Innovative Design and Fast Trach Project Implementation

Click Here & Upgrade
PDF Complete
Documents
Expanded Features Unlimited Pages
Innovative Design & Fast Track Project Implementation
Jan Lilja Director
ISPE Nordic
PDF Complete
Documents
Agenda
n Case Study: Turn-Key supply of a Modular Aseptic Manufacturing Facility in 17 months n Conclusions
Pharmaceutical Biotechnology ISPE Nordic Middle East
PDF Complete
Documents
The Modular Concept An Enabling Technology

n Modular design and fabrication
The term Modular is a wide-ranging concept. In this case it means turn-key supply of complete facilities including all installations, designed, built and IQ:ed off site.
PDF Complete
Documents
The Modular Concept An Enabling Technology

n 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 groundbreaking work - Same experienced fabrication team independent of final location - Allows for full installation and testing off-site
4
PDF Complete
Documents
The Value of Fast Project Implementation

Same Start with Earlier Completion Date
Fast Track Project Convent ional Project
Faster-to-Market Earlier return on investment Less use of resources Defined/known process
Same Completion Date with Later Start

Less risk at decision point
- Clinical trials results - More info about market conditions - Better developed process
Fast Track Project Convent ional Project
Efficient use of financial resources
PDF Complete
Documents
The Modular Concept A Flexible Technology

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 (Astra Zeneca, Genentech)
PDF Complete
Documents
Moving the facility

n Cost of relocation
Estimated cost for relocation is about 10-15% of the initial investment (manufacturing building including process, clean utility and HVAC equipment and systems)
n Time schedule for relocation

Estimated time required for relocation is about 4-8 months including disassembly, transport, reassembly and requalification (IQ/OQ)
PDF Complete
Documents
Case Study: Turn-key supply of a Modular Aseptic Manufacturing Facility
PDF Complete
Documents
The Companys Project Requirements

n The investment should relieve demands on existing facilities and avoid potential delays/shutdown of operations n Design to higher seismic importance (2,5 in California, San Francisco) 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 from existing site infrastructure
PDF Complete
Documents
The Companys Guiding Principles

n Minimize distraction on current projects and Operations Deliver the project using off-site modular facility technology with an integrated project approach Utilize off-site installation of long lead equipment n Utilize vendor standards (engineering, construction and documentation) n Small team that is empowered to make decisions and have access 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
10
PDF Complete
Documents
Client 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
11
PDF Complete
Documents
Project Scope
Size of facility 3,200 sqm, including process areas, mechanical areas for clean utilities and HVAC, lockers,cafeteria, goods receiving area with cold storage - 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
12
PDF Complete
Documents
17 months from start Detailed Design to OQ complete

ID 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Task Name Revised Plan Project Budget Set Board approval Basic Design Detail Design Fabrication Fill Line testing Pack and ship Support area Pack and ship process area 1st module arrivse on site Permitting Foundation and Site Work Erect modules Re-assembly and start up Qualification through OQ PQ Media Fills Qaul Lots Stability FDA review and approval 1/9 10/17 2005 2006 2007 Oct Nov Dec Jan Feb Mar Apr May Jun JulAug Sep Oct Nov Dec Jan Feb Mar Apr May Jun JulAug Sep Oct Nov Dec Jan Feb Mar Apr May Jun JulAug 2/1 2/8
13
PDF Complete
Documents
Batch division of design and fabrication

n Define and focus on critical areas of 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 early dispatch of modules to the supplier of the lyophilizer
14
PDF Complete
Documents
Divide building for simplified access
Process Area
Support Area
15
PDF Complete
Documents
Pre-assembled facility at modular suppliers workshop
16
PDF Complete
Documents
Facility required to blend in with surroundings
17
PDF Complete
Documents
Start-up at the modular suppliers workshop

n The facility was assembled at the workshop (except lyo) n Start-up and FAT of the following systems:
Filling line WFI system CIP system BAS system IMS system
n Tests documented according to GDP to use for validation n Building and Fire official inspections
18
PDF Complete
Documents
Installation of the vial washer
19
PDF Complete
Documents
Start-up of the filling machine
20
PDF Complete
Documents
Testing of the filling line
21
PDF Complete
Documents
Disassembly and preparation for shipment
22
PDF Complete
Documents
Innovative 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
23
PDF Complete
Documents
Lyo in 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) was installed directly into the modules and all testing was performed in their work shop. Meanwhile the rest of the building was already on it s way to the client s site.
24
PDF Complete
Documents
Project Delivery Geography
Tonawanda
Sweden Holland
San Francisco
25
PDF Complete
Documents
Modules at lyo suppliers workshop
26
PDF Complete
Documents
Modules stacked up with lyo installed
27
PDF Complete
Documents
Facility on final site ready for docking of the lyo modules
28
PDF Complete
Documents
Filling line on site
29
PDF Complete
Documents
FDA approved facility in 27 months
30
PDF Complete
Documents
Achievements
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 the workshops of Pharmadule and BOC Edwards n Training executed and operational documentation completed before shipment to site
31
PDF Complete
Documents
Conclusions
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
32
PDF Complete
Documents
Conclusions
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

33
PDF Complete
Documents
Thank you for the attention! Questions?
34

Innovative Design and Fast Trach Project Implementation

Caricato da

Informazioni sul documento

Copyright

Formati disponibili

Condividi questo documento

Condividi o incorpora il documento

Opzioni di condivisione

Hai trovato utile questo documento?

Questo contenuto è inappropriato?

Copyright:

Formati disponibili

Innovative Design and Fast Trach Project Implementation

Caricato da

Copyright:

Formati disponibili

Click Here & Upgrade

Expanded Features Unlimited Pages

Innovative Design & Fast Track Project Implementation

Jan Lilja Director

Click Here & Upgrade

Expanded Features Unlimited Pages

Pharmaceutical Biotechnology ISPE Nordic Middle East

Click Here & Upgrade

Expanded Features Unlimited Pages

The Modular Concept An Enabling Technology

Pharmaceutical Biotechnology ISPE Nordic Middle East

Click Here & Upgrade

Expanded Features Unlimited Pages

The Modular Concept An Enabling Technology

Click Here & Upgrade

Expanded Features Unlimited Pages

The Value of Fast Project Implementation

Faster-to-Market Earlier return on investment Less use of resources Defined/known process

Same Completion Date with Later Start

Efficient use of financial resources

Pharmaceutical Biotechnology ISPE Nordic Middle East

Click Here & Upgrade

Expanded Features Unlimited Pages

The Modular Concept A Flexible Technology

Pharmaceutical Biotechnology ISPE Nordic Middle East

Click Here & Upgrade

Expanded Features Unlimited Pages

Moving the facility

n Time schedule for relocation

Pharmaceutical Biotechnology ISPE Nordic Middle East

Click Here & Upgrade

Expanded Features Unlimited Pages

Case Study: Turn-key supply of a Modular Aseptic Manufacturing Facility

Pharmaceutical Biotechnology ISPE Nordic Middle East

Click Here & Upgrade

Expanded Features Unlimited Pages

The Companys Project Requirements

Pharmaceutical Biotechnology ISPE Nordic Middle East

Click Here & Upgrade

Expanded Features Unlimited Pages

The Companys Guiding Principles

Click Here & Upgrade

Expanded Features Unlimited Pages

Client Project Objectives

Click Here & Upgrade

Expanded Features Unlimited Pages

Click Here & Upgrade

Expanded Features Unlimited Pages

17 months from start Detailed Design to OQ complete

Pharmaceutical Biotechnology ISPE Nordic Middle East

Click Here & Upgrade

Expanded Features Unlimited Pages

Batch division of design and fabrication

Pharmaceutical Biotechnology ISPE Nordic Middle East

Click Here & Upgrade

Expanded Features Unlimited Pages

Divide building for simplified access

Pharmaceutical Biotechnology ISPE Nordic Middle East

Click Here & Upgrade

Expanded Features Unlimited Pages

Pre-assembled facility at modular suppliers workshop

Pharmaceutical Biotechnology ISPE Nordic Middle East

Click Here & Upgrade

Expanded Features Unlimited Pages