khoshbin harvard final presentation, july 24, 08 · 3 niaid’s program overview high-containment...

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High-Containment LaboratoryDesign & Construction - A Practical Approach

Presented by:Jean P (Fred) Khoshbin R.A.Gary Zackowitz R.A.Babak (Bob) Farahpour P.E.

Engineering Methods for the Control of Airborne Infections: An International Perspective Harvard School of Public Health Center for Continuing Professional EducationJuly 14 - 25, 2008 Boston, Massachusetts

Part 1Part 1: Planning and Design : Planning and Design

Part 2Part 2: Architectural detailing and Construction : Architectural detailing and Construction

Part 3Part 3: Engineering and Commissioning : Engineering and Commissioning

Lecture OverviewLecture Overview

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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.

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NIAID’s Program Overview

High-containment LaboratoryDesign & Construction

Part One - Planning and Design

Presented by:Jean P (Fred) Khoshbin R.A.

Harvard School of Public Health Center for Continuing Professional EducationJuly 14 - 25, 2008 Boston, Massachusetts

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Key Planning Elements1. Community Relations 2. Site Selection3. Threat & Risk Assessment (TRA) & Biosecurity4. Environmental Approval Process5. Project /Construction Planning Team6. Communication / Users Expectations 7. Program Definition8. Standard Operating Procedures (SOPs) Design Impact9. Business Model Impact on Design10. Scientific Equipment Selection11. Value Engineering (VE)12. Operation and Maintenance (O&M)13. Access to Infrastructure and Utilities14. Cost – Project / Operation15. Constraints and Challenges of Planning Biocontaiment Facilities

in Developing Countries

1- Community Relations

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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

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2- Site Selection

Site Selection - 1

• 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

In addition to the typical analysis and site selection criteria, the following should be thoroughly investigated

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Site Selection-2TRA 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

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Threat & Risk Assessment (TRA)& Biosecurity - 1TRA:

– 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.

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Threat & Risk Assessment (TRA)& Biosecurity - 3

The TRA and Biosecurity have major impacts on project design and cost

RISK ASSESSMENT

DESIGN BASIS TACTICS

LEVEL OF PROTECTION

DESIGN CRITERIA PROTECTIVE

MEASURES

THREAT ASSESSMENT

VULNERABILITY ANALYSIS

CONSEQUENCE

LIKELIHOOD

Threat & Risk Assessment (TRA)& Biosecurity - 4Security Design Security Design –– Exterior Exterior

Vehicular exclusion Vehicular exclusion

Pedestrian exclusion Pedestrian exclusion

Building access controlBuilding access control

Security Design Security Design –– Interior Interior

Onion concept (layers)Onion concept (layers)

Monitoring security access systemsMonitoring security access systems

Intrusion detection systems Intrusion detection systems

Biometric identification systemsBiometric identification systems

Control centers (fire command, security control, and building coControl centers (fire command, security control, and building controls)ntrols)

CCTV and monitoring systemsCCTV and monitoring systems

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Threat & Risk Assessment (TRA)& Biosecurity - 5Possible Design mitigation strategies to enhance security Possible Design mitigation strategies to enhance security

(based on the TRA)(based on the TRA)

Blast resistant constructionBlast resistant construction

Progressive collapse structural designProgressive collapse structural design

Entry lobby and loading dock blast protectionEntry lobby and loading dock blast protection

Box within a box conceptBox within a box concept

Redundancy of building systemsRedundancy of building systems

Emergency generator protectionEmergency generator protection

Air intake protectionAir intake protection

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Environmental Approval ProcessEnvironmental Approval Process--11Cost & 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

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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.)

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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

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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 onthe program

7 - Program Definition

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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

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Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th Edition (2007), CDC/NIH

Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets (2nd Edition), CDC/NIH

NIH Design Policy and Guidelines, (May 2003)

CDC Select Agents

World Health Organization (WHO) Laboratory BiosafetyManual

Program Definition - 3Identify requirement for registrations, certification or validation of the facility and the scientific program.

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. InternationalBuilding Codes (IBC), National Fire Protection Association (NFPA) Codes, etc.

Program Definition - 4

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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)?


• 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

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• 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 -8Flexibility is costly and not infinite

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

Flexibility Strategies Flexibility Strategies --11

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HEPA filtration zones (multiple zones, parallel filtration for corridors and shared facilities)

Flexibility Strategies Flexibility Strategies -- 22

1 2

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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

Flexibility Strategies Flexibility Strategies -- 33

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• 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)?

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

Square footage VS scientific programSquare footage VS scientific program


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Net-to-Gross Ratios:

BSL-2: 50% - 58%

BSL-3: 35% - 45%

BSL-3 Ag: close to BSL-4

BSL-4: < 25%

What to expectWhat to expect

BSL-2 BSL-3 BSL-3 Ag BSL-4


8 - Standard Operating Procedures (SOPs) Design Impact

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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

LEGEND

Containment Zone

Directional Airflow

Door Interlocks

Card Reader

Biometric Reader

Airflow Indicator


Example – 1: Engineered enhancements

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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 / guardhouseVestibules with interlocked doors (per biosafety input)Biometric securitySpace for storage of clean PPEBench for donning PPEElectrical outlet for recharging PAPRs (if required)Mirror for adjusting PAPRsBoxes/red bags for disposal of soiled PPEShower (if required)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

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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 ModelImpact on Design

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Business ModelImpact 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

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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)

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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 useand flexibility

Value Engineering (VE) - 2

VW van after VE

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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.

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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

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Utility distribution and access strategy

Typical floor-to-floor heights 16’ without interstitial22’ - 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 -1

Access to infrastructure & utilities -2

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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.

• 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

Compare APPLES to APPLES

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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 PlanningBiocontainment Facilities in Developing Countries

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Constraints and Challenges of PlanningBiocontainment 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 PlanningBiocontainment 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)

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[email protected]@niaid.nih.gov

Part One - Planning and Design

khoshbin harvard final presentation, july 24, 08 · 3 niaid’s program overview high-containment...

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