SUMMER TRANING REPORT

ON
GLOBAL INSTUMENT CO.
AMBALA CANTT

IN PARTIAL FULFILMENT OF THE REQUIREMENT FOR THE AWARD

OF DEGREE OF BACHELAR OF BUISNESS ADMINISTRATION (BBA)

SUBMITTED TO:- SUBMITTED BY:-

Dr. Amita Muskan
(Assistant` professor) Roll no. 1211602010032
DEPARTMENT OF MANAGMENT University rollno. 210000322
BBA(5th sem)
GANDHI MEMORIAL NATIONAL COLLEGE
AMBALA CANTT,HARYANA
GLOBAL INSTIMENT CO.
(LABORATORY INSTUMENTS)

LABORATORY DESIGN
AND MAINTENANC
LABORATORY DESIGN AND MAINTANCE

LABORATORY BIOSAFETY MANUA

iii

Contents
Acknowledgements vi Glossary of terms viii Executive summary xiv

SECTION 1 Introduction 1

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

2.2 Storage 4

2.3 Surfaces and finishes 5

2.4 Furniture 7

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
CONTENTS v
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

SECTION 6 Planning 27

6.1 Planning team 29

6.2 Risk assessment and needs assessment 30

6.3 User requirement brief 33

6.4 Costs 34

6.5 Time scale 35

6.6 Quality 36

SECTION 7 Design 37

7.1 User requirement specification 38

7.2 Workflow diagrams 39

7.3 Typical project design stages 39

7.4 Budget 41

7.5 Procurement 42

SECTION 8 Construction 45

8.1 Site investigations 45

8.2 Products and materials: quality control 47

8.3 Documentation 48
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

References 62

Further information 63

ANNEX 1. Example of a user requirement brief 64

ANNEX 2. Example of a user requirement specification 66

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
 ACKNOWLEDGEMENTS vii
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

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.

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 highefficiency
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
 1

SECTION

1 INTRODUCTION

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
 2

laboratory facilities, safety equipment and work practices are locally relevant, proportionate to needs and
sustainable.

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.

SECTION
DESIGN CONSIDERATIONS -
 3

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.  The laboratory activities can be performed safely, efficiently and
ergonomically.  The normal movement of personnel, specimens, materials and
waste can be
performed safely without disturbing or affecting ongoing work in laboratories.  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.  Hidden spaces
or surfaces, such as behind or underneath furniture and equipment, can be
accessed for maintenance, cleaning and decontamination.  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
 4

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.
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  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. 
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.  If
used, tilework must be sealed to avoid dirt and other contaminants accumulating in the grouting and
seams.

 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.  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. 
Floor drains in the laboratory must include grills or water traps to prevent insects,
rodents or other vermin entering.

2.3.2 Windows
 Windows should normally be sealed but may be openable when the laboratory is
 6
designed to be naturally ventilated.  If openable, they must be designed to prevent insects or

vermin entering the laboratory, and they should be lockable.  Openable windows should be easily

operated and remain easily accessible to facilitate opening and closing as needed.  Natural ventilation

design should avoid strong air movements and draughts that

might interfere with the proper functioning of equipment.

2.3.3 Doors
 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.  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.  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. 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.  Furniture must be easily cleanable,

appropriate (in size and function) and sufficiently

robust to withstand planned use.  Furniture must not include any fabric surfaces which may

absorb and hold

contaminants.  Furniture on lockable wheels can be easily moved, allowing easy access for cleaning

and/or decontamination.  Furniture with ergonomic adjustment features allows for comfort while working

and

can help reduce the possibility of incidents/accidents.  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.  Carpets and rugs must not be used including carpet tiles.

Consider the following specifications for bench tops.  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,
 7
acids, alkalis and organic solvents.  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.

 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
 8
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.
SECTION 9

3 DESIGN CONSIDERATIONS -

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.
 10
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.
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.  Windows in a laboratory with heightened control measures should be closed and
sealed.  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.  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.  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:  fitting additional containment accessories to the equipment, for example, safety buckets or
containment rotors in centrifuges;  using additional safety features on equipment, such as automatic
shutdown on centrifuges or bead beaters;  dedicating equipment (in dedicated rooms) for use only for
tasks with infectious material to avoid cross-contamination; and  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:  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 highrisk 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
SECTION
DESIGN

CONSIDERATIONS -

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
 16
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  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.  The laboratory ventilation must have HEPA
filtration of both the supply and exhaust air (normally double HEPA).  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.  The
cabinet line must be operated at negative pressure to the surrounding laboratory at all
times.
 18
 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).  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  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.  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.  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.  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.  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.  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.  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.  The protective suits will require a dedicated, breathing air system,
with multiple layers of redundancy to ensure personnel safety all times.

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
SECTION 4 DESIGN CONSIDERATIONS - MAXIMUM CONTAINMENT MEASURES 23
19
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
 25
20
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.

SECTION
SECTION

FRAMEWORK OF A 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
 21
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,
SECTION
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.

6 PLANNING
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.
 22
The following national planning tools were reviewed during the development of this
monograph:

 the Royal Institute of British Architects (RIBA) plan of work – 2013 (9), and

 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).
23
 24

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
 SECTIO 7 DESIGN 25

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).  Planned purpose of the

laboratory; for example, as a diagnostic, research,

pharmaceutical or reference laboratory.  Requirements for national or international laboratory

accreditation/certification or legislative requirements.

 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.  Processes that require rooms; for example, animal work, sterilization work, or work
needing aeration or controlled temperatures.  Amount of space required, based on, for example,

the expected number of

personnel.  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).  Adjustments required in the
 SECTIO 7 DESIGN 26

specimen workflow; for example, separate specimen reception or space, and equipment for specimen
storage.  General building regulations; for example, fire alarms or sprinkler systems.  Adequate availability of
utilities; for example, sufficient power supply, water supply, wastewater treatment and removal, waste
discard and similar requirements for autoclaves.  Locally available maintenance and service expertise. 
Necessary environmental control systems.  Personnel facilities; for example, toilets, rooms for breaks, or
office spaces separate from laboratory working spaces.  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).  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.  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 are

measures available for post-exposure prophylaxis. Multidrugresistant
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 IN RISK CONTROL RESULTS OF NEEDS

RISK ASSESSMENT MEASURES ASSESSMENT
 SECTIO 7 DESIGN 27

Laboratory procedures  § disinfection § space for specimen

specimen § autoclaving reception including data entry,
receipt and recording microscopy, slide staining,
§ PPE autoclave, storage of waste and
§ direct smear
§ sharps container storage of disinfectant 
microscopy to detect acid-fast
§ first-aid kit power and water
bacilli  autoclaving and
supply for autoclave
disposal of waste (by external § autoclave 
contractor) sealed containers for § adequate and
correctly located sockets
§ decontamination of transport
§ environmental control
laboratory after any spills
for special storage conditions
Equipment to be used 
for disinfectant, such as
PPE (personal temperature, humidity 
protective equipment) hooks for laboratory
(laboratory coats, latex gloves) coats separate from personal
 Equipment clothing, space for laundry
(refrigerator, heat block/flame, outside laboratory 
microscope, sharps hand-washing basin
container, autoclave) for hand hygiene after glove
§ sealed transport removal and water supply 
container space and workflow
for equipment placement
§ incubator (autoclave, incubator, analyser)
§ space for first-aid kit,
shortterm 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 IN RISK CONTROL MEASURES RESULTS OF NEEDS
RISK ASSESSMENT ASSESSMENT
Other factors that may affect  ensure restricted access § need for system that ensures
laboratory operations only authorized personnel
 occasional crime in the have access (such as keys, key
area cards)
§ bars to windows on the ground
floor
Potential situations in which § BSC (to process suspected or § space, electric supply and
exposure or release could occur documented specimens of exhaust for BSC
§ aerosol exposure to and/or MDR-TB and XDR-TB) § consideration of workflow (for
release of M. tuberculosis from § respiratory protective example, avoiding placing BSC
a spill equipment in high-traffic areas)
§ contact with contaminated § gloves, gowns and respiratory § space to store respiratory
surfaces protective equipment when protective equipment and other
§ improperly treated waste handling PPE
waste and decontaminating
spills
 SECTIO 7 DESIGN 28

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:  cost of the land on which to build (if applicable), and any services

and access

improvements required;  cost of permissions and licencing required for construction to

proceed (if

applicable);

 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

 SECTIO 7 DESIGN 29

- maintenance – including specialists for certification and validation, and for the first 5 years of occupancy

and use;  materials costs – all the building materials required to construct the building;

n equipment costs – all the equipment required to fit out the laboratory;  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;  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;  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;  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

 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
 SECTIO 7 DESIGN 30

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.
 SECTIO 7 DESIGN 31

SECTION

7 DESIGN
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)
 SECTIO 7 DESIGN 32

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 7.1Project 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.

 SECTIO 7 DESIGN 33

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.

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.
 SECTIO 7 DESIGN 34

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.
 SECTIO 7 DESIGN 35

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
 SECTIO 7 DESIGN 36

laboratory equipment needed for the core requirements is in black text, and the additional equipment for
heightened control measures is in orange text.
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.
 SECTIO 7 DESIGN 37

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.

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.
 8
SECTION
CONSTRUCTION

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
39
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
Further detailed construction and engineering work may also be required involving
the following areas:  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  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 part A document from the builder on deliverables which outlines the
of the operating and specifications of the system or feature, how to use it and how it
maintenance manuals) 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:  repeatability of the system operation
under various outside influences, such as
temperature, humidity and pressure;  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);

 stability, accuracy, reliability and repeatability of control systems;  responsiveness of systems to

changing environments and other varying laboratory

conditions, including normal, emergency and recovery modes of operation;  efficiency of the

operation of the systems, consistent with predicted criteria of

operating costs; and  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.
SECTION

9 OPERATION 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.
 46
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).
 47
 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.  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.  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.  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).  The
HEPA housing should be designed to withstand structural changes from pressure
fluctuations and not be distorted during filter installation due to over tightening.  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.
 48
When preparing maintenance contracts (for the facility and/or for scientific
machinery and equipment), consideration may be given to the following questions.  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.  What is the availability
of parts and consumables? How long would parts take to be delivered?  Is a spare parts kit available
which would allow certain preventative maintenance to be done in-house?  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; look
only safe access and clear. 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 arrange rainwater guttering system; if required
junctions action to clear. use additional safety equipment.
Where further action is indicated
arrange safe work\ access.

Quarterly As monthly As monthly As monthly

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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 of
operation and damage. exceptionally high rainfall or before and
or general after severe (tropical storms, and
condition. 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
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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:  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