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Title: Human%20


1
Human Animal Health Laboratories from Concept
to Commissioning Yanko Ivanov Ragip
Bayraktar,EU Technical Assistance to Avian
Influenza Preparedness Response Project, EU
2
Contents
  • Biosafety Biosecurity considerations and
    principles
  • Assessment for laboratory need and decision
    making process and rationale for investments in
    laboratories or not.
  • Determination of functions and scope of work in a
    laboratory
  • Commissioning and operations.
  • Design and construction Issues.

3
Laboratory biosafety biosecurity - definitions
  • Laboratory biosafety is the term used to
    describe the containment principles, technologies
    and practices that are implemented to prevent
    unintentional exposure to pathogens and toxins,
    or their accidental release.
  • Laboratory biosecurity refers to institutional
    and personal security measures designed to
    prevent the loss, theft, misuse, diversion or
    intentional release of pathogens and toxins.

4
Laboratory biosecurity as a complement to
laboratory biosafety
  • Laboratory biosafety and biosecurity mitigate
    different risks, but they share a common goal
    keeping valuable biological materials safely and
    securely inside the areas where they are used and
    stored.
  • Good laboratory biosafety practices reinforce and
    strengthen laboratory biosecurity systems.

5
Conflicts (Biosafety vs Biosecurity)
Accountability Compliance SOPs
Emergency routines GLP Safety
cabinets Personal safety equipment
Inventory control Access control Transfer
security Physical security Information security
Biosafety
Biosecurity
containment
Incident reporting Incident response
planning Revision Training
Supervised by appointed Biosafety
officer Regulated by national work environment
safety law
Supervised by appointed Biosecurity or Biosafety
officer Should consult with law enforcement
officials and security experts
6
Why biosafety practices?
  • Protection
  • - workers
  • - products
  • - co-workers
  • - lab support personnel
  • - environment

7
Biosafety levels
  • BSL1 - agents not known to cause disease (no or
    low individual and community risk).
  • BSL2 - agents that cause human or animal
    diseases with moderate individual or low
    community risk (e.g. blood borne diseases).
  • BSL3 - indigenous/exotic agents associated with
    human disease and with potential for aerosol
    transmission - high individual risk (respiratory)
    low community risk)
  • BSL4 - dangerous/exotic agents of life
    threatening nature serious diseases readily
    transmitted.

8
Biosafety Level 3 Risk Assessment
  • What is the natural host of the biological agent?
  • Does the agent cross species barriers?
  • Is it a wild-type agent or attenuated?
  • Is the agent infectious for a normal healthy
    adult?
  • What effect will the agent have on an adult if
    immunocompromised? if pregnant?

9
Biosafety Level 3 Risk Assessment
  • What is the mode of transmission for the agent?
    - contact,
  • - mucous membrane exposure,
  • - ingestion,
  • - inoculation,
  • - inhalation
  • What volume of the agent is being manipulated?
  • What is the concentration of the agent?
  • What is the infectious dose of the agent?

10
Biosafety Level 3 Risk Assessment
  • Prophylaxis
  • What, if any immunizations are required?
  • What pharmaceuticals are available?
  • What is the effectiveness of prophylaxis?
  • Post-exposure
  • What are the anti-microbial agents available for
    treatment?
  • What is the effectiveness of treatment?

11
Relation of risk groups to biosafety levels,
practices and equipment
Risk group Biosafety level (BSL) Laboratory type Lab. practice Safety equipment
1 Basic BSL- 1 Basic teaching and research Good microbiol. techniques (GMT) None, open bench work
2 Basic BSL- 2 Diagnostic services and research GMT protective clothing biohazard sign Open bench plus bio safety cabinet (BSC) for potential aerosols
3 Containment BSL- 3 Special diagnostic services and research As BSL-2 plus special clothing controlled access directional airflow Biosafety cabinet and/or other primary devices for all activities
4 Maximum Containment BSL- 4 Dangerous pathogen units As BSL-3 plus airlock entry, shower exit and special waist disposal Class-3 BSC or positive pressure suites in conjunction with class-2 BSCs, double ended autoclave trough the wall and filtered air

12
Summary of biosafety level requirements
  • BIOSAFETY LEVEL


    1
    2 3 4
  • Isolation of laboratory
    No
    No Yes Yes
  • Room sealable for decontamination
    No No
    Yes Yes
  • Ventilation
  • inward airflow
    No
    Desirable Yes Yes
  • controlled ventilating system
    No Desirable
    Yes Yes
  • HEPA-filtered air exhaust
    No No
    Yes/Nob Yes
  • Double-door entry
    No No Yes
    Yes
  • Airlock No No
    No Yes
  • Airlock with shower
    No
    No No Yes
  • Anteroom
    No
    No Yes
  • Anteroom with shower
    No No
    Yes/Noc No
  • Effluent treatment
    No
    No Yes/Noc Yes
  • Autoclave
  • on site
    No
    Desirable Yes Yes
  • in laboratory room
    No
    No Desirable Yes
  • double-ended
    No
    No Desirable Yes
  • Biological safety cabinets
    No Desirable
    Yes Yes
  • Personnel safety monitoring capabilityd
    No No
    Desirable Yes

13
BIOSAFETY AND BIOSECURITY LABORATORY DESIGN
CRITERIA
  • Laboratory location
  • Wipe-clean surfaces
  • Heating, ventilation and air-conditioning (HVAC)
    system
  • Directional airflow and cascade negative pressure
  • Laboratory furniture and equipment
  • Laboratory rooms, size and orientation
  • Sample reception
  • Double door autoclave and decontamination chamber
    for solid waste materials
  • Water supply and sewerage system
  • Electrical system

14
Essential Building Principles
  • Primary containment barrier is the first barrier
    between agent and man (such as gloves, gowns,
    masks, biosafety cabinets, respiratory protection
    etc.)
  • Secondary containment barrier is the barrier
    between agents and environment (airtight rooms,
    air handling and filtration, air locks, showers,
    laundry, sewage treatment, waste disposal,
    sterilisers, redundant services as well as
    equipment and material niches.
  • Tertiary containment barrier represents an
    additional organisational barrier with the
    physical operation with items such as walls,
    fences, security, quarantine and animal exclusion
    zones.

15
Work flow considerations
  • During the programming phase it is essential to
    define how various elements are processed,
    including animals (clean and dirty), people,
    wastes (carcasses, solid, other), samples from
    animals, laundry, feed and bedding (if used).

16
The containment barriers
  • The containment barriers should be physical
    barriers constructed with a series of integrated
    building components to form an airtight interior
    environment separate from the surrounding
    research environment and neighbouring community.
    The barrier is also to be defined by operational
    practices examples of these secondary
    barriers include work areas that are separate
    from public areas, decontamination, shower and
    hand-washing procedures and equipment, special
    ventilation systems, directional airflow through
    the use of air pressure differentials, double
    door autoclaves, liquid waste treatment, donning
    of personal protective equipment (and removal
    upon exit) and restricted personnel access.

17
Specimen Reception, Dispatch Area and "Grey
Areas"
  • A good specimen reception would be an isolated
    containment area, yet a "grey area", for the
    preliminary handling of diagnostic specimens by
    experienced pathology personnel. This would
    ensure the correct movement of samples to
    laboratories or autopsy.
  • A specimen reception located next to the autopsy
    area would help to integrate the system of
    controlled movement of materials into the secure
    laboratories or animal facilities. A "grey area"
    would also be an appropriate area to hold reagent
    awaiting innocuity tests or whilst inactivation
    is proven.
  • Samples destined for other reference laboratories
    may be safely removed from the "grey area"
    without a perception of possible adventitious
    contamination that might occur if the samples
    were manipulated in the high containment
    laboratories before they are removed.

18
Security and related systems
  • Typically there are various operational zones
    within containment facilities. Access control to
    one zone does not necessarily give access control
    to all rooms or areas within that zone. There are
    various programs that require individual access
    control for the appropriate personnel.
  • Fire alarm

19
Security Zone 1 Property Protection Area
(uncontrolled)
  • The entire building should monitor entrance
    zones with CCTV cameras
  • Employee / visitor parking should have CCTV
    monitoring
  • Rear Loading docks should have CCTV monitoring
  • The electrical transformer vaults should be
    secured

20
Security Zone 2 Limited Areas / Non-Containment
  • These areas require a primary level access
    control credential (proximity card) to enter.
    Cards should be coded to permit entry into
    specific Limited Areas based on the need to
    access.
  • Laboratory corridors (non-containment)
  • Loading dock storage receiving areas and animal
    delivery airlocks

21
Security Zone 3 Exclusion Area / Non-Containment
  • This areas directly support containment
    operations and require a third level card access
    control
  • Housing animal receiving airlock
  • Clean autoclave rooms
  • Basement area where liquid treatment system is
    located
  • Mechanical penthouse serving all HEPA filters and
    Air Handling Units, exhaust fans
  • Building operation control areas accommodating
    building automation systems

22
Security Zone 4 Exclusion Areas Containment
  • These areas are designated as Secondary
    Containment Spaces in which the design and access
    is controlled primarily to allow researchers and
    operators into the facility. Entry into these
    areas will require two-level access control,
    proximity card and PIN and/or biometric. Exit
    from these areas will require the proximity card.
    All entrances will have a CCTV camera for
    monitoring.
  • CL3 laboratory shower entrance zone
  • CL3 decontamination airlocks

23
Security Zone 5 Exclusion Areas Containment
  • These areas are designated as Lab Containment
    Spaces or specialised areas in the design. Entry
    and exit will require keypad entry of a PIN
    and/or biometric, which authorises access only to
    specific modules or spaces. All areas will have
    CCTV and motion detection.
  • CL3 laboratories
  • CL3 animal holding rooms

24
Security Zone 6 Exclusion Areas Containment
Pathogen Storage Freezers
  • All freezers should have access control. All
    rooms are equipped with additional security
    features including motion detection, door access
    control, CCTV camera monitoring and special
    access and use procedures.

25
Aerosol Control
  • Sources of Biohazardous Aerosols
  • Impact of Ventilation on Aerosol Load
  • Air filtration
  • Airlocks
  • Anterooms as a Control Mechanism
  • Cascade negative pressure
  • SOP and PPE as a Control Mechanism

26
Sources of Biohazardous Aerosols
  • Biohazardous aerosols of concern in the
    laboratory setting are generated by a number of
    manipulations involving infectious material. such
    as sonification, mixing, pouring and pipetting
    centrifugation, during an accident etc. In animal
    facilities, aerosols of infectious pathogens may
    be generated by infected animals breathing,
    sneezing or coughing respiratory pathogens.

27
Ventilation
  • Issues related to ventilation in containment
    facilities include directional airflow, airflow
    velocities, pressure differential between
    adjacent spaces and air exchange rates.
  • Directional airflow is used to create zones of
    hazard by moving air from areas clear of
    hazardous aerosol contamination to areas of
    higher potential for hazardous aerosol
    contamination. This provides for two functions
  • - 1) control of the hazardous aerosol minimises
    the possibility of inadvertent exposure outside
    of the laboratory space and
  • - 2) knowledge of where the aerosol hazard
    exists and the extent of the hazard allows
    personnel to follow appropriate protocols if they
    are required to enter areas where aerosols may
    exist.

28
Air filtration
  • Where the risk assessment indicates that a
    significant aerosol release of pathogens outside
    of primary containment is probable and would
    create a hazard to people or the environment
    outside of the facility, the exhaust system
    should be HEPA filtered to prevent the release of
    the pathogens outside of the laboratory.

29
Airlocks
  • Airlocks have one primary purpose to eliminate
    or minimise the transfer of air from the
    containment zone to a non-containment zone or
    from one zone or level of containment to another
    to avoid cross- contamination.
  • Airlocks, whether it is a PPE room, change room,
    shower, anteroom, or decontamination chamber (a
    device to transfer large pieces of equipment),
    requires special attention for room tightness,
    door control and ventilation design. Airlock
    entry ports for specimens, materials and animals
    must be available as well.

30
Airlocks- cont.
  • The airlocks should include the following
  • Interlocking doors preventing two doors opened at
    once
  • Directional airflow measurement capability
    (pressure sensors and alarms)
  • Door swings to accommodate direction of airflow
    and passage of equipment
  • Direct ventilation of supply and/or exhaust
    inside airlock depending on many criteria
  • Vision panels in doors unless its designated as
    a change room
  • Tight doors depending on which side and method of
    controls integration

31
Anterooms and two doors in series
  • Considerable control of airborne micro-organisms
    can be achieved with the addition of an anteroom
    to the laboratory or animal holding room.
  • This is the basis for the requirement in BSL-3
    or equivalent facilities to have entry by two
    doors in series.
  • A laboratory with Class III biosafety cabinets
    is only accessible through a minimum of two
    doors.

32
Cascade negative pressure
  • The pressure decreases at each containment
    barrier and is lowest at the location of highest
    potential or effective contamination. For
    example security corridor -30 Pa, shower -60 Pa,
    laboratory -90 Pa, animal room -120 Pa.

33
Technical details about pressure differentiation
and backflow prevention
  • Pressure differentials in animal facilities are
    held at approximately 50 Pa lower pressure than
    the point of personnel entry so that there is
    airflow into the room upon door opening.
  • Backflow prevention for containment labs is
    necessary to prevent back siphoning of
    contaminated liquids and air. Types of backflow
    solutions are dependent on the medium that is
    considered water, air, gas, and steam.

34
Electrical system
  • The electrical systems of containment
    laboratories ensure that all of the systems
    cohesively work together to manage the three
    essential criteria for biocontainment
  • Protection of the staff
  • Protection of scientific programs
  • Protection of the environment and adjacent
    communities
  • Electrical systems can be segregated into normal
    power systems, emergency power systems,
    uninterruptible power systems (UPS),
    communication systems, data and information
    systems, lightning control systems, security
    systems, lighting systems, equipment monitoring
    systems, automation control systems, life safety
    systems, harmonic control systems and telemetry
    systems.

35
Emergency power strategy
  • Emergency power planning for containment
    facilities does not mean that all loads need to
    have this provision. It means that critical loads
    may include life safety, virus collection,
    sensitive equipment and ventilation systems may
    be all required. One particular emergency power
    strategy could be
  • 100 of fire systems
  • 100 of building automation
  • 100 of security
  • 100 of HVAC (chilling / heating pumps, fans
    valves)
  • 50 of lab receptacles
  • 50 of animal room receptacles
  • 25 of in-door lighting systems
  • 10 of non-lab space
  • 10 of outdoor lighting
  • 100 of air compressors for containment control
  • 0 of compressors for non-containment control
  • 100 of all Biological safety cabinets,
    freezers, incubators
  • 100 of all liquid / solid effluent treatment
    systems

36
Emergency Power
  • Emergency power is needed when there are
    interruptions or problems with the normal power
    provided by the utility. The emergency power will
    allow the facility to continue to operate,
    usually in a reduced mode feeding only those
    items considered essential to operate the
    laboratory and maintain life safety systems. The
    run time is dictated by the amount of fuel on
    hand and availability from the suppliers. Fuel
    storage capacity should ideally be considered for
    at least 48 hours of operation for a containment
    facility.

37
Identification
  • Proper identification is extremely important on
    all systems and equipment. The most expeditious
    method of handling this would be to consult with
    the end user to enter their naming convention on
    the design and construction drawings. This is
    important when systems are being integrated
    within existing facilities or where a
    computerised maintenance management system will
    be utilised.

38
The identification should provide information on
the following
  • Voltage and Phases
  • Type of power, normal emergency or UPS
  • Lighting or Power circuits
  • Approximate location (e.g. a floor or a wing or
    building number)
  • Short circuit fault current potential at each
    panel
  • Substations (should have a mimic bus on the
    front of the gear)
  • Receptacles (should identify panel and circuit
    number)
  • Switches (line voltage switches should also
    identify the panel and circuit number)
  • Disconnects / Motor Starters not in an MCC (the
    source should be indicated, as well as the
    voltage and the identifier of the load being
    served)
  • Motor Starters in Motor Control Centres (the
    name of the load that is served)

39
Labels
  • The labels should be colour coded to provide
    indication of the system. For example
  • Normal Power Black background / white
    letters.
  • Normal Lighting White background / black
    letters.
  • Emergency Power Red Background / white
    letters.
  • Emergency Lighting White Background / red
    letters.
  • UPS Panel Yellow background / black letters.

40
Indicator Lights
  • Indicator lights should be provided with LEDs
    (Light Emitting Diodes) as opposed to
    incandescent lamps wherever possible. The LEDs
    have a much longer life expectancy than the
    incandescent lamps providing more reliable
    indication while consuming significantly less
    energy. Indicator lights provide a quick
    assessment of equipment status which is helpful
    in all situations, especially emergencies.

41
Effluent treatment
  • Heat treatment 95 C
  • Chemical treatment

42
Redundancy
  • Redundancy is defined as having more than one
    system supporting an individual mechanical
    function. It would be wrong to assume that each
    and every mechanical system or device needs to
    have redundancy. The primary areas for redundancy
    need to focus on the three principles of
    bio-containment- environment protection,
    personnel protection and product (or scientific
    outcome) protection. Therefore, during a design
    process the issue of redundancy needs to be well
    thought out.

43
Laboratory animal facilities
  • Facilities for laboratory animals used for
    studies of infectious disease should be
    physically separated from other activities such
    as animal production, quarantine and clinical
    laboratories. As microbiological containment of
    infected animals is more difficult than for
    laboratory cultures, animal facilities should be
    located remotely from experimental laboratories
    as well. For security reasons, the animal house
    should be an independent, detached unit. If it
    adjoins a laboratory, the design should provide
    for its isolation from the public parts of the
    laboratory should such need arise, and for its
    decontamination and disinfestation.

44
Planning Experimental Work
  • In an animal bio-containment facility, a basic
    assumption is that animals will not bring any
    disease into the facility that will compromise
    either the planned experiment or other animals.
    Therefore animals must be introduced via a path
    that is free from disease agents and that no
    disease agent will escape from within while fresh
    animals are introduced.
  • Access to animal rooms is limited to personnel
    that have been advised of potential hazards, are
    trained, meet specific requirements.

45
Waste Disposal
  • The safe handling of infectious wastes must be
    considered as part of the experimental plan.
  • Urine and faecal wastes for animals infected with
    Level 3 and 4 agents must be decontaminated
    either by heat or chemical treatment.
  • Discarded surgery or necropsy tissues from
    infected animals are usually sterilised by
    autoclaving and carcasses by rendering at high
    temperature, steam sterilisation, incineration or
    chemical decontamination such as alkaline
    hydrolysis.
  • All infectious wastes that cannot be
    decontaminated or autoclaved will immediately be
    placed in red infectious waste bags.

46
Laboratory commissioning
  • Laboratory commissioning may be defined as the
    systematic review and documentation process
    signifying that specified laboratory structural
    components, systems and/or system components have
    been installed, inspected, functionally tested
    and verified to meet national or international
    standards, as appropriate.
  • Laboratories designated as Biosafety Levels 14
    will have different and increasingly complex
    commissioning requirements
  • The commissioning process and acceptance criteria
    should be established early, preferably during
    the programming phase of the construction or
    renovation project.

47
Why laboratory commissioning?
  • The commissioning process provides the
    institution and the surrounding community with a
    greater degree of confidence that the structural,
    electrical, mechanical and plumbing systems,
    containment and decontamination systems, and
    security and alarm systems will operate as
    designed, to assure containment of any
    potentially dangerous microorganisms being worked
    with in a particular laboratory or animal
    facility.

48
List of laboratory systems in the commissioning
plan
  • 1. Building automation systems including links to
    remote monitoring and control sites
  • 2. Electronic surveillance and detection systems
  • 3. Electronic security locks and proximity device
    readers
  • 4. Heating, ventilation (supply and exhaust) and
    air-conditioning (HVAC) systems
  • 5. High-efficiency particulate air (HEPA)
    filtration systems
  • 6. HEPA decontamination systems
  • 7. HVAC and exhaust air system controls and
    control interlocks
  • 8. Airtight isolation dampers
  • 9. Laboratory refrigeration systems
  • 10. Boilers and steam systems

49
List of laboratory systems in the commissioning
plan cont.
  • 11. Fire detection, suppression and alarm systems
  • 12. Domestic water backflow prevention devices
  • 13. Processed water systems (i.e. reverse
    osmosis, distilled water)
  • 14. Liquid effluent treatment and neutralization
    systems
  • 15. Plumbing drain primer systems
  • 16. Chemical decontaminant systems
  • 17.Medical laboratory gas systems
  • 18. Breathing air systems
  • 19. Service and instrument air systems
  • 20. Cascading pressure differential verification
    of laboratories and support areas
  • 21. Local area network (LAN) and computer data
    systems

50
List of laboratory systems in the commissioning
plan cont.
  • 22. Normal power systems
  • 23. Emergency power systems
  • 24. Uninterruptible power systems
  • 25. Emergency lighting systems
  • 26. Lighting fixture penetration seals
  • 27. Electrical and mechanical penetration seals
  • 28. Telephone systems
  • 29. Airlock door control interlocks
  • 30. Airtight door seals
  • 31.Window and vision-panel penetration seals
  • 32. Barrier pass-through penetration

51
List of laboratory systemsin the commissioning
plan cont.
  • 33. Structural integrity verification concrete
    floors, walls and ceilings
  • 34. Barrier coating verification floors, walls
    and ceilings
  • 35. Biosafety Level 4 containment envelope
    pressurization and isolation functions
  • 36. Biological safety cabinets
  • 37. Autoclaves
  • 38. Liquid nitrogen system and alarms
  • 39.Water detection systems (e.g. in case of
    flooding inside containment zone)
  • 40. Decontamination shower and chemical additive
    systems
  • 41. Cage-wash and neutralization systems
  • 42.Waste management.

52
Failures in BSL-laboratories
  • August 2007 FMD outbreak at Pirbright in Surrey,
    UK
  • 3rd August first case of FMD fount at a farm in
    Normandy
  • 6th August second case of FMD at a farm near the
    first
  • 6th August FMD strain identified as O1 BFS67
  • Strain not currently found naturally in the world
  • Strain originates from the 1967 FMD epidemic in
    the UK
  • Strain used as reference in laboratories and
    pharmaceutical production plants

53
Turkish AI Laboratories
  • Eight regional Veterinary Control and Research
    Institutes (VCRIs) provide laboratory services
    with the ability to achieve virus isolation.
    Three of them, Bornova, Pendik and Etlik house AI
    laboratories in charge of virus identification.
    Bornova houses the national reference laboratory.
    They are equipped and competent to undertake a
    broad range of standard diagnostic HPAI tests and
    provide technical backstopping to the other 5
    regional laboratories authorized for AI
    diagnostics. However the conditions of those
    three laboratories do not meet the required
    bio-safety standards. Therefore GDPC plans to
    upgrade them to BSL 3.

54
UK FMD outbreak in 2007
  • Pirbright
  • Area holds two BLS laboratories
  • for work with FMD
  • Labs used by three organizations
  • Institute for Animal Health (IAH)
  • Merial Ltd
  • Stabilitech Ltd.
  • IAH and Stabilitech used onlysmall amounts of
    live FMD.
  • Merial produced large volumes of FMD vaccine.

55
UK FMD outbreak in 2007
  • Findings of the investigation- Containment
    failure due to
  • Inefficient inactivation of waste water
    (biosafety breach)
  • Broken waste water piping due to poormaintenance
  • High precipitation allowed sewers to overflow
  • Construction work at the site allowed entry and
    exit of unsupervised personnel and vehicles
    (biosecurity breach)
  • Source Final report on potential breaches of
    biosecurity at the Pirbright site 2007. September
    2007, available at
  • http//www.hse.gov.uk

56
Other recent failures
  • Texas AM University (2006 2007)
  • New BSL-4 laboratory at the CDC (2007)
  • Lessons learned
  • All possible contingencies must be in place to
    ensure containment and security
  • Incidents must be reported
  • Establishment of BSL-3 or BSL-4 laboratory is a
    long term financial commitment, not just an
    initial one
  • Source High-Containment Biosafety Laboratories
    Preliminary Observations on the Oversight of
    the Proliferation of BSL-3 and BSL-4 Laboratories
    in the United States. October 4, 2007,
    published by the GAO, at p. 14.
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