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Uwe Mueller-Doblies - National Academies

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Anticipating Biosecurity Challenges of the Global Expansion of High Containment
Biological Laboratories, Istanbul, Turkey 11-13 July 2011
Risk based design of facilities
for high consequence animal
pathogens
Uwe MГјller-Doblies
Dr med.vet. MRCVS Dipl ECVPH
Pirbright Laboratory, Institute for Animal Health UK
Institute for Animal Health
Pirbright Laboratory
Institute for Animal Health
BBSRC Pirbright Site
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Large Animal Facilities
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IAH Pirbright Laboratory (2014)
1.
2.
3.
4.
5.
6.
FMDV
SVDV
Marek’s Disease
AHSV
LSDV
Sheep & Goat Pox
Virus
7. ASFV
8. PPRV
9. RPV
10. 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 1990
protection of workers from risks related to exposure to biological agents at work
B. Containment levels
A. Containment measures
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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
Recommended
Yes
Yes, via airlock
No
Recommended
Yes
Yes
Yes
Yes
No
Recommended
Yes
Recommended
Yes
Yes
Yes, for bench
Yes, for bench and floor
Yes, for bench, walls, floor
and ceiling
Recommended
Yes
Yes
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
3. Access is to be restricted to nominated
workers only
4. The workplace is to be sealable to permit
disinfection
5. Specified disinfection procedures
6. The workplace is to be maintained at an air
pressure negative to atmosphere
7. Efficient vector control e.g. rodents and
insects
8. Surfaces impervious to water and easy to
clean
9. Surfaces resistent to acids, alkalis, solvents,
disinfectants
10. Safe storage of a biological agent
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(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?
Hazard Groups for Viruses
Environmental/veterinary hazard group
(Environmental Protection)
Environmental and Human Health Hazard Groups
vhg 4
vhg 3
vhg 2
FMDV
Rinderpest
ASFV
ENDV, SVDV
HPAI, Rabies
Nipah, Ebola,
Marburg
BTV,
(BVDV)
VSV, NSDV
RVFV,
Akabane, EEE,
WEE, VEE, JE,
WNV
Hendra
RHDV, BVDV
AI, NDV
BSE, Q Fever
OHFV, (TBE),
HIV, HepEV
vhg 1
hhg 1
hhg 2
hhg 3
CCHFV, Lassa,
Junin,
Machupo,KFDV
hhg 4
Human hazard group (operator protection)
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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
people
SOP
off-site
Barrier
Shower quarantine
PPE
fomites lab SOP
Barrier
Process
off-site
Process
effluent disinfection
heat
inactivation
aerosol Lab SOPsMBSC 1В°HEPA 2В° HEPA
0
24-Sep-14
200
400
IAH Target Risk Level for
a consequential release
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Inward
airflow
600
800
years -1
Bowtie Risk Management Diagram
Thesis Enterprise Risk Management Tool
courtesy ABS Consulting
Institute for Animal Health
Layer of Protection Analysis
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Controls – Protection Layers
Passive 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
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 Protection
for 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
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
file
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Use of Thesis Software
Courtesy of ABS Consulting
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Factors determining the fumigation strategy
Fumigation Requirements
Fumigant Specific Issues
Sealability
Environmental Conditioning
Operational Requirements
Toxicity
Pressure differentials
no hot and cold spots
Frequency
Penetration into porous materials
(e.g. paper/cloth)
fumigant concentrations
stable relative humidity
emergency or planned
ventilation in adjacent spaces
Temperature >20 degree C
means of testing sealability before
fumigation
air mixing in the space
Work Place Exposure Limits
validation requirements
4log or 6 log
Overpressure protection
with or without soiling
BIs or target organisms
fumigant dispersion properties
Material Compatibility
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THANK YOU !!
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Questions ?
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