Transcript Biocontainment Construction

Biocontainment
Construction
Commissioning
2009
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-ˈsāf-tē\
Pronunciation: \bī-ō-kən-ˈtān-mənt\
Function: noun
Function: noun
Date: 1977
Date: 1985
: safety with respect to the effects of
biological research on humans and
the environment
: the containment of extremely
pathogenic organisms (as viruses)
usually by isolation in secure facilities to
prevent their accidental release
especially during scientific research
http://www.merriam-webster.com/dictionary/biocontainment
Containment
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
Examples
•Abrin Bacillus anthracis
•Botulinum neurotoxins Brucella abortus
•Botulinum neurotoxin producing species of Clostridium
Brucella melitensis
•Cercopithecine herpesvirus 1 (Herpes B virus) Brucella
suis
•Clostridium perfringens epsilon toxin Burkholderia mallei
(formerly Pseudomonas mallei)
•Coccidioides posadasii/Coccidioides immitis
Burkholderia pseudomallei (formerly
Pseudomonas
•Conotoxins pseudomallei)
•Coxiella burnetii Hendra virus
•Crimean-Congo haemorrhagic fever virus Nipah virus
•Diacetoxyscirpenol Rift Valley fever virus
•Eastern Equine Encephalitis virus Venezuelan Equine
Encephalitis virus
•Ebola virus
•Francisella tularensis
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
Biosafety
Guides and
Publications
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
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Department of Homeland Security (DHS) – Project Bioshield, new
interagency campus
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NIAID develops Strategic Plan for Biodefense Research 2/2002 –
RCE/NBL/RBL
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Emphasis on National Lab Network – Public Health
Industry Trends
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Since 2001 number of BSL-3 and BSL-4 laboratories has more than
tripled.
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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
http://animallabnews.com/articles.asp?pid=187
http://www.gao.gov/products/GAO-08-108T
http://www.gao.gov/products/GAO-08-108T
Full Report GAO-08-108T Page 9-10 2007
Operational Oversight
Who’s in Charge?
http://www.gao.gov/products/GAO-08-108T
Full Report GAO-08-108T Page 13 2007
Risk Assessment
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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
design
http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s2.htm
Biocontainment Facilities
BSL-1
Typical undergraduate research
laboratory, few restrictions, few
safety features, generally
unrestricted access
BSL-2
Trained personnel, some
additional safety features, safety
cabinets are present, no ventilation
requirements, access restricted
during experiments
http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s2.htm
High Containment Facilities
BSL-3
Trained and verified personnel, great
risk of infection, work performed
within safety cabinets or other
containment equipment, double
doors, greater restricted access,
independent ventilation systems,
impermeable workspace
BSL-3Ag
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
workspace
BSL-4
Highly trained and expert personnel,
extreme health risk, highly infectious
diseases, extremely restricted
access, all work must be performed
wearing a pressurized and ventilated
suit, laboratory in complete isolation
from rest of building, all work
documented.
http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s2.htmhttp://ww
w.afm.ars.usda.gov/ppweb/PDF/601-2-ARS.pdf
BSL Configurations
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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
Assessment
Pathogens affecting livestock researched in labs or with small
animals would need enhanced type of BSL-3 (lab) or ABSL-3
(animals)
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
PPE
Body
Suit
Secondary Barrier
Air Pressure
Resistant
(APR) Door
Secondary Barrier
DSCS
Leak Detection
EDS
Lab Envelope
Secondary Barrier
HEPA
Dunk Tank
Researcher
Safety
Alarms
Windows
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
is
CxCentric
•
Focus
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Communication
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Documentation
•
Containment
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Life Safety
Construction BioCx … Fundamentals
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Focus
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Big picture thinking – CM to Subs to Owner.
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The User needs to be engaged – SOP’s.
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CxA gives the user a functional building.
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User confidence without concern of operational glitches.
Construction BioCx … Fundamentals
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Communication
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Communication is key amongst the entire team.
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Project meetings must occur.
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There will be Endurance issues once occupied
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“Lessons Learned” is valuable
Construction BioCx … Fundamentals
Documentation
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No Documentation – No Certification
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Checklists, FPT’s, IST’s and special challenge testing
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System Mapping can help everyone – put the systems together
Construction BioCx … Fundamentals
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Containment
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Pressure Decay – back boxes, envelopes, special devices
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Envelope Seal – Architectural Dependencies
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Pressure Control
Stable Envelope Control (Terminal Units)
Construction BioCx …
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Sample Envelope Loop Tune
Construction BioCx …
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Sample Envelope Loop Tune
Construction BioCx …
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Sample Envelope Loop Tune
Construction BioCx …
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Sample Envelope Loop Tune
Construction BioCx …
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Sample Envelope Loop Tune
Construction BioCx … Fundamentals
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Life Safety
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Fire
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Security (egress)
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Breathing Air
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Leak Detection
High Containment Commissioning Process
High Containment Commissioning Process
Construction BioCx … Fundamentals
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Final IST
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Fire
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Security (egress)
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Spore Samples
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FMCS
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Power
High Containment Commissioning Process
Websites:
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AALAS – http://www.aalas.org/index.aspx
ARS – http://www.ars.usda.gov/main/site_main.htm?modecode=19-40-00-00
CDC – http://www.cdc.gov/
Office of Biotechnology Activities – http://oba.od.nih.gov/oba/about_oba.html
DHHS – http://www.hhs.gov/
NIH – http://www.nih.gov/
USDA APHIS – http://www.aphis.usda.gov/
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