Table of  Contents

Chapter 1
Introduction. . . . . . .  . 1
Chapter 2
Biological Safety. . . . . . .  . 4
2.1 Risk Groups .. . . . . . .  .  4
2.2 Containment Levels. . . . . . .  . 5
2.3 Risk Assessment. . . . . . .  . 7
2.4 Health and Medical Surveillance . . . . . 9
2.5 Management of Biological Safety . . . . . 10
2.6 Biosecurity . . . . . . . . . . 12
Chapter 3
Handling Infectious Substances. . . . . .  18
3.1 Operational Practices for Laboratories . . . 19
3.1.1 General Practices. . . . . . . .  19
3.1.2 Containment Level 2. . . . . . . 22
3.1.3 Containment Level 3. . . . . . . 23
3.1.4 Containment Level 4. . . . . .. 26
Chapter 4
Laboratory Design and Physical Requirements . . . 30
4.1 Matrix 1: Laboratory Location and Access . . . . 30
4.2 Matrix 2: Surface Finishes and Casework . . . . 33
4.3 Matrix 3: Heating, Ventilation and
Air Conditioning . . . . . . . . . . . . . . . . . . 35
4.4 Matrix 4: Containment Perimeter . . . . . . . . . 39
4.5 Matrix 5: Laboratory Services . . . . . . . . . . . 41
Chapter 5
Commissioning, Certification and Recertification
for CL3 and CL4 Laboratories. . . . . . . . . . . . . 46
5.1 Introduction . . . . . . . . . . . . . . . . . . . . . 46
5.1.1 Commissioning. . . . . . . . . . . . . . . . . 46
5.1.2 Certification . . . . . . . . . . . . . . . . . . 47
5.1.3 Recertification . . . . . . . . . . . . . . . . . 47
5.2 Room Integrity . . . . . . . . . . . . . . . . . . . 48
5.2.1 Matrix 6: Room Integrity . . . . . . . . . . . 48
5.2.2 Room Pressure Decay Testing . . . . . . . . . 49
5.3 Air Handling Systems . . . . . . . . . . . . . . . 50
5.3.1 Matrix 7: Air Handling Systems . . . . . . . 51
5.4 Matrix 8: Laboratory Equipment and Services . . 54
Chapter 6
Large Scale Production of Microorganisms . . . . . 57
6.1 Introduction . . . . . . . . . . . . . . . . . . . . . 57
6.2 Scope . . . . . . . . . . . . . . . . . . . . . . . . . 58
6.3 Operational Practices and Physical
Requirements . . . . . . . . . . . . . . . . . . . . 58
6.3.1 Containment Level 1 Large Scale . . . . . . . 58
6.3.2 Containment Level 2 Large Scale . . . . . . . 60
6.3.3 Containment Level 3 Large Scale . . . . . . . 61
Chapter 7
Program Specific Guidelines . . . . . . . . . . . . . 63
7.1 Laboratory animals . . . . . . . . . . . . . . . . . 63
7.1.1 General Requirements . . . . . . . . . . . . . 63
7.1.2 Non-human Primates . . . . . . . . . . . . . 65
7.2 Recombinant DNA and Genetic Manipulation . 68
7.3 Cell Lines. . . . . . . . . . . . . . . . . . . . . . . 70
7.3.1 Risk Assessment . . . . . . . . . . . . . . . . 71
7.3.2 Contamination with Infectious Agents . . . . 72
7.3.3 Self-Self Experiments . . . . . . . . . . . . . 75
Chapter 8
Decontamination . . . . . . . . . . . . . . . . . . . . 78
8.1 Introduction . . . . . . . . . . . . . . . . . . . . . 78
8.2 Autoclaves . . . . . . . . . . . . . . . . . . . . . . 79
8.3 Chemical Disinfection . . . . . . . . . . . . . . . 80
8.4 Gaseous Decontamination of Rooms . . . . . . . 82
8.5 Liquid Effluent Treatment Systems . . . . . . . . 83
8.6 Irradiation . . . . . . . . . . . . . . . . . . . . . . 83
8.7 Incineration . . . . . . . . . . . . . . . . . . . . . 84
8.8 New Technologies. . . . . . . . . . . . . . . . . . 85
Chapter 9
Biological Safety Cabinets . . . . . . . . . . . . . . . 88
9.1 Introduction . . . . . . . . . . . . . . . . . . . . . 88
9.2 Classes and Characteristics of Biological
Safety Cabinets . . . . . . . . . . . . . . . . . . . 88
9.3 Installation and Certification. . . . . . . . . . . . 91
9.4 Use of the Cabinet. . . . . . . . . . . . . . . . . . 93
Chapter 10
Regulatory Aspects for Handling Infectious
Substances. . . . . . . . . . . . . . . . . . . . . . . . 103
10.1 Importation and Transfer of Human
Pathogens . . . . . . . . . . . . . . . . . . . . . . 103
10.2 Export of Pathogens. . . . . . . . . . . . . . . . . 104
10.3 Transportation. . . . . . . . . . . . . . . . . . . . 105
10.4 Importation, Transfer, and Containment
of Animal Pathogens . . . . . . . . . . . . . . . . 106
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . 109