AS/NZS 2243.3:2010
Safety in laboratories - Microbiological safety and containment
Sets out requirements, responsibilities and general guidelines relating to safety in laboratories and containment of microorganisms and prions where they are handled. It is intended for laboratories, including animal, plant and invertebrate containment facilities, whether integral or separate to the laboratory, where microbiological work such as research, teaching, diagnosis, quality control and regulatory analysis, e.g. of foodstuffs, water and effluents, pharmaceuticals and cosmetics, is undertaken. The Standard assists in addressing the obligations placed on employers and employees under occupational health and safety legislation to take care of both themselves and others in the workplace.
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AS/NZS 2243.3:2010 SAFETY IN LABORATORIES - MICROBIOLOGICAL SAFETY AND CONTAINMENT
PREFACE
CONTENTS
FOREWORD
SECTION 1 SCOPE AND GENERAL
1.1 SCOPE
1.2 OBJECTIVE
1.3 REFERENCED DOCUMENTS
1.4 DEFINITIONS
1.4.1 Aerosol
1.4.2 Airlock
1.4.3 Anteroom
1.4.4 Antiseptic
1.4.5 Aseptic technique
1.4.6 Biohazard
1.4.7 Biological safety cabinets
1.4.8 Biosafety
1.4.9 Biosafety committee (BC)
1.4.10 Change room
1.4.11 Competent person
1.4.12 Containment
1.4.13 Containment facility
1.4.14 Cross-contamination
1.4.15 Decontamination
1.4.16 Diagnostic specimen
1.4.17 Disinfectant
1.4.18 Exposure standard
1.4.19 HEPA filter
1.4.20 Infectious microorganism
1.4.21 Invertebrates
1.4.22 Microbiological hazard
1.4.23 Microbiological spill
1.4.24 Microorganisms
1.4.25 Pathogen
1.4.26 Personal protective equipment (PPE)
1.4.27 Prions
1.4.28 Risk assessment
1.4.29 Shall
1.4.30 Sharps
1.4.31 Should
1.4.32 Sterile
1.4.33 Sterilization
1.4.34 Viable
1.5 ABBREVIATIONS
SECTION 2 ORGANIZATION AND RESPONSIBILITY
2.1 RESPONSIBILITY
2.1.1 Management policy
2.1.2 Risk assessment
2.1.3 Organizational arrangements for the implementation and monitoring of biosafety
2.1.4 Safety officer(s)
2.1.5 Laboratory or facility supervisor
2.1.6 Personal responsibility
2.2 QUARANTINE MATERIALS
2.2.1 Australia
2.2.2 New Zealand
2.3 LABORATORIES USING GENETICALLY MODIFIED ORGANISMS (GMOs)
2.3.1 Australia
2.3.2 New Zealand
2.4 LABORATORY 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 Immunization
2.6.5 At-risk persons
2.6.6 Precautions for women
2.7 INCIDENT REPORTING
2.8 EMERGENCY RESPONSE AND CONTINGENCY PLANS
2.8.1 Emergency plan
2.8.2 Contingency plan
2.8.3 First aid kit
SECTION 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 animal infectious microorganisms
3.2.3 Plant infectious microorganisms
3.2.4 Invertebrates carrying microorganisms
3.3 RISK-GROUPING OF MICROORGANISMS BY TYPE
3.3.1 General
3.3.2 Human and animal infectious microorganism risk group examples
3.3.3 Plant pathogen risk group examples
3.3.4 Invertebrate 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
SECTION 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 LOCATION
SECTION 5 LABORATORY CONTAINMENT FACILITIES
5.1 LABORATORY PHYSICAL CONTAINMENT
5.2 REQUIREMENTS FOR PC1 LABORATORIES
5.2.1 General
5.2.2 Construction
5.2.3 Work practices
5.3 REQUIREMENTS FOR PC2 LABORATORIES
5.3.1 General
5.3.2 Multiple room PC2 facilities
5.3.3 Construction
5.3.4 Ventilation
5.3.5 Containment equipment
5.3.6 Work practices
5.4 REQUIREMENTS FOR PC3 LABORATORIES
5.4.1 General
5.4.2 Construction
5.4.3 Multiple room PC3 facilities
5.4.4 Laboratory ventilation
5.4.5 Access to services
5.4.6 Containment equipment
5.4.7 Work practices
5.4.8 Health monitoring
5.5 REQUIREMENTS FOR PC4 LABORATORIES
5.5.1 General
5.5.2 Construction
5.5.3 Ventilation
5.5.4 Containment equipment
5.5.5 Work practices
5.5.6 Health monitoring
SECTION 6 ANIMAL CONTAINMENT FACILITIES
6.1 REQUIREMENT FOR ANIMAL CONTAINMENT FACILITIES
6.2 PRINCIPLES OF ANIMAL CONTAINMENT
6.3 OTHER CONSIDERATIONS ASSOCIATED WITH ANIMAL CONTAINMENT
6.3.1 Designing facilities for different aspects of animal handling
6.3.2 The occurrence of allergic reactions in personnel handling animals
6.3.3 Air change rates for animal containment facilities
6.3.4 Decontamination and disposal of animal waste
6.3.5 Transport of animals and animal tissues between facilities
6.3.6 Dissection and post-mortem examinations
6.4 REQUIREMENTS FOR ANIMAL PC1 FACILITIES
6.4.1 General
6.4.2 Construction
6.4.3 Work practices
6.5 REQUIREMENTS FOR ANIMAL PC2 FACILITIES
6.5.1 General
6.5.2 Construction
6.5.3 Ventilation
6.5.4 Containment equipment
6.5.5 Work practices
6.6 REQUIREMENTS FOR 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 ANIMAL PC4 FACILITIES
6.7.1 General
6.7.2 Alternative locations for animal work
6.7.3 Construction
6.7.4 Ventilation
6.7.5 Containment equipment
6.7.6 Work practices
6.7.7 Health monitoring
SECTION 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
7.3.5 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
7.5 REQUIREMENTS FOR PLANT PC4 FACILITIES
7.5.1 General
7.5.2 Construction
7.5.3 Ventilation
7.5.4 Work practices
7.5.5 Health monitoring
SECTION 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
8.3.5 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
SECTION 9 MICROBIOLOGICAL SPILLS
9.1 GENERAL
9.2 PLANNING
9.2.1 General
9.2.2 Emergency provisions for personnel
9.2.3 Clean-up materials and equipment
9.3 SPILLS INSIDE BIOLOGICAL SAFETY CABINETS
9.3.1 General
9.3.2 Small spills
9.3.3 Larger spills
9.4 SPILLS OUTSIDE BIOLOGICAL SAFETY CABINETS
9.4.1 General
9.4.2 Spills in PC2 facilities that can be cleaned up by the worker
9.4.3 Spills in PC2 facilities that should be cleaned up by a dedicated spills clean-up team
9.4.4 Spills in PC3 facilities
9.4.5 Spills in PC4 facilities where no positive pressure suit is worn
9.4.6 Spills in PC4 facilities where a positive pressure suit is worn
9.5 CENTRIFUGE SPILLS
SECTION 10 CHEMICALS, PPE AND SPECIAL EQUIPMENT
10.1 CHEMICALS
10.2 PERSONAL PROTECTIVE EQUIPMENT (PPE)
10.2.1 General
10.2.2 Laboratory coats, gowns, coveralls and aprons
10.2.3 Footwear
10.2.4 Eye and face protection
10.2.5 Respiratory protection
10.2.6 Gloves
10.3 CENTRIFUGES
10.3.1 General
10.3.2 Centrifuge use and maintenance
10.3.3 Centrifuges lacking aerosol containment
10.3.4 Centrifuge rooms
10.4 FREEZE-DRYING AND RECONSTITUTION OF CULTURES
10.5 LIQUID NITROGEN
10.6 PRESSURE STEAM STERILIZERS
10.6.1 General
10.6.2 Air removal methods for steam sterilizers
10.6.3 Downward-displacement steam sterilizers
10.6.4 Pre-vacuum (porous load) steam sterilizers
10.6.5 Times for sterilization
10.6.6 Monitoring of sterilization cycles
10.6.7 Chamber pressure relief valves
10.6.8 Barrier wall steam sterilizers
10.7 BIOLOGICAL SAFETY CABINETS
10.7.1 Class I and II BSCs
10.7.2 Class III BSCs
10.8 LAMINAR FLOW CYTOTOXIC DRUG SAFETY CABINETS
10.9 HEPA FILTERS
10.9.1 Specification
10.9.2 Installation and maintenance
SECTION 11 CLEANING
11.1 GENERAL
11.2 CLEANING PERSONNEL
11.3 CLEANING OF EQUIPMENT
11.4 WALLS AND SHELVES
11.5 FLOOR CLEANING
SECTION 12 CONTAMINATED MATERIALS AND WASTE
12.1 COLLECTION
12.2 DECONTAMINATION AND DISPOSAL OF WASTES
12.2.1 General
12.2.2 Validation of waste decontamination processes
12.2.3 Decontamination methods
12.2.4 Prions
12.2.5 Secondary contamination considerations
12.2.6 Uncontaminated waste
SECTION 13 TRANSPORT OF INFECTIOUS AND OTHER BIOLOGICAL MATERIALS
13.1 GENERAL
13.2 TRANSPORT REGULATIONS
13.3 TRANSPORT DEFINITIONS OF BIOLOGICAL MATERIALS
13.4 CLASSIFICATION AND PACKAGING
13.4.1 General
13.4.2 Infectious substances
13.4.3 Biological products
13.4.4 Genetically modified microorganisms and organisms
13.4.5 Medical or clinical wastes
13.5 TRANSPORT OF INFECTED ANIMALS
13.6 DOCUMENTATION
APPENDIX A - REFERENCED AND RELATED DOCUMENTS
A1 SCOPE
A2 REFERENCED DOCUMENTS
A3 OTHER REFERENCED PUBLICATIONS
A4 RELATED DOCUMENTS
APPENDIX B - EXAMPLE MICROBIOLOGICAL INCIDENT/ILLNESS REPORT FORM
APPENDIX C - ADDITIONAL CONTAINMENT REQUIREMENTS FOR POLIOVIRUS
C1 SCOPE
C2 REQUIREMENTS
APPENDIX D - BIOLOGICAL HAZARD SIGNS
D1 BIOLOGICAL HAZARD SYMBOL
D2 GENERAL MICROBIOLOGICAL LABORATORY SIGN
APPENDIX E - WATER AND GAS SUPPLIES TO CONTAINMENT FACILITIES
E1 SCOPE
E2 WATER SUPPLIES
E2.1 Backflow prevention
E2.2 Looped services (e.g. water from reverse osmosis systems or demineralized water)
E3 GAS SERVICES
E3.1 General gas service requirements
E3.2 Backflow prevention
APPENDIX F - CHEMICAL DISINFECTANTS
F1 INTRODUCTION
F2 SUSCEPTIBILITY OF MICROORGANISMS
F3 TYPES OF CHEMICAL DISINFECTANTS
F4 FACTORS AFFECTING ACTIVITY OF DISINFECTANTS
F5 CHOICE OF DISINFECTANT
F6 PROPERTIES OF COMMONLY-USED DISINFECTANTS
F6.1 Chlorine
F6.2 Iodine
F6.3 Formaldehyde
F6.4 Glutaraldehyde
F6.5 Peracetic acid
F6.6 Peroxygen biocides
F6.7 Hydrogen peroxide
F6.8 Chlorine dioxide
F6.9 Alcohols
F6.10 Phenolics
F6.11 Quaternary ammonium compounds
F6.12 Chlorhexidine
F6.13 Acids and alkalis
F6.14 Ortho-phthalaldehyde (OPA)
F7 CONTAMINATION OF DISINFECTANTS
APPENDIX G - EXAMPLES OF RECOMMENDED LAYOUTS FOR PC3 AND PC4 FACILITIES
APPENDIX H - RECOMMENDATIONS ON ACCEPTABLE ROOM AIRTIGHTNESS
H1 SCOPE
H2 INTRODUCTION
H3 AEROSOL CONTAINMENT
H4 LOSS OF AEROSOL AND GASEOUS CONTAINMENT
H5 DETERMINATION OF CONTAINMENT STRUCTURE INTEGRITY
H6 PRACTICAL APPLICATION OF CRITERIA
H7 STRUCTURAL AIR LEAKAGE TESTING
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References
Safety in laboratories - Recirculating fume cabinets
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AS/NZS 2243.3:2010 SAFETY IN LABORATORIES - MICROBIOLOGICAL SAFETY AND CONTAINMENT
PREFACE
CONTENTS
FOREWORD
SECTION 1 SCOPE AND GENERAL
1.1 SCOPE
1.2 OBJECTIVE
1.3 REFERENCED DOCUMENTS
1.4 DEFINITIONS
1.4.1 Aerosol
1.4.2 Airlock
1.4.3 Anteroom
1.4.4 Antiseptic
1.4.5 Aseptic technique
1.4.6 Biohazard
1.4.7 Biological safety cabinets
1.4.8 Biosafety
1.4.9 Biosafety committee (BC)
1.4.10 Change room
1.4.11 Competent person
1.4.12 Containment
1.4.13 Containment facility
1.4.14 Cross-contamination
1.4.15 Decontamination
1.4.16 Diagnostic specimen
1.4.17 Disinfectant
1.4.18 Exposure standard
1.4.19 HEPA filter
1.4.20 Infectious microorganism
1.4.21 Invertebrates
1.4.22 Microbiological hazard
1.4.23 Microbiological spill
1.4.24 Microorganisms
1.4.25 Pathogen
1.4.26 Personal protective equipment (PPE)
1.4.27 Prions
1.4.28 Risk assessment
1.4.29 Shall
1.4.30 Sharps
1.4.31 Should
1.4.32 Sterile
1.4.33 Sterilization
1.4.34 Viable
1.5 ABBREVIATIONS
SECTION 2 ORGANIZATION AND RESPONSIBILITY
2.1 RESPONSIBILITY
2.1.1 Management policy
2.1.2 Risk assessment
2.1.3 Organizational arrangements for the implementation and monitoring of biosafety
2.1.4 Safety officer(s)
2.1.5 Laboratory or facility supervisor
2.1.6 Personal responsibility
2.2 QUARANTINE MATERIALS
2.2.1 Australia
2.2.2 New Zealand
2.3 LABORATORIES USING GENETICALLY MODIFIED ORGANISMS (GMOs)
2.3.1 Australia
2.3.2 New Zealand
2.4 LABORATORY 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 Immunization
2.6.5 At-risk persons
2.6.6 Precautions for women
2.7 INCIDENT REPORTING
2.8 EMERGENCY RESPONSE AND CONTINGENCY PLANS
2.8.1 Emergency plan
2.8.2 Contingency plan
2.8.3 First aid kit
SECTION 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 animal infectious microorganisms
3.2.3 Plant infectious microorganisms
3.2.4 Invertebrates carrying microorganisms
3.3 RISK-GROUPING OF MICROORGANISMS BY TYPE
3.3.1 General
3.3.2 Human and animal infectious microorganism risk group examples
3.3.3 Plant pathogen risk group examples
3.3.4 Invertebrate 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
SECTION 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 LOCATION
SECTION 5 LABORATORY CONTAINMENT FACILITIES
5.1 LABORATORY PHYSICAL CONTAINMENT
5.2 REQUIREMENTS FOR PC1 LABORATORIES
5.2.1 General
5.2.2 Construction
5.2.3 Work practices
5.3 REQUIREMENTS FOR PC2 LABORATORIES
5.3.1 General
5.3.2 Multiple room PC2 facilities
5.3.3 Construction
5.3.4 Ventilation
5.3.5 Containment equipment
5.3.6 Work practices
5.4 REQUIREMENTS FOR PC3 LABORATORIES
5.4.1 General
5.4.2 Construction
5.4.3 Multiple room PC3 facilities
5.4.4 Laboratory ventilation
5.4.5 Access to services
5.4.6 Containment equipment
5.4.7 Work practices
5.4.8 Health monitoring
5.5 REQUIREMENTS FOR PC4 LABORATORIES
5.5.1 General
5.5.2 Construction
5.5.3 Ventilation
5.5.4 Containment equipment
5.5.5 Work practices
5.5.6 Health monitoring
SECTION 6 ANIMAL CONTAINMENT FACILITIES
6.1 REQUIREMENT FOR ANIMAL CONTAINMENT FACILITIES
6.2 PRINCIPLES OF ANIMAL CONTAINMENT
6.3 OTHER CONSIDERATIONS ASSOCIATED WITH ANIMAL CONTAINMENT
6.3.1 Designing facilities for different aspects of animal handling
6.3.2 The occurrence of allergic reactions in personnel handling animals
6.3.3 Air change rates for animal containment facilities
6.3.4 Decontamination and disposal of animal waste
6.3.5 Transport of animals and animal tissues between facilities
6.3.6 Dissection and post-mortem examinations
6.4 REQUIREMENTS FOR ANIMAL PC1 FACILITIES
6.4.1 General
6.4.2 Construction
6.4.3 Work practices
6.5 REQUIREMENTS FOR ANIMAL PC2 FACILITIES
6.5.1 General
6.5.2 Construction
6.5.3 Ventilation
6.5.4 Containment equipment
6.5.5 Work practices
6.6 REQUIREMENTS FOR 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 ANIMAL PC4 FACILITIES
6.7.1 General
6.7.2 Alternative locations for animal work
6.7.3 Construction
6.7.4 Ventilation
6.7.5 Containment equipment
6.7.6 Work practices
6.7.7 Health monitoring
SECTION 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
7.3.5 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
7.5 REQUIREMENTS FOR PLANT PC4 FACILITIES
7.5.1 General
7.5.2 Construction
7.5.3 Ventilation
7.5.4 Work practices
7.5.5 Health monitoring
SECTION 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
8.3.5 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
SECTION 9 MICROBIOLOGICAL SPILLS
9.1 GENERAL
9.2 PLANNING
9.2.1 General
9.2.2 Emergency provisions for personnel
9.2.3 Clean-up materials and equipment
9.3 SPILLS INSIDE BIOLOGICAL SAFETY CABINETS
9.3.1 General
9.3.2 Small spills
9.3.3 Larger spills
9.4 SPILLS OUTSIDE BIOLOGICAL SAFETY CABINETS
9.4.1 General
9.4.2 Spills in PC2 facilities that can be cleaned up by the worker
9.4.3 Spills in PC2 facilities that should be cleaned up by a dedicated spills clean-up team
9.4.4 Spills in PC3 facilities
9.4.5 Spills in PC4 facilities where no positive pressure suit is worn
9.4.6 Spills in PC4 facilities where a positive pressure suit is worn
9.5 CENTRIFUGE SPILLS
SECTION 10 CHEMICALS, PPE AND SPECIAL EQUIPMENT
10.1 CHEMICALS
10.2 PERSONAL PROTECTIVE EQUIPMENT (PPE)
10.2.1 General
10.2.2 Laboratory coats, gowns, coveralls and aprons
10.2.3 Footwear
10.2.4 Eye and face protection
10.2.5 Respiratory protection
10.2.6 Gloves
10.3 CENTRIFUGES
10.3.1 General
10.3.2 Centrifuge use and maintenance
10.3.3 Centrifuges lacking aerosol containment
10.3.4 Centrifuge rooms
10.4 FREEZE-DRYING AND RECONSTITUTION OF CULTURES
10.5 LIQUID NITROGEN
10.6 PRESSURE STEAM STERILIZERS
10.6.1 General
10.6.2 Air removal methods for steam sterilizers
10.6.3 Downward-displacement steam sterilizers
10.6.4 Pre-vacuum (porous load) steam sterilizers
10.6.5 Times for sterilization
10.6.6 Monitoring of sterilization cycles
10.6.7 Chamber pressure relief valves
10.6.8 Barrier wall steam sterilizers
10.7 BIOLOGICAL SAFETY CABINETS
10.7.1 Class I and II BSCs
10.7.2 Class III BSCs
10.8 LAMINAR FLOW CYTOTOXIC DRUG SAFETY CABINETS
10.9 HEPA FILTERS
10.9.1 Specification
10.9.2 Installation and maintenance
SECTION 11 CLEANING
11.1 GENERAL
11.2 CLEANING PERSONNEL
11.3 CLEANING OF EQUIPMENT
11.4 WALLS AND SHELVES
11.5 FLOOR CLEANING
SECTION 12 CONTAMINATED MATERIALS AND WASTE
12.1 COLLECTION
12.2 DECONTAMINATION AND DISPOSAL OF WASTES
12.2.1 General
12.2.2 Validation of waste decontamination processes
12.2.3 Decontamination methods
12.2.4 Prions
12.2.5 Secondary contamination considerations
12.2.6 Uncontaminated waste
SECTION 13 TRANSPORT OF INFECTIOUS AND OTHER BIOLOGICAL MATERIALS
13.1 GENERAL
13.2 TRANSPORT REGULATIONS
13.3 TRANSPORT DEFINITIONS OF BIOLOGICAL MATERIALS
13.4 CLASSIFICATION AND PACKAGING
13.4.1 General
13.4.2 Infectious substances
13.4.3 Biological products
13.4.4 Genetically modified microorganisms and organisms
13.4.5 Medical or clinical wastes
13.5 TRANSPORT OF INFECTED ANIMALS
13.6 DOCUMENTATION
APPENDIX A - REFERENCED AND RELATED DOCUMENTS
A1 SCOPE
A2 REFERENCED DOCUMENTS
A3 OTHER REFERENCED PUBLICATIONS
A4 RELATED DOCUMENTS
APPENDIX B - EXAMPLE MICROBIOLOGICAL INCIDENT/ILLNESS REPORT FORM
APPENDIX C - ADDITIONAL CONTAINMENT REQUIREMENTS FOR POLIOVIRUS
C1 SCOPE
C2 REQUIREMENTS
APPENDIX D - BIOLOGICAL HAZARD SIGNS
D1 BIOLOGICAL HAZARD SYMBOL
D2 GENERAL MICROBIOLOGICAL LABORATORY SIGN
APPENDIX E - WATER AND GAS SUPPLIES TO CONTAINMENT FACILITIES
E1 SCOPE
E2 WATER SUPPLIES
E2.1 Backflow prevention
E2.2 Looped services (e.g. water from reverse osmosis systems or demineralized water)
E3 GAS SERVICES
E3.1 General gas service requirements
E3.2 Backflow prevention
APPENDIX F - CHEMICAL DISINFECTANTS
F1 INTRODUCTION
F2 SUSCEPTIBILITY OF MICROORGANISMS
F3 TYPES OF CHEMICAL DISINFECTANTS
F4 FACTORS AFFECTING ACTIVITY OF DISINFECTANTS
F5 CHOICE OF DISINFECTANT
F6 PROPERTIES OF COMMONLY-USED DISINFECTANTS
F6.1 Chlorine
F6.2 Iodine
F6.3 Formaldehyde
F6.4 Glutaraldehyde
F6.5 Peracetic acid
F6.6 Peroxygen biocides
F6.7 Hydrogen peroxide
F6.8 Chlorine dioxide
F6.9 Alcohols
F6.10 Phenolics
F6.11 Quaternary ammonium compounds
F6.12 Chlorhexidine
F6.13 Acids and alkalis
F6.14 Ortho-phthalaldehyde (OPA)
F7 CONTAMINATION OF DISINFECTANTS
APPENDIX G - EXAMPLES OF RECOMMENDED LAYOUTS FOR PC3 AND PC4 FACILITIES
APPENDIX H - RECOMMENDATIONS ON ACCEPTABLE ROOM AIRTIGHTNESS
H1 SCOPE
H2 INTRODUCTION
H3 AEROSOL CONTAINMENT
H4 LOSS OF AEROSOL AND GASEOUS CONTAINMENT
H5 DETERMINATION OF CONTAINMENT STRUCTURE INTEGRITY
H6 PRACTICAL APPLICATION OF CRITERIA
H7 STRUCTURAL AIR LEAKAGE TESTING
Previous versions
AS/NZS 2243.3:2010
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