo, prepare for addition of a second

n Clean utility generation included in new facility, other utilities fromexisting site infrastructure




Cli k H & U d



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The CompanyThe Company’’s Guiding Principless Guiding Principles

n Minimize distraction on current projects and Operations

Deliver the project using off-site modular facility technology withan integrated project approach

Utilize off-site installation of long lead equipment

n Utilize vendor standards (engineering, construction anddocumentation)

n Small team that is empowered to make decisions and haveaccess to senior level management

Clear and prompt decision making

Decisions made within 24 hours

n Leverage vendor validation capabilities

Risk assessment based approach to validation







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Client Project ObjectivesClient Project Objectives

n Deliver a manufacturing facility

Cost to be equal to conventional alternative

Speed is a critical success factor

On time, through tailor-made, flexible approach

Licensed (Fda) in 28 months for $65 M

Licensed for 1 liquid product

Licensable for full product portfolio

Prepared for future expansion







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Project ScopeProject Scope

Size of facility 3,200 sqm, including process areas, mechanical areas for clean utilities and HVAC, lockers,cafeteria, goods receiving area with coldstorage

- Water pre-treatment equipment (outside of modular building)

- 1 WFI still- 1 Clean Steam Generator - 1 Vial washer and sterilizing tunnel- 1 Vial filler - 2 vial cappers- 1 lyophilizer

- 2 bulk-prep stations (including glycol cooling)- 1 CIP/SIP station for movable tanks

- 6 air handling systems (including automation)- Information management system (batch data collection) GAMP







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17 months from start Detailed Design to17 months from start Detailed Design to

OQ completeOQ completeID Task Name

1 Revised Plan

2 Project Budget Set

3 Board approval

4 Basic Design

5 Detail Design

6 Fabrication7 Fill Line testing

8 Pack and ship Support

9 Pack and ship process

10 1st module arrivse on

11 Permitting

12 Foundation and Site W

13 Erect modules

14 Re-assembly and start

15 Qualification through O

16 PQ

17 Media Fills

18 Qaul Lots

19 Stability

20 FDA review and appro

2/1

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O N DeJaFeM ApM JuJuAuSeO N D JaF M ApM JuJuAuSeO N D JaFeM ApM Ju JuAu

2005 2006 2007







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BatchBatch division of design anddivision of design and fabricationfabrication

n Define and focus on critical areasof the facility

n Building separated in support area

and process area to allow for simplified access

n Building divided into 7 batches

n The lyophilization area treated as a

separate batch to allow for earlydispatch of modules to the supplier of the lyophilizer







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Divide building for simplified accessDivide building for simplified access

Process Area

Support Area







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PrePre--assembled facility at modular assembled facility at modular

supplier supplier ’’s workshops workshop


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Facility required to blend in withFacility required to blend in with

surroundingssurroundings


pg





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18ISPE NordicPharmaceutical Biotechnology

Middle East

StartStart--upup at theat the modular modular supplier supplier ’’ss

workshopworkshopn The facility was assembled at the

workshop (except lyo)

n Start-up and FAT of the followingsystems:

Filling line

WFI system

CIP system

BAS system

IMS system

n Tests documented according toGDP to use for validation

n Building and Fire officialinspections

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Installation of the vial washer Installation of the vial washer


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StartStart--up of the filling machineup of the filling machine


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E d d F t



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Testing of the filling lineTesting of the filling line


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Disassembly and preparation for Disassembly and preparation for

shipmentshipment


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Innovative approachInnovative approach

n Move (part of) the facility to the vendor

Use experienced vendor resources

Use workshop facilities

Use commissioning capabilities (temporary utilities, etc.)

Do a thorough debugging and start-up at vendor

Make IQ and part of OQ tests in final installation at vendor


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Middle East

LyoLyo in a boxin a box

To shorten the time schedule and minimize

risk and testing, a part of the building was

sent to BOC Edwards.

The complete lyophilizer system (chamber,condensor and Compressor skid) wasinstalled directly into the modules and alltesting was performed in their work shop.

Meanwhile the rest of the building wasalready on its way to the clients site.


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Project Delivery GeographyProject Delivery Geography

SwedenTonawanda

San Francisco

HollandSweden

Tonawanda

San Francisco

Holland


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Modules atModules at lyolyo supplier supplier ’’s workshops workshop


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Modules stacked up withModules stacked up with lyolyo installedinstalled


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Pharmaceutical BiotechnologyMiddle East

FacilityFacility on finalon final sitesite readyready for for dockingdocking of of

thethe

lyolyo

modulesmodules


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Filling line on siteFilling line on site

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AchievementsAchievements

n Able to absorb 3 months schedule delay in permits

n Modular building including all process and clean utility equipment

designed, fabricated and tested in 10 months

n Substantial start up, commissioning and testing completed in theworkshops of Pharmadule and BOC Edwards

n Training executed and operational documentation completed before

shipment to site

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ConclusionsConclusions

The Modular concept allows for different kinds of FLEXIBILITY

OWNER:

- Early finish or deferred start

- Allocation period of capital expenditure optimized- Much faster depreciation possibilities of the facility (not fixed asset)

DESIGN & FABRICATION:

- Customized solution, standardized approach (20/80)

- Off-site construction in several locations (executor, vendors)- Batch approach to fabrication (independent blocks)

- Independent site preparation work (not on critical path)

- Less disturbances for ongoing work on site

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ConclusionsConclusions

The Modular concept allows for different kinds of FLEXIBILITY

PROJECT TEAM

- Less client resources required- Focus on core competences

* Pharmadule (design, execution, validation)* Vendors (installation & testing)* Client (URS, process, PQ, manufacturing start-up)

FUTURE

- Built in flexibility for new equipment/processes- Ease of expansion with minimal down-time- Re-location at existing or to new site

Result: FLEXIBLE & FAST(ER) PROJECT Implementation


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