Design and Construction of Biocontainment Laboratories · –BSL zones –Pressures –People flow (maintenance, operators, visitors…) –Material flow (sample/product, waste, disposals…)

1) Introduction

2) Project Needs

3) Project Preparation

4) Project Realization

5) Conclusions

Page 1Belgian Biosafety Symposium on 3 December 2009 2009 © Group-IPS

Design and Construction of

Biocontainment Laboratories

Page 12009 © Group-IPS

Effective management of a biocontainment facility

design and construction project

Belgian Biosafety Symposium on 3 December 2009

1) Introduction

2) Project Needs



5) Conclusions


Aim of the presentation

• Giving a better insight in the different steps of an

investment project

• Giving a better insight in the different people involved

in a project

• Proving the importance of biosafety risk analysis

• Identifying the critical steps for biosafety

1) Introduction

2) Project Needs



5) Conclusions


Introduction

• The logic of a biocontainment facility project

is not different then any other investment

project!

• However…

– Biosafety constraints can give very

important technical and spatial impacts

– Those impacts can change a strategic

position of a project

1) Introduction

2) Project Needs



5) Conclusions


Introduction, impact of biosafety constraints

• Construction costs increases exponential with the required biosafety

level

• Construction Time (incl. Qualification) increases exponential with

the required biosafety level.

• Required surface increases exponential with the required biosafety

level

• Operational costs (and processing time) increase also exponential

with the required biosafety level (BSL3 facilities have generally the

highest operational cost in the industry)

No Bio Safety Level Bio Safety level 3

0

50

100

150

200

250

300

350

BSL1

BSL2

BSL2+

BSL3

0

100

200

300

400

500

600

700

BSL1

BSL2

BSL2+

BSL3

Construction Cost (%)

Operational Cost (%)

1) Introduction

2) Project Needs



5) Conclusions


Introduction, master impacts

• Biosaferty can be mastered by a profound

risks analysis, identifying the real (biosafety)

risks for the concerned activities, not only

applying procedures!

• Identified risks can be controlled by

– technical means and design of the facility (CAPEX)

– operation procedures and work practices (OPEX)

– PPE and adapted equipment (CAPEX/OPEX)

1) Introduction

2) Project Needs



5) Conclusions


• The later a change is introduced in a project, the more impact

it has on timing and investment costs.

Introduction, impact of time on change

BASIC DESIGN

DETAILED DESIGN

CONSTRUCTION

USER REQUIREMENTS

FEASABILITY

1) Introduction

2) Project Needs



5) Conclusions


Introduction, managing project = managing risk

• Conclusion

– Risks have to identified as precise as

possible to identify the most appropriate

solution

– The notion of biosafety and the related

consequences have to be introduced in a

project as from the early beginning

– To avoid change during the project every

step has to be validated on biosafety level

1) Introduction

2) Project Needs



5) Conclusions


Introduction, Project Life Cycle

PROJECT

REALISATION

PROJECT

PREPARATION

IDENTIFY THE NEEDGroup’s Strategy

Logistics and Market

Project Evaluation

Investment

AnalysisPermitting Procurement

Process Definition

Layout

Basic Design

Budget / Fin. Model

Operational Model

Feasibility

Profitability

Topography

Local customs

Architecture

Environment

Permit Requests

Local negotiations

Basic Specifications

Purchase Strategy

Integrated Inquiry

Negotiations

Contractual-

Agreements

Decision to

Invest

Building Permit

Environm. Permit

Contracts

Purchase Orders

Need defined

Project Management

Project Administration

Cost Control

Quality Management

Quantity Management

Layout

Time Schedule

Integrated Engineering

Site & Safety Management

CE Label, Validation

Financing

Structured

Financing

Due Diligence

Technology

Market

Finance

Management

Recruitment

Training

Interim Plant

Management

Operational

Project Needs

Process Description*

Project Preparation

Basic design

Permitting

Procurement

Project Realisation

Construction

Qualification

Operation

*User requirements

1) Introduction

2) Project Needs



5) Conclusions


Introduction, different players

• Steering Pole (overall strategy of the company)

– Strategic level of the company

• USER Pole (defines the need)

– Physically will use the facility (or has the

knowledge of the activity) and therefore defines the

needs.

• Design & Construction Pole (realises the project)

– Translates a need in a virtual facility (design)

– Translates the virtual facility in a built facility

– Check if the built facility is compliant

• Compliances Pole (overall policy of the company and

legal requirements)

– Will control the facility and therefore defines the

context in which the needs have to be translated to

a built facility

1) Introduction

2) Project Needs



5) Conclusions


• Steering Pole

– Operational Manager

– Management User

– Management D&C Pole

– Shareholder‟s representative

• USER Pole (user representative)

– Actual and future operators of the facility

– Actual and future maintenance of the facility

• Design & Construction Pole (project manager)

– Design office (internal/external)

– Contractors

– Qualification team

• Compliances Pole (consultance)

– Environment Health & Safety, Bio Safety Officer ,

Quality Assurance, Quality Control, Validation

Team…

Introduction, Project Team

PROJECT TEAM

1) Introduction

2) Project Needs



5) Conclusions


Introduction, Time Schedule

Basic design (50% USER, 50% D&C)

Feasibility study (20% USER, 80% D&C)

Construction (10% USER, 90% D&C)

Detailed design (20% USER, 80% D&C)

Qualification (50% USER, 50% D&C)

Users requirements (80% USER, 20% D&C)

• Overall time frame (18 to more than 36 months)

Hand-Over (90% USER, 10% D&C)

D&C – Design and Construction

In this stage of the project the concepts are defined

Change after this phase of the project has a mayor

Impact on costs and timing !

1) Introduction

2) Project Needs



5) Conclusions


Project Needs , << Users Requirements >>

• Objective and Justification of the Project

• Compliances of the Project

– Quality (e.g. GMP, GLP…)

– Safety (incl. Biosafety)

– Energy

• General description of the activity and process

– Organisation chart

– Schematic Product/Sample flow diagrams

• Detailed description of each step of activity

– Definition of BSL zones on the flow diagrams

• Technical requirements

– Fluids, Environmental parameters…

– Redundancies

• Assessment of the evolution of the needs

– Flexibility

– Expansion possibilities

1) Introduction

2) Project Needs



5) Conclusions


Project Needs, avoid copy paste

• Note : People tend to define a need based upon what

they know or have today and not on what they really

need TOMORROW.

– Force people to project themselves into the future,

by means of benchmark visits, workshops,

simulations…

– Do not accept non motivated answers (e.g. “I need

the same lab as today + 50%”)

– Make assumptions on change (new technologies,

new markets, change of legislation…)

• Note : The more flexibility the higher the cost and the

longer the planning

1) Introduction

2) Project Needs



5) Conclusions


Project Needs, reorganization, standardization

• Note : Very often a project goes together with a

reorganisation, this reorganisation should be

conceived before or in parallel with the project, NOT

afterwards!

• Note : In larger projects it happens very often that the

user that defines the project is not the one that will use

the facility

– A certain degree of standardisation is needed as

the users that define the project are often not the

once that use the facility

– Strategic decisions should be motivated in written

form (paper statements, risk analysis, GAP

analysis…)

1) Introduction

2) Project Needs



5) Conclusions


Project Needs, Difficulties of Communication

• Techniques have impact on use and use has impact on

techniques, but….

– USER Pole

• incubation, clinical studies phase 1, cross

contamination…

• useful m2, quality, image, FTE….

– D&C Pole

• N/m2, dimensioning pressure, P&ID, nD, l/min,

safety valves, AHU

• euros, working days, brute m2 ….

• Find a common language and interest !

– Linear meter of working bench, Room Data

Sheets…

– Find a good balance in-between investment and

operations

1) Introduction

2) Project Needs



5) Conclusions


Project Needs , Functioning diagrams

1) Introduction

2) Project Needs



5) Conclusions


Project Preparation , << Basic Design >>

• General Layout

– BSL zones

– Pressures

– People flow (maintenance, operators, visitors…)

– Material flow (sample/product, waste, disposals…)

• Room by Room (preliminary RDS)

– Equipment positioning

– Compliances and quality levels

• Technical concepts

– Flow Charts and preliminary P&ID

– Functional descriptions

• Validation Master Plan (preliminary) !

– Risk assessment

– Elements to validate

P&ID – Piping and Instrument

Diagram

RDS – Room Data Sheet

1) Introduction

2) Project Needs



5) Conclusions


Project Preparation, Lay-out strategy

• Independent BSL3 unit

– Containment limited to the unit itself;

support rooms not contained

• BSL3 suite

– Unit and support rooms gathered into one

organised containment area

• Integrated BSL3 unit (“box in a box” concept)

– BSL3 units integrated in an organised suite

of a lower Bio Safety level (BSL2 or BSL2+)

“BSL2+” - non-official biological

containment level that has

been created by a number of

institutions to manage the

large gap between BSL2 and

BSL3 requirements, it has

been locally recognized

by some authorities.

BSL3 suite Integrated BSL3 unitIndependent BSL3 unit

1) Introduction

2) Project Needs



5) Conclusions


Project Preparation, Lab Organisation - Example

1) Introduction

2) Project Needs



5) Conclusions


Project Preparation, P&ID - Example

P&ID – Piping and Instrument

Diagram

= „bible‟ between the project team and the maintenance

and user !

1) Introduction

2) Project Needs



5) Conclusions


Project Preparation, People and Material Flow

Material to be autoclaved

Material to be autoclaved

(recyclable)

Material in

Biological Sample

Staff logistic non confined

Staff Waste evacuation

Staff logistics confined

Staff Lab

Visitors

Waste

Waste to decontaminate

• A good circulation plan (people and material) helps

you to identify the risks.

1) Introduction

2) Project Needs



5) Conclusions


Project Preparation, Permitting

• Present in time to the authorities

– Discuss needs (informal) with authorities

– Present basic design to the authoraties

1) Introduction

2) Project Needs



5) Conclusions


Project Preparation, Procurement

Generic Specialized

Low

High

Bio

Safe

ty Involv

em

ent

Civil

Works

HVACFinishing

Decontamination

Equipment

FurnitureProcess

Piping

Black Piping

1) Introduction

2) Project Needs



5) Conclusions


Project Realization

• Besides the construction phase, two extra

phases are added :

– Validation/Qualification

– Transfer of activities

• Installation of equipment can be a

problem, ask help from specialist

movers

• Risk analysis for moving activities

(changed parameters)

– Training of staff

• Those phases should be planned and

anticipated as from the basic design!

1) Introduction

2) Project Needs



5) Conclusions


Conclusions, Input BSO

• The BSO identifies the RISKS, communicates them and

assures that they are mastered.

• The BSO GIVES ADVICE and CONTROLS at ALL

stages of the project (main input during user

requirements and basic design)

• The BSO APPROUVES

– the User Requirements

– Basic Design (incl. the VMP)

– Critical parts in the Detailed Design and

Construction

– Specific validation protocols

BSO – BioSafety Officer

1) Introduction

2) Project Needs



5) Conclusions


Conclusions , How to Impose Bio Safety in a Project

• Every pole has its own interests, Bio Safety is only one

of the needed compliances…

• Argumentation

– Inform the team on the legal context

– Make and explain risk assessments

– Make the project team be accomplice to Bio Safety

– Leave flexibility to the project team (User and D&C)

to allow as well technical and operational solutions

• To avoid

– Impose technical solutions without understanding

or argumentation

1) Introduction

2) Project Needs



5) Conclusions


Speaker

Patrick DE GRAEVE, ir [email protected]

IPS Belgium sa

Industrial Projects Services

Porte de l'Europe

Av. Robert Schuman, 16

1400 Nivelles - Belgium

www.group-ips.com

Documents

Design and Construction of Biocontainment Laboratories · –BSL zones –Pressures –People flow (maintenance, operators, visitors…) –Material flow (sample/product, waste, disposals…)