Human & Animal Health Laboratories: from Concept to Commissioning Yanko Ivanov & Ragip Bayraktar, EU Technical Assistance to Avian Influenza Preparedness & Response Project, EU. Contents. Biosafety & Biosecurity considerations and p rinciples
Human & Animal Health Laboratories: from Concept to CommissioningYanko Ivanov & Ragip Bayraktar,EU Technical Assistance to Avian Influenza Preparedness & Response Project, EU
Personal safety equipment
Incident response planning
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
- lab support personnel
- mucous membrane exposure,
— inward airflow No DesirableYes Yes
— controlled ventilating system No Desirable Yes Yes
— HEPA-filtered air exhaust No No Yes/NobYes
— on site No Desirable Yes Yes
— in laboratory room No No Desirable Yes
— double-ended No No Desirable Yes
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).
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.
• 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
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.
This areas directly support containment operations and require a third level card access control
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
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
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.
Biohazardous aerosols of concern in the laboratory setting are generated by a number of manipulations involving infectious material.such assonification, 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.
Issues related to ventilationin containment facilities include: directional airflow, airflow velocities, pressure differentialbetween adjacent spaces and air exchange rates.
- 1) control of the hazardous aerosol minimises the possibility of inadvertentexposure outside of the laboratory space and;
- 2) knowledge of where the aerosol hazard existsand the extent of the hazard allows personnel to follow appropriate protocols if they arerequired to enter areas where aerosols may exist.
Where the risk assessmentindicates that a significant aerosol release of pathogens outside of primary containment isprobable and would create a hazard to people or the environment outside of the facility, theexhaust system should be HEPA filtered to prevent the release of the pathogens outside of the laboratory.
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 (adevice 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.
The airlocks should include the following:
Considerable control of airborne micro-organisms can be achieved withthe addition of ananteroom to the laboratory or animal holding room.
This is the basis for therequirement 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.
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.
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.
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
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.
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.
• 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 andcircuit 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)
The labels should be colour coded to provide indication of the system. Forexample:
• 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.
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.
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.
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.
The commissioning process provides theinstitution and the surrounding community with a greater degree of confidence thatthe structural, electrical, mechanical and plumbing systems, containment anddecontamination systems, and security and alarm systems will operate as designed, toassure containment of any potentially dangerous microorganisms being worked within a particular laboratory or animal facility.
1. Building automation systems including links to remote monitoring and controlsites
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
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
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
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
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
for work with FMD
Source: Final report on potential breaches of biosecurity at the Pirbright site 2007. September 2007, available at:
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.