Design and Construction of Biocontainment Laboratories

Transcription

1 Design and Construction of Biocontainment Laboratories Effective management of a biocontainment facility design and construction project Page 11

2 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 Page 2

3 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 Page 3

4 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) Construction Cost (%) Operational Cost (%) BSL1 BSL2 BSL2+ BSL3 No Bio Safety Level Bio Safety level BSL1 BSL2 BSL2+ BSL3 Page 4

5 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) Page 5

6 Introduction, impact of time on change The later a change is introduced in a project, the more impact it has on timing and investment costs. CONSTRUCTION DETAILED DESIGN USER REQUIREMENTS FEASABILITY BASIC DESIGN Page 6

7 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 Page 7

8 Introduction, Project Life Cycle IDENTIFY THE NEED PROJECT PREPARATION Investment Analysis Process Definition Layout Basic Design Budget / Fin. Model Operational Model Feasibility Profitability Group s Strategy Logistics and Market Project Evaluation Need defined Permitting Topography Local customs Architecture Environment Permit Requests Local negotiations Procurement Basic Specifications Purchase Strategy Integrated Inquiry Negotiations Contractual- Agreements Financing Structured Financing Due Diligence Technology Market Finance Management Project Needs Process Description* Project Preparation Basic design Permitting Procurement Project Realisation Construction Qualification Operation *User requirements Decision to Invest Building Permit Environm. Permit Contracts Purchase Orders Operational PROJECT REALISATION Project Management Project Administration Cost Control Quality Management Quantity Management Layout Time Schedule Integrated Engineering Site & Safety Management CE Label, Validation Recruitment Training Interim Plant Management Page 8

9 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 Page 9

10 Introduction, Project Team 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 PROJECT TEAM Page 10

11 Introduction, Time Schedule Overall time frame (18 to more than 36 months) D&C Design and Construction Users requirements Feasibility study Basic design Detailed design Construction Qualification Hand-Over (80% USER, 20% D&C) (20% USER, 80% D&C) (50% USER, 50% D&C) (20% USER, 80% D&C) (10% USER, 90% D&C) (50% USER, 50% D&C) (90% USER, 10% D&C) 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! Page 11

12 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 Page 12

13 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 Page 13

14 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 ) Page 14

15 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 Page 15

16 Project Needs, Functioning diagrams Page 16

17 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 Page 17

18 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. Independent BSL3 unit BSL3 suite Integrated BSL3 unit Page 18

19 Project Preparation, Lab Organisation - Example Page 19

20 Project Preparation, P&ID - Example = bible between the project team and the maintenance and user! P&ID Piping and Instrument Diagram Page 20

21 Project Preparation, People and Material Flow A good circulation plan (people and material) helps you to identify the risks. Visitors Staff Lab Staff logistics confined Staff Waste evacuation Staff logistic non confined Waste Waste to decontaminate Biological Sample Material in Material to be autoclaved (recyclable) Material to be autoclaved Page 21

22 Project Preparation, Permitting Present in time to the authorities Discuss needs (informal) with authorities Present basic design to the authoraties Page 22

23 BioSafety Involvement Project Preparation, Procurement High Decontamination Equipment Finishing HVAC Furniture Process Piping Low Civil Works Generic Black Piping Specialized Page 23

24 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! Page 24

25 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 Page 28

26 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 Page 29

27 Speaker Patrick DE GRAEVE, ir arch IPS Belgium sa Industrial Projects Services Porte de l'europe Av. Robert Schuman, Nivelles - Belgium Page 30