Risk based design of facilities for high consequence animal pathogens

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


BBSRC Pirbright Site

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9 clean

1011

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Large Animal Facilities

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9

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


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?


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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Human hazard group (operator protection)

Environmental and Human Health Hazard Groups


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


Bowtie Risk Management Diagram

Thesis Enterprise Risk Management Toolcourtesy ABS Consulting


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


Environmental Protection

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Environmental Protectionfor liquid and surface contamination


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


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


THANK YOU !!

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Questions ?

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Documents

Risk based design of facilities for high consequence animal pathogens