Institute for Animal Health
Risk based design of facilities for high consequence animal pathogens
Uwe Müller-DobliesDr med.vet. MRCVS Dipl ECVPH
Pirbright Laboratory, Institute for Animal Health UK
Institute for Animal HealthPirbright Laboratory
Anticipating Biosecurity Challenges of the Global Expansion of High Containment Biological Laboratories, Istanbul, Turkey 11-13 July 2011
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BBSRC Pirbright Site
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9 clean
1011
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Large Animal Facilities
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1011
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IAH Pirbright Laboratory (2014)
1. FMDV2. SVDV3. Marek’s Disease4. AHSV 5. LSDV 6. Sheep & Goat Pox
Virus7. ASFV 8. PPRV 9. RPV10. BTV &
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Risk based design of facilities for high consequence animal pathogens 12 July 2011
1. Controls: compliance based versus risk based?
2. Working towards a target risk design
3. How to communicate risk based controls
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COUNCIL DIRECTIVE 90/679/EEC of 26 November 1990protection of workers from risks related to exposure to biological agents at work
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A. Containment measures B. Containment levels
2 3 4
1. The workplace is to be separated from any other activities in the same building
No Recommended Yes
2. Input air and extract air to the workplace are to be filtered using (HEPA) or likewise
No Yes, on extract air Yes, on input and extract air
3. Access is to be restricted to nominated workers only
Recommended Yes Yes, via airlock
4. The workplace is to be sealable to permit disinfection
No Recommended Yes
5. Specified disinfection procedures Yes Yes Yes
6. The workplace is to be maintained at an air pressure negative to atmosphere
No Recommended Yes
7. Efficient vector control e.g. rodents and insects
Recommended Yes Yes
8. Surfaces impervious to water and easy to clean
Yes, for bench Yes, for bench and floor Yes, for bench, walls, floor and ceiling
9. Surfaces resistent to acids, alkalis, solvents, disinfectants
Recommended Yes Yes
10. Safe storage of a biological agent Yes Yes Yes, secure storage
11. An observation window, or, alternative, is to be present, so that occupants can be seen
Recommended Recommended Yes
12. A laboratory is to contain own equipment No Recommended Yes
13. Infected material including any animal is to be handled in a safety cabinet or isolator or other suitable containment
Where appropriate Yes where infection is by airborne route Yes
14. Incinerator for disposal of animal carcases Recommended Yes (available) Yes, on site
(What is the required containment level? ) What are the appropriate controls to reduce the risk to an
acceptable residual level?
• What is the acceptable risk of release?• What is the acceptable risk of operator
exposure?• What is the acceptable residual risk for cross
contamination? (GMP)• What are the biological properties?• What laboratory activity inherent risks does the
laboratory have to cater for?
• - Do we sufficiently understand the risks?
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Hazard Groups for Viruses
vhg 4FMDV
RinderpestASFV
ENDV, SVDV HPAI, RabiesNipah, Ebola,
Marburg
vhg 3BTV,
(BVDV)VSV, NSDV
RVFV, Akabane, EEE, WEE, VEE, JE,
WNV
Hendra
vhg 2RHDV, BVDV AI, NDV BSE, Q Fever OHFV, (TBE),
vhg 1
HIV, HepEVCCHFV, Lassa,
Junin, Machupo,KFDV
hhg 1 hhg 2 hhg 3 hhg 4
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(En
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Human hazard group (operator protection)
Environmental and Human Health Hazard Groups
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Safety Target?
• how often are we prepared to accept a consequential release? (25 facilities)
• 1 outbreak per 10 facility years 1-5 per year• 1 outbreak per 50 facility years 1 per 2
years• 1 outbreak per 500 facility years 1 in 20 years
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Target Risk Concept
Apr 22, 2023IAH Target Risk Level for a consequential release
years -1
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Bowtie Risk Management Diagram
Thesis Enterprise Risk Management Toolcourtesy ABS Consulting
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Layer of Protection Analysis
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Controls – Protection LayersPassive Controls Dynamic Controls Management Controls
air tight barrier construction
directional inward air flow Alarm Response Protocol
Double Exhaust HEPA filtration, supply HEPA protection
Air changes HEPA filter validation
Air tight doors Open door velocity air flow Protective Clothing
Multiple compartment access lobbies
Barrier shower & change protocols
Process validation
Box in a box principle Fully encapsulated suits Procedures
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Identification of risk paths and (semi)-quantitative assessment of the controls
• risk reduction achieved by the control• reliability/availability of the control• detectability of a control failure• independence of controls (not dependent on
the same service e.g. electricity, steam, etc)
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Operator Protection
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vaccination
disease in operator
spread of disease to
the communit
y
isolation of exposed worker
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Environmental Protection
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Environmental Protectionfor liquid and surface contamination
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Laboratory Biosecurity Controls
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Assessment methodologies
• FMEA- Failure mode effect analsysis• HAZOP- Hazard operability studies• SWIFT- structured what if • ARMS- Availability reliability and
maintainability analysis• LOPA – Layer of protection analysis
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IEC 61508 Functional Safety of Electrical/Electronic/Programmable Electronic Safety-related Systems – definition of Safety Integrity Levels (SILs) for safety related controls
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Aerosol release from double ended autoclave
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Use of Thesis SoftwareCourtesy of ABS Consultingfile
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Factors determining the fumigation strategy
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Toxicity
Penetration into porous materials(e.g. paper/cloth)
Work Place Exposure Limits
4log or 6 log
with or without soiling
BIs or target organisms
validation requirements
fumigant dispersion properties
Material Compatibility
Fumigant Specific Issues
Pressure differentials
fumigant concentrations
ventilation in adjacent spaces
means of testing sealability beforefumigation
Overpressure protection
Sealability
no hot and cold spots
stable relative humidity
Temperature >20 degree C
air mixing in the space
Environmental Conditioning
Frequency
emergency or planned
Operational Requirements
Fumigation Requirements
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THANK YOU !!
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Questions ?
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