Chapter 7,Guidelines for laboratory
and facility commissioning试运转
Laboratory/facility commissioning may be
defined as the systematic review and
documentation process signifying that specified
laboratory structural components,systems and/or
system components have been installed,inspected,
functionally tested and verified to meet national or
international standards,as appropriate,
The respective building system’s design criteria
and design function establish these requirements,
In other words,laboratories designated as
Biosafety Levels 1–4 will have different and
increasingly complex commissioning requirements,
Geographical and climatic conditions,such as
geological fault lines地质断层带 or extreme heat,cold
or humidity may also affect the laboratory design
and therefore the commissioning requirements,
Upon the completion of the commissioning
process,the pertinent有关的 structural components
and support systems will have been subjected to the
various operating conditions and failure modes that
can be reasonably expected,and will have been
approved.
The commissioning process and acceptance
criteria should be established early,preferably
during the programming phase of the construction
or renovation project.
By acknowledging the commissioning process
early in the project,architects,engineers,safety
and health personnel and ultimately the laboratory
occupants understand the performance
requirements of the specific laboratory and set
uniform expectations for laboratory and/or facility
performance,
The commissioning process provides the
institution and the surrounding community with a
greater degree of confidence that the structural,
electrical,mechanical and plumbing管道 systems,
containment and decontamination systems,and
security and alarm systems will operate as designed,
to assure containment of any potentially dangerous
microorganisms being worked with in a particular
laboratory or animal facility.
Commissioning activities generally begin during
the programming phase of the project and proceed
through the construction and subsequent warranty
period for the laboratory/facility,Warranty
periods should generally extend for one year
following occupancy.
It is recommended that a commissioning agent is
retained who is independent of the architectural,
engineering and construction firms involved in the
design and construction,
The commissioning agent serves as an advocate
for the institution constructing or renovating the
laboratory and should be considered as a member
of the design team; involvement of the agent in the
early programming phase of the project is essential,
In some cases,the institution may act as its own
commissioning agent,In the case of more complex
laboratory facilities (Biosafety Levels 3 or 4),the
institution may wish to retain an outside
commissioning agent who has demonstrated
experience and success in the commissioning of
complex biosafety laboratory and animal facilities,
When an independent commissioning agent is
used,the institution should still be a member of the
commissioning team,It is recommended that,in
addition to the commissioning agent,the
institution’s Safety Officer,Project Officer,
Programme Manager and a representative of the
Operations and Maintenance staff are also part of
the team.
The following is a list of laboratory systems and
components that may be included in a
commissioning plan for functional testing,
depending on the containment level of the facility
being renovated or constructed,
The list is not exhaustive无遗漏的,Obviously,the
actual commissioning plan will reflect the
complexity of the laboratory being planned,
1,Building automation systems including links to
remote monitoring and control sites
2,Electronic surveillance and detection systems
3,Electronic security locks and proximity device
readers电子安全锁和接近装置阅读器
4,Heating,ventilation (supply and exhaust) and
air-conditioning (HVAC) systems
5,High-efficiency particulate air (HEPA)
filtration systems
6,HEPA decontamination systems
7,HVAC and exhaust air system controls and
control interlocks (HVAC=Heating,ventilation and air-
conditioning)
8,Airtight isolation dampers
9,Laboratory refrigeration systems
10.Boilers and steam systems
11.Fire detection,suppression and alarm systems
12.Domestic water backflow prevention devices
13.Processed water systems (i.e,reverse osmosis,
distilled water)
14.Liquid effluent treatment and neutralization
systems
15.Plumbing drain primer systems管道排水引流系统
16.Chemical decontaminant systems
17.Medical laboratory gas systems
18.Breathing air systems呼吸供气系统
19.Service and instrument air systems仪器设备供气系统
20.Cascading pressure differential verification of
laboratories and support areas实验室和支持区域不同级别压力差的验证
21.Local area network (LAN) and computer data
systems
22.Normal power systems
23.Emergency power systems
24.Uninterruptible power systems
25.Emergency lighting systems
26.Lighting fixture penetration seals照明固定装置的防穿透密封
27.Electrical and mechanical penetration seals
28.Telephone systems
29.Airlock door control interlocks联动装置
30.Airtight door seals
31.Window and vision-panel penetration seals
32.Barrier pass-through penetration
33.Structural integrity verification,concrete
floors,walls and ceilings
34.Barrier coating隔离涂层 verification,floors,
walls and ceilings
35.Biosafety Level 4 containment envelope
pressurization and isolation functions
36.Biological safety cabinets
37.Autoclaves
38.Liquid nitrogen system and alarms
39.Water detection systems (e.g,in case of
flooding inside containment zone)
40.Decontamination shower and chemical
additive systems
41.Cage-wash and neutralization systems
42.Waste management.
Chapter 8.Guidelines for
laboratory/facility certification
Laboratories are complex and dynamic
environments,Today’s biomedical research and
clinical laboratories must be able to adapt quickly
to continuously increasing public health needs and
pressures,
An example of this is the need for laboratories to
adjust priorities to meet the challenges of emerging
or re-emerging infectious diseases,
In order to assure that adaptation and
maintenance are undertaken promptly and in an
appropriate and safe manner,all biological
research and clinical laboratories should be
regularly certified,Laboratory certification helps
to ensure that:
1,Proper engineering controls are being used
and are functioning adequately as designed
2,Appropriate site and protocol specific
administrative controls are in place
3,Personal protective equipment is appropriate
for the tasks being performed
4,Decontamination of waste and materials has
been adequately considered and proper waste
management procedures are in place
5,Proper procedures for general laboratory
safety,including physical,electrical and chemical
safety are in place.
Laboratory certification differs from laboratory
commissioning activities (Chapter7) in several
important ways,
Laboratory certification is the systematic
examination of all safety features and processes
within the laboratory (engineering controls,
personal protective equipment and administrative
controls),
Biosafety practices and procedures are also
examined,Laboratory certification is an on-going
quality and safety assurance activity that should
take place on a regular basis.
Adequately trained safety and health or biosafety
professionals may conduct laboratory certification
activities,
Institutions may employ personnel having the
appropriate skill-set required for conducting audits
检查,surveys or inspections (these terms are used
interchangeably) associated with the certification
process,
However,institutions may consider engaging or
be required to engage a third party to provide these
services.
Biomedical research and clinical laboratory
facilities may develop audit,survey or inspection
tools to help ensure consistency in the certification
process,
These tools should be flexible enough to allow for
the physical and procedural differences between
laboratories necessitated by the type of work being
conducted,while at the same time providing a
consistent approach within the institution,
Care must be taken to ensure that these tools are
used only by appropriately trained personnel,and
that they are not used as a substitute for a sound
professional biosafety assessment,Examples of
such tools are provided in Tables 5–7.
Findings of the audit,survey or inspection should
be discussed with laboratory personnel and
management,
Within the laboratory,an individual should be
identified and made responsible for ensuring that
corrective actions are taken for all deficiencies
identified during the audit process,
Certification of the laboratory should not be
completed,and the laboratory should not be
declared functional,until deficiencies have been
adequately addressed.
The complexity of Biosafety Level 4 laboratory
operations goes beyond the scope of this manual,
For details and further information,please contact
the WHO Biosafety 1 programme
洒水装置
and facility commissioning试运转
Laboratory/facility commissioning may be
defined as the systematic review and
documentation process signifying that specified
laboratory structural components,systems and/or
system components have been installed,inspected,
functionally tested and verified to meet national or
international standards,as appropriate,
The respective building system’s design criteria
and design function establish these requirements,
In other words,laboratories designated as
Biosafety Levels 1–4 will have different and
increasingly complex commissioning requirements,
Geographical and climatic conditions,such as
geological fault lines地质断层带 or extreme heat,cold
or humidity may also affect the laboratory design
and therefore the commissioning requirements,
Upon the completion of the commissioning
process,the pertinent有关的 structural components
and support systems will have been subjected to the
various operating conditions and failure modes that
can be reasonably expected,and will have been
approved.
The commissioning process and acceptance
criteria should be established early,preferably
during the programming phase of the construction
or renovation project.
By acknowledging the commissioning process
early in the project,architects,engineers,safety
and health personnel and ultimately the laboratory
occupants understand the performance
requirements of the specific laboratory and set
uniform expectations for laboratory and/or facility
performance,
The commissioning process provides the
institution and the surrounding community with a
greater degree of confidence that the structural,
electrical,mechanical and plumbing管道 systems,
containment and decontamination systems,and
security and alarm systems will operate as designed,
to assure containment of any potentially dangerous
microorganisms being worked with in a particular
laboratory or animal facility.
Commissioning activities generally begin during
the programming phase of the project and proceed
through the construction and subsequent warranty
period for the laboratory/facility,Warranty
periods should generally extend for one year
following occupancy.
It is recommended that a commissioning agent is
retained who is independent of the architectural,
engineering and construction firms involved in the
design and construction,
The commissioning agent serves as an advocate
for the institution constructing or renovating the
laboratory and should be considered as a member
of the design team; involvement of the agent in the
early programming phase of the project is essential,
In some cases,the institution may act as its own
commissioning agent,In the case of more complex
laboratory facilities (Biosafety Levels 3 or 4),the
institution may wish to retain an outside
commissioning agent who has demonstrated
experience and success in the commissioning of
complex biosafety laboratory and animal facilities,
When an independent commissioning agent is
used,the institution should still be a member of the
commissioning team,It is recommended that,in
addition to the commissioning agent,the
institution’s Safety Officer,Project Officer,
Programme Manager and a representative of the
Operations and Maintenance staff are also part of
the team.
The following is a list of laboratory systems and
components that may be included in a
commissioning plan for functional testing,
depending on the containment level of the facility
being renovated or constructed,
The list is not exhaustive无遗漏的,Obviously,the
actual commissioning plan will reflect the
complexity of the laboratory being planned,
1,Building automation systems including links to
remote monitoring and control sites
2,Electronic surveillance and detection systems
3,Electronic security locks and proximity device
readers电子安全锁和接近装置阅读器
4,Heating,ventilation (supply and exhaust) and
air-conditioning (HVAC) systems
5,High-efficiency particulate air (HEPA)
filtration systems
6,HEPA decontamination systems
7,HVAC and exhaust air system controls and
control interlocks (HVAC=Heating,ventilation and air-
conditioning)
8,Airtight isolation dampers
9,Laboratory refrigeration systems
10.Boilers and steam systems
11.Fire detection,suppression and alarm systems
12.Domestic water backflow prevention devices
13.Processed water systems (i.e,reverse osmosis,
distilled water)
14.Liquid effluent treatment and neutralization
systems
15.Plumbing drain primer systems管道排水引流系统
16.Chemical decontaminant systems
17.Medical laboratory gas systems
18.Breathing air systems呼吸供气系统
19.Service and instrument air systems仪器设备供气系统
20.Cascading pressure differential verification of
laboratories and support areas实验室和支持区域不同级别压力差的验证
21.Local area network (LAN) and computer data
systems
22.Normal power systems
23.Emergency power systems
24.Uninterruptible power systems
25.Emergency lighting systems
26.Lighting fixture penetration seals照明固定装置的防穿透密封
27.Electrical and mechanical penetration seals
28.Telephone systems
29.Airlock door control interlocks联动装置
30.Airtight door seals
31.Window and vision-panel penetration seals
32.Barrier pass-through penetration
33.Structural integrity verification,concrete
floors,walls and ceilings
34.Barrier coating隔离涂层 verification,floors,
walls and ceilings
35.Biosafety Level 4 containment envelope
pressurization and isolation functions
36.Biological safety cabinets
37.Autoclaves
38.Liquid nitrogen system and alarms
39.Water detection systems (e.g,in case of
flooding inside containment zone)
40.Decontamination shower and chemical
additive systems
41.Cage-wash and neutralization systems
42.Waste management.
Chapter 8.Guidelines for
laboratory/facility certification
Laboratories are complex and dynamic
environments,Today’s biomedical research and
clinical laboratories must be able to adapt quickly
to continuously increasing public health needs and
pressures,
An example of this is the need for laboratories to
adjust priorities to meet the challenges of emerging
or re-emerging infectious diseases,
In order to assure that adaptation and
maintenance are undertaken promptly and in an
appropriate and safe manner,all biological
research and clinical laboratories should be
regularly certified,Laboratory certification helps
to ensure that:
1,Proper engineering controls are being used
and are functioning adequately as designed
2,Appropriate site and protocol specific
administrative controls are in place
3,Personal protective equipment is appropriate
for the tasks being performed
4,Decontamination of waste and materials has
been adequately considered and proper waste
management procedures are in place
5,Proper procedures for general laboratory
safety,including physical,electrical and chemical
safety are in place.
Laboratory certification differs from laboratory
commissioning activities (Chapter7) in several
important ways,
Laboratory certification is the systematic
examination of all safety features and processes
within the laboratory (engineering controls,
personal protective equipment and administrative
controls),
Biosafety practices and procedures are also
examined,Laboratory certification is an on-going
quality and safety assurance activity that should
take place on a regular basis.
Adequately trained safety and health or biosafety
professionals may conduct laboratory certification
activities,
Institutions may employ personnel having the
appropriate skill-set required for conducting audits
检查,surveys or inspections (these terms are used
interchangeably) associated with the certification
process,
However,institutions may consider engaging or
be required to engage a third party to provide these
services.
Biomedical research and clinical laboratory
facilities may develop audit,survey or inspection
tools to help ensure consistency in the certification
process,
These tools should be flexible enough to allow for
the physical and procedural differences between
laboratories necessitated by the type of work being
conducted,while at the same time providing a
consistent approach within the institution,
Care must be taken to ensure that these tools are
used only by appropriately trained personnel,and
that they are not used as a substitute for a sound
professional biosafety assessment,Examples of
such tools are provided in Tables 5–7.
Findings of the audit,survey or inspection should
be discussed with laboratory personnel and
management,
Within the laboratory,an individual should be
identified and made responsible for ensuring that
corrective actions are taken for all deficiencies
identified during the audit process,
Certification of the laboratory should not be
completed,and the laboratory should not be
declared functional,until deficiencies have been
adequately addressed.
The complexity of Biosafety Level 4 laboratory
operations goes beyond the scope of this manual,
For details and further information,please contact
the WHO Biosafety 1 programme
洒水装置
