Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
Project No. TR 06.AI/SV
Technical Assistance to Avian Influenza Preparedness and Response
Human & Animal Health
Laboratories: from Concept to
Commissioning
Yanko Ivanov & Ragip Bayraktar,
EU Technical Assistance to Avian Influenza
Preparedness & Response
Project, EU
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
Conflicts
(Biosafety vs Biosecurity)
Accountability
Compliance SOP’s
Emergency routines
GLP
Inventory control
Access control
Biosafety
containment
Transfer security
Physical security
Information security
Safety cabinets
Personal safety equipment
Supervised by appointed
Biosafety officer
Regulated by national work
environment safety law
Biosecurity
Incident reporting
Supervised by appointed
Incident response planning Biosecurity or Biosafety officer
Should consult with law
Revision
enforcement officials and security
Training
experts
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
Why biosafety practices?
• Protection:
- workers
- “products”
- co-workers
- lab support personnel
- environment
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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?
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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?
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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?
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
Relation of risk groups to biosafety levels, practices and equipment
Risk
group
Biosafety
level (BSL)
1
Basic BSL- 1
2
Basic BSL- 2
3
Containment
BSL- 3
4
Maximum
Containment
BSL- 4
Laboratory type
Lab. practice
Safety equipment
Basic teaching
and research
Good microbiol.
techniques (GMT)
None, open bench work
Diagnostic
services and
research
GMT + protective
clothing biohazard
sign
Open bench plus bio –
safety cabinet (BSC) for
potential aerosols
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
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
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
Summary of biosafety level requirements
•
•
•
•
•
•
•
•
•
•
•
•
Isolation of laboratory
Room sealable for decontamination
Ventilation:
— inward airflow
— controlled ventilating system
— HEPA-filtered air exhaust
Double-door entry
Airlock
Airlock with shower
Anteroom
Anteroom with shower
Effluent treatment
Autoclave:
— on site
— in laboratory room
— double-ended
Biological safety cabinets
Personnel safety monitoring capabilityd
1
No
No
BIOSAFETY LEVEL
2
3
No
Yes
No
Yes
No
No
No
No
No
No
No
No
No
Desirable
Desirable
No
No
No
No
No
No
No
Yes
Yes
Yes/Nob
Yes
No
No
Yes
Yes/Noc
Yes/Noc
No
No
No
No
No
Desirable
Yes
No
Desirable
No
Desirable
Desirable
Yes
No
Desirable
4
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
—
No
Yes
Yes
Yes
Yes
Yes
Yes
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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).
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
Security Zone 2: Limited Areas / NonContainment
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
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
Security Zone 3: Exclusion Area / NonContainment
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
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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 it’s designated as a
change room
Tight doors depending on which side and method of
controls integration
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
Anterooms and two doors in series
Considerable control of airborne microorganisms 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.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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)
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
Effluent treatment
• Heat treatment – 95 C
• Chemical treatment
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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 1–4 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.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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 airconditioning (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
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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 only
small amounts of live FMD.
– Merial produced large volumes
of FMD vaccine.
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
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 poor
maintenance
• 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
Technical Assistance to Avian Influenza Preparedness and Response
An EU-funded project managed by the Central Finance & Contracts Unit
Other recent failures
• Texas A&M 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.