Laboratory Design and Maintenance

LABORATORY BIOSAFETY MANUAL I
FOURTH EDITION
AND
ASSOCIATED MONOGRAPHS
LABORATORY DESIGN
AND MAINTENANCE
II LABORATORY DESIGN AND MAINTENANCE
LABORATORY BIOSAFETY MANUAL
FOURTH EDITION
AND
ASSOCIATED MONOGRAPHS
LABORATORY DESIGN
AND MAINTENANCE
Laboratory design and maintenance
(Laboratory biosafety manual, fourth edition and associated monographs)
ISBN 978-92-4-001139-7 (electronic version)
ISBN 978-92-4-001140-3 (print version)
© World Health Organization 2020

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Design and layout by Paul Bloxham
iii
Contents
Acknowledgementsvi
Glossary of termsviii
Executive summaryxiv
SECTION 1 Introduction1
1.1 Laboratory design features1
1.2 Risk assessment and needs assessment1
SECTION 2 Design considerations - core requirements3
2.1 Facility space3
2.2 Storage4
2.3 Surfaces and finishes5
2.4 Furniture7
2.5 Facilities and systems7
2.6 Laboratory equipment9
SECTION 3 Design considerations - heightened control measures11
3.1 Selecting heightened control measures11
3.2 Additional separation and design features12
3.3 Laboratory equipment14
3.4 Directional airflow and inward airflow15
3.5 Waste disposal16
3.6 Laboratory emergency response17

iv LABORATORY DESIGN AND MAINTENANCE
SECTION 4 Design considerations -
maximum containment measures19
4.1 Additional separation and design features 19
4.2 Controlled access21
4.3 Directional airflow21
4.4 Waste disposal23
4.5 Laboratory emergency response24
SECTION 5 Framework of a laboratory project25
SECTION 6 Planning27
6.1 Planning team29
6.2 Risk assessment and needs assessment30
6.3 User requirement brief33
6.4 Costs34
6.5 Time scale35
6.6 Quality36
SECTION 7 Design37
7.1 User requirement specification38
7.2 Workflow diagrams39
7.3 Typical project design stages39
7.4 Budget41
7.5 Procurement42
CONTENTS v
SECTION 8 Construction45
8.1 Site investigations45
8.2 Products and materials: quality control47
8.3 Documentation48
8.4 Testing and commissioning49
8.5 Acceptance and handover50
8.6 Accreditation and certification51
SECTION 9 Operation and maintenance53
9.1 Safety of maintenance personnel54
9.2 Design for maintenance54
9.3 Operating and maintenance manuals55
9.4 Maintenance contracts56
9.5 Planned maintenance56
9.6 Breakdown maintenance58
9.7 Maintenance records and inspections59
SECTION 10 Decommissioning laboratory facilities61
References62
Further information63
ANNEX 1. Example of a user requirement brief64
ANNEX 2. Example of a user requirement specification66

vi LABORATORY DESIGN AND MAINTENANCE
Acknowledgements
Principal coordinator
Dr Kazunobu Kojima, World Health Organization, Switzerland
Scientific contributors
Mr Allan Bennett, Public Health England (WHO Collaborating Centre for Applied
Biosafety and Training), United Kingdom of Great Britain and Northern Ireland
Prof. Stuart Blacksell (Team lead), University of Oxford/Mahidol-Oxford Tropical

Medicine Research Unit, Thailand
Prof. Joachim Frey, University of Bern, Switzerland
Ms Marianne Heisz (Deputy team lead), Public Health Agency of Canada (WHO
Collaborating Centre for Biosafety and Biosecurity), Canada
Dr Greg Smith, Department of Health, Australia
Mr Joe Tanelli, Public Health Agency of Canada (WHO Collaborating Centre for
Biosafety and Biosecurity), Canada
Mr Andrew Thompson, University of Oxford, United Kingdom of Great Britain and

Northern Ireland
Mr Mark Wheatley, Department for Environment, Food and Rural Affairs, United
Kingdom of Great Britain and Northern Ireland
Project management
Ms Lisa Stevens, World Health Organization, France
Ms Rica Zinsky, World Health Organization, Switzerland

ACKNOWLEDGEMENTS vii
Reviewers
Dr Christina Carlson, World Health Organization, Switzerland and Centers for Disease
Control and Prevention (WHO Collaborating Centre for Biosafety and Biosecurity),
United States of America
Prof. David R Harper, Chatham House – Centre on Global Health Security, United
Kingdom of Great Britain and Northern Ireland
Ms Heather Sheeley, Public Health England (WHO Collaborating Centre for Applied
Biosafety and Training), United Kingdom of Great Britain and Northern Ireland
Prof. Folker Spitzenberger, Technical University of Applied Sciences Lübeck, Germany
Technical editing
Ms Fiona Curlet
Financial support
Development and publication of this document have been made possible with
financial support from the Global Partnership Program, Global Affairs Canada, the
Biosecurity Engagement Program, United States Department of State and the Defense
Threat Reduction Agency, US Department of Defense.
viii LABORATORY DESIGN AND MAINTENANCE
Glossary of terms
Accident: An inadvertent occurrence that results in actual harm such as infection, illness,
injury in humans or contamination of the environment.
Accreditation: The assessment and attestation of competency.
Aerosol: Liquid or solid particles suspended in air and of a size that may allow inhalation
into the lower respiratory tract (usually less than 10 micrometres in diameter).
Biological agent: A microorganism, virus, biological toxin, particle or otherwise

infectious material, either naturally occurring or genetically modified, which may
have the potential to cause infection, allergy, toxicity or otherwise create a hazard to
humans, animals, or plants.
Biological safety cabinet (BSC): An enclosed, ventilated working space designed

to provide protection to the operator, the laboratory environment and/or the work
materials for activities where there is an aerosol hazard. Containment is achieved by
segregation of the work from the main area of the laboratory and/or through the use
of controlled, directional airflow mechanisms. Exhaust air is passed through a high-
efficiency particulate air (HEPA) filter before recirculating into the laboratory or into the
building’s heating, ventilation and air conditioning system. There are different classes (I,
II and III) of BSCs that provide different levels of containment.
Biosafety: Containment principles, technologies and practices that are implemented to

prevent unintentional exposure to biological agents or their inadvertent release.
Biosecurity: Principles, technologies and practices that are implemented for the
protection, control and accountability of biological materials and/or the equipment,
skills and data related to their handling. Biosecurity aims to prevent their unauthorized
access, loss, theft, misuse, diversion or release.
Bunding: A tank of a minimum height used to contain spills which can then be drained
or pumped under control. It is usual to provide bunding which has a volume equivalent
to 110% of the potential spill volume.
Calibration: Establishment of the relationship between the measurement provided by

the instrument and the corresponding values of a known standard, allowing correction
to improve accuracy. For example, laboratory equipment such as pipetting devices
may need calibration periodically to ensure proper performance.
Certification: A third-party testimony based on a structured assessment and formal

documentation confirming that a system, person or piece of equipment conforms to
specified requirements, for example, to a certain standard.
GLOSSARY OF TERMS ix
Clean: Visually free of soil and below specified levels of analytes.
Commissioning: Process of bringing an item into operation and ensuring that it is in

good working order. On building projects, commissioning refers primarily to building
services.
Commissioning agent: Individual or company independent of the builder that does the
commissioning work.
Consequence (of a laboratory incident): The outcome of an incident (exposure to and/

or release of a biological agent) of varying severity of harm, occurring in the course of
laboratory operations. Consequences may include a laboratory-associated infection,
other illness or physical injury, environmental contamination, or asymptomatic carriage
of a biological agent.
Containment: The combination of physical design parameters and operational practices

that protect personnel, the immediate work environment and the community from
exposure to biological agents. The term “biocontainment” is also used in this context.
Contamination: The introduction of undesired biological agents into tissues and

specimens or onto surfaces.
Core requirements: A set of minimum requirements defined in the fourth edition of

the World Health Organization (WHO) Laboratory biosafety manual to describe a
combination of risk control measures that are both the foundation for, and an integral
part of, laboratory biosafety. These measures reflect international standards and best
practice in biosafety that are necessary to work safely with biological agents, even
where the associated risks are minimal.
Decommissioning: Process of stopping work, decontaminating and making safe

a facility such that residual risk in the facility is reduced to an acceptable risk.
Decommissioning may be followed by re-commissioning, repurposing or demolition.
Decontamination: Reduction of viable biological agents or other hazardous materials

on a surface or object(s) to a pre-defined level by chemical and/or physical means.
Design features: Practical and commonly used design solutions used to meet and
satisfy stated design requirements. This could be a hand-washing basin with a knee-
operated water tap, or a window allowing vision through a door or into a space.
Design requirements: Stated features required by a needs assessment which must be

included in the design and which are set out in the user requirement specification.
Design team: A group of (professional) people brought together with the main
purpose of designing a building, including specifications and drawings, schedules and
programmes. They may be the same as, different to, or part of a construction team.
x LABORATORY DESIGN AND MAINTENANCE
Directional airflow: Air moving from an active (caused by an intentional force) or passive
(air movement as a secondary effect) air source to an active extraction location.
Disinfectant: Agents capable of eliminating viable biological agents on surfaces or in

liquid waste. These will have varying effectiveness depending on the properties of the
chemical, its concentration, shelf life and contact time with the agent.
Emergency response: An outline of the behaviours, processes and procedures to be

followed when handling sudden or unexpected situations, including exposure to or
release of biological agents. The goal of an emergency response is to prevent injuries
or infections, reduce damage to equipment or the environment, and accelerate
resumption of normal operations.
Engineering controls: Risk control measures that are built into the design of a
laboratory or laboratory equipment to contain the hazards. Biological safety cabinets
(BSCs) and isolators are forms of engineering control in order to minimize the risk of
exposure to and/or unintended release of biological agents.
Exposure: An event during which an individual comes in contact with, or is in close

proximity to, biological agents with the potential for infection or harm to occur. Routes
of exposure can include inhalation, ingestion, percutaneous injury and absorption and
are usually dependent upon the characteristics of the biological agent. However, some
infection routes are specific to the laboratory environment and are not commonly seen
in the general community.
Fumigation: Use of a poisonous gas or vapour to remove contamination of a biological

agent from a surface, piece of equipment or area.
Good microbiological practice and procedure (GMPP): A basic laboratory code of

practice applicable to all types of laboratory activity with biological agents, including
general behaviours and aseptic techniques that should always be observed in the
laboratory. This code serves to protect laboratory personnel and the community from
infection, prevent contamination of the environment and provide protection for the
work materials in use.
Handover: An important and irreversible event when ownership of and all

responsibility for the project passes from the builder to the user or owner.
Hazard: An object or situation that has the potential to cause adverse effects when
an organism, system or (sub)population is exposed to it. In the case of laboratory
biosafety, the hazard is defined as biological agents which have the potential to cause
adverse effects to personnel and/or humans, animals, and the wider community and
environment. A hazard does not become a “risk” until the likelihood and consequences
of that hazard causing harm are taken into account.
GLOSSARY OF TERMS xi
Heightened control measures: A set of risk control measures as described in the WHO
Laboratory biosafety manual that may need to be applied in a laboratory facility
because the outcome of a risk assessment indicates that the biological agents being
handled and/or the activities to be performed with them are associated with a risk
that cannot be brought to an acceptable risk with the core requirements only.
High efficiency particulate air (HEPA) filter: These filters are composed of many
randomly oriented fibres that create a fibrous matrix through which air can pass.
Particles travelling with the air may be captured by the fibres, effectively filtering the air.
Inactivation: Removal of the activity of biological agents by destroying or inhibiting

reproductive or enzyme activity.
Incident: An occurrence that has the potential to, or results in, the exposure of
laboratory personnel to biological agents and/or their release into the environment
that may or may not lead to actual harm.
Infectious dose: The amount of biological agent required to cause an infection in the
host, measured in number of organisms. Often defined as the ID50, the dose that will
cause infection in 50% of those exposed.
Inward airflow: Passive or active airflow that comes from outside a room or device.
Likelihood (of a laboratory incident): The probability of an incident (that is exposure to

and/or a release of a biological agent) occurring in the course of laboratory work.
Maximum containment measures: A set of highly detailed and stringent risk control
measures described in the fourth edition of the WHO Laboratory biosafety manual that
are considered necessary during laboratory work where a risk assessment indicates
that the activities to be performed pose very high risks to laboratory personnel, the
wider community and/or the environment, and therefore an extremely high level of
protection must be provided. These are especially needed for certain types of work
with biological agents that may have catastrophic consequences if an exposure or
release were to occur.
Needs assessment: A structured analysis to determine what purpose the proposed

building and its systems are required to serve based on all planned activities to be
carried out.
Personal protective equipment (PPE): Equipment and/or clothing worn by personnel

to provide a barrier against biological agents, thereby minimizing the likelihood of
exposure. PPE includes but is not limited to, laboratory coats, gowns, full-body suits,
gloves, protective footwear, safety glasses, safety goggles, masks and respirators.
Procurement: The process of purchasing goods or services. There are many different
routes by which the design and construction of a building can be procured.
xii LABORATORY DESIGN AND MAINTENANCE
Project manager: A project manager is a specialist adviser who represents the

laboratory management/facility owner and is responsible for the day-to-day
management of a project.
Qualification: A performance ensuring process typically associated with validation of

complex systems and equipment.
Redundancy: Repetitions of systems or parts of a system to provide protection in the

case of a primary system failure. For example, a series of high efficiency particulate air
(HEPA) filters in case one or more fail when used to move laboratory air to the outside
environment.
Residual risk: Risk that remains after carefully selected risk control measures have
been applied. If residual risk is not acceptable, it may be necessary to apply additional
risk control measures or to stop the laboratory activity.
Risk: A combination of the likelihood of an incident occurring and the severity of the
consequences (harm) if that incident were to occur.
Risk assessment: A systematic process of gathering information and evaluating the

likelihood and consequences of exposure to or release of workplace hazard(s) and
determining the appropriate risk control measures to reduce the risk to an acceptable
risk.
Risk control measure: Use of a combination of tools, which include communication,

assessment, training, and physical and operational controls, to reduce the risk of an
incident/event to an acceptable risk. The risk assessment cycle will determine the
strategy that should be used to control the risks and the specific types of risk control
measures required to achieve this.
Safety culture: A set of values, beliefs and patterns of behaviour instilled and facilitated
in an open and trusting atmosphere by individuals and organizations working together
to support or enhance best practice for laboratory biosafety, irrespective of whether it is
stipulated in applicable codes of practice and/or regulations.
Sharps: Any device or object that is a puncture or wound hazard because of its
pointed ends or edges. In the laboratory, sharps can include needles, syringes with
attached needles, blades, scalpels or broken glass.
Soap: A water soluble cleaning compound used for cleaning skin and other materials.
Note, soap does not necessarily inactivate biological agents.
Standard operating procedures (SOPs): A set of well-documented and validated

stepwise instructions outlining how to perform laboratory practices and procedures in
a safe, timely and reliable manner, in line with institutional policies, best practice and
applicable national or international regulations.
GLOSSARY OF TERMS xiii
Sterilization: A process that kills and/or removes all biological agents including spores.
Testing (of laboratory design features and equipment during construction and/or
maintenance): A physical check that an entity meets a specified need or target figure.
Testing is normally included with other activities such as commissioning, validation and
verification. For example, tests can be of water pressure, water quality and/or light level.
Transmission: The transfer of biological agent(s) from objects to living things, or

between living things, either directly or indirectly via aerosols, droplets, body fluids,
vectors, food/water or other contaminated objects.
User requirement brief: An outline documented statement defining the requirements

identified by the user that must be fulfilled by the completed project.
User requirement specification: A detailed documented statement defining all the

requirements identified by the user (during the needs assessment) that must be
fulfilled and verified by the completed project.
Validation: Systematic and documented confirmation that the specified requirements

are adequate to ensure the intended outcome or results. For example, in order
to prove a material is decontaminated, laboratory personnel must validate the
robustness of the decontamination method by measurement of the remaining
biological agents against the detection limit by chemical, physical or biological
indicators.
Verification: Confirmation that a given item (product, process or system) satisfies the
specified requirements. For example, verification that the performance of an autoclave
meets the standards specified by the manufacturer should be performed periodically.
Workflow (laboratory workflow): A stepwise analysis of planned processes in the

laboratory that enables understanding and communication of the sequential steps
in each process and what facilities, services, systems and space are required at each
step. The workflow can be further broken down into the flow of personnel, specimens,
materials and waste.
xiv LABORATORY DESIGN AND MAINTENANCE
Executive summary
The planning, design, construction, operation and maintenance, as well as the
renovation and repurposing, of laboratories is a vast subject that requires input from
many professionals working in a wide range of disciplines, including science, finance,
human resources, architecture, engineering and construction. Therefore, a clear,
objective, pragmatic and realistic understanding of the needs driving the laboratory
project must be set out. Building a new or refurbishing an existing laboratory is an
infrequent event and the resultant facilities need to remain usable and sustainable for
the life of the laboratory, normally decades. It is therefore vital that decisions are taken
with clarity of purpose to realistically and pragmatically address the function required
from the laboratory project. This monograph describes the design features or design
considerations that apply to different types of facility, including laboratories with core
requirements and facilities needing heightened control or maximum containment
measures. The targeted readership for this monograph is people involved in the risk
assessment and in the laboratory design or renovation, such as senior management,
laboratory manager, biosafety officer, architects, designers, construction engineers
and builders.
The information in this monograph on laboratory design and maintenance is designed

to accompany and support the fourth edition of the WHO Laboratory biosafety
manual (core document) and other associated monographs. The manual and the
monographs adopt a risk- and evidence-based approach to biosafety rather than a
prescriptive approach to ensure that laboratory facilities, safety equipment and work
practices are locally relevant, proportionate to needs and sustainable. Emphasis is
placed on the importance of a “safety culture” that incorporates risk assessment, good
microbiological practice and procedure and standard operating procedures, relevant
training of personnel, and prompt reporting of incidents and accidents followed by
appropriate investigation and corrective actions. This new approach aims to facilitate
laboratory design and ways of operating that ensure greater sustainability while
maintaining adequate and appropriate control of biosafety.
The other associated monographs provide detailed information and help implement
systems and strategies on the following specialized topics: risk assessment, biological
safety cabinets and other primary containment devices, personal protective equipment,
decontamination and waste management, biosafety programme management and
outbreak preparedness and resilience.
This monograph focuses on the planning, design, construction, operation and

maintenance of laboratory facilities. These facilities are most likely to be laboratories
with core requirements. However, the monograph also gives advice if the risk
assessment determines that heightened control measures or maximum containment
measures are needed. Information on decommissioning a laboratory is also provided.
xv
xvi LABORATORY DESIGN AND MAINTENANCE
1
INTRODUCTION
SECTION
1
1.1 Laboratory design features
When designing a laboratory, determining the biological, radiological and chemical
hazards, the type of work to be performed and the implementation of risk control
measures are fundamental considerations. In order to determine how the work can
be performed safely and effectively, a risk assessment and a needs assessment must
be completed to assess the types of laboratory activities planned. While much of the
facility design will be dictated by the placement of the equipment and systems required
to perform laboratory procedures, biosafety and biosecurity must be considered when
selecting the facility design and its features. This section provides an overview of the
facility design features that are necessary for building and operating laboratories that
best facilitate and fulfil biosafety requirements.
Section 2 covers the design features for core requirement laboratories that must
be incorporated in all laboratories. For laboratories where a risk assessment has
determined that heightened control measures are required for some laboratory
processes, additional risk control measures, design features or modifications may be
necessary to maintain a safe working environment. These additional considerations
are described in section 3. Where the risk assessment indicates maximum containment
measures are required, the design features are outlined in section 4.
1.2 Risk assessment and needs assessment

Biological laboratories must be designed, constructed, operated and maintained to
fulfil their intended role and to keep laboratory personnel, the environment and the
wider community safe from the risks associated with handling biological agents.
The information in this monograph on laboratory design and maintenance is designed

to accompany and support the fourth edition of the WHO Laboratory biosafety
manual (1) (core document) and other associated monographs. The manual and the
monographs adopt a risk- and evidence-based approach to biosafety rather than a
prescriptive approach to ensure that laboratory facilities, safety equipment and work
practices are locally relevant, proportionate to needs and sustainable.
2 LABORATORY DESIGN AND MAINTENANCE
The other associated monographs provide detailed information and help implement
systems and strategies on the following specialized topics: risk assessment (2),
biological safety cabinets and other primary containment devices (3), personal
protective equipment (4), decontamination and waste management (5), biosafety
programme management (6) and outbreak preparedness and resilience (7).
When building a new laboratory, or repurposing or renovating an existing laboratory,

those responsible for the ownership and management of the laboratory must
determine how to manage biological and chemical hazards by the implementation
of risk control strategies; which should then drive the planning and design of the
facility. To accomplish this goal, before starting the design process for the construction,
repurposing or renovation, a thorough risk assessment is required to identify the
hazards and decide the risk control measures that need to be incorporated into the
design. A needs assessment should also be performed to define any other laboratory
design features required to reduce the risks or facilitate needed functions.
The likelihood of an incident (such as an exposure to and/or release of a biological

agent) and the severity of the consequences are analysed in the risk assessment.
This risk assessment must consider, for example, the biological agents to be handled,
procedures to be performed and the workflow of the procedures (including specimens,
personnel, consumables, waste).
Depending on the type and magnitude of risk identified, core requirements,

heightened control measures or maximum containment measures may be necessary
to control the biological risks. More information on conducting risk assessments can
be found in section 2 of the fourth edition of the WHO Laboratory biosafety manual (1)
and in Monograph: risk assessment (2). The risk assessment monograph provides risk
assessment templates to help support and justify decisions on laboratory requirements.
The necessary risk control measures and design features that are identified should
be the basis for design professionals to plan the design, construction, repurposing or
renovation of the laboratory. Sections 5 to 10 outline basic principles of the phases
of laboratory construction projects, including performing the initial risk assessment,
typical design stages, and construction, commissioning, operation and maintenance of
a new, repurposed or renovated facility.
3
DESIGN CONSIDERATIONS -
SECTION
2 CORE REQUIREMENTS
2.1 Facility space
2.1.1 Laboratory floor space
The planning phase of laboratory design is the most important step in ensuring the
site of the laboratory has enough floor space for the intended laboratory activities.
Adequate movement and working space are important considerations in any
laboratory facility. The space must be sufficient to accommodate all the required
design features of a core laboratory, including hand-washing basins, benches, sinks
and worktops as well as equipment such as refrigerators and freezers. Furthermore,
the workflow associated with laboratory processes (number of specimens, personnel,
waste) must be considered at the start of any design process. In addition, the space
to house all the furnishings and equipment, including ancillary and mobile equipment,
and accommodate all personnel must be considered. Furthermore, the floor space
allocated must be adequate for the laboratory activity to be conducted safely. When
considering the allocation of floor space, the following conditions must be met.
n The laboratory activities can be performed safely, efficiently and ergonomically.
n The normal movement of personnel, specimens, materials and waste can be

performed safely without disturbing or affecting ongoing work in laboratories.
n In case of an emergency, there is sufficient space for personnel to move quickly, or be

assisted, carried or even dragged if illness or injury has occurred.
n Hidden spaces or surfaces, such as behind or underneath furniture and equipment,

can be accessed for maintenance, cleaning and decontamination.
n There is adequate space and access for any necessary safety equipment, such as
isolation switches, fire extinguishers and safety showers.
2.1.2 Corridors and doors
Corridors, doors and laboratories must be of sufficient width to allow easy delivery,
removal and replacement of laboratory equipment. Ensure mandatory requirements
are in place for emergency exit and for access by emergency services by designing
corridors, doors and laboratories of a minimum width – wide enough for the planned
laboratory operations (for example, for big trolleys, if used) and compliant with any
national regulations.
These corridors and exits must be kept clear at all times to allow emergency exit; they
must not be used as storage locations. Similarly, do not use technical areas and plant
rooms (for example, wastewater treatment areas) as extra storage areas.
2.1.3 Floor space for other facilities
Floor space must be allocated for additional facilities for personnel use, such as toilets/
bathrooms, eating/drinking areas and office facilities. This space must be located
outside of the working space of the core requirement laboratory. Spaces for personnel
to leave and store personal items, outer garments (coats) and clean laboratory coats
must be provided.
2.2 Storage
2.2.1 Consumables and reagents
Sufficient floor space and/or shelving must be available to house consumables and
reagents safely and securely in the long and short term. To prevent clutter, bench tops,
shelves and aisles must not be used to hold supplies other than those for immediate use.
Long-term storage spaces outside of the laboratory should be provided. Pest control
measures should be taken based on the local circumstances to protect consumables
and reagents.
2.2.2 Chemicals
Specialized storage cabinets need to be available for hazardous reagents and

chemicals, such as those with flammable, oxidizing or corrosive properties. Space for
emergency supplies such as eye washes, first-aid materials and biological or chemical
spill kits must also be provided and be appropriately located.
SECTION 2 DESIGN CONSIDERATIONS - CORE REQUIREMENTS 5
2.2.3 Specimens
Specimen storage may require large amounts of refrigerator or freezer space

within the facility. Electrical supplies to refrigerators and freezers, their resilience to
interruption, the likely additional heat gain as well as temperature monitoring of
these devices and associated alarms need to be taken into consideration. Physical
security of specimens may also need to be considered depending on associated
biosecurity requirements, any mandatory legislative requirements and a biosecurity
risk assessment.
2.2.4 Waste
Enough floor space must be provided to enable safe and secure storage of waste
before it is decontaminated or transported for disposal. Space must also be provided
to facilitate waste movement, which may include the use of trolleys or the loading of
waste disposal trucks; therefore, doorways and corridors must be sufficiently wide to
accommodate these needs.
The location of waste and/or waste decontamination units (such as autoclaves) must
be considered so that odour and excessive heat generated do not affect other areas
or personnel in the laboratory. Where an incinerator is available onsite or where
waste is collected and disposed off-site, consideration needs to be given to necessary
segregation, secure storage and, importantly, custody of any sensitive or infectious
waste before decontamination, destruction or final disposal. Further information
on waste disposal can be found in Monograph: decontamination and waste
management (5).
2.3 Surfaces and finishes
2.3.1 Walls and floors
n Walls and floors must be smooth and continuous surfaces. This may require the use
of coving, whereby curved edges (rather than corners or crevices) are introduced
using mouldings between the floor and walls, and, where needed, between walls
and walls or walls and the ceiling.
n Materials used for walls and floors must be easy to clean, and impermeable and
resistant to the chemicals and disinfectants used in the laboratory. For example, vinyl
or linoleum are suitable materials for floors.
n If used, tilework must be sealed to avoid dirt and other contaminants accumulating
in the grouting and seams.
n Floors must be of sufficient load-bearing capacity to hold the furnishings, equipment

and personnel. They should also keep the risk of slipping low in normal use.
n Walls must be solid and properly finished according to function. For example, wall
protection may be required to prevent damage by trolleys, or splash backs may
need to be placed behind sinks and hand-washing basins.
n Floor drains in the laboratory must include grills or water traps to prevent insects,
rodents or other vermin entering.
2.3.2 Windows
n Windows should normally be sealed but may be openable when the laboratory is
designed to be naturally ventilated.
n If openable, they must be designed to prevent insects or vermin entering the

laboratory, and they should be lockable.
n Openable windows should be easily operated and remain easily accessible to

facilitate opening and closing as needed.
n Natural ventilation design should avoid strong air movements and draughts that
might interfere with the proper functioning of equipment.
2.3.3 Doors
n Doors to the core requirements laboratory must be lockable and must have a vision
panel to see into the laboratory. Internal laboratory doors must be fitted with vision
panels so that workers are visible and to prevent collisions.
n Doors must be compliant with applicable building regulations (for example, fire
ratings), should preferably be self-closing, and wide enough to move equipment,
materials or waste easily.
n Doors should be appropriately labelled. At a minimum they should have:
- the international biohazard symbols where biohazardous materials are handled

or stored,
- the contact details of the responsible person for the laboratory, in case of an
emergency, and
- an indication that access to the area is restricted.
n External doors and windows should be secured against the entry of pests and
wildlife based on the local circumstances.
2.4 Furniture
Consider the following specifications for furniture in the laboratory.
n Furniture must be easily cleanable, appropriate (in size and function) and sufficiently
robust to withstand planned use.
n Furniture must not include any fabric surfaces which may absorb and hold
contaminants.
n Furniture on lockable wheels can be easily moved, allowing easy access for cleaning
and/or decontamination.
n Furniture with ergonomic adjustment features allows for comfort while working and
can help reduce the possibility of incidents/accidents.
n Curtains and blinds with absorbent surfaces must not be used as they may
accumulate dust and are not easily cleaned if material is spilled on or near them.
n Carpets and rugs must not be used including carpet tiles.
Consider the following specifications for bench tops.
n Bench tops must be impervious to water and resistant to heat and the chemicals
and disinfectants that may be used in the laboratory, for example, acids, alkalis and
organic solvents.
n Wood, tile, metal, concrete or painted bench tops are acceptable if they are
appropriately sealed so that they are easily cleanable and resistant to the chemicals
used in the laboratory.
n Bench tops should have curved edges wherever possible for easy cleaning.
2.5 Facilities and systems
2.5.1 Hand washing
Hand-washing facilities must be provided in each room of the laboratory where

procedures, including waste handling, are performed. These facilities should be
located as close as possible to the exit door. This area should be dedicated to hand
washing only and kept separate from any sinks where chemicals or contaminated
liquids are processed. Running water must be available, preferably operated by
a hands-free mechanism (elbow, wrist, knee or foot). Soap (in dispensers), or an
equivalent product, must also be provided. Provision of dermatological products such
as hand lotions/moisturizers should be considered.
2.5.2 Electrical supplies
Electrical supplies must be of sufficient capacity and reliability for safe and effective
operation of all electrical and electronic devices. These supplies include cabling, fuses
and outlets, which must be earthed to prevent shocks in case of malfunction. The
electrical supply must be sufficiently stable to sustain the laboratory equipment used.
Where necessary or recommended, installation of an uninterruptable power supply
system or stabilizers may be considered to minimize voltage spikes and to reduce
interruptions to the electrical supply. In some cases, an electrical generator may also
be needed where interruption happens frequently. Electrical supplies should be placed
away from wet processes and in accordance with local electrical safety requirements.
2.5.3 Lighting
Lighting must be adequate for all activities. The specific lighting needs may vary for
different areas of the laboratory. Therefore, the lighting requirements of procedures
should be assessed so that those needing more light (or low light levels) can be
appropriately lit (or shaded) using artificial means, while using natural daylight
wherever possible to save energy. Undesirable shadows, reflections and glare
should be avoided. The direction of light sources must be designed so that personnel
can avoid working in their own shadow. Emergency lighting needs to be bright
enough and available long enough to ensure safe exit from the laboratory and also
containment of the current work if the situation allows. It is also important to consider
glare from daylight through windows as well as undesirable solar heat gain.
2.5.4 Environmental controls
Environmental controls, including comfort cooling and/or heating systems (to provide
a comfortable temperature) and air conditioning (to control of the condition of the
air), may be necessary as a temperature and/or humidity control measure to ensure a
comfortable working environment for personnel to perform their tasks safely and with
optimal efficiency.
These systems should be selected, designed and installed in such a way as to avoid
undesirable airflow or turbulence on and around working surfaces. Care should
be taken when installing supplementary wall mounted comfort cooling systems or
adding ceiling fans and/or using fixed and oscillating desk or pillar fans which can
produce high velocity and turbulent airflows as such airflows often conflict directly with
biosafety needs.
2.5.5 Safety systems
Safety systems are dictated by the needs assessment and must comply with
government regulations and/or applicable building regulations. Installation of safety
systems for fire, including fire alarms, and for laboratory gases, where applicable,
must be considered.
2.6 Laboratory equipment

Many specialized tools and items of equipment are required to carry out modern
laboratory processes and operations. The space required to accommodate this
equipment and necessary utilities (such as water, electricity, gas, drainage, telephones)
should be considered during the early stages of the laboratory design. This planning
is necessary to ensure that adequate floor space is provided for safe use of the
equipment. The space required for effective equipment cleaning, decontamination
and maintenance must also be considered. In addition, sufficient space along the
route needed for the initial delivery of the equipment to the facility and/or its final
removal from the facility must be ensured. The manufacturer’s instructions for the
positioning of each piece of equipment must always be followed before incorporating
it into the laboratory design so that it can be operated safely.
Where high heat loads or airflows are emitted, supplementary systems to facilitate
cooling and/or heat removal should be considered. Equipment producing high
airflows should be sited with due consideration to equipment and work that may be
sensitive to room airflows, for example, open bench work.
11
SECTION
3 HEIGHTENED CONTROL
MEASURES
3.1 Selecting heightened control measures

When selecting laboratory risk control measures, national regulations and guidelines
must always be consulted first to ensure compliance.
For most laboratory activities, the likelihood of exposure to and/or release of a

biological agent is rare or unlikely, with a negligible to minor severity of consequences.
Such activities do not need added risk control measures beyond the core requirements.
Where the risk assessment for laboratory activities indicates a higher risk, the
laboratory design needs to consider heightened control measures in addition to
the core requirements to ensure a safe working environment. Information on and
templates for risk assessments can be found in Monograph: risk assessment (2).
The heightened control measures implemented should be appropriate and sufficient

to reduce the specific risks that contribute to the likelihood and/or consequence of an
exposure and/or release. For example, a procedure with an aerosol risk should have
a risk control measure that is effective in reducing aerosol exposure to the person
performing the procedure and other laboratory personnel and/or the environment. For
this reason, the most appropriate heightened control measure will vary considerably
depending on the biological agents being handled, laboratory activities being
performed and potential transmission routes. Heightened control measures will have
advantages and disadvantages that must be carefully evaluated when selecting the
appropriate ones to bring risks to acceptable risks. Where the risks evaluated are
considered high, cost–benefit analyses should be performed to assess options such as
outsourcing the work. In addition, a detailed evaluation should be made of heightened
control measures that could be implemented to improve the laboratory facility. The risk
control measures chosen will be most effective when they are selected to meet local
needs and have been adapted to meet the local availability of equipment, materials
and skills.
Usually, heightened control measures should be selected based on a risk assessment

and the available evidence of their effectiveness, either through peer-reviewed
studies or other reliable sources of information. Where reliable information does not
exist, in-house validation of risk control measures may be required. Where applicable,
publishing in-house validation studies in peer-reviewed journals should be considered
so that others can benefit from the conclusions of such studies.
This information includes new data, previous incidents and the effectiveness of
the risk control measures. More information on heightened control measures
can be found in section 4 of the fourth edition of the WHO Laboratory biosafety
manual (1).
Where heightened control measures are applied, it is important to reassess the

residual risk after the risk control measure is selected and estimate whether this
measure has effectively bought the residual risk to an acceptable risk.
3.2 Additional separation and design features

Laboratory activities for which a risk assessment suggests the need for heightened
control measures may require greater separation from more populated areas
to reduce the risk of exposure to and/or release of a biological agent. Different
facility design features and techniques may need be used to achieve this additional
separation.
3.2.1 Site selection
During the laboratory planning process, it is essential to consider the physical location
of the laboratory build site.
Where the laboratory is part of a larger facility, such as a hospital, or an academic

or research institution, the build site of the laboratory may be in a separate building.
If a separate building is not possible, then the laboratory may be in an area located
behind or away from common walkways between other rooms or buildings of the
facility.
Where the laboratory must share a building with other departments or faculties,
consider placing the laboratory at the end of a corridor with no onward access, and/
or constructing wall(s) and/or doors to separate the laboratory from unrestricted
areas of traffic.
Where specific procedures are being conducted within the laboratory, physical
separation may also be achieved by building additional rooms or by incorporating a
primary containment device (such as a BSC) into the laboratory design. In addition,
separating the heating ventilation and air conditioning system could be considered.
SECTION 3 DESIGN CONSIDERATIONS - HEIGHTENED CONTROL MEASURES 13
3.2.2 Anterooms
An anteroom is an intermediary room used to create an additional layer of separation

and safety between the heightened control measures laboratory and outside rooms
or the general laboratory. Anterooms are commonly used as a changing area,
where laboratory coats and other PPE that are to be used inside the laboratory are
put on. This room provides personnel with a place to remove and store personal
clothing before putting on the dedicated laboratory clothing that may be potentially
contaminated once in the laboratory. Laboratory clothing must be stored separately
from personal clothing. The anteroom may also be used to house a hand-washing sink
and as a storage room for the laboratory.
In rare cases, where considerable aerosol generation in the laboratory is expected, the
anteroom can act as part of a pressure cascade to prevent any backflow of air. For
more information on pressure differentials, refer to subsection 3.4.
Anteroom doors should normally be opened one door at a time so that both the outer
and inner doors are never open at the same time, with the inner door opening into the
laboratory space. This sequential opening may be specified as a required procedure
that all personnel must adhere to. Alternatively, an electronic interlocking system can
be installed. In this case, it is important to consider emergency escape procedures,
should this automated system fail. Self-closing doors may also be helpful.
3.2.3 Controlled access systems
In addition to physical segregation, control devices should be considered to ensure

that only appropriately trained and authorized personnel can access the laboratory.
Controlled access systems will also address biosecurity concerns.
Controlled access systems vary in method and complexity. Generally, the simpler the
controlled access system, the more likely it is to be used and maintained effectively.
Examples of controlled access systems that may be used in the facility design include
non-reproducible keys, card pass readers, access code key pads or a reception and/
or security desk.
It is important to note that any controlled access system must also have an
appropriate monitoring and management system if they are to be used effectively.
Procedures must be in place for detection and follow-up of failures, accidents or
breaches. As the need for heightened control measures increases, it is important
to ensure that the access systems log both entry to and exit from the facility, and
are designed to allow entry and exit of only one person at a time to prevent
unauthorized access.
3.2.4 Additional design features
Some types of heightened control measures that could be included in a laboratory

design are outlined below. It should be noted that the list is not definitive and simply
offers some insight into possible measures.
n Windows in a laboratory with heightened control measures should be closed and

sealed.
n Where gaseous disinfection (fumigation) is selected as a heightened control measure

for decontamination, the airtightness of the laboratory room or space will need to
be enhanced. This enhancement can be achieved by sealing all surfaces and/or
laboratory penetrations (passageways in the wall, floor, ceiling or other surface) to
prevent the escape of hazardous gases.
n The laboratory exhaust airstream should be designed to discharge in a way that

reduces the likelihood that any people, animals and/or the outside environment will be
exposed to the exhaust air; for example, by discharging exhausts away from air intake
vents. Alternatively, or additionally, exhaust air can be filtered before exhausting.
n Provide sufficient space for the onsite treatment of laboratory waste, or provide
dedicated secure storage for laboratory waste until it can be transported off-site for
decontamination.
3.3 Laboratory equipment

The following safeguards may need to be considered for the equipment being used
during the laboratory procedures:
n fitting additional containment accessories to the equipment, for example, safety

buckets or containment rotors in centrifuges;
n using additional safety features on equipment, such as automatic shutdown on

centrifuges or bead beaters;
n dedicating equipment (in dedicated rooms) for use only for tasks with infectious
material to avoid cross-contamination; and
n using additional, dedicated safety equipment to protect against infectious aerosols.
The most commonly used engineering control for limiting aerosol risks is a primary
containment device, for example, a BSC. In addition to reducing exposure to aerosols,
these devices also act to isolate aerosol-generating work or equipment from other
areas of the laboratory.
Different types of BSCs are available. Other non-standard designs of primary

containment devices have come into use for several reasons, including cost, portability
and requirements for a customized design.
Workflow steps where there is a risk of generating aerosols are often conducted inside
a BSC (or other primary containment device) that is held at a pressure lower than the
laboratory space (negative pressure). In open-fronted devices, this pressure difference
causes air to be drawn into the front opening in a laminar flow and at a velocity which
will normally prevent the release of most of an aerosol from the cabinet, assuming
correct use. Air is passed through a series of HEPA filters and then exhausted back
into the room or to the outside atmosphere depending on the type of cabinet and
installation arrangement. In order to provide protection to the user of the BSC, other
laboratory personnel and the wider environment, the BSC must be:
n set up and used correctly,
n in good working order, and
n certified or validated and the certification must be up to date.
The protection factor of the safety cabinet must not be compromised by room airflows,
including those generated by supplementary ventilation and cooling systems, other
machinery or movement (for example, of people or the use of laboratory doors).
More information on the types, functions and uses of BSCs and other containment
devices can be found in Monograph: biological safety cabinets and other primary
containment devices (3).
3.4 Directional airflow and inward airflow

Where a risk assessment determines that a risk of exposure to aerosols exists,
directional airflow or a pressure cascade may be used to protect against aerosols
containing biological agents and direct them away from people or objects that may
otherwise become exposed. Directional airflow at the equipment level is commonly
used by primary containment devices, such as BSCs. With an open-fronted device
(for example, Class I and II BSC), the effect on the surrounding area of a BSC is called
inward airflow. All workflow steps where a risk of aerosol generation is present must
be conducted inside the BSC. In very rare situations, where aerosol generation occurs
outside BSCs, a pressure cascade or directional airflow at the room level may be
required.
3.4.1 HEPA filters
HEPA filters capable of trapping microorganisms are integrated in risk control

measures (8); for example, in BSCs. These filters ensure filtration of air to remove
biological agents and support product protection (that is protection from
contamination of the specimen or material handled). When a facility has HEPA
filtration on either a direct/exhaust air distribution system or a passive system (air
transfer ports, pressure differential lines) in a laboratory using heightened control
measures, the laboratory designer should consider the needs for maintenance, testing,
validation, decontamination and access when deciding on a location for the HEPA
filter(s) and housing.
3.5 Waste disposal

When incorporating decontamination and waste management into facility design,
it is important to ensure sufficient space for waste storage, movement and/or
decontamination systems such as autoclaves. Further information on waste disposal
can be found in Monograph: decontamination and waste management (5).
The movement of contaminated waste should be kept to a minimum, especially

when the risks associated with handling waste from biological agents increase, either
because the biological agents have more severe consequences or the likelihood of
exposure increases. When the risks of handling contaminated waste are high, barrier
type decontamination systems (double-ended autoclaves) may be needed, and even
incinerators. Note that national or international regulations and standards may require
local decontamination of potentially infectious waste.
Enhanced autoclave functions include double-ended machines with hermetic barriers

and special programmes, cycles and test functions. Where such enhanced functions
are indicated by the risk assessment, it is essential to ensure that these functions are
specified in detail in the user requirement specification. In addition, care must be
taken in the formal process of qualification and validation, including all necessary and
rigorous factory testing together with onsite acceptance and performance testing.
In a small number of cases, and in line with the risk assessment, a dedicated liquid
disposal sink and drain may be required for liquid waste in order to prevent the
release of potentially contaminated liquid waste outside the laboratory. Alternatively,
an effluent decontamination system can be used for larger volumes where high-
risk liquids cannot practically be collected and treated in small volumes. An effluent
decontamination system helps decontaminate potentially contaminated liquids using
either heat or chemical treatment before disposal into a sink or public sewer system.
Heat decontamination is usually more expensive to install and maintain. However, the
effectiveness of chemical decontamination may be difficult to monitor, and corrosion
of the drains or tanks is common. Decontamination may be done immediately, as the
liquid enters the system, or the liquid may be collected and stored in specialized tanks
and then decontaminated in bulk before disposal into normal waste systems. Devices
to prevent backflow, including deep seal syphons, which take into consideration
pressure cascades and ventilation systems, may also be used to prevent any
contaminated liquids, aerosols, vapours or chemicals from moving back up the drain.
3.6 Laboratory emergency response

Introducing additional segregation, separation and access controls to the facility
design can also result in barriers and challenges to emergency response to deal with
adverse events that may occur. The installation of systems that allow monitoring of the
safety of the personnel working inside should be considered. As with controlled access
systems, these systems should be complemented by procedural controls to ensure that
monitoring is effective and emergency responses are initiated when necessary.
An emergency escape route from inner segregated areas must be established and
communicated to personnel to enable them to use it effectively. If electronically
controlled access systems are used, contingencies for emergency response must be
considered in case the access system fails; for example, if there is power failure. In
case of a medical emergency, personnel inside the facility must be able to call for
help. Emergency systems, and associated monitoring and response procedures, are
particularly important if a laboratory allows personnel to work alone.
The medical emergency response team (onsite or external) should be informed about
the risks of the biological agents that are handled in the laboratory and the medical
equipment that is accessible close to the laboratory. Furthermore, the response team
must be instructed on the emergency entry and exit routes and procedures to be taken
in case of a medical emergency.
19
SECTION
4 MAXIMUM CONTAINMENT
MEASURES
For the majority of laboratory activities, laboratory facilities will be designed to perform work safely under
core requirements, or with certain heightened control measures in accordance with the risk assessment.
However, in exceptional circumstances, a facility designed with maximum containment measures will be
required to control the highest risks. These high risks arise from work with biological agents that have severe
consequences and when there is a high likelihood of exposure to and/or release of these biological agents.
It is important to understand that laboratories requiring maximum containment measures are very expensive
to plan, design and build. They are also very expensive to operate and maintain. The high-risk operations
often mean these laboratories will fall under national regulations and oversight mechanisms for biosafety
and biosecurity. This means special permits or approvals must be sought even before starting the planning
process for such a laboratory. These facilities require a very high level of technical expertise and experience,
not only for their planning, design and construction, but also for their operation and maintenance. It is
essential before starting such a project to ensure that trained and experienced personnel are available for
all aspects of the project, including the design, construction, operation and maintenance. For these reasons,
before building a maximum containment facility, other options for the work must be considered such as the
use of an alternative biological agent or procedure where possible, or the outsourcing of work to another
appropriate facility.
The following information on facilities with maximum containment measures is not

exhaustive and is intended only as introductory material. Before such a laboratory
is constructed and put into operation, intensive consultations should be held with
national authorities, biosafety experts and other institutions that have had experience in
operating similar facilities to determine the exact design specifications.
4.1 Additional separation and design features

Facilities with maximum containment measures are designed around the use of primary containment
systems within which all procedures with biological agents are performed. The intention of risk control
measures used in laboratories requiring maximum containment measures is to place

an impermeable physical barrier (provided by a full body suit or by a Class III BSC)
between the laboratory personnel undertaking the work and the biological agent
which they may otherwise be exposed to while performing that work. Two main
systems are currently used in laboratories with maximum containment measures.
These systems are the so-called cabinet line laboratory and suit laboratory.
4.1.1 Cabinet line laboratory
A cabinet line laboratory is one where work is performed using more than one Class
III BSC or isolator acting as a sealed primary containment device. The cabinets or
isolators are interconnected in a cabinet line configuration which is used to house all
the laboratory equipment and working space required. Secure access to controlled
inner and outer changing rooms is required for entry and exit to the laboratory, with
personnel making a complete change of clothing on entering and exiting the room
containing the cabinet line. A minimum passage through two interlocking doors must
exist, forming an additional anteroom/airlock, before entering the rooms containing
the BSCs or isolators (cabinet room). A shower room is situated between the changing
areas which should be used on each exit or in the event of emergencies depending on
the risk assessment.
Supplies and materials brought into the cabinet line must be introduced through an
integral double-door, pass-through autoclave, dunk tank or fumigation chamber.
Once the outer door of the transfer device is securely closed, personnel inside the
laboratory can open the inner door to bring the materials into the cabinet line.
The doors of the autoclave or fumigation chamber should also be interlocked in
such a way that the outer door cannot open again (after the inner door has been
opened) unless the autoclave has been operated through a sterilization cycle or the
decontamination chamber has been successfully decontaminated.
4.1.2 Suit laboratory
A suit laboratory for work with biological agents requires personnel to first put on a
one-piece, positive-pressure protective suit complete with a separate breathing air
supply, which is fully isolated from the room air. The breathing air system must provide
adequate airflow and pressure to meet the manufacturer’s specifications for the suits.
Furthermore, the quality of the air must be monitored continuously for toxic gases and
annually for several other contaminants.
The breathing air system must be equipped with a back-up system (typically bottled
air or large reservoirs of compressed air with a fail-safe connection to the breathing
air line) to allow for a safe exit from the laboratory should the primary breathing air
system be compromised. A decontamination shower in an airlock is also needed for
safe exit from the suit laboratory before removal of the suit.
SECTION 4 DESIGN CONSIDERATIONS - MAXIMUM CONTAINMENT MEASURES 21
As with a cabinet line laboratory, there must be effective systems to allow for the safe
introduction of materials and specimens into the laboratory. Again, this can be through
double-ended autoclaves, dunk tanks and fumigation chambers.
4.2 Controlled access

The laboratory using maximum containment measures must be in a separate building
or in a clearly delineated zone within a secure building. Entry and exit of personnel
and supplies must be through an airlock or pass-through system. On entering,
personnel must put on a complete change of clothing. Before leaving, they should
remove the laboratory clothing and take a full body shower before putting on their
personal clothing.
4.3 Directional airflow

Negative pressure must be maintained inside the facility. Both supply and exhaust
air must be HEPA-filtered. All protective HEPA filters need to be tested and certified
annually. The HEPA filter housings may be designed to allow the filter to be
decontaminated in place before removal. Alternatively, the filter can be removed
in a sealed, gas-tight primary container for subsequent decontamination and/or
destruction by incineration.
There are significant differences in the ventilating systems of the cabinet line laboratory
and suit laboratory:
4.3.1 Cabinet line laboratory
n The laboratory room must be maintained at negative pressure supported by a

pressure cascade through the entrance rooms and anterooms. There must be
a dedicated system with alarms and monitoring covering all critical system and
operating conditions.
n The laboratory ventilation must have HEPA filtration of both the supply and exhaust
air (normally double HEPA).
n Redundant exhaust fans are required to provide a back-up to ensure that the facility
remains under negative pressure at all times even in the event of an exhaust fan failure.
The supply and extract systems must be interlocked to prevent over-pressurization.
n The cabinet line must be operated at negative pressure to the surrounding

laboratory at all times.
n The supply air to the cabinet line may be drawn from within the room through a
HEPA filter mounted on the cabinet or supplied directly through the supply air system
(but always through a HEPA filter).
n Exhaust air from the cabinet line must pass through a minimum of two HEPA filters
before release outdoors.
The containment system must have adequate back-up systems to ensure maintenance
of negative pressure under foreseeable failure conditions.
4.3.2 Suit laboratory
n Dedicated room air supply and exhaust systems are required. The supply and
exhaust components of the ventilating system are balanced to provide directional
airflow within the suit area from the area of least risk to the area(s) of greatest risk.
n Redundant exhaust fans are required to provide a back-up, thereby ensuring that
the facility remains under negative pressure at all times even in the event of an
exhaust fan failure. There should also be redundancy within the power supply to the
facility to ensure continuous operation.
n All critical ventilation, pressure differential, life safety and operational systems must
be continually monitored and have alarms. An appropriate system of controls must
be used to prevent positive pressurization of the suit laboratory.
n HEPA-filtered supply air must be provided to the suit area, decontamination shower
and decontamination airlocks or chambers. The exhaust air from these areas must
be passed through two HEPA filters in series before release outdoors.
n Exhaust air from the suit laboratory must be passed through two HEPA filters in series
before release outdoors. Alternatively, after double HEPA filtration, exhaust air may
be recirculated, but only within the suit laboratory.
n Under no circumstances should the exhaust air from the maximum containment suit
laboratory be recirculated to other areas. Great care must be taken if air within the
suit laboratory is to be recirculated.
n The build-up of chemical fumes from disinfectants and other activities must be taken
into account if considering any recirculation of air. The possible impact to animal
rooms on recirculation of air must also be considered.
n The protective suits will require a dedicated, breathing air system, with multiple
layers of redundancy to ensure personnel safety all times.
SECTION 4 DESIGN CONSIDERATIONS - MAXIMUM CONTAINMENT MEASURES 23
All protective HEPA filters need to be tested and certified annually. The HEPA filter
housings may be designed to allow the filter to be decontaminated in place before
removal. Alternatively, the filter can be removed in a sealed, gas-tight primary
container for subsequent decontamination and/or destruction by incineration.
4.4 Waste disposal

The objective of maximum containment measures is to maintain at all times a physical,
impermeable barrier between the biological agent and the laboratory personnel, and
the wider community and environment. This objective applies from initial specimen
receipt through to final decontamination and disposal. Waste disposal requirements
will vary from facility to facility, but it is widely acknowledged that no waste must leave
the laboratory unless having first been fully decontaminated. The risk assessment also
helps to identify the most suitable decontamination method.
All liquid waste (effluents) from the suit area, autoclave, decontamination chamber,
decontamination shower and cabinet line must be decontaminated before discharge.
Heat treatment is the preferred method since it can be validated more consistently and
reliably than chemical treatment. Effluents may also require adjustment to a neutral
pH and temperature reduction before discharge. Backflow prevention mechanisms
should be installed in all effluent drains as well as deep siphons to prevent backflow of
air and aerosols. These siphons should be deep to cope with normal pressure and loss
of negative pressure in the room. As with room ventilation, HEPA-protected drainage
vents will require two HEPA or equivalent filters in series to prevent release of drainage
vapours and aerosols to atmosphere. Depending on the results of the risk assessment,
water from personal showers and toilets in the outer changing area, which are outside
the containment measures, may be discharged directly to the sewer system without
treatment. The personal hygiene shower in the cabinet line facility may be treated in
an effluent treatment plant depending on the risk assessment.
A double-door, pass-through autoclave must be available in the laboratory area

for decontamination of laboratory materials, equipment and solid waste. Other
methods of decontamination must be available for equipment and items that cannot
withstand steam sterilization. These other methods include gaseous decontamination
(such as hydrogen peroxide or formaldehyde) or chemical decontamination in a
barrier dunk tank.
4.5 Laboratory emergency response

No individual should work alone and unattended in facilities with maximum
containment measures. Working in laboratories using maximum containment
measures relies on a buddy system where pairs of individuals enter and leave the
facility together. This system allows each individual to check the protective equipment
of their partner and that protection systems are correctly used. Personnel working in
the laboratory should be visually monitored at all times. Therefore, the facility must
be equipped with well-designed vision panels allowing a full and clear view of all
spaces at all times. Where this cannot be achieved by windows alone, a combination
of mirrors and/or video surveillance may be used.
As restricted entry controls may be numerous, emergency extraction of personnel

presents challenges. Therefore, personnel must be trained in emergency extraction
procedures in the event of personnel injury or illness. Protocols for emergency
response procedures must be developed, simulated and practised so that emergency
response personnel can navigate the facility design and controls and deliver an
appropriate response. This protocol should be developed in conjunction with local
authorities, and communication to the emergency response personnel of the risks and
value of life versus biosafety for these situations should be considered.
A method of communication for both routine use and in emergencies must be installed,
so that personnel working within the maximum containment facility and laboratory/
support personnel stationed outside the laboratory can communicate without difficulty.
25
FRAMEWORK OF A
SECTION
5
LABORATORY PROJECT
The process of a typical project to build, renovate or repurpose a laboratory begins with the facility idea or
requirement, proceeds through planning to design, construction, commissioning, operation and maintenance.
While this conceptual framework outlines the typical steps and stages of most laboratory construction
projects, it is a guide only and the framework may vary widely depending on place and time, governance,
procurement methods, markets and many other factors. The steps and stages in the framework are
expanded and illustrated at each main stage in the following sections. Some important elements require
careful attention, especially budgets, personnel and schedules.
Details of the planning, layouts and design requirements adopted for the facility are determined directly by
the risk assessment and needs assessment. Therefore, before the construction, repurposing or renovation
process can begin, a detailed risk assessment must be carried out in order to determine the specific risk
control measures that need to be implemented. In addition, a facility-specific needs assessment is required to
define all other design features needed for the laboratory.
27
PLANNING
SECTION
6
To facilitate the process of planning, designing, constructing, operating and
maintaining a laboratory or facility, it may be useful to use a model approach to help
map out and understand the various stages and activities that are required. Various
models, including nationally recognized systems, exist that outline work stages and
detail the tasks and outputs required at each stage. Those involved in the planning
should identify useful model resources and/or consult their national architect´s
organization and building regulatory agency early in the planning phase.
Planning (Figure 6.1) can be divided into two parts: the pre-planning phase and the
planning phase. The pre-planning phase comprises everything that precedes and
leads up to the start of the project; it includes the initial idea, the identification of need
at the senior level and the agreement to proceed in a particular direction. The main
activity of the planning phase is to bring together a team of relevant experts to perform
a risk assessment and a needs assessment. The risk assessment identifies the need for
risk control measures and indicates if core requirements are enough for the planned
laboratory or if heightened control measures or even maximum containment measures
are advisable. The needs assessment will establish the nature and purpose of the
laboratory and define the details of the work that will be performed there and all the
equipment required.
It is important during the planning phase that realistic costs are determined, and that key
deliverables are established that support project goals and serve as progress milestones.
The following national planning tools were reviewed during the development of this
monograph:
n the Royal Institute of British Architects (RIBA) plan of work – 2013 (9), and
n the American Institute of Architects. AIA Document D200™ – 1995 (10).
Other national systems and concepts exist and can be used as planning tools. In the
absence of a nationally recognized system, one or both of the above-mentioned tools
can be accessed online and are free of charge to use (see references and the further
reading/information section).
Planning phase Identify purpose of the new

or renovated facility
Initial agreement No Stop process
Yes
Select team from internal

personnel and external resource
Check if facility requires

regulatory oversight
Risk assessment:
- gather information Confirm and/or expand team
- evaluate the risks
Review and reconsider
risk assessment
Risk assessment acceptable:
- risk control strategy defined
No
and agreed
- risk control measures selected
Yes
Conduct a detailed
needs assessment

Needs assessment acceptable No
needs assessment
Yes
Formulate user requirement brief

(URB)
URB
No URB agreed
Yes
Establish total cost of project
Agreement to proceed No Stop process
Yes
Draft user requirement

specification (URS)
user requirement specification
No Agree URS
Yes
Develop cost estimates,

agree total budget,
identify time scales,
Review and reconsider cost develop programme,
estimates, total budget, time agree procurement route/s
scales, programme and/or
procurement route
No Agreement to proceed No Stop process
Yes
Proceed to design phase
Figure 6.1 Project flowchart, planning phase

SECTION 6 PLANNING 29
6.1 Planning team

In order to conduct a thorough and effective risk assessment and a comprehensive
needs assessment, a strong team of knowledgeable individuals with experience in
laboratory design, operation and management is needed. The following subsections
outline the people, or groups of people, who are important contributors to the
planning phase of the laboratory project. The number of individuals involved in the
planning process will depend on the size of the project and the complexity of the work
that is to be performed in the laboratory.
The project team will initially include selected members of the organization for which
the facility is being constructed. Construction professionals can be added later and are
often appointed by the organization undertaking the design-related tasks. Afterwards,
the project team may expand further as builders and subcontractors are employed to
carry out the construction and commissioning work.
6.1.1 Senior management or facility owner
The senior management or the facility owner is the authority from a public or private
organization in need of the new, renovated or repurposed laboratory. The senior
management may designate a senior administrator, laboratory director, departmental
head or similar to be its representative. This person is responsible for leading, or
monitoring the effectiveness of, the risk assessment and the associated needs
assessment. This individual is also responsible for managing the formulation of the
user requirement brief and user requirement specifications, and determining and
overseeing the project budget. This person is often referred to as the project sponsor.
6.1.2 Laboratory management and biosafety professionals
The laboratory management includes the people who have thorough and specialist
knowledge of the intended function of and procedures planned in the laboratory. In
many cases, these people are already performing this kind of work in their everyday
jobs. The main responsibility of this group of experts is to perform the risk assessment.
This assessment includes defining: the laboratory activities that will be performed; the
biological agents that will/may be used; the properties of the specimens that will/may
be used; the equipment required; and the workflow of the laboratory activities. The
outcome of the risk assessment will inform the risk control measures needed and the
facility design. For this reason, laboratory management should include experts in the
risk assessment process and implementation of its outcomes. Ideally, individuals who
are familiar with standards/regulations specific to biosafety and laboratories should
also be part of the laboratory management team. Biosafety professionals may be the
most suitable candidates to fill these roles, although other laboratory personnel and
support personnel may be suitable too.
6.1.3 Project manager
The field of architecture and construction can be unfamiliar to scientific and laboratory
personnel. Therefore, a project manager is essential to take on coordinating activities.
The project manager acts as the senior management’s representative, prioritizing the
interests of the management when dealing with the various actors in the design and
construction process, such as the architects, engineers, builders and subcontractors.
The project manager is normally responsible for overseeing and managing all phases
of the project, including procurement, design, construction, installation, commissioning,
handover and operational training of users of the completed laboratory. The project
manager can also support the development of a budget to secure enough funding to
complete the laboratory and put it into operation.
6.1.4 Design team
The design team may be made up of design professionals including architects,

engineers and surveyors. Appointment of the design team can begin during the
planning phase. It is important to engage design professionals with laboratory design
and construction experience. If this is not possible, professionals who have done similar
work to similar standards may be suitable, such as those with experience of hospital
design and construction projects.
6.2 Risk assessment and needs assessment

Once the project team is assembled, the purpose and the functions of the laboratory
must be agreed upon. This part of the process involves considering and listing the
many factors that contribute to the operation of a successful laboratory. It is important
to make this assessment as detailed as possible so that the designs that are developed
are closely aligned with the needs and intended functions of the laboratory. This
assessment will also ensure that the costs of the project are properly justified by the
needs of the laboratory.
Information on performing a risk assessment (Table 6.1), can be found in Monograph:

risk assessment (2). This monograph includes short and long risk assessment templates
and associated guidance.
A needs assessment should consider the following issues (among others).
n Planned purpose of the laboratory; for example, as a diagnostic, research,

pharmaceutical or reference laboratory.
n Requirements for national or international laboratory accreditation/certification or

legislative requirements.
n Reasons for the repurposing/renovation/construction; for example, need for

increased safety measures following the outcome of the risk assessment, or need for
additional space because of an increased number of duties.
n Processes that require rooms; for example, animal work, sterilization work, or work
needing aeration or controlled temperatures.
n Amount of space required, based on, for example, the expected number of
personnel.
n Nature of specimen (organs, liquids, specimen in sealed tubes, microbial culture)

and analysis methods to be used (for example, culture, polymerase chain reaction,
serology) and their related requirements (for example, separate rooms for different
tasks).
n Adjustments required in the specimen workflow; for example, separate specimen

reception or space, and equipment for specimen storage.
n General building regulations; for example, fire alarms or sprinkler systems.
n Adequate availability of utilities; for example, sufficient power supply, water supply,
wastewater treatment and removal, waste discard and similar requirements for
autoclaves.
n Locally available maintenance and service expertise.
n Necessary environmental control systems.
n Personnel facilities; for example, toilets, rooms for breaks, or office spaces separate
from laboratory working spaces.
n Floor space requirements for all physical elements (equipment, personnel, biosafety
controls), for facilitating movement (walkways, hallways), for storage of consumables
and reagents and for additional facilities (toilets, rooms for breaks, offices).
n Technical space for the location of the building engineering services, as well as space
for services to pass between floors in multistorey buildings – riser space.
n What currently exists; for example, laboratories embedded in hospitals, and

comparison with needs assessment.
Table 6.1 Risk control measures needed based on a risk assessment and the related
needs based on a needs assessment for an antibiotic testing laboratory for tuberculosis
CHARACTERISTICS OF THE BIOLOGICAL AGENT

Biological agent(s) Mycobacterium tuberculosis
Expected specimens Sputum, urine, other body fluids or infected tissues
Route of transmission Airborne, percutaneous routes, ingestion, contact/fomites
Infectious dose (ID) ID50 estimated to be < 10 bacilli
Treatment/preventive Effective immunization is not routinely available. Antibiotics

measures are available for post-exposure prophylaxis. Multidrug-
resistant tuberculosis and extensively drug-resistant
tuberculosis strains exist and specimens containing these
strains are expected to be received. Susceptible to 5 000
ppm hypochlorite, 10 minutes exposure time and autoclave at
121 °C for 15 minutes
Pathogenicity Highly transmissible
FACTORS CONSIDERED RISK CONTROL RESULTS OF NEEDS

IN RISK ASSESSMENT MEASURES ASSESSMENT
Laboratory procedures § disinfection § space for specimen
§ specimen receipt and § autoclaving reception including data
recording entry, microscopy, slide
§ PPE
staining, autoclave, storage
§ direct smear microscopy to § sharps container of waste and storage of
detect acid-fast bacilli
§ first-aid kit disinfectant
§ autoclaving and disposal
§ autoclave § power and water supply for
of waste (by external
§ sealed containers for autoclave
contractor)
transport § adequate and correctly
§ decontamination of
located sockets
laboratory after any spills
§ environmental control for
Equipment to be used special storage conditions
§ PPE (personal protective for disinfectant, such as
equipment) (laboratory temperature, humidity
coats, latex gloves) § hooks for laboratory coats
§ Equipment (refrigerator, separate from personal
heat block/flame, clothing, space for laundry
microscope, sharps outside laboratory
container, autoclave) § hand-washing basin for
§ sealed transport container hand hygiene after glove
§ incubator removal and water supply
§ space and workflow for
equipment placement
(autoclave, incubator,
analyser)
§ space for first-aid kit, short-
term waste storage before
and after autoclaving
§ space for cleaning,
disinfection and storage of
transport containers
Table 6.1 Risk control measures needed based on a risk assessment and the related
needs based on a needs assessment for an antibiotic testing laboratory for
tuberculosis (continued)
FACTORS CONSIDERED RISK CONTROL RESULTS OF NEEDS

IN RISK ASSESSMENT MEASURES ASSESSMENT
Other factors that may affect § ensure restricted access § need for system that ensures
laboratory operations only authorized personnel
§ occasional crime in the area have access (such as keys,
key cards)
§ bars to windows on the
ground floor
Potential situations in which § BSC (to process suspected § space, electric supply and
exposure or release could or documented specimens of exhaust for BSC
occur MDR-TB and XDR-TB) § consideration of workflow
§ aerosol exposure to and/or § respiratory protective (for example, avoiding
release of M. tuberculosis equipment placing BSC in high-traffic
from a spill § gloves, gowns and areas)
§ contact with contaminated respiratory protective § space to store respiratory
surfaces equipment when handling protective equipment and
§ improperly treated waste waste and decontaminating other PPE
spills
BSC = biological safety cabinet; MDR-TB = multidrug-resistant tuberculosis; PPE = personal

protective equipment; XDR-TB = extensively drug-resistant tuberculosis
6.3 User requirement brief

Once the risk assessment and needs assessment have been performed, an outline
document should be developed to communicate the outcomes of these assessments
to the designers. This document is the user requirement brief. Further input may
be required by specialists with experience in laboratory design and the planned
laboratory work and processes to help develop the user requirement brief into a more
detailed and comprehensive set of user requirement specifications (discussed in the
subsection 7.1). These specialists can be from within or outside the group for whom the
facility is being designed/constructed. An example of a user requirement brief can be
found in Annex 1.
6.4 Costs
Planning a new facility or the refurbishment or repurposing of an existing facility
normally requires a business case to justify the need for the proposed laboratory
project and to secure the required funding. This business case will be built on the risk
assessment and needs assessment and should demonstrate the benefits that will be
produced by the facility against the estimated cost of building/renovating/repurposing
it. It is fundamental to identify all the anticipated costs that will be incurred during
planning, designing, constructing, commissioning, delivering, operating and
maintaining any new, refurbished or repurposed facility.
These costs include the following:
n cost of the land on which to build (if applicable), and any services and access
improvements required;
n cost of permissions and licencing required for construction to proceed (if

applicable);
n cost of the time of various teams/people required at each of the following stages
- planning
- design
- construction
- training – training required for all laboratory users and technical and
maintenance support personnel (ongoing)
- preparatory (pre-operation) – for example, writing SOPs
- operation – for at least the first 5 years of occupancy and use
- maintenance – including specialists for certification and validation, and for the
first 5 years of occupancy and use;
n materials costs – all the building materials required to construct the building;
n equipment costs – all the equipment required to fit out the laboratory;
n consumables costs – all of the items consumed by the laboratory daily/weekly (for
example, pipettes, gloves, slides, waste bags, reagents, PPE) for the first 5 years;
n training costs – training courses (onsite and off-site) and training placements;
n development costs – development of laboratory policies, standards and guidance,

including SOPs;
n operating costs – costs besides staffing time/costs, that is spare parts and other
consumables (oils, gaskets, filters) for the first 5 years;
n cost of operating the facility including miscellaneous costs (for example, cost of
activities not directly related to the laboratory work such as specimen transportation
or specimen collection) for the first 5 years;
n maintenance costs – above the base level laboratory operating cost, including
planned preventative maintenance and periodic shutdowns as and when required;
n energy and utility costs
- energy and utilities required to construct the facility
- energy and utilities required to operate the facility (ongoing for the first 5 years);
and
n other costs not listed above but which may be specific to the project, country or
region.
It is advisable also to include a contingency allowance in the estimation of costs. This

allowance is a percentage figure added to the total cost to cover unforeseen events
and changes, or anything missed or not fully considered. As the project progresses,
the costs become more certain and the contingency allowance can be reduced
accordingly.
6.5 Time scale

Deciding on a time scale is a complex task and has critical consequences if not
done correctly. For each project activity, a finite time must be allocated, and the risks
and consequences of delays must be evaluated. Developing an initial schedule will
normally be the responsibility of the project manager. This schedule will then be
confirmed or adjusted on appointment of a builder.
Establishing a schedule may be based on a required or fixed end date or, more
realistically, on time blocks with the end date predicated on the start date which is
finalized only once a contract is in place with a builder. Any fixed end date chosen
must be realistic.
Construction contracts once signed will normally be based on an agreed price and
a fixed schedule with a start date and an end date. Changes to these dates will
generally have a financial impact.
However, as the project progresses, small delays will inevitably occur. Delays are
cumulative and consequently the remaining tasks will need to be done in less time
if the end date is to be met. This often has an adverse effect on the installation
quality and on the testing and commissioning activity. Under such time pressure,
the installation and subsequent testing and commissioning activities may be
poorly executed which may undermine the previous work and result in trouble and
danger for the users. It is therefore essential for all laboratory projects to ensure
that the construction schedule is practical and realistic, and includes contingencies
for expenditure and delays. Time allowed for testing and commissioning must be
realistic and strictly defended by the project manager.
6.6 Quality
Quality is of key importance in the design and construction of a laboratory facility.
The quality of design, workmanship and finishing are fundamental elements and
must meet the requirements of the risk assessment, needs assessment and the
articulation of the user requirement brief and user requirement specification. The
quality of the final designs and specifications, the accuracy of the schedule and
budget, and the quality of the project management are all vital components of the
total quality. Quality management should run through the project from beginning
to end. If quality is taken into consideration at all stages of the project, it will help
ensure that the final product meets the required standard.
37
DESIGN
SECTION
7
Once all of the elements of the risk assessment and needs assessment have been fully
considered and defined, a comprehensive list of all the facility’s needs will emerge.
From this list, a user requirement brief (subsection 6.3) and then a user requirement
specification (subsection 7.1) must be developed that communicate to the design team
and subsequent construction team what requirements define the project (Figure 7.1)
Design phase Approval to proceed from

planning to design phase
Seek advice on
procurement routes
available
Choose procurement route
Appoint additional
designers or contractors
Concept design
Revise concept design
No Approve concept design Depending on the nature

of the procurement route,
Yes there may be no design
review or approval stage
Schematic design available
Revise schematic design
No Approve schematic design
Yes
Detailed design
Revise detailed design

Proceed to
No Approve detailed design Yes
construction phase
No
Unacceptable outcome
Stop process
Figure 7.1 Project flowchart, design phase

7.1 User requirement specification

The user requirement specification may be developed by an architect or designer for
small or simple projects or by a larger design team for more complex projects. There
are likely to be several rounds of discussion between the senior management, the
laboratory management, the project manager and the design team to agree on the
most appropriate final user requirement specification to inform the facility design and
layout. Other issues also need to be considered, such as materials to be used, surface
finishes, laboratory furniture, even colour schemes and the appearance of the finished
laboratory. The architect or laboratory designer must be informed of the planned
laboratory workflows so they can understand all required spatial dependencies and so
that any proposed design solutions are tailored to the planned needs of the laboratory.
This can sometimes be facilitated by the design team appointing their own consultant
laboratory professionals in support.
An example of a user requirement specification can be found in Annex 2.
When a final design and layout have been agreed upon, more specific design work
may be necessary for the technical aspects of the facility. Detailed design drawings,
specifications and equipment schedules, and later shop drawings, may be needed
for laboratory furniture, fixtures and fittings, mechanical and electrical components,
static load-bearing components, and plumbing and air conditioning systems, among
others. The finalized designs must consider ergonomics for the laboratory users
in all planned workflows. In addition, careful attention should be paid to ensure
maintenance can be carried out effectively. It is a good idea to obtain an independent
review or peer review at each stage of the design (subsection 7.3.4) and also to carry
out benchmarking. Benchmarking is a way of assessing other existing facilities that
perform the same or similar functions and evaluating and reviewing the risk control
measures they use in order to establish a clear target for the level of quality to be
achieved for the project.
7.1.1 Design review and benchmarking
In order to perform a design review, a consultation process or activity may be

facilitated through national and international professional networks such as biosafety
organizations or through organizational and institutional networks or government
departments, depending on each individual circumstance. For the purpose of
benchmarking, it can be useful to arrange fact-finding visits to reference projects to
exchange experiences, data and knowledge. It is important to share both positive and
negative experiences as well as knowledge, so that valuable lessons can be shared,
similar outcomes can be anticipated and designs adjusted to correct any deficiencies.
Benchmarking must allow an optimized user requirement specification to be reached

that is most functional and cost-effective to meet the requirements informed by the risk
assessment and needs assessment.
SECTION 7 DESIGN 39
7.2 Workflow diagrams

Workflow diagrams are valuable communication tools enabling the laboratory
management and the design team to communicate effectively on a common platform.
They are simplified plans that illustrate the laboratory process steps. Workflow
diagrams change, and several revisions may be needed to achieve an optimum
arrangement that can be used in the final architectural laboratory floorplan, general
arrangement and/or design drawings.
Figure 7.2 gives three examples of workflow diagrams that illustrate layouts for
laboratories requiring core requirements, common heightened control measures, and
more comprehensive heightened control measures.
7.3 Typical project design stages

Depending on the size, scale and complexity of the project, there may be distinct
design stages or these stages may merge. There are many design approaches
and procurement methods, but the following design stages are common to most
procurement routes – although sometimes they are named differently.
7.3.1 Concept design
The concept design (also known as outline design) is the first step in the design
process and gives an impression or vision of the project. It contains the risk control
measures to be included as defined by the risk assessment. The concept design is
the first opportunity for the design team members to study the design and provide
feedback based on their understanding of the needs of the users as articulated in the
user requirement brief or user requirement specification. This design stage helps refine
project cost data and project time scales and can inform stakeholders what to expect of
the planned facility.
7.3.2 Schematic design
During the schematic design (also known as developed or scheme design), the
concept design is developed in more detail. However, the level of detail is still
insufficient to construct the facility. Depending on the chosen procurement route, the
builder could be appointed to complete the detailed design. Costs and time scales are
further refined.
Core requirements Heightened control measures Heightened control measures

laboratory example laboratory example laboratory example
+ BSC + BSC, safety buckets in
centrifuge, second
inactivation step of the
biological agent, autoclave
No handling of 5 4 3 5 4 3 5 4 3
biological agents
Handling of 2 2 2
biological agents BSC BSC
in containment
Open handling of 1 1 1
biological agent 6 6 6
9 9 9
7 8 7 8 7 8
Laboratory Features of the laboratory Features of the laboratory Features of the laboratory
equipment equipment in a core equipment in a heightened equipment in a heightened
requirements laboratory control measures laboratory control measures laboratory
Specimen storage 1 refrigerator 1 refrigerator 1 refrigerator

Workbench 2 open specimen handling 2 no open specimen handling 2 no open specimen handling
Centrifuge 3 normal 3 normal 3 with safety buckets
Heatblock 4 only inactivation method 4 only inactivation method 4 plus second inactivation
method
Sink and drainer 5 preparation of disinfection 5 preparation of disinfection 5 preparation of disinfection
solution solution solution
Biological safety no yes – open specimen yes – open specimen
cabinet handling handling
Processed 6 freezer 6 freezer 6 freezer
specimens
storage
Waste 7 waste storage 7 waste storage 7 autoclave
management
Storage of 8 shelf 8 shelf 8 shelf
consumables
Hand wash basin 9 hand hygiene 9 hand hygiene 9 hand hygiene
Core requirements Heightened control measures

Figure 7.2 Examples of workflow diagrams for laboratories with core requirements and heightened control
measures as informed by the outcome of a risk assessment. These laboratories have similar laboratory
activities but different risks. The core requirement laboratory works on biological agents that can be handled
without containment. The laboratory with common heightened control measures includes a biological safety
cabinet (BSC). The laboratory with additional heightened control measures for handling more hazardous
infectious biological agents has a BSC, uses two inactivation methods, safety buckets in the centrifuge and
waste inactivation by an autoclave. In the table below the workflow diagrams, the laboratory equipment
needed for the core requirements is in black text, and the additional equipment for heightened control
measures is in orange text.
SECTION 7 DESIGN 41
7.3.3 Detailed design
Detailed design (also known as technical design) is the final step of the design process.
In this stage, detailed drawings, specifications, schedules and lists needed to facilitate
the construction process are produced. This design should clearly describe in detail
all the elements, systems and equipment that will be built and installed to form the
functioning facility.
Further information will still be needed to enable the final manufacture and installation
of some parts – such as steelwork and ductwork shop drawings – but the completion
of the detailed design allows the construction phase of the project to start.
7.3.4 Support activities for design
During each of the design stages, it can be useful to continue to build on earlier
information gathering and fact-finding activity (see subsection 7.1.1), which may
include further benchmarking exercises. This can be especially useful where new
information is obtained or where similar projects are ongoing but are already at an
advanced stage or have faced problems.
It can also be useful to seek independent peer review of the new laboratory design
proposals; this can be done at each design stage. Peer review takes time and involves
financial costs, but such review is essential as the complexity of the design increases.
Peer reviews can be undertaken by suitably experienced in-house personnel, or by
independent specialists and experts.
7.4 Budget
Finalization of the user requirement specification should allow the design team to
produce an accurate estimate of the facility’s final construction cost. It is important to
consider this before moving forward so that the costs can be justified to those funding
the project. The finalization process requires a person skilled in estimating the costs
associated with various design features, risk control measures, and/or resources being
requested, and taking account of the needs specified in the user requirements.
During this stage, a contingency allowance should be considered. About 10–15% of

the estimated facility cost may be added during the construction process to cover
changes or adjustments that will almost certainly need to be made. Furthermore,
costs must also be added to finance parallel and post-construction activities, such as
commissioning and training activities. These activities will ensure that the constructed
facility is not only finished, but functional and able to be used and maintained. Refer
also to subsection 6.4.
In many cases, a fixed budget is provided (by government, for example) or is available
(through a donor, for example), which can be a constraint for the project. Under such
circumstances, it is essential to define the laboratory activities of the planned facility
and to assess if it will fully meet the requirements of the risk assessment and needs
assessment.
It is important to realize that a construction process, a renovation or a repurposing

could take several years from planning to handover. In this time, equipment from
manufacturers can become obsolete and/or be replaced by new models. It is
therefore important to include such contingencies in the budget and to track these
changes with equipment manufacturers and the design team or builders who are
providing the infrastructure support.
Excessively long planning and building processes may result in unnecessary cost
increases, which can reduce the viability of the laboratory project. Similarly, if a budget
is not available or is insufficient, or if the targets of the user requirements are too high,
then the project may need to be stopped or substantially revised at this stage, or even
earlier in the planning and design process.
Further iterations of the user requirement specification may be required to ensure

that the project design matches the approved budget, or the budget may need to be
adjusted. Engineering options may need to be discussed and equivalent alternatives
for a given product or system explored to balance cost. However, quality and
performance should match the original design requirement; otherwise any savings
made in capital costs could be lost because of increased owning and operating costs.
Cheaper but potentially inferior system components should be avoided, as they may
in fact turn out to be far more expensive in the medium and long term with increased
breakdown frequency and higher ongoing maintenance and repair costs.
7.5 Procurement
Procurement is a broad topic. Rules and requirements governing procurement may
vary from country to country and organization to organization. Rules for procurement
in the public sector may not always be fully compatible with the complex needs of a
successful laboratory project.
If procurement rules allow, it is safer to complete the design as an independent and

separate preliminary activity and have it fully costed and peer reviewed before the
appointment of the construction company (the so-called design–bid–build approach).
The independent design team can be retained by the laboratory management or
facility owner to manage the quality controls throughout the construction phase and
advise the laboratory management on the completeness of the testing, commissioning,
documentation and training needed before the formal handover.
SECTION 7 DESIGN 43
Another procurement route is the so-called design and build route, where the design
and construction phases are undertaken by one company. Any changes made to
the design tend to incur substantial costs, and these generally increase more as the
project moves closer to completion. In addition, a decrease in quality is common in
design and build with inevitable consequences on critical completion activities, such
as testing and commissioning. Appointing and authorizing an independent body to
undertake quality control may help here.
45
CONSTRUCTION
SECTION
8
With appropriate commitment to a realistic budget and approval of the preceding
planning and design phases, builders and/or their subcontractors can be engaged to
execute the project construction phase, typically overseen and managed by the project
manager. Key to good project management is facilitating effective communication and
documentation processes. As construction moves towards completion, commissioning
is undertaken to ensure that the finished construction is in line with all of the original
user requirement specifications and the detailed design drawings and specifications
made by the design architects and engineers.
The construction phase (Figure 8.1) normally starts on a fixed date and has a fixed
schedule or programme, which is one of the conditions of the contract between the
senior management/owner and the builder (or principal contractor).
The builder will typically take possession of the site at the start of construction, which
becomes their legal responsibility, and which is returned only at completion and
handover of the project. The builder is responsible for security of the site during the
construction phase. The builder will also become responsible for the health and safety of
all workers and visitors to the site as well as all people in the vicinity of the site including
the general public.
8.1 Site investigations

As required, the builder may appoint subcontractors, such as plumbers, electricians and
air conditioning companies. The builder may also carry out additional site investigations
and surveys, as needed. The need for further site investigations in the construction
phase assumes that an appropriate level of site investigation was already done during
the design stage and may be complete before the appointment of a builder. However,
some work may be required that was not possible to carry out earlier because of, for
example, lack of availability of the site, or the occupancy and use of an existing building.
If a design and build route is followed, this work may needs to be done during this stage
of the project.
Some preliminary tests may also be performed to confirm design assumptions (for
example, capacity of the electrical supply, water supply, drainage and sewerage
systems and other utilities), especially on existing equipment, services or utility supplies
where refurbishment, repurposing or expansion is being undertaken.
Construction phase Approval to proceed from

design to construction phase
Confirm procurement route
Develop tender documents

Revise and resubmit
tender documents
No Tender documents approved
Appoint contractor
Start construction
Complete fit-out:
- risk control measures are
implemented
Complete testing and

commissioning
Complete all documentation,

operation and maintenance
manuals
Consider maintenance options
Optional: Appoint maintenance

contractor/maintenance team
(internal or external)
Verify testing, commissioning

and documentation
Refuse handover until all
requirements are completed
satisfactorily
Are the facility and
No documentation 100% complete
Yes
Handover – owner takes

ownership of the finished project
Proceed to operational phase
Figure 8.1 Project flowchart, construction phase

SECTION 8 CONSTRUCTION 47
Further detailed construction and engineering work may also be

required involving the following areas:
n layout of laboratory rooms, location, size and layout of

technical spaces, support areas and plant rooms (where not
included at the design stage);
n shop drawings, for example, of specialized equipment, ducts and steelwork;
n calculations for system components (where not included at the design stage);
n specialist installations, for example, air handling units and autoclaves;
n water supply;
n electricity supply including various voltages, mono and triphase supplies; and
n wastewater effluents requiring special treatments such as biological inactivation or

chemical detoxification for biosafety and environmental reasons.
8.2 Products and materials: quality control

Samples of materials should be submitted to demonstrate the required (specified)
and agreed quality. Sample products and workmanship can be provided and or
constructed and approved. These approved sample elements can then be used to
measure the quality of subsequent workmanship and/or materials against. This work
can be in one part of the construction or even part of a separate mock-up construction.
The more complex or critical the needs of the finished facility are, the more a separate
mock-up of key components, finishes and features can contribute to the success of the
project and is well worth the investment.
In complex laboratories, the movement of materials through the facility spaces, as

well as the planned movement of people, specimens containing biological agents and
associated waste streams can also be mocked up and physically tested.
One quality control measure that is vital in all laboratory construction projects is the
continuous protection of all surfaces, finishes and installed equipment. If they are not
protected during construction, they can be damaged. The integrity of the finished
flooring, for example, will considerably affect facility cleaning or decontamination
and durability. The same is true for walls and for benches and other surfaces. Good
management at all levels and clear specifications for protection can help reduce all but
accidental damage, which should always be rectified before final handover.
8.3 Documentation
If the planning and design phases have been carried out effectively, clear and
detailed documentation (drawings and specifications) should be available to direct
the construction team to accurately complete the laboratory project construction.
Communication, coordination and management of the various actions and actors
is an important part of the process and is key to success in construction. Scrutiny of
everything and at every level by those responsible for the design, its proper functioning
and its formal sign off should be ensured at all stages of the project.
Detailed records should be kept of all meetings and all decisions that are mutually
agreed. The project manager should discuss and collectively agree with the builder
and subcontractor(s) their specific roles and responsibilities. This agreement should
be recorded in a formal contract before the beginning of the construction process.
Additional methods of accountability may need to be implemented, such as the use
of signature sheets for builders and/or subcontractors to acknowledge when they
have reviewed and agreed with any discussions, and/or other written documentation
described in Table 8.1. Control of changes is important as almost all changes will affect
costs and may also affect project time schedules.
In Table 8.1 some common formal documented communication and recording methods
are explained. These are not the only methods used. Documented communications
may vary by name and purpose depending on the time and place and the type of
contract being used. Documents may also include instructions of the project manager,
early warning notices and technical queries.
Table 8.1 Common documented communications and recording methods
DOCUMENT DESCRIPTION
Request for information Documents provided from builder to the senior
management/owner or their design team asking for a
clarification or additional supplementary information
relating to a question over the design or user requirement
specification which they believe is unclear
Request for approval When approval is required to conduct a certain action
Change control order To track changes and associated costs and possible delays
Technical submittal When approval is required for proposed components and

systems by the builder
Defect notice A document indicating that an item has been rejected and
must be made good or replaced by the builder/installer
As-built drawing An update that reflects all changes made by the builders
Technical documents (as A document from the builder on deliverables which outlines
part of the operating and the specifications of the system or feature, how to use it and
maintenance manuals) how it must be maintained to function effectively.
8.4 Testing and commissioning

During the construction activity, there may be a requirement for specific testing,
verification and recording of issues such as ground conditions, reinforcing steel and
concrete strength. These tests and test results must be inspected, authorized and
signed off by the project manager or other design team members before further work
proceeds. As construction progresses, it will be necessary to check and inspect the
quality of workmanship of the work before it is covered or enclosed. Steelwork and
concrete reinforcement, for example, must be checked and approved, and brickwork
and blockwork walls will need to be checked before render or plaster is applied. Any
hidden features (pipes, wires and ducts) will need to be checked and tested before
being covered or enclosed. This inspection, checking and testing must be written into
the project specifications by the designers and the quality control process must be
carefully followed throughout. Some specific construction features may need to be
inspected several times including firebreaks and partitions to ensure that the lives of
the people using the building will not be at risk during use.
When the construction phase comes to an end, the facility or the renovated/
repurposed laboratory must be thoroughly inspected and checked for quality,
compliance and functionality against the design documents before it is handed over to
the senior management and it becomes operational. Other approval processes may
be necessary before full operation (licensing, for instance). Depending on the size and
purpose of a laboratory, it might be necessary to check and test elements at both the
beginning and the end of the construction phase. Any defects should be identified in
the testing and commissioning phase by the project manager and design team and
must be satisfactorily corrected by the builder/subcontractor prior to final handover.
Commissioning involves the testing of all items constructed, fitted or installed to show
that they are complete and functional according to previously agreed specifications.
Commissioning should occur throughout the construction phase, checking, testing and
approving what is being executed, against the user requirement specification and/
or the more detailed project design drawings and specifications. Commissioning is
usually carried out by the person responsible for installation, checking is performed
by a commissioning engineer, and verification and scrutiny by the designer (or an
independent entity). On more complex projects, an independent commissioning agent
can be used to carry out this function and should be engaged to advise from early in the
design phase.
As changes may be required and made throughout the construction process,

commissioning agents (and/or the project manager and design team) must review all
written communications and technical documentation for conformity and alignment
with the design specifications.
Handover of any construction project is a milestone and responsibility shifts from the
builder back to the senior management/facility owner and laboratory manager. It
is essential in all laboratory projects that the facility is completely finished before the
handover is agreed.
8.5 Acceptance and handover

The builder is responsible for the quality of the completed facility in accordance with
the contract, the design drawings and the contract specifications. As construction
reaches completion, the senior management/laboratory manager must accept the
work and take over responsibility for the oversight of the facility and its function. This
is a formal contractual process and with a formal handover. All contract work must
be completed, inspected, verified, accepted and signed off by a competent person or
persons acting directly for the senior management.
At the handover, functional testing of all equipment and systems must be complete
and inspected, and fully signed off against all technical documentation. In addition, all
construction design features must be approved as they are specified in the as-built
information. If these elements are not completed satisfactorily, then handover should
be delayed until the project manager has received the needed approvals from the
design team and/or the commissioning and validation team as described in the list
below.
The responsibility of the project manager is to ensure that all the testing,
commissioning, validation, verification and qualification tasks – however simple
or complex – are complete, specifically in the opinion of a suitably qualified and
competent person undertaking the inspection. It is also important that the as-built
information and the operation and maintenance manuals (see subsection 9.3) are
complete, comprehensive, accurate and useful. These will underpin all the operation
and maintenance of the laboratory. Scrutiny at this stage of the project must be
complete.
When evaluating the completed laboratory systems for acceptance, in addition to

installation quality, the following points may also need to be considered/tested:
n repeatability of the system operation under various outside influences, such as

temperature, humidity and pressure;
n operational stability of the system for a period of time consistent with the intended
operation of the laboratory (usually at least a day but it could be longer);
n stability, accuracy, reliability and repeatability of control systems;
n responsiveness of systems to changing environments and other varying laboratory

conditions, including normal, emergency and recovery modes of operation;
n efficiency of the operation of the systems, consistent with predicted criteria of

operating costs; and
n ability to maintain systems, including proper and safe access to components and
owner training, to ensure a long-term, high-level performance; this might include
safe 24-hour access to such systems and necessary normal lighting and emergency
lighting.
8.6 Accreditation and certification

If required, a well-recognized standard should be chosen that is suited for the
intended purpose and is specified for either certification or accreditation. The
assessment body providing certification should be properly accredited by authoritative
national bodies or competent authorities to carry out the particular assessment
formally.
Formal assessment of laboratory processes for biosafety vary around the world and
are most often found in countries with national oversight systems. In these cases,
inspectors (authorized by the national authority or another competent authority)
inspect laboratories against an acceptable standard (often a national biosafety
standard). If the laboratory meets the standard, it may be certified. Many countries do
not certify and simply authorize activities in laboratories that have been found to meet
the national standard.
To identify necessary certification, national regulations can give guidance. National

regulations should be consistent with standards of the International Organization for
Standardization and the International Electrotechnical Commission.
8.6.1 Certification of engineering controls
Beyond laboratory certification, specific certification exists for engineering controls.

A good example is the certification of BSC by field testing. Various standards exist
for the certification of BSC (11,12). A field-testing certifier should be accredited by the
accrediting body. Determining if a certifier is qualified requires verification of the
certifier’s credentials, references, work history, accreditation and any other relevant
factors.
53
OPERATION
SECTION
9 AND MAINTENANCE
Well-functioning laboratory equipment and systems contribute to biosafety of the

laboratory. Maintenance plays an important role in keeping the laboratory equipment
and systems reliable (Figure 9.1). There are two types of maintenance: planned
maintenance (predictive maintenance and preventative maintenance) and unplanned
maintenance (breakdown maintenance or emergency maintenance, also called
corrective maintenance) – see subsections 9.5 and 9.6.
Operational phase
Start operational phase
Consider maintenance options
Maintenance option with

Set up in-house core personnel maintenance Appoint competent maintenance
maintenance team management team and contractor(s)
contractors as needed
Design maintenance plan and

perform planned maintenance
Training – Train all personnel on

building operation
Write standard operating

procedures (SOPs)
Provide training and practice on

SOPs
Continually monitor performance

- review risk control measures
Conduct periodic programme

assessments
(for example, facility fitness,
maintenance programme)
Continual improvement
Figure 9.1 Project flowchart, operational phase

A detailed maintenance plan should minimize problems and help avoid common
and predictable breakdowns. Maintenance will require a trained knowledgeable and
competent team supplied with the correct tools and spare parts.
9.1 Safety of maintenance personnel

The safe and optimum operation of a laboratory is dependent on support personnel,
and such personnel must be given appropriate safety training.
Skilled engineers and trades people who maintain and repair the structure, facilities
and equipment of the laboratory should have knowledge of the nature of the work of
the laboratory, and of the importance of safety regulations and procedures. Testing
of engineering controls after servicing, for example, testing the efficiency of BSC after
new filters have been fitted, may be carried out by or under the supervision of the
biosafety officer. Ideally the hazards of the laboratory should be removed or isolated
before engineering or repair work is undertaken. Engineering and maintenance
personnel may need to enter laboratories with clearance and supervision by the
biosafety officer and/or the laboratory manager. Establishing SOPs can standardize
and facilitate common understanding and execution of laboratory entry and exit
procedures for non-laboratory personnel.
9.2 Design for maintenance

As with all key elements of the process required to plan, design, construct, operate
and maintain laboratory facilities discussed throughout this monograph, good
maintenance begins in the early planning and design stages. Depending on the
level of complexity of the facility and required design features, the need to facilitate
the appropriate maintenance of the structure, its envelope, its finishes, fixtures and
fittings, and of course its engineering services will vary. Access space is also essential
to maintain, service, calibrate, and validate or certify key biosafety equipment such
as BSCs and autoclaves. Systems should be retested and checked before work with
biological agents starts.
Where possible, maintenance services and systems should be located outside the
main laboratory space, even for core requirement laboratories, to avoid the need for
maintenance personnel to enter the laboratory. This reduces the risk to these personnel
and minimizes interruptions to the laboratory work.
The following example for HEPA filter maintenance illustrates what needs to be
considered to maintain this equipment (based on the risk assessment and/or needs
assessment).
SECTION 9 OPERATION AND MAINTENANCE 55
n Clearly define minimum clearance requirements around the housing (typically

provided or recommended by the manufacturer) to ensure sufficient space to test
and remove the HEPA filter or any associated housing components.
n Clearly label the HEPA housing with biohazard symbols to ensure that it is obvious
to anyone who has access to the technical space that the HEPA filter housing
is potentially contaminated. Ideally, access to any plant room containing such
equipment should be controlled and restricted.
n Clearly identify the HEPA housing and which areas of the containment space it
serves so that it can be referenced in a maintenance/testing schedule.
n The HEPA housing should have a visual monitoring device to provide an indication
of both the performance and state of the HEPA filter in use (such as a pressure
differential monitoring gauge across the HEPA filter).
n The HEPA housing should be designed to withstand structural changes from pressure
fluctuations and not be distorted during filter installation due to over tightening.
n The HEPA housing should be mounted to a solid frame such as the floor in a plant
room, or a steel frame in the ceiling space with appropriate vibration restraints to
withstand any structural shifts.
9.3 Operating and maintenance manuals

The detailed design, specifications and drawings should always include clear
requirements addressed to all manufacturers, suppliers, builders and installers to
ensure that complete operating and maintenance instructions are provided for the
finished facility. These operating and maintenance manuals should include the
complete set of as-built drawings, schedules and all necessary information required
to develop a comprehensive planned preventative maintenance schedule for all
elements of the facility. In addition, operating and maintenance manuals should
cover only the specific components and systems that are finally installed or fitted
and refer only to those specific elements that are part of the finished facility. The
contract documents should also state the date of delivery of these manuals. Manuals
should always be provided early enough to enable full scrutiny, checking and review
before any proposed completion and handover date. Complete, well-drafted,
understandable and approved operating and maintenance manuals must be a
prerequisite to handover (see subsection 8.5).
9.4 Maintenance contracts

Laboratories must strictly follow maintenance manuals for all laboratory equipment,
systems, and/or engineered facility components. As a minimum, this maintenance
includes annual maintenance procedures. Maintenance contracts for the technical
systems and laboratory equipment may need to be agreed with relevant engineers
or manufacturers. Laboratory equipment is becoming more and more complex, and
regular maintenance, calibration and validation are needed to ensure accurate
diagnostic results. Specialist technicians trained in the specific equipment are needed
for such work.
When preparing maintenance contracts (for the facility and/or for scientific machinery
and equipment), consideration may be given to the following questions.
n Does the system or equipment have a manufacturer warranty and what is its
duration? Do not pay for something to be serviced or repaired that is already
covered by a warranty.
n What is the availability of parts and consumables? How long would parts take to be
delivered?
n Is a spare parts kit available which would allow certain preventative maintenance to
be done in-house?
n After the warranty period expires, what service contractors are available and at what
cost?
- What terms and conditions can be negotiated in the service contract?
- Is the service contract long or short term?
- Is there an automatic renewal clause?
- Are there cancellation fees?
- Is there a guaranteed response time by the supplier/manufacturer?
- Are parts and travel included in the costs of the service contract?
9.5 Planned maintenance

Maintenance plans should have lists of tasks that need to be done for all cycles and
all items that require maintenance, including inspections, routine checks, maintenance
and replacements. Each system (for example, heating, ventilation and air conditioning,
pressure systems, wastewater treatment) can be broken down into appropriate parts
and a unique plan made for each part.
Table 9.1 Example of planned preventative maintenance – external rainwater drainage system
PLANNED PREVENTIVE MAINTENANCE TASK LIST NO: A001
ELEMENT: EXTERNAL ENVELOPE ITEM: RAINWATER DRAINAGE SYSTEM
TIMING INSPECTION ACTION COMMENTS/INSTRUCTIONS

Daily N/A N/A Daily frequency not required
Weekly Visual inspection Report obvious obstructions, arrange Visual inspection from ground level;
only safe access and clear. look over entire system and identify
any problems.
Monthly Check all Clear away obvious obstructions and Using safe temporary access
downpipes, collections of debris. Report any equipment and working in a buddy
hoppers, obstructions or blockages requiring system, inspect key locations in
gullies and further action/equipment and rainwater guttering system; if
junctions arrange action to clear. required use additional safety
equipment. Where further action
is indicated arrange safe work\
access.
Quarterly As monthly As monthly As monthly
Six-monthly Full inspection to Clean all guttering, hoppers, gullies, Using contract-hired access
be completed, junctions and downpipes. equipment (cherry picker or
all gutters and scaffolding), make safe access
hoppers available to complete system,
carry out full cleaning, condition
inspection and report; select
seasonal inspection dates.
Annually As six-monthly As 6-monthly; in addition, take a As six-monthly

photographic record of condition.
5-yearly As annually As annually; in addition, check all As annually

fixings, remediate and replace
as necessary, and identify and
remediate any corrosion.
Exceptional Visually check Report function and/or observed To be done during and after periods
operation and damage. of exceptionally high rainfall or
or general before and after severe (tropical
condition. storms, and significant climatic
or geographical events, such as
earthquakes.
N/A = not applicable.

The plan will typically cover the tasks and timing of inspections: daily, weekly, monthly,
yearly, and 5 –, 10 – or even 15–yearly or longer depending on the manufacturer’s or
supplier’s advice. Six-monthly, bimonthly and quarterly timings are also common. The
example of planned preventive maintenance given in Table 9.1 is for a rainwater and
drainage collection system.
Equipped with such plans for building elements, services and equipment, from the
simple to the complex, a comprehensive planned preventative maintenance schedule
can be carried out that will ensure correct, safe and reliable operation of all building
systems.
9.6 Breakdown maintenance

Unplanned maintenance events, breakdowns and emergencies are unavoidable – but
they should occur rarely in a well-maintained and operated facility. However, plans
should be made for such events. This planning might include the availability of: spare
components and tools; personnel (technicians on call); and back-up systems, fixed or
portable. The ability to react well to unplanned maintenance events can be enhanced
by good training and supported by good design for both access and lighting. Lighting
for maintenance should include fixed emergency lighting, portable emergency lighting
and torches/flashlights in technical areas. Avoid placing key equipment and machinery
outdoors where the weather could make such items more difficult to maintain.
9.6.1 Spare parts and tools
Common spares that may be held for such critical breakdowns include fan and motor
belt drives, fuses, possibly motors for critical equipment, and consumables such as light
bulbs, filters and strainers. Spare parts must be catalogued, stored appropriately and,
importantly, located for easy access and use.
Other parts and tools could be similarly stored, which will help the technician to rapidly
respond to and resolve the emergency or breakdown. Shadow boards for organizing
a set of tools are common in many industries. In secure technical areas and locked
plant rooms, such boards are an effective and inexpensive way of managing tools
needed for maintenance. Alternatively, if feasible, a mobile tool station can be useful.
In addition to having obvious spare parts and consumables and the necessary
tools, repair kits for specific systems, such as water pipe networks, may be useful. For
smaller pipes, repair kits can include some spare pipe and fittings as well as some
proprietary repair kits. For larger pipes, temporary repairs may be done with tapes
and bands to resolve the problem until a more permanent repair can be undertaken.
The time between temporary repairs and final repair must be kept short. A well-trained,
responsive and reactive technical team must be available to respond to this type of
problem.
9.6.2 Flooding and leaks
Potential leaks and floods caused by emergency breakdowns must be considered

in the design phase of the project. Areas can be designated for the location of wet
services and have waterproof flooring, bunding, drainage systems and, if feasible, leak
detection systems. Other design measures can help minimize the risk of failures and
consequent flooding, such as the appropriate: selection and specification of materials;
location of header tanks and water feeds; specification of installation quality; and final
testing. These measures should be combined with rigorous quality control, witness
testing and scrutiny.
9.7 Maintenance records and inspections

As well as maintenance planning, detailed and accurate records are needed using
manuals, log books, journals and schedules.
In addition to normal planned maintenance, it is good practice to conduct regular

housekeeping visits. A housekeeping visit or inspection is a planned walk through a
plant room or technical space by maintenance personnel on duty, which looks carefully
for problems and listens for unusual sounds and noises. In addition, strange smells,
especially of smoke or drains, should be investigated.
A well-established process to manage maintenance, monitoring and repair records

might be necessary to support the requirements for laboratory quality management.
Laboratory users are important in supporting this process. A laboratory maintenance
system includes:
n regular walk-through inspection
n log book
n laboratory personnel observation/notification.
A laboratory quality management system or a suitable log book can be used to record
observations which should be acted upon as necessary based on a supervisory review
by the laboratory manager or maintenance supervisor. All personnel working in the
laboratory can be involved in laboratory quality management, including safety and
security personnel. Laboratory users should identify and record simple issues such
as: peeling paint, peeling sealants, wet patches, water marks or traces of water leaks,
rusty pipes and smoke or odd smells. A mechanism is needed to notify maintenance
personnel of such observations so as to prevent bigger problems occurring later.
An inventory template and a self-inspection checklist can be found in Monograph:
biosafety programme management (6).
61
DECOMMISSIONING
SECTION
10
LABORATORY FACILITIES
Laboratory facilities can include many different types and sizes of laboratory in
different locations, from a small one-room laboratory space to an entire campus,
and can include animal housing facilities and manufacturing facilities. These
facilities can also have specialist facilities or equipment such as autoclaves, effluent
decontamination systems and incinerators. For decommissioning, the same basic
process can be followed and adapted to fit the situation at hand. The key to successful
decommissioning is sound and thorough risk assessment, good planning and
meticulous documentation.
Risk evaluations (as part of the risk assessment) that are carefully and thoroughly
carried out should identify all risks associated with the planned decommissioning of a
laboratory facility and its equipment. Most laboratory equipment and the laboratory
space itself can generally be rendered safe by following the existing SOPs used
for routine periodic maintenance or planned shutdowns. When GMPP have been
consistently applied in the facility, the risk of contamination should be low and restricted
to known locations.
References
1. Laboratory biosafety manual, fourth edition. Geneva: World Health Organization;
2020 (Laboratory biosafety manual, fourth edition and associated monographs).
2. Risk assessment. Geneva: World Health Organization; 2020 (Laboratory biosafety

manual, fourth edition and associated monographs).
3. Biological safety cabinets and other primary containment devices. Geneva: World
Health Organization; 2020 (Laboratory biosafety manual, fourth edition and
associated monographs).
4. Personal protective equipment. Geneva: World Health Organization; 2020

(Laboratory biosafety manual, fourth edition and associated monographs).
5. Decontamination and waste management. Geneva: World Health Organization;

2020 (Laboratory biosafety manual, fourth edition and associated monographs).
6. Biosafety programme management. Geneva: World Health Organization; 2020

7. Outbreak preparedness and resilience. Geneva: World Health Organization; 2020

8. ISO 29463-4:2011: High-efficiency filters and filter media for removing particles
in air — Part 4: Test method for determining leakage of filter elements-Scan method
[website]. Geneva: International Standards Organization; 2017 (https://www.iso.
org/standard/51838.html, accessed 30 January 2020).
9. RIBA plan of work. London: Royal Institute of British Architects; 2013 (https://www.
ribaplanofwork.com/, accessed 9 January 2020).
10. AIA Document D200™–1995. Project checklist. Washington (DC): American Institute
of Architects; 1995 (http://content.aia.org/sites/default/files/2016-09/AIA-D200-
1995-Free-Sample-Preview.pdf, accessed 9 January 2020).
11. NSF/ANSI 49: Biosafety Cabinetry Certification. Ann Arbor (MI): NSF (http://www.
nsf.org/services/by-industry/pharma-biotech/biosafety-cabinetry/nsf-ansi-49-
biosafety-cabinetry-certification, accessed 6 January 2020).
12. BS EN 12469:2000 Biotechnology – Performance criteria for microbiological

safety cabinets. London: BSI; 2000 (https://www.en-standard.eu/bs-en-12469-
2000-biotechnology-performance-criteria-for-microbiological-safety-cabinets/,
accessed 16 July 2020).
63
Further information
HTM 67. Laboratory fitting out system. London: The Stationery Office; 2005. (HTM
building components series; https://assets.publishing.service.gov.uk/government/
uploads/system/uploads/attachment_data/file/144202/HTM_67.pdf, accessed 30
January 2020).
ISO 15190:2003. Medical laboratories — requirements for safety. Geneva: International

Standards Organization; 2010 (https://www.iso.org/standard/38477.html, accessed 30
January 2020).
Swiss Society of Engineers and Architects [website] (https://www.sia.ch/en/the-sia/,

accessed 9 January 2020).
ANNEX 1. EXAMPLE OF A
USER REQUIREMENT BRIEF
Sample User Requirement Brief (URB)
Title Laboratory upgrade: central diagnostic laboratory and national reference laboratory
Location Central Public Free Hospital, Medical Avenue, Midtown.
Date 30 February 2020.
Purpose: To refurbish, update and upgrade the central diagnostic laboratory facility and national
reference laboratory in line with published government plans to meet the guidelines of the fourth
edition of the WHO Laboratory biosafety manual. This has been facilitated with support of WHO
and the World Bank.
Funding Funding will be from the central government (70%) supported by the World Bank (30%).
Budget Project construction and commissioning budget 125 000.00 to project completion, + 25 000/year
for the first 4 years operational budget (total budget 250 000).
Contracting Ministry of Public Works on behalf of the Ministry of Health.
authority
Background The central diagnostic laboratory and national reference laboratory located at the Central Public
Free Hospital in Midtown was originally constructed in 1905. Since opening, it has provided a
key diagnostic service to the central hospital and all outlying hospitals in Midtown district
and region. Although some improvements were made in the 1970s, a lack of funding since
then, combined with substantial underinvestment in facility maintenance (including the loss of
60% of trained hospital maintenance personnel), has led to an obvious decline in standards at the
facility which fall below core laboratory requirements.
Criticality During all refurbishment works, the central diagnostic laboratory and national reference
laboratory must continue to operate at full capacity. To allow the laboratories to continue
work, space has been set aside in an adjacent building in which a temporary facility can be set
up and to which personnel and equipment can be moved during the main construction work.
Requirements
1 The project should start the construction phase on 30 February 2021.
2 The project should complete the construction phase on 30 February 2023.
3 Design and planning phases will start immediately on receipt of this URB.
4 Detailed programmes to prepare a temporary facility and move personnel, including refresher
training, should be created and agreed to align with the project time schedule.
5 The refurbished facility will be required to operate for a minimum of 30 years with correct
planned preventative maintenance. An allowance for the first 4 years of operation including
maintenance is included in the budget indicated above.
6 The temporary facility should be fitted out in accordance with the risk assessment and needs
assessment governing the temporary facility needed to maintain diagnostic service.
7 The refurbished facility should be fitted out in accordance with the risk assessment and needs
assessment governing the facility needed to provide full diagnostic services.
8 The project risk assessment are appended to this URB. Questions and requests for direction in
relation to this assessment should be addressed only to the designated laboratory management
and laboratory management team.
65
Sample User Requirement Brief (URB) (continued)
9 The project needs assessment are appended to this URB. Questions and requests for direction in
relation to this assessment should be addressed only to the designated laboratory management
and laboratory management team.
10 Usable area: existing usable area is 50 m2 including specimen receipt and three laboratory
rooms.
11 Personnel numbers: five laboratory personnel, two support personnel and one maintenance
technician.
12 Specimen throughput (average) is 50 specimens per day.
13 Nature of specimens: typical diagnostic specimens generated from hospital patient
care, including blood, sputum, urine, stool and biopsy tissues. Often heightened control
measures are necessary.
Project manager Responsible project manager, senior project manager, Ministry of Public Works.
Important Address all project questions to the project manager first; all project decisions must be signed
by the project manager only.
WHO = World Health Organization.
ANNEX 2. EXAMPLE OF
A USER REQUIREMENT
SPECIFICATION
Sample User Requirement Specification (URS)
Location Central Public Free Hospital, Medical Avenue, Midtown
Date 31 April 2020
Purpose To refurbish, update and upgrade the central diagnostic laboratory facility and national
reference laboratory in line with published government plans to meet the guidelines of the fourth
edition of the WHO Laboratory biosafety manual. This has been facilitated with support of WHO
and the World Bank.
Funding Funding will be from central government (70%) supported by the World Bank (30%).
Budget Project construction and commissioning budget 125 000.00 to project completion, + 25 000/year
for first 4 years operational budget (total budget 250 000).
Contracting Ministry of Public Works on behalf of the Ministry of Health.
Authority
Background The central diagnostic laboratory and national reference laboratory located at the Central Public
Free Hospital in Midtown was originally constructed in 1905. Since opening, it has provided a key
diagnostic service to the central hospital and all outlying hospitals in Midtown district and region.
Although some improvements were made in the 1970s, a lack of funding since then, combined
with substantial underinvestment in facility maintenance (including the loss of 60% of trained
hospital maintenance personnel), has led to an obvious decline in standards at the facility which
fall below core laboratory requirements.
Criticality During all refurbishment works, the central diagnostic laboratory and national reference
laboratory must continue to operate at full capacity. To allow the laboratories to continue work,
space has been set aside in an adjacent building in which a temporary facility can be set up and
to which personnel and equipment can moved during the main construction work.
Requirements
1 Follow guidance of the WHO Laboratory biosafety manual and its associated monograph on
laboratory construction.
2 Materials of construction – use locally available materials wherever possible that meet the
requirements of both the risk assessment and needs assessment attached to the URB (issued 29
January 2020).
3 Surfaces and finishes – use locally available materials wherever possible that meet the
requirements of both the risk assessment and needs assessment attached to the URB (issued 29
January 2020).
4 Correct application – ensure that manufacturers’ data sheets and installation/application
instructions are always fully followed when applying substrates (plaster) and all paints or similar
finishes. Ensure the correct environmental conditions exist before application/construction and
that the correct drying times are adhered to.
67
Sample User Requirement Specification (URS) (continued)

5 Mechanical and electrical services – use locally available equipment and systems wherever
possible that meet the requirements of both the risk assessment and needs assessment attached
to the URB (issued 29 January 2020).
6 Maintenance provision – ensure sufficient access to all equipment that requires maintenance
inside the laboratory and serving the laboratory (including a demonstration on completion).
7 External design conditions:
• Summer maximum temperature 35 °C
• Summer maximum humidity 85% relative humidity
• Winter minimum temperature 5 °C
• Winter minimum humidity – saturated (100%).
8 Internal design conditions:
• Winter – temperature 18 °C and relative humidity 30–70%
• Summer – temperature 25 °C and relative humidity 30–70%
• Lighting – average illuminance 400 lux with task illumination at workbenches 500 lux
• Uniformity of lighting generally 80%, avoid glare and ensure shadowing on worktops is
eliminated
• Noise – noise rating 45 (fixed machinery and equipment only, excluding scientific machinery).
9 Emergency lighting – maintained illuminance of 5 lux for 30 minutes to facilitate safe shutdown of
work and safe exit from the laboratory facility (use distributed battery units not central system).
10 Fire protection:
• Provide fixed fire detection and alarms with strobes and sounders in laboratory rooms; ensure
correct selection of detectors (heat, smoke or combined) based on area served
• Ensure all construction meets local fire codes and compartmentation and resistance times.
• Ensure all fire and life safety systems are signed off by authorized signatory from the Ministry of
Public Works.
11–99 Many more such requirements between 11 and 99 – not shown in this sample URS
100 Concrete testing – all concrete must pass the Ministry of Public Works laboratory test, TOC_LAB_
rev002C
101 Slip resistance test – test floors in laboratory against Ministry of Public Works slip test: ST001_
LAB_Rev001
102 Commissioning and testing – Commission and test all mechanical and electrical equipment in
line with Ministry of Public Works testing and commissioning guidance: TCT001_LAB_Rev005B
103 Final documentation – All testing, commissioning and completion documentation must be
complete and submitted to the Senior Project Manager, Ministry of Public Works no later than
two weeks before planned project handover. This is to allow a two-week trouble-free operating
period to pass before the project is formally signed off and handed over. Failure to submit
complete documentation and/or failure to obtain Ministry of Public Works approval shall prevent
handover.
104 Operating and maintenance manuals – These manuals are to be submitted in final draft as part
of the final documentation mentioned above but must be completed six weeks before handover
(except for completed testing and commissioning sections).
Project manager Nadia Sharif, Senior Project Manager, Ministry of Public Works
Important Address all project questions to the project manager first; all project decisions must be signed by
project manager only.
URB = user requirement brief; WHO = World Health Organization.

69

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LABORATORY BIOSAFETY MANUAL I

© World Health Organization 2020

1.1 Laboratory design features1

1.2 Risk assessment and needs assessment1

SECTION 2 Design considerations - core requirements3

2.1 Facility space3

2.3 Surfaces and finishes5

2.5 Facilities and systems7

2.6 Laboratory equipment9

SECTION 3 Design considerations - heightened control measures11

3.1 Selecting heightened control measures11

3.2 Additional separation and design features12

3.3 Laboratory equipment14

3.4 Directional airflow and inward airflow15

3.5 Waste disposal16

3.6 Laboratory emergency response17

SECTION 4 Design considerations -

maximum containment measures19

4.1 Additional separation and design features 19

4.2 Controlled access21

4.3 Directional airflow21

4.4 Waste disposal23

4.5 Laboratory emergency response24

SECTION 5 Framework of a laboratory project25

6.1 Planning team29

6.2 Risk assessment and needs assessment30

6.3 User requirement brief33

6.5 Time scale35

7.1 User requirement specification38

7.2 Workflow diagrams39

7.3 Typical project design stages39

8.1 Site investigations45

8.2 Products and materials: quality control47

8.4 Testing and commissioning49

8.5 Acceptance and handover50

8.6 Accreditation and certification51

SECTION 9 Operation and maintenance53

9.1 Safety of maintenance personnel54

9.2 Design for maintenance54

9.3 Operating and maintenance manuals55

9.4 Maintenance contracts56

9.5 Planned maintenance56

9.6 Breakdown maintenance58

9.7 Maintenance records and inspections59

SECTION 10 Decommissioning laboratory facilities61

ANNEX 1. Example of a user requirement brief64

ANNEX 2. Example of a user requirement specification66

Dr Kazunobu Kojima, World Health Organization, Switzerland

Prof. Stuart Blacksell (Team lead), University of Oxford/Mahidol-Oxford Tropical

Prof. Joachim Frey, University of Bern, Switzerland

Dr Greg Smith, Department of Health, Australia

Mr Andrew Thompson, University of Oxford, United Kingdom of Great Britain and

Ms Lisa Stevens, World Health Organization, France

Ms Rica Zinsky, World Health Organization, Switzerland

Prof. Folker Spitzenberger, Technical University of Applied Sciences Lübeck, Germany

Accreditation: The assessment and attestation of competency.

Biological agent: A microorganism, virus, biological toxin, particle or otherwise

Biological safety cabinet (BSC): An enclosed, ventilated working space designed

Biosafety: Containment principles, technologies and practices that are implemented to

Calibration: Establishment of the relationship between the measurement provided by

1.1 Laboratory design features1

1.2 Risk assessment and needs assessment1

SECTION 2 Design considerations - core requirements3

2.1 Facility space3

2.3 Surfaces and finishes5

2.5 Facilities and systems7

2.6 Laboratory equipment9

SECTION 3 Design considerations - heightened control measures11

3.1 Selecting heightened control measures11

3.2 Additional separation and design features12

3.3 Laboratory equipment14

3.4 Directional airflow and inward airflow15

3.5 Waste disposal16

3.6 Laboratory emergency response17

maximum containment measures19

4.1 Additional separation and design features 19

4.2 Controlled access21

4.3 Directional airflow21

4.4 Waste disposal23

4.5 Laboratory emergency response24

SECTION 5 Framework of a laboratory project25

6.1 Planning team29

6.2 Risk assessment and needs assessment30

6.3 User requirement brief33

6.5 Time scale35

7.1 User requirement specification38

7.2 Workflow diagrams39

7.3 Typical project design stages39

8.1 Site investigations45

8.2 Products and materials: quality control47

8.4 Testing and commissioning49

8.5 Acceptance and handover50

8.6 Accreditation and certification51

SECTION 9 Operation and maintenance53

9.1 Safety of maintenance personnel54

9.2 Design for maintenance54

9.3 Operating and maintenance manuals55

9.4 Maintenance contracts56

9.5 Planned maintenance56

9.6 Breakdown maintenance58

9.7 Maintenance records and inspections59

SECTION 10 Decommissioning laboratory facilities61

ANNEX 1. Example of a user requirement brief64

ANNEX 2. Example of a user requirement specification66