Standard
Track updates
AS/NZS 2243.3:2022
[Current]Safety in laboratories, Part 3: Microbiological safety and containment
Specifies requirements and gives recommended practices relating to safety in laboratories in which microorganisms are handled. Includes descriptions of risk group categories for microorganisms and requirements for facilities of corresponding containment levels.
Published: 25/11/2022
Pages: 199
Table of contents
Cited references
Content history
Table of contents
Header
About this publication
Preface
Introduction
1 Scope and general
1.1 Scope
1.2 Application
1.3 Normative references
1.4 Terms and definitions
1.5 Abbreviations
2 Organizational responsibility
2.1 Responsibility
2.1.1 Risk assessment
2.1.2 Establishment and management of a biosafety committee
2.1.3 Biological safety officer
2.1.4 Person with responsibility for the operation of the laboratory or facility
2.1.5 Responsibility of laboratory personnel
2.2 Biosecurity material
2.2.1 Australia
2.2.2 New Zealand
2.3 Laboratories using genetically modified organisms
2.3.1 Australia
2.3.2 New Zealand
2.4 Laboratory and facility biosecurity
2.5 Commissioning
2.6 Health management
2.6.1 General
2.6.2 Injuries and infections
2.6.3 Blood samples
2.6.4 Vaccination of workers
2.6.5 At-risk persons
2.6.6 Risks to pregnant women and the unborn child
2.7 Incident management and reporting
2.8 Emergency response plans
2.8.1 Emergency plan
2.8.2 First aid kit
3 Degree of hazard from microorganisms
3.1 General
3.2 Classification of microorganisms by risk group
3.2.1 General
3.2.2 Human and terrestrial animal infectious microorganisms
3.2.3 Plant infectious microorganisms
3.2.4 Invertebrates carrying microorganisms
3.2.5 Aquatic infectious microorganisms
3.3 Risk-grouping of microorganisms by type
3.3.1 General
3.3.2 Human and animal infectious microorganism risk group examples
3.3.2.1 Bacteria
3.3.2.2 Parasites
3.3.2.3 Fungi
3.3.2.4 Viruses
3.3.3 Plant risk group examples
3.3.4 Invertebrate risk group examples
3.3.5 Aquatic risk group examples
3.4 Human and animal clinical and diagnostic specimens
3.5 Quality assurance of cultures and materials
3.6 Work with human, animal or plant cells
3.7 Prions
3.8 Scale of cultures
4 Principles of containment
4.1 General
4.2 Containment measures
4.2.1 General
4.2.2 Primary containment measures
4.2.3 Secondary containment measures
4.2.4 Tertiary containment measures
4.3 Physical containment classifications
4.3.1 General
4.3.2 Physical containment level 1 (PC1)
4.3.3 Physical containment level 2 (PC2)
4.3.4 Physical containment level 3 (PC3)
4.3.5 Physical containment level 4 (PC4)
4.4 Design
5 Laboratory containment facilities
5.1 Laboratory physical containment
5.2 Requirements for Laboratory PC1 facilities
5.2.1 General
5.2.2 Construction
5.2.3 Work practices
5.3 Requirements for Laboratory PC2 facilities
5.3.1 General
5.3.2 Multiple room PC2 facilities
5.3.3 Construction
5.3.4 Ventilation
5.3.5 Containment equipment
5.3.5.1 Biological safety cabinets
5.3.5.2 Cytotoxic drug safety cabinets
5.3.5.3 Centrifuges
5.3.6 Work practices
5.4 Requirements for Laboratory PC3 facilities
5.4.1 General
5.4.2 Construction
5.4.3 Ventilation
5.4.4 Access to services
5.4.5 Containment equipment
5.4.6 Work practices
5.4.7 Health monitoring
5.5 Requirements for Laboratory PC4 facilities
5.5.1 General
5.5.2 Construction
5.5.2.1 General
5.5.2.2 Positive pressure suit area
5.5.3 Ventilation
5.5.3.1 General
5.5.3.2 Positive pressure suit area
5.5.4 Containment equipment
5.5.5 Work practices
5.5.5.1 General
5.5.5.2 Positive pressure suit area
5.5.6 Health monitoring
6 Terrestrial animal containment facilities
6.1 Requirements for terrestrial animal containment facilities
6.2 Principles of terrestrial animal containment
6.3 Other considerations associated with terrestrial animal containment
6.3.1 Designing facilities for different aspects of terrestrial animal handling
6.3.2 The occurrence of allergic reactions in personnel handling terrestrial animals
6.3.3 Air change rates for terrestrial animal containment facilities
6.3.4 Decontamination and disposal of terrestrial animal waste
6.3.5 Transport of terrestrial animals and animal tissues between facilities
6.3.6 Dissection and post-mortem examinations
6.4 Requirements for Terrestrial Animal PC1 facilities
6.4.1 General
6.4.2 Construction
6.4.3 Work practices
6.5 Requirements for Terrestrial Animal PC2 facilities
6.5.1 General
6.5.2 Construction
6.5.3 Ventilation
6.5.4 Containment equipment
6.5.4.1 Biological safety cabinets
6.5.4.2 Animal change stations
6.5.5 Work practices
6.6 Requirements for Terrestrial Animal PC3 facilities
6.6.1 General
6.6.2 Construction
6.6.3 Ventilation
6.6.4 Access to services
6.6.5 Containment equipment
6.6.6 Work practices
6.6.7 Health monitoring
6.7 Requirements for Terrestrial Animal PC4 facilities
6.7.1 General
6.7.2 Alternative locations for animal work
6.7.3 Construction
6.7.3.1 General
6.7.3.2 Positive pressure suit area
6.7.4 Ventilation
6.7.4.1 General
6.7.4.2 Positive pressure suit area
6.7.5 Containment equipment
6.7.6 Work practices
6.7.6.1 General
6.7.6.2 Positive pressure suit area
6.7.7 Health monitoring
7 Plant containment facilities
7.1 General
7.2 Requirements for Plant PC1 facilities
7.2.1 General
7.2.2 Location
7.2.3 Construction
7.2.4 Work practices
7.3 Requirements for Plant PC2 facilities
7.3.1 General
7.3.2 Location
7.3.3 Construction
7.3.4 Containment equipment
7.3.4.1 Biological safety cabinets
7.3.4.2 Centrifuges
7.3.5 Work practices
7.4 Requirements for Plant PC3 facilities
7.4.1 General
7.4.2 Location
7.4.3 Construction
7.4.4 Ventilation
7.4.5 Access to services
7.4.6 Work practices
8 Invertebrate containment facilities
8.1 General
8.2 Requirements for Invertebrate PC1 facilities
8.2.1 General
8.2.2 Location
8.2.3 Construction
8.2.4 Work practices
8.3 Requirements for Invertebrate PC2 facilities
8.3.1 General
8.3.2 Location
8.3.3 Construction
8.3.4 Containment equipment
8.3.4.1 Biological safety cabinets
8.3.4.2 Centrifuges
8.3.5 Work practices
8.4 Requirements for Invertebrate PC3 facilities
8.4.1 General
8.4.2 Location
8.4.3 Construction
8.4.4 Ventilation
8.4.5 Access to services
8.4.6 Containment equipment
8.4.7 Work practices
8.5 Requirements for Invertebrate PC4 facilities
8.5.1 General
8.5.2 Construction
8.5.3 Ventilation
8.5.4 Work practices
8.5.5 Health monitoring
9 Aquatic organism containment facilities
9.1 General
9.2 Principles of aquatic organism containment
9.3 Other considerations associated with aquatic organism containment
9.3.1 Designing facilities for different aspects of aquatic organism handling
9.3.2 The occurrence of allergic reactions in personnel handling aquatic organisms
9.3.3 Air change rates for aquatic organism containment facilities
9.3.4 Decontamination and disposal of aquatic organism waste
9.3.5 Transport of aquatic organisms and organism tissues between facilities
9.3.6 Dissection and post-mortem examinations
9.4 Requirements for Aquatic Organism PC1 facilities
9.4.1 General
9.4.2 Construction
9.4.3 Work practices
9.5 Requirements for Aquatic Organism PC2 facilities
9.5.1 General
9.5.2 Construction
9.5.3 Ventilation
9.5.4 Containment equipment
9.5.4.1 Biological safety cabinets
9.5.5 Work practices
9.6 Requirements for Aquatic Organism PC3 facilities
9.6.1 General
9.6.2 Construction
9.6.3 Ventilation
9.6.4 Access to services
9.6.5 Containment equipment
9.6.6 Work practices
9.6.7 Health monitoring
10 Microbiological spills
10.1 General
10.2 Planning
10.2.1 General
10.2.2 Emergency provisions for personnel
10.2.3 Clean-up materials and equipment
10.3 Spills inside biological safety cabinets
10.3.1 General
10.3.2 Small spills
10.3.3 Larger spills
10.4 Spills outside biological safety cabinets
10.4.1 General
10.4.2 Spills in PC1 and PC2 facilities that can be cleaned up by the worker
10.4.3 Spills in PC2 facilities that should be cleaned up by a dedicated spills clean-up team
10.4.4 Spills in PC3 facilities
10.4.5 Spills in PC4 facilities where positive pressure suits are not worn
10.4.6 Spills in PC4 facilities where positive pressure suits are worn
10.5 Centrifuge spills
11 Chemicals, personal protective equipment and special equipment
11.1 Chemicals
11.1.1 General
11.1.2 Dunk tanks, footbaths and disinfectant dispensers
11.2 Personal protective equipment
11.2.1 General
11.2.2 Laboratory coats, gowns, coveralls and aprons
11.2.3 Footwear
11.2.4 Eye and face protection
11.2.5 Respiratory protection
11.2.6 Gloves
11.3 Centrifuges
11.3.1 General
11.3.2 Centrifuge use and maintenance
11.3.3 Centrifuges lacking aerosol containment
11.3.4 Centrifuge rooms
11.4 Freeze-drying and reconstitution of cultures
11.5 Liquid nitrogen
11.6 Pressure steam sterilizers
11.6.1 General
11.6.2 Air removal methods for steam sterilizers
11.6.3 Downward-displacement steam sterilizers
11.6.4 Pre-vacuum (porous load) steam sterilizers
11.6.5 Times for sterilization
11.6.6 Monitoring of sterilization cycles
11.6.7 Chamber pressure relief valves
11.6.8 Barrier wall steam sterilizers
11.7 Biological safety cabinets
11.7.1 Classes I and II biological safety cabinets
11.7.2 Class III biological safety cabinets
11.8 Laminar flow cytotoxic drug safety cabinets
11.9 Vacuum systems
11.10 HEPA filters
11.10.1 Specification
11.10.2 Installation and maintenance
11.11 Liquid effluent decontamination systems
11.11.1 General
11.11.2 Safety considerations
11.11.3 Methods of liquid effluent decontamination
11.11.4 Requirements for liquid effluent decontamination systems
11.11.4.1 Performance requirements
11.11.4.2 Operational requirements
11.11.4.3 Construction requirements
11.11.5 Storage and handling of chemicals
11.11.6 Pressure relief valves
11.11.7 Biological indicators for heat-based liquid effluent decontamination systems
12 Cleaning
12.1 General
12.2 Cleaning personnel handling infectious material
12.3 Cleaning of equipment
12.4 Walls and shelves
12.5 Floor cleaning
13 Contaminated materials and waste
13.1 Collection
13.2 Decontamination and disposal of wastes
13.2.1 General
13.2.2 Validation of waste decontamination processes
13.2.3 Decontamination methods
13.2.3.1 Pressure steam sterilization
13.2.3.2 Chemical disinfection
13.2.3.3 Incineration/high heat treatment
13.2.3.4 Dry heat sterilization
13.2.3.5 Other methods
13.2.4 Prions
13.2.5 Secondary contamination considerations
13.2.5.1 Radioactive waste
13.2.5.2 Chemical waste
13.2.6 Uncontaminated waste
13.3 Decontamination of liquid wastes
14 Transport of infectious and other biological materials
14.1 General
14.2 Transport regulations
14.3 Transport definitions of biological materials
14.4 Classification and packaging
14.4.1 General
14.4.2 Infectious substances
14.4.3 Biological products
14.4.4 Genetically modified microorganisms and organisms
14.4.5 Medical or clinical wastes
14.5 Transport of infected animals
14.6 Documentation
Appendix A
A.1 Scope
A.2 General
A.3 Phases of poliovirus containment
A.3.1 Phase I: Preparation for containment of poliovirus type 2
A.3.2 Phase II: Poliovirus type 2 containment period
A.3.3 Phase III: Final poliovirus containment
A.4 Additional requirements for working with poliovirus
A.5 Contacts for the national polio inventory and notification of matters relating to poliovirus
Appendix B
B.1 Biological hazard symbol
B.2 General microbiological laboratory sign
Appendix C
C.1 Scope
C.2 Water supplies
C.2.1 Backflow prevention
C.2.2 Looped services
C.3 Gas services
C.3.1 General gas service requirements
C.3.2 Backflow prevention
Appendix D
D.1 Introduction
D.2 Susceptibility of microorganisms
D.3 Types of chemical disinfectants
D.4 Factors affecting activity of disinfectants
D.5 Choice of disinfectant
D.6 Properties of commonly-used disinfectants
D.6.1 Chlorine
D.6.2 Iodine
D.6.3 Formaldehyde
D.6.4 Glutaraldehyde
D.6.5 Peracetic acid
D.6.6 Peroxygen biocides
D.6.7 Hydrogen peroxide
D.6.8 Chlorine dioxide
D.6.9 Alcohols
D.6.10 Phenolics
D.6.11 Quaternary ammonium compounds
D.6.12 Chlorhexidine
D.6.13 Acids and alkalis
D.6.14 Ortho-phthalaldehyde
D.6.15 Ozone
D.6.16 Ultraviolet light radiation
D.7 Contamination of disinfectants
Appendix E
Appendix F
F.1 Scope
F.2 Introduction
F.3 Aerosol containment
F.4 Loss of aerosol and gaseous containment
F.5 Determination of containment structure integrity
F.6 Practical application of criteria
F.7 Structural air leakage testing
Appendix G
G.1 Primary barrier: Biological safety cabinet
G.1.1 General
G.1.2 User instruction
G.1.3 Personal protective equipment
G.1.4 Germicidal ultraviolet lamps
G.1.5 Electric power regulation
G.1.6 Functional checks
G.1.7 Location
G.1.8 Pre-operational measures
G.2 Use of biological safety cabinets
G.2.1 General
G.2.2 Breakdown procedure
G.2.3 Decontamination
G.2.4 Inspection and testing
G.2.5 Work health and safety
G.3 Protection from ionizing radiation
G.3.1 Hazards to operator
G.3.2 Working practices
G.3.3 Legislative requirements
G.3.4 Classification of laboratories
G.3.5 Modification of biological safety cabinets
G.3.6 Gaseous or volatile radio-nuclides
G.3.7 Shielding
G.3.8 Handling procedures
G.3.9 Working practices
G.4 Protection from non-ionizing radiation
Bibliography
Cited references in this standard
[Current]
Cleanrooms, workstations, safety cabinets and pharmaceutical isolators — Methods of test, Method 7: Determination of integrity of HEPA filter installations not terminally mounted
[Current]
Controlled environments, Part 2: Biological safety cabinets Class II — Design
[Current]
Cleanrooms, workstations, safety cabinets and pharmaceutical isolators — Methods of test, Method 10: Determination of air pressure of cleanrooms and pharmaceutical isolators
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