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Risk based design of facilities for high consequence animal pathogens

Institute for. Animal Health. 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 M ü ller -Doblies

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Risk based design of facilities for high consequence animal pathogens

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  1. Institute for Animal Health 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 Müller-Doblies Dr med.vet. MRCVS Dipl ECVPH Pirbright Laboratory, Institute for Animal Health UK Institute for Animal Health Pirbright Laboratory

  2. BBSRC Pirbright Site 11 10 8 9 clean

  3. Large Animal Facilities 11 10 8 9

  4. IAH Pirbright Laboratory (2014)

  5. Risk based design of facilities for high consequence animal pathogens 12 July 2011 Controls: compliance based versus risk based? Working towards a target risk design How to communicate risk based controls

  6. COUNCIL DIRECTIVE 90/679/EEC of 26 November 1990protection of workers from risks related to exposure to biological agents at work

  7. (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?

  8. Hazard Groups for Viruses Environmental and Human Health Hazard Groups Environmental/veterinary hazard group(Environmental Protection) Human hazard group (operator protection)

  9. 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

  10. Target Risk Concept years -1 IAH Target Risk Level for a consequential release

  11. Bowtie Risk Management Diagram Thesis Enterprise Risk Management Tool courtesy ABS Consulting

  12. Layer of Protection Analysis

  13. Controls – Protection Layers

  14. 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)

  15. Operator Protection vaccination disease in operator spread of disease to the community isolation of exposed worker

  16. Environmental Protection

  17. Environmental Protectionfor liquid and surface contamination

  18. Laboratory Biosecurity Controls

  19. 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

  20. Aerosol release from double ended autoclave Use of Thesis SoftwareCourtesy of ABS Consulting file

  21. Factors determining the fumigation strategy

  22. THANK YOU !!

  23. Institute for Animal Health Questions ?

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