Summary

The first training manual for new staff working in BSL3/4 labs.

This guide is based on a course developed in 2007 by the EU COST action group 28b which serves as a standard for many courses BSL3/4 training courses worldwide. The four-day course consists of lectures and practical training with the lecturers covering all the different possibilities of organising a BSL-3/4 lab including the adaptation to the local requirements of biosafety, safety at work, and social regulations.

This book covers bio-containment, hazard criteria and categorisation of microbes, technical specifications of BSL-3 laboratories and ABSL-3 laboratories, personal protective gear, shipping BSL-3 and BSL-4 organisms according to UN and IATA regulations, efficacy of inactivation procedures, fumigation, learning from a history of lab accidents, handling samples that arrive for diagnostic testing and bridging the gap between the requirements of bio-containment and diagnostics. Course participants can not only use the book for their actual training event but it will remain a useful reference throughout their career in BSL3/4 labs.

Author Biography

Mandy C. Elschner is a researcher at the Friedrich-Loeffler-Institute, Federal Research Institute for Animal Health, Institute for Bacterial Infections and Zoonoses, Jena, Germany. She leads the working group ?BSL 3-agents? and is the head of the Reference Laboratories for Glanders and Anthrax. She obtained her academic degree at the University of Leipzig and authored and co-authored in 25 national and international publications.

Patrick Butaye is a senior researcher active at the Veterinary and Agrochemical Research center and a professor at the University of Ghent, Faculty of Veterinary medicine. He obtained his academic degrees at the University of Ghent. He authored and co-authored in more than 70 international scientific publications.

Manfred Weidmann is a senior scientist at the Department of Virology of the University Medical Center Göttingen Germany. He obtained his degree from the Johannes-Gutenberg University of Mainz working on the pathogenesis of Clostridium difficille. Ever since he has worked on developing rapid diagnostic tools for the detection of arboviruses and haemorrhagic fever viruses in cooperation with partners from third world countries. He obtained the 2003 Abbot Diagnostic Award. He authored and co-authored 28 international scientific publications.

Nigel Silman is the Strategic Coordinator for Research & Development at the Health Protection Agencys? Centre for Emergency Preparedness & Response at Porton Down in the UK. He is the HPA research lead for Diagnostics and Detection and also responsible for the scientific overview of specialist reference and contract microbiology services for a range of exotic & emerging infectious diseases. He has authored and co-authored 26 international scientific publications.

Acknowledgement X

Preface XI

List of Contributors XIII

Introduction 1
Manfred Weidmann

References 3

1 Laboratory Biosafety in Containment Laboratories 5
Annette A. Kraus and Ali Mirazimi

1.1 Routes of Infection 5

1.2 Classification of Microorganisms 6

1.3 General Containment Principles 7

1.4 Specific Containment Principles 7

1.4.1 Biosafety Level 1 Laboratory 8

1.4.2 Biosafety Level 2 Laboratory 8

1.4.3 Biosafety Level 3 Laboratory 8

1.4.4 Biosafety Level 4 Laboratory 9

1.5 Design of a Suit-Based-BSL-4 Laboratory with Negative Pressure 9

1.6 Safety Routines 11

Summary 11

References 12

2 Hazard Criteria and Categorization of Microbes Classification Systems 13
Nigel Silman

2.1 Facility Requirements 16

2.2 Exceptions to the Rules 18

Summary 19

3 Technical and Practical Aspects of BSL-3 Laboratories 21
Frank T. Hufert and Manfred Weidmann

3.1 Technical Aspects–Facilities, Secondary Barriers 21

3.1.1 Air Filtration Systems 23

3.1.2 Water 23

3.1.3 Fire Protection 24

3.2 Practical Aspects–Safety Equipment, Primary Barriers 25

3.2.1 Staff 25

3.3 Personal Protective Equipment (PPE) 25

3.3.1 Primary Barriers and Working Procedures 26

Summary 29

References 29

4 Animal Biosafety Level 3 Facility – Enhancements When Dealing with Large Animals 31
Francesc Xavier Abad, David Solanes, and Mariano Domingo

4.1 Enhancements to Upgrade a Standard Animal ABSL-3 Facility to a LABSL-3 Facility Housing Large Animals 33

4.2 Additional Recommendations 36

Summary 38

References 38

5 Personal Protective Equipment 41
Nigel Silman

5.1 Definitions 41

5.2 Regulatory Background 41

5.3 Routes of Entry and Types of PPE 42

5.4 Use of PPE 45

Summary 45

6 Shipping of Infectious Substances According IATA-DGR Regulations 47
Mandy Elschner and Martin Heller

6.1 Introduction 47

6.2 Classifications and UN Code 47

6.3 Limitations 49

6.4 Packaging 49

6.5 Packing Instruction 650 for Biological Substance, Category B 51

6.6 Packing Instruction 620 for Infectious Substance, Category A; UN 2814 and UN 2900 53

6.7 Packing Instruction 904 (UN 1845) for Dry Ice 55

6.8 Documentation 56

Summary 58

References 58

7 Disinfection and Decontamination 59
Patrick Butaye

7.1 Introduction 59

7.2 Ways of Decontamination/Disinfection 60

7.3 Physical Disinfection/Decontamination 61

7.4 Irradiation 61

7.5 Factors Influencing Chemical Disinfection/Decontamination 62

7.5.1 Temperature 62

7.5.2 Time of Contact 62

7.5.3 Microorganism 63

7.5.4 Surface Type (Absorbant vs Nonabsorbant) 63

7.5.5 Liquid 63

7.5.6 pH 64

7.5.7 Presence and Type of Dirt 64

7.5.8 Concentration of the Product 64

7.5.9 High-Pressure Water Cleaning 64

7.5.10 Water Used 65

7.5.11 Mechanism/Methods of Decontamination 65

7.5.12 Inoculum Concentration 65

7.6 Testing the Activity of a Certain Product 65

7.6.1 Physical Disinfection 65

7.6.2 Chemical Disinfection 66

7.6.2.1 Introduction 66

7.6.2.2 Phase 1 Studies 66

7.6.2.3 Phase 2 Studies 67

7.6.2.4 Phase 3 Studies 68

7.7 Chemical Compounds Used as Disinfectants 69

7.7.1 Introduction 69

7.7.2 Phenols 69

7.7.3 Chlorine Derivatives 69

7.7.4 Iodophores 70

7.7.5 Quaternary Ammonium Compounds 70

7.7.6 Amphoteres 70

7.7.7 Aldehydes 71

7.7.8 Calcium Oxide, Lime 71

7.7.9 Alcohols 71

7.7.10 Chlorhexidine 72

7.7.11 Peroxides 72

7.7.12 Peracetic Acid 72

7.7.13 Sodium Hydroxide 72

7.8 Conclusion 73

Summary 73

References 73

8 Fumigation of Spaces 75
Nigel Silman

8.1 Definitions 75

8.2 Practicalities 76

8.3 Fumigation Process 76

8.4 Validation of Fumigation 79

8.5 Post-Fumigation 80

8.6 Fumigation of Cabinets 81

8.7 Emergency Plans 82

8.8 Conclusions 82

Summary 82

9 Learning from a History of Laboratory Accidents 83
Manfred Weidmann

9.1 Introduction 83

9.2 Strains 83

9.3 Eye Protection 84

9.4 Necropsies, Animal Experiments, and Sharps 85

9.5 Skin Protection 86

9.6 The Omnipresence of Aerosol 87

9.7 Centrifugation 89

9.8 Spills 89

9.9 Laboratory Accident Statistics 90

Summary 91

References 91

10 Bridging the Gap between Requirements of Biocontainment and Diagnostics 95
Manfred Weidmann, Frank T. Hufert, and Nigel Silman

Summary 97

References 97

11 Risk Assessment Procedures 99
¢ªAsa S. Bj¨orndal

11.1 Introduction 99

11.2 Risk Identification 100

11.2.1 Timing of Assessment 100

11.2.2 A Qualitative Risk Assessment 100

11.2.3 Systematic Documentation 101

11.3 Additional Points for General Risk 102

Summary 105

Supplemental Materials

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