Biocontainment Construction Commissioning

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Mike Brueggerhoff CxA
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Biosafety                                 Biocontainment
 Biosafety                                Biocontainment

One entry found.                          One entry found.

Main Entry: bio·safe·ty                   Main Entry: bio·con·tain·ment

Pronunciation: \ˌbī ō-ˌsāf tē\
                  -      -                Pronunciation: \bī-ō-kən-ˈtān-mənt\

Function: noun                            Function: noun

Date: 1977                                Date: 1985

: safety with respect to the effects of   : the containment of extremely
biological research on humans and         pathogenic organisms (as viruses)
the environment                           usually by isolation in secure facilities to
                                          prevent their accidental release
                                          especially during scientific research


   A fundamental objective of any biosafety program is the
   containment of potentially harmful biological agents. The
   term "containment" is used in describing safe methods,
   facilities and equipment for managing infectious materials in
   the laboratory environment where they are being handled or
   maintained. The purpose of containment is to reduce or
   eliminate exposure of laboratory workers, other persons, and
   the outside environment to potentially hazardous agents. The
   use of vaccines may provide an increased level of personal
   protection. The risk assessment of the work to be done with
   a specific agent will determine the appropriate combination
   of these elements.

                                                          BMBL, 5th ed. – Section III
Select Agents and Toxins
The Public Health Security and Bioterrorism Preparedness and Response Act of
2002, Subtitle A of Public Law 107-188 (42 U.S.C. 262a), requires DHHS (Dept of
Health & Human Services) to regulate the possession, use, and transfer of
biological agents or toxins (i.e., select agents and toxins) that could pose a
severe threat to public health and safety. The Agricultural Bioterrorism Protection
Act of 2002, Subtitle B of Public Law 107-188 (7 U.S.C. 8401), requires the USDA
to regulate the possession, use, and transfer of biological agents or toxins (i.e.,
select agents and toxins) that could pose a severe threat to animal or plant
health, or animal or plant products. These Acts require the establishment of a
national database of registered entities, and set criminal penalties for failing to
comply with the requirements of the Acts. In accordance with these Acts, DHHS
and USDA promulgated regulations requiring entities to register with the CDC or
the APHIS if they possess, use, or transfer a select agent or toxin (42 C.F.R. Part
73, 7 C.F.R. Part 331, and 9 C.F.R. Part 121). CDC and APHIS coordinate
regulatory activities for those agents that would be regulated by both agencies
(“overlap” select agents).

                                                                       BMBL, 5th ed. – Appendix F
   Select Agent
       Select Agent
        : Select agents are chemically,
        physically, or biologically active
        principles capable of producing an
        effect that Health and Human
        Services considers to have the
        potential to pose a severe threat to
        human health

•Abrin Bacillus anthracis
                                                             •Conotoxins pseudomallei)
•Botulinum neurotoxins Brucella abortus
                                                             •Coxiella burnetii Hendra virus
•Botulinum neurotoxin producing species of Clostridium
                                                             •Crimean-Congo haemorrhagic fever virus Nipah virus
              Brucella melitensis
                                                             •Diacetoxyscirpenol Rift Valley fever virus
•Cercopithecine herpesvirus 1 (Herpes B virus) Brucella
                                                             •Eastern Equine Encephalitis virus Venezuelan Equine
                                                              Encephalitis virus
•Clostridium perfringens epsilon toxin Burkholderia mallei
                                                             •Ebola virus
              (formerly Pseudomonas mallei)
                                                             •Francisella tularensis
•Coccidioides posadasii/Coccidioides immitis
              Burkholderia pseudomallei (formerly
High Containment
      BSL3 & BSL4
                           A to Z …
 Articles have been and continue to be written on HC Biocontainment + Cx.
                  These articles carry the same theme ….
                         • Very Complex Projects
             • Construction Schedule Drives the project = NO
                      • Architectural Dependencies
                         • User Engaged = MUST
                  • Documentation – Cx to Certification
                       • Select Agent Certification
                       • Compliance - Guidelines
Guides and
Affects of 9/11 and Anthrax Attack
 •   USA Patriot Act (Signed 10/01)& Public Health Security and
     Bioterrorism Preparedness and Response Act of 2002 – spawned the
     Select Agent rule

 •   Department of Homeland Security (DHS) – Project Bioshield, new
     interagency campus

 •   NIAID develops Strategic Plan for Biodefense Research 2/2002 –

 •   Emphasis on National Lab Network – Public Health
Industry Trends

 •   Since 2001 number of BSL-3 and BSL-4 laboratories has more than

 •   No formal checklist of certification tasks and requirements exists for the
     building process.

 •   Agencies place the responsibility with the owner or end user to develop
     a detailed account of the building, its systems, and its methods to safely
     conduct research.

 •   Select Agent rule requires institutions to notify DHS via CDC or USDA of
     possession of specific pathogen or toxins

Full Report GAO-08-108T Page 9-10 2007
Operational Oversight
    Who’s in Charge?

                        Full Report GAO-08-108T Page 13 2007
Risk Assessment

 •   Modes of transmission determine classification of laboratory
     and required containment design

 •   Select agents classified as life threatening and/or incurable also
     determine classification of laboratory and required containment

Biocontainment Facilities

BSL-1                               BSL-2
Typical undergraduate research      Trained personnel, some
laboratory, few restrictions, few   additional safety features, safety
safety features, generally          cabinets are present, no ventilation
unrestricted access                 requirements, access restricted
                                    during experiments

High Containment Facilities
BSL-3                                      BSL-4
Trained and verified personnel, great      Highly trained and expert personnel,
risk of infection, work performed          extreme health risk, highly infectious
within safety cabinets or other            diseases, extremely restricted
containment equipment, double              access, all work must be performed
doors, greater restricted access,          wearing a pressurized and ventilated
independent ventilation systems,           suit, laboratory in complete isolation
impermeable workspace                      from rest of building, all work
Agricultural facility for large animals,
highly trained and expert personnel,
great risk of infection amongst
animals and plants, as well as
humans, greater restricted access,
sewage decontamination and exit
showers in addition to BSL-3
requirements, impermeable
BSL Configurations
  •   BSL = working with a Select Agent in a Lab
  •   ABSL = working with a Select Agent in an Animal in a Lab

  •   Either can require “enhancement” based on the agent
  •   Enhancement is site specific and determined by Risk

  •   Pathogens affecting livestock researched in labs or with small
      animals would need enhanced type of BSL-3 (lab) or ABSL-3
  •   Pathogens affecting livestock researched in labs or with large
      animals would need BSL-3Ag
Primary and Secondary
   Containment Examples
           Envelope Barriers
Primary Barrier

    Glove Box
       Primary Barrier

Secondary Barrier

                    Air Pressure
                    (APR) Door
Secondary Barrier


                    Leak Detection

                        Lab Envelope
                   Secondary Barrier
                                               Dunk Tank
                 HEPA      Researcher


                              Deep Traps

Bioseal Damper
Construction BioCx …

 • Different kinds of facilities

 • Different kinds of systems

 • Unique Risks

 • Accountability and Oversight

 • Individual and Public Safety
High Containment
 •   Focus

 •   Communication

 •   Documentation

 •   Containment

 •   Life Safety
Construction BioCx … Fundamentals
•   Focus

    •   Big picture thinking – CM to Subs to Owner.

    •   The User needs to be engaged – SOP’s.

    •   CxA gives the user a functional building.

    •   User confidence without concern of operational glitches.
Construction BioCx … Fundamentals
•   Communication

    •   Communication is key amongst the entire team.

    •   Project meetings must occur.

    •   There will be Endurance issues once occupied

    •   “Lessons Learned” is valuable
Construction BioCx … Fundamentals

•       Documentation

    •   No Documentation – No Certification

    •   Checklists, FPT’s, IST’s and special challenge testing

    •   System Mapping can help everyone – put the systems together
Construction BioCx … Fundamentals

•   Containment

    •   Pressure Decay – back boxes, envelopes, special devices

    •   Envelope Seal – Architectural Dependencies

    •   Pressure Control

    •   Stable Envelope Control (Terminal Units)
Construction BioCx …
•   Sample Envelope Loop Tune
Construction BioCx …
•   Sample Envelope Loop Tune
Construction BioCx …
•   Sample Envelope Loop Tune
Construction BioCx …
•   Sample Envelope Loop Tune
Construction BioCx …
•   Sample Envelope Loop Tune
Construction BioCx … Fundamentals
•   Life Safety

    •   Fire

    •   Security (egress)

    •   Breathing Air

    •   Leak Detection
High Containment Commissioning Process
High Containment Commissioning Process
Construction BioCx … Fundamentals

•   Final IST

                •   Fire

                •   Security (egress)

                •   Spore Samples

                •   FMCS

                •   Power
High Containment Commissioning Process

•   AALAS –
•   ARS –
•   CDC –
•   Office of Biotechnology Activities –
•   DHHS –
•   NIH –