Bio-containment Michael C. Connor, PE Principal Atlanta, Georgia

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Bio-containment
Michael C. Connor, PE
Principal
Atlanta, Georgia
Differences in
BSL-2, BSL-3, BSL-3Ag and
BSL-4
Labs and Animal Facilities
Biosafety Level 2 (BSL-2)*. Used with
agents of moderate potential hazard to
personnel, animals, and the environment,
with minimal economic loss to the animal
industries
*CDC-NIH Biosafety in Microbiology and Biomedical
Laboratories, 5th edition
Wall Construction: Gypsum Board or Masonry
Ceiling Construction: Lay-in acoustic tile with vinyl surface
Biosafety Level 3 (BSL-3)* is applicable to clinical,
diagnostic, teaching, research or production facilities
In which work is done with indigenous or exotic
agents which may cause serious or potentially lethal
disease as a result of exposure by the inhalation route.
*CDC-NIH Biosafety in Microbiology and Biomedical
Laboratories, 5th edition
Wall Construction: Clean Room panel (BSL-3),
Masonry (BSL-3+) or Poured Concrete (BSL-3++)
Ceiling Construction: Clean Room Gasketed Panel System
(BSL-3) or Exposed Structure (BSL-3+) or Coated
Structure (BSL-3++)
Example of Panel System
Wall Construction: Masonry
Biosafety Level 3 Agriculture (BSL-3Ag). Used
with pathogens that present a risk of causing
infections of animals and plants and causing a
great economic harm. (Foot and Mouth Disease is
the premier example.)
ZOONOTIC DISEASES are diseases caused by infectious agents
that can be transmitted between (or are shared by) animals and humans.
USDA-ARS and APHIS
http://www.afm.ars.usda.gov/ppweb/242-01m.htm#H308
Wall Construction: Poured Concrete with Coating
Ceiling Construction: Exposed Structure
with Coating
POWERED AIR
PURIFYING
RESPIRATOR
(PAPR)
BSL-4
WATER
SHOWER
CHEMICAL
SHOWER
CHEMICAL
TANK
BSL - 4
BSL - 4
Information resources:
American Biological Safety Association web site
http://www.absa.org/resriskgroup.html
CDC-NIH Biosafety in Microbiology and Biomedical
Laboratories, 5th edition
http://des.od.nih.gov/
NIH Design and Policy Guidelines
http://des.od.nih.gov/eWeb/planning/htm/nihpol.htm
USDA/ ARS/ APHIS
http://www.afm.ars.usda.gov/ppweb/242-01m.htm#H308
Break
BSL-2 Laboratory
BSL-2 Laboratory
• Design commissioning – verify designed access to
various commissioning points of measurement –
Volume Control Boxes don’t conflict with cable trays,
etc.
• Verify air flows in accordance with air flow
schedules.
• Verify space pressurization.
• Verify access to critical components – Pressure and
air flow transmitters.
• Verify labeling of all components requiring
maintenance.
BSL-3 Laboratory
BSL-3 Laboratory
BSL-3 Laboratory
•
•
•
•
•
•
•
All of the items covered in BSL-2.
Autoclave qualification.
Inspect room penetrations and seals – smoke test.
Verify VHP effectiveness.
Calibrate local pressure indicators
Security system qualification
NSF 49 - 2004 test of BSC’s cabinets
BSL-3ag Laboratory
BSL-3ag Laboratory
BSL-3ag Laboratory
• All of the requirements for BSL-2 and BSL-3
• Autoclave temperature profile.
– Place typical load in autoclave
– Thermocouple mapping of chamber with multi
channel recorder.
• Air Pressure Resistant (APR) door verification.
– Air Compressor
– Air Quality
• Wall Coating Testing
– Pull-off testing
– Spark Testing
• Inspect utility penetrations
– Visually inspect BOTH sides of penetrations.
BSL-3ag Laboratory
• Space Pressure Decay Testing
– Room must hold 500 Pa (+/-) with a maximum decay
to 250 Pa in 20 minutes.
– Epoxy Seal conduits with wiring.
– Impervious wall surfaces.
• HEPA Filter challenges per BSL-3.
• Helium leak testing of Ducts and HEPA housings
– Outboard test
– 1 x 10 –5 cc/sec acceptance criteria. 1 x 10-6 cc/sec
atmospheric background level – requires mass
spectrometer NOT thermal conductivity equipment to
sense at this level.
BSL-3ag Laboratory
• Pressure decay testing of double wall plumbing drain
pipe
– Test Annular space
– Hold negative pressure – limit to 5 psi MAX
• Waste treatment plant endotoxin challenge – 6 log
reduction of Colony Forming Units (CFU), heat
resistant bacteria (Bacillus Steareothermophillus)
used for challenge.
BSL-4
• Same as BSL-3ag
• Commissioning Breathing Air System
• Commissioning Chemical Shower System
Large Animal BSL-3 Facilities
NCFAD,Winnipeg
ARS, Ames
IAH,Pirbright
PIADC,Greenport
CISA,Valdeolmos
AHRC, Athens
DVIV, Lindholm
CVI,Lelystad
FRCVDA,Tubingen
IVI,Mittelhausern
CISRO,Geelong
CISA
Valdeolmos
.
Case Study #1: BSL-3Ag Construction Project
1991 – First
edition of ARS
242.1 Guideline
for BSL-3Ag
released
1978 – Dean
of CVM
proposes BioContainment
Facility
1986 – $8 Million
secured from
USDA
1990 – First
Design
Completed
1991 – Project
Shelved for lack of
State Funding
1998 – Second
edition of ARS
242.1 Guideline
for BSL-3Ag
released
1996 – Start 1999 – Law
Construction Suit Filed by
Contractor
2002 – Third
edition of ARS
242.1 Guideline
for BSL-3Ag
released
2003 – Lost
RBL Grant
Money
Case Study #1: BSL-3Ag
•
•
•
•
•
•
•
Project Financial Performance
$16,000,000 Construction Contract
$4,000,000 in Change Orders
$11,700,000 in Damages Sought by Contractor
$2,400,000 spent by State in Defense of law suit
$3,000,000 paid to Contractor to settle suit
$47,000,000 to bring building up to current ARS
standards (includes soft costs)
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