High-Containment Laboratory Design & Construction - A Practical Approach

Engineering Methods for the Control of Airborne Infections: An International Perspective Harvard School of Public Health Center for Continuing Professional Education July 14-25, 2008 Boston, Massachusetts High-Containment Laboratory Design & Construction - A Practical Approach Presented by: Jean P (Fred) Khoshbin R.A. Gary Zackowitz R.A. Babak (Bob) Farahpour P.E. Lecture Overview Part 1: Planning and Design Part 2: Architectural detailing and Construction Part 3: Engineering and Commissioning 1

NIAID s Program Overview NIAID s Biodefense Program currently includes a total of 15 facilities 13 Regional Bio-containment Laboratories (RBL) 2 National Bio-containment Laboratories (NBL) Project size: Varies from 26,000 GSF to 192,000 GSF Project cost: Varies from $18 Mil. to $191 Mil. 2

NIAID s Program Overview High-containment Laboratory Design & Construction Harvard School of Public Health Center for Continuing Professional Education July 14-25, 2008 Boston, Massachusetts Part One - Planning and Design Presented by: Jean P (Fred) Khoshbin R.A. 3

Key Planning Elements 1. Community Relations 2. Site Selection 3. Threat & Risk Assessment (TRA) & Biosecurity 4. Environmental Approval Process 5. Project /Construction Planning Team 6. Communication / Users Expectations 7. Program Definition 8. Standard Operating Procedures (SOPs) Design Impact 9. Business Model Impact on Design 10. Scientific Equipment Selection 11. Value Engineering (VE) 12. Operation and Maintenance (O&M) 13. Access to Infrastructure and Utilities 14. Cost Project / Operation 15. Constraints and Challenges of Planning Biocontaiment Facilities in Developing Countries 1- Community Relations 4

Community Relations -1 To be most successful, the Community Relations plan should be in place at the planning stage of the new laboratory All elected officials, community leaders, and institutional leadership should be briefed on the plans for the lab, its timeline, and its mission Involve citizen groups, and residents in a constant exchange of information Provide an Emergency response plan to address community concerns by partnering with: The local fire and rescue department The Public Health Officials Community Relations - 2 Transparency is paramount, voluntary sharing of information with the communities help build trust and confidence Use tools that have proven effective: Websites Newsletters Public information briefings Community outreach does not stop with the completion of the project Keep the community relations process separate from the Environmental Assessment process 5

2- Site Selection Site Selection - 1 In addition to the typical analysis and site selection criteria, the following should be thoroughly investigated The impact of your site selection and site alternatives on the community Possible impact on the project cost and schedule due to local threats and community opposition Costs due to local codes and requirements Availability of infrastructure Proximity to scientific research communities 6

Site Selection-2 TRA Impact Security setbacks (roads, parking areas, adjacent properties) Perimeter security barriers (pedestrian, vehicular, access gates) Vehicular inspection (guard booths, inspection areas) CCTV surveillance visibility & lighting Maintenance and delivery access Fresh air intakes and exhaust air reintrainment Vibration considerations 3 - Threat & Risk Assessment (TRA) & Biosecurity 7

Threat & Risk Assessment (TRA) & Biosecurity - 1 TRA: Identify local, national, and international threats that could compromise the safety of the general public, the environment, the security of the personnel, the research, and the facility Identify solutions to mitigate identified risks and threats Threat & Risk Assessment (TRA) & Biosecurity -2 Biosecurity : To protect pathogens from unauthorized people and malevolent acts through the application of security measures, protocols, and facility design. 8

Threat & Risk Assessment (TRA) & Biosecurity - 3 THREAT ASSESSMENT DESIGN BASIS TACTICS VULNERABILITY ANALYSIS RISK ASSESSMENT DESIGN CRITERIA PROTECTIVE MEASURES CONSEQUENCE LIKELIHOOD LEVEL OF PROTECTION The TRA and Biosecurity have major impacts on project design and cost Threat & Risk Assessment (TRA) & Biosecurity - 4 Security Design Exterior Vehicular exclusion Pedestrian exclusion Building access control Security Design Interior Onion concept (layers) Monitoring security access systems Intrusion detection systems Biometric identification systems Control centers (fire command, security control, and building controls) CCTV and monitoring systems 9

Threat & Risk Assessment (TRA) & Biosecurity - 5 Possible Design mitigation strategies to enhance security (based on the TRA) Blast resistant construction Progressive collapse structural design Entry lobby and loading dock blast protection Box within a box concept Redundancy of building systems Emergency generator protection Air intake protection 4 - Environmental Approval Process 10

Environmental Approval Process-1 Cost & Schedule Impact National Environmental Policy Act (NEPA) process / Environmental Assessment (EA) or Environmental Impact Statement (EIS) Basis of design / SOPs included as part of studies Public participation (State specific for EA, required for EIS) Alternative site analysis Threat & Risk analysis Environmental Justice analysis Dispersion analysis For projects using Federal funds in the USA, NEPA process has to be completed prior to starting any construction activities. 5 - Project / Construction Planning Team 11

Project Planning Team Scientific Investigators Occupational Health & Safety / Biosafety Specialist Veterinarian / Vivarium Manager Architects & Engineers Laboratory / Vivarium Planner Facilities Engineer Cost Estimator Commissioning Agent Fire Protection Engineer Peer Review Panel (depending on project complexity) Construction Team Owner / owner s rep. User groups rep. Architect / engineer (Construction Administration team) Construction Manager (CM) Contractor / subcontractors Testing, balance, and controls Commissioning agent (independent) Regulatory agencies (building inspectors, government regulators, etc.) 12

6 - Communication / User Expectations Communication / User Expectations - 1 We don t always speak the same language, Science - GMP = Good Manufacturing Practices? Construction - GMP = Guaranteed Maximum Price? Conveying and translating scientific program information into design requirements can be challenging. Lack of understanding of biosafety principles and application Commissioning problems Maintenance issues Reliance on SOPs as a design solution Understand the Basis of Design document 13

Communication /User Expectations - 2 Don t assume anything Ask the project architect & engineer to walk you through the layout and explain the design to ensure it responds to scientific program needs Consider that major design changes after 35% will result in schedule delay and additional fees Biocontaiment design is a complex puzzle Community relations Security Environmental impact Site planning Science Biosafety Architecture & Engineering Overlooking and not understanding one could have major impact on the program 7 - Program Definition 14

Program Definition 1 Pathogen? Program Definition -2 Defining the level of containment is directly related to risk assessment of the pathogens to be studied including: Concentration Quantity/infectious dose Route of transmission Once the risks are identified, the BMBL and other applicable guidelines can be used to set a design direction. Avian Influenza requires more building infrastructure than TB 15

Program Definition - 3 Identify requirement for registrations, certification or validation of the facility and the scientific program. Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5 th Edition (2007), CDC/NIH Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets (2 nd Edition), CDC/NIH NIH Design Policy and Guidelines, (May 2003) CDC Select Agents World Health Organization (WHO) Laboratory Biosafety Manual Program Definition - 4 USDA Agricultural Research Service (ARS) Facilities Design Standards 242.1M-ARS (July 2002), US Department of Agriculture (BSL-3Ag requirements) Arthropod Containment Guidelines, Version 3.1 (2001), American Society of Tropical Medicine and Hygiene Guide for the Care and Use of Laboratory Animals, National Research Council, Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) Locally applicable building and zoning codes, e.g. International Building Codes (IBC), National Fire Protection Association (NFPA) Codes, etc. 16

Program Definition -5 Interlocking doors? Sealed doors? APR doors (pneumatic, mechanical)? Room as primary containment? Breathing air? Chemical shower? HEPA on exhaust filtration? Double HEPA on exhaust? HEPA on supply? Pass-through personnel change and shower rooms that control access to the containment spaces? Hand washing sink? Pass through Autoclave? Equipment fumigation room? Liquid effluents collected and decontaminated/sterilized? Cook tank? Containment spaces designed, constructed, and certified as primary containment barriers (air resistant construction)? Program Definition -6 Containment Strategy: Cabinet as the primary containment Room as the primary containment Glove box Micro Isolators Flexible film isolator (Bio-Bubble) Animal: Type species (rodents, primates, birds, fish, large animals) Instectory Animal census Type of racks/ caging), multi-species vivarium will require additional infrastructure and cost more 17

Program Definition -7 Scientific equipment / Scientific cores: Aerobiology, Imaging, Microscopy, etc. Room decontamination Vaporized Hydrogen Peroxide (VHP)? Para Formaldehyde? Chlorine Dioxide? Liquid/waste/equipment/carcass Decontamination Autoclave Effluent decontamination (Chemical neutralization, Cook tank, etc.) Gas decontamination Irradiation Tissue digestion Program Definition -8 Flexibility is costly and not infinite Flexibility Strategies -1 Redundancy of power and building systems / failure mode Redundant power source Redundant HVAC systems Emergency generator Redundant utility source, i.e. water, steam, fuel UPS system Suite arrangement vs. open labs 18

Program Definition -9 Flexibility Strategies - 2 HEPA filtration zones (multiple zones, parallel filtration for corridors and shared facilities) 1 2 3 Program Definition - 10 Flexibility Strategies - 3 Program and regulatory physical requirements (HEPA filtration, shower out, supply air HEPA filtration, etc.) Multi-species animal facilities (rodents, primates, caging types) Good Lab Practices (GLP) Vibration free zones Regulatory approval / registration /certification 19

Program Definition - 11 BSL-3 + (Enhanced)???????? Don t assume the design team understand the exact needs/ infrastructure required. HEPA supply and exhaust filtration? Pass-through personnel change and shower rooms that control access to the containment spaces? Liquid effluents collected and decontaminated/sterilized? Containment spaces designed, constructed, and certified as primary containment barriers (air resistant construction)? Program Definition - 12 Square footage VS scientific program Type of studies / agents Anticipated number of scientific studies Duration/ sequence of studies Bench and hood space per researcher (BSL3, BSL2, Support) Equipment requirements (sterilization, imaging, aerobiology, etc.) Risk assessment (multi-agent segregation requirements, SOPs, security requirements) Animal species and census (animals, cages, racks) Support infrastructure space requirement Utility space requirements Costs, Project / operational costs 20

Program Definition - 13 What to expect Net-to-Gross Ratios: BSL-2: 50% - 58% BSL-3: 35% - 45% BSL-3 Ag: close to BSL-4 BSL-4: < 25% BSL-2 BSL-3 BSL-3 Ag BSL-4 8 - Standard Operating Procedures (SOPs) Design Impact 21

Standard Operating Procedures (SOPs) Design Impact - 1 SOPs should drive the design of your facility, not the other way around SOPs should not be a substitute for lack of design features Standard Operating Procedures (SOPs) Design Impact - 2 Example 1: Engineered enhancements LEGEND Containment Zone Directional Airflow Door Interlocks Card Reader Biometric Reader Airflow Indicator 22

Example -2 : Investigator Accessing and exiting Containment: Vehicular screening or exclusion > Security Screening / card access > Entry to personnel zone > Facility gowning (as required) > Card access to biocontainment zone > Gowning in vestibule per SOP > Access through second interlocked door> Biometric access to specific containment suite vestibule> Access through second interlocked door> Gowning per SOPs > Entry into animal or procedure room. Outer PPE removal and red-bagging per SOPs> Hand wash > Exit to vestibule or shower> Additional PPE removal/red bag & shower (as required) > Don clean PPE per SOPs> Exit containment suite with biometric reader through second interlocked door to containment zone corridor > Remove and red bag PPE> Hand wash / shower out > Exit containment zone through second interlocked door > Don street clothing > Exit via card reader. Design Implications: Vehicular screening station / guardhouse Vestibules with interlocked doors (per biosafety input) Biometric security Space for storage of clean PPE Bench for donning PPE Electrical outlet for recharging PAPRs (if required) Mirror for adjusting PAPRs Boxes/red bags for disposal of soiled PPE Shower (if required) Standard Operating Procedures (SOPs) Design Impact - 3 Pass-through autoclave loading/unloading areas; maintenance access to autoclave outside of containment Standard of Operating Procedures -4 (SOPs) Security protocols for visitors and personnel Agent receiving and shipping procedures Animal receiving procedures Containment entry and exit protocol for personnel Agent manipulations procedures Emergency procedures (spill, fire, power failure, loss of pressurization, shut down because of inclement weather, etc.) Liquid waste decontamination and disposal (including use of sinks) Solid waste decontamination and disposal 23

Standard of Operating Procedures -5 (SOPs) Containment area room decontamination (gas, vapor, surface decon) Vaporized Hydrogen Peroxide (VHP) Para Formaldehyde Chlorine Dioxide Maintenance protocols Lab shut down protocol Pest management Animal care and use Specialty cores (aerobiology, surgery, treatment, tissue harvest, etc.) Animal gray-out (if applicable) Emergency shower / sprinkler system use and containment 9 - Business Model Impact on Design 24

Business Model Impact on Design - 1 Who will do the work, i.e. contractor, guest researchers Training Security/Background Check/Select Agent Vaccination Duration of study Specialized equipments, i.e. Imaging, Aerobiology GLP 10 - Scientific Equipment Selection 25

Scientific Equipment Selection - 1 Evaluation of equipment type including options could save both space and cost, i.e. pass-through autoclave with decon port that could also serve as a fumigation room. Change/modification to selected scientific equipment could have major design and cost impacts Infrastructure Size of existing travel path Size of existing room Consider the implications of equipment options on design, operation, and cost, i.e. Class III cabinet Throughput calc. for scientific equipments 11 - Value Engineering (VE) 26

Value Engineering (VE) - 1 Participate in the VE process The proposed VE items must be evaluated by the project team, not the Architect/Engineer only Understand the implications of the proposed VE items to your program and building operation, i.e. banking HEPA filters Evaluate the impact of the proposed VE items on future use and flexibility Value Engineering (VE) - 2 VW van after VE 27

12 - Operation and Maintenance Operation and Maintenance -1 Containment vs Maintenance Are they allowed to access containment? Who will do the repair? Maintenance can be done only during down time. Background check Urgency Compare cost of interstitial floor VS and the consequences of no interstitial. 28

Operation and Maintenance - 2 Special requirements by outside utility vendors Existing institutional standards and operational procedures impact on equipment selections and SOPs Existing campus infrastructure / utility support will have an impact on the design, operation, and SOPs Security requirements Fire department access 13 - Access to infrastructure & utilities 29

Access to infrastructure & utilities -1 Utility distribution and access strategy Typical floor-to-floor heights 16 without interstitial 22-23 including interstitial 18-28 mechanical penthouse HEPA filter service areas Access to air terminal boxes Effluent piping access Utility space requirements Access to infrastructure & utilities -2 30

14 - Cost Project /Operation Project Cost There are no simple answers or exact cost for biocontaiment facilities The facility costs are project specific and vary: existing site conditions, infrastructure, size of each containment level, type of equipment, specific program requirements, security requirements, locality, etc. Compare APPLES to APPLES Using an average cost for planning purposes will most likely result in underestimating or overestimating the project cost When budgeting, consider the total project cost. i.e. cost of permitting, cost of security requirements, cost of studies such as EA or EIS and project delivery method 31

Operation Cost Consider the following categories when preparing operational cost: Core salaries, i.e. scientist, administration, etc. Facilities, i.e. utilities, repairs. Security Indirect costs, i.e. regulatory services, housekeeping Equipment, supplies, animals, etc 15 - Constraints and Challenges of Planning Biocontainment Facilities in Developing Countries 32

Constraints and Challenges of Planning Biocontainment Facilities in Developing Countries -1 - Institutional awareness of biosafety implications and requirements - Availability of infrastructure - Structural integrity of existing facilities - Renovation VS new construction - Availability of equipment - Availability of skilled labor - Local climatic conditions Constraints and Challenges of Planning Biocontainment Facilities in Developing Countries -2 - Local building codes - Defining the scope of work (program) - Lack of understanding of local design parameters and availability of materials by international A/Es - Accurate cost and schedule projections - Ability to localize the design documents (substitutions) 33

Part One - Planning and Design fkhoshbin@niaid.nih.gov 34