Presented By: Zibusiso M. Masuku
Facilities & Safety: Biosafety and Biosecurity
Welcome
Welcome to the Facilities & Safety: Biosafety and
Bio Security Module
2
Module Outline
Facilities & Safety Biosafety and biosecurity
Biorisk Management The main elements of biosafety Risk assessment defined Biosafety level requirements Develop laboratory floor plans – exercise Wrap-up
Module Objectives
At the end of this module, participants will be able to: Be familiar with the drivers of safety in the laboratory; Be familiar with the general safety requirements for the laboratory; Understand the concept of biosafety and biosecurity (as elements of
Biorisk Management), and describe the main elements in biocontainment; Identify the differences between biosafety levels 1-4, and understand the
criteria and requirements for determining the appropriate biosafety; Understand the different laboratory equipment used in biocontainment
facilities.
Activity: Pre-Presentation Questionnaire
Instructions: Individually, complete the Pre-Presentation Questionnaire in your guide. Take 5 minutes
Facility & Safety Overview
The primary objective is for laboratory facilities to be safe, and an accessible environment for personnel to conduct their work. The key is to reduce injury and/or illness. Minimise hazards. To ensure quality of work
Legal requirements.
Safety Institution: Oversight & Enforcement
Laboratory safety drivers – compliance to legislation and regulations; quality standards and for accreditation. Examples of these include the following:
Occupational Health and Safety Act 85 of 1993. Regulations for Hazardous Biological Agents 2001. Clinical Laboratory Standards Institute (CLSI – formally NCCLS). ISO15189:2012 Checklist For Medical Laboratories (SANAS
accreditation). WHO Laboratory Assessment Toolkit.
Roles and Responsibilities
These should be clearly defined for the entire institute: Management Laboratory personnel Committees, e.g. Safety Committee Support services
General Requirements for Laboratories
To ensure the safety of personnel (including the environment) and the quality of work, the following requirements have to be met: Administrative controls – including Good Lab Practices (GLP), SOP’s, and
accident management plans; Engineering controls - building and laboratory design considerations (e.g.
controlled ventilation systems); Safety Equipment and PPE – must be appropriate for tasks General lab safety procedures – including physical, biohazard, fire, chemical
and electrical safety Waste management/handling procedures – treatment and disposal (from
“cradle-to-grave”).
Ref: Mycobacteriology Laboratory Manual, 1st Edition, 2014
Standard Safety Practices
NO IN LABORATORY
Standard Safety Practices (continued…)
YES IN LABORATORY
Standard Safety Practices (continued…)
YES IN LABORATORY
Use separate waste containers (usually colour coded) for all potentially harmful and dangerous materials.
Waste Management Fire and Evacuation Drills
Monthly and yearly exercises must be organized for fire drills and laboratory evacuation procedures.
Safety Signs
Warning and instruction labels must be visible.
Documentation
Risk Assessment and Hazard Identification. Laboratory Safety Manual. Records of (but not limited to):
Staff training Equipment servicing Equipment calibration
Identification of Risks
Risks in laboratories may be numerous and laboratory workers encounter these risks. A Risk assessment is compulsory for the laboratory director in order to
manage and reduce risks to laboratory employees.
Safety procedures explaining what to do in case of accidents, injuries and contamination need to be written, staff must be trained and have easy access to all procedures.
Record of staff exposures to hazards, actions taken when this occurs, and procedures put into place must be maintained so as to prevent future occurrences.
Laboratory Hazards
Physical Chemical Biological
Physical and Biological Hazards
Physical Hazards: Handling equipment and poor maintenance
Biological Hazards: Aerosols and droplets are the main sources of contamination
Image: WHO: Training Toolkit
Chemical Hazards
Separate cabinets for storage:
Spill containment cabinet Hazardous waste storage Flammable liquids storage
Biosafety & Biosecurity in Laboratories – Levels 1 - 4
The prevention of exposures, occupationally acquired infections, and release of organisms to the environment by laboratory workers in the biomedical environment.
The fundamental objective being the containment of the potentially harmful agents.
What is Biosafety?
Standard microbiological practices
Special practices
Safety equipment (Primary Containment Barriers)
Laboratory facilities (Secondary Containment Barriers)
Elements of Biosafety
The protection of pathogens, toxins, and sensitive information from loss, theft and subsequent misuse.
What is Biosecurity?
The risk associated with biological materials in the laboratory
Bio-risk encompasses biosafety and biosecurity
CWA 15793 outlines a comprehensive, international bio-risk management
system framework
Bio-risk
What is Bio-containment?
Describes safe methods, facilities and equipment for managing infectious
agents in the laboratory
Purpose is to reduce or eliminate exposure of laboratory workers and outside environment to potentially hazardous agents
Elements of Biocontainment
Practices and Procedures
Facility Design Safety Equipment
The proper mix of the three elements is
assessed by the needs and specific hazards of
the facility
Plus Occupational Health
Primary barriers (safety equipment) BSCs- all procedures Personal Protective Equipment (PPE) Isolators and Ventilated Racks
Secondary barriers (facilities)
Design parameters to protect people surrounding the laboratory and the community
Separate building or isolated zone
Special HVAC systems and controls
Containment Barriers
Strategies Using
Inward directional airflow
Isolation dampers
Sealing service penetrations
Backflow prevention
Filtration
Standard Operating Procedures
Achieving Containment
Lab Ante Rm
Sterilizer
BSC
Primary Containment
Secondary Containment
Biological Safety Cabinet (BSC)
Autoclaves
Isolators
Ventilated Cages
Transfer Chambers
Dunk Tanks
Sinks
Laboratory Equipment
Safety Equipment
Personal Protective Equipment (PPE)
Safety Equipment (continued…)
Waste disposal and safety cabinets
Safety Equipment (continued…)
Biological Safety Cabinets (BSCs)
Primary means of containment
Three (3) design types: Class I, Class II, and Class III
Designed to provide protection for: Personnel
Directional flow of air into cabinet
Environment HEPA filtered exhaust
Product (except for Class I) Laminar flow of HEPA filtered air
Safety Equipment (continued…)
Types of Biological Safety Cabinets
Class I BSC Class II BSC Class III BSC
Establishing BSL/ ABSL Levels
Performing a Risk Assessment The foundation of Biosafety and the basis for BSLs Perform a comprehensive hazard evaluation of the
hazard posed by the infectious agent
Determine additional safety enhancements based on the laboratory functions or activities
*N.B. The same risk assessment process can be followed when establishing ABSL facility levels
Risk Groups
*Biosafety in Microbiological and Biomedical Laboratories, 5th Edition
Risk Groups vs Biosafety Levels
Relation of risk group to biosafety levels, practices and equipment
*Laboratory Biosafety Manual, 3rd Edition
Biosafety level requirements
Summary of biosafety level requirements
*Laboratory Biosafety Manual, 3rd Edition
BSL-1
Agents not known to cause disease
(Bacillus subtilis, infectious canine hepatitis)
Utilize Standard Microbiological Procedures No Special Practices required Areas not separated from other areas
BSL-1 Laboratory
Hand washing sink Windows with fly screens Fume hoods Signage
BSL-2
Agents associated with human disease (Hepatitis B virus, Salmonella spp.)
Work involving agents that pose moderate hazards to personnel and the environment Personnel are trained to handle pathogens Restricted access while in operation Aerosol or splash-producing procedures are conducted in
containment equipment
BSL-2 (continued… )
In addition to BSL-1 requirements: “Site-Specific” Biosafety manual with Standard Operating Procedures
(include spill response and emergency procedures) Autoclave available Minimize procedures that cause splashes/aerosol formation Transport of materials in “special” containers
BSL-2 Laboratory
BSL-3 Laboratories
Designed for Risk Group 3 micro organisms: May be transmitted by the airborne route, indigenous/exotic agents
associated with human disease
Often have a low infectious dose to produce effects
Can cause serious or life-threatening disease
Yellow fever virus, Hantaan virus, TB
BSL-3 Laboratories (continued…)
In Addition to BSL-2 requirements: “Hands-free sink”
Restrict the use of “sharps” and glass
Wrap-around/solid-front gown, head covering and possibly shoe covers
Eye protection and possibly respiratory protection is worn
Decontaminate solid materials/waste prior to removal from the lab
Additional primary and secondary barriers to minimize the release of infectious organisms
Additional features to prevent transmission of BSL3 organisms: Appropriate respiratory protection HEPA filtration of exhausted laboratory air Strictly controlled laboratory access
BSL-3 Laboratories (continued…)
BSL-3 Laboratories (continued…)
Physically separate from access corridors
Self-closing double door Exhausted air is not re-circulated Negative airflow into laboratory
BSL-3 Laboratory
BSL-3 Laboratories (continued…)
BSL3 Laboratory: Layout Option A
*Public Health Agency Canada
BSL-3 Facility Design
Segregation from public access
Eyewash station
Sink for handwashing
Ventilation systems critical
BSL-3 Facility Design (continued…)
Slip-resistant floors Bench tops should be impervious to water and
resistant to disinfectants, acids, alkalis, organic solvents and moderate heat
Walls, ceilings, floors and furniture should be
easy to clean
BSL-3 Facility Design (continued…)
Z.M. Masuku
Directional inward airflow
Pressure monitoring devices at entry
Physical Laboratory Design
BSL-3 Facility Design (continued…)
Physical Laboratory Design Controlled access Antechamber equipped with clean/dirty change and body shower Interlocking entry doors Alarms for HVAC failure (indication devices in laboratory space) Decontamination – dunk tank, pass through box
BSL-3 Facility Design (continued…)
Physical Laboratory Design
Exhaust air HEPA filtered
Backflow prevention on supply air (bubble-tight dampers)
Directional airflow
BSL-3 Facility Design (continued…)
Physical Laboratory Design – Solid & Effluent Waste Sterilisation
Autoclave in laboratory (barrier design)
Kill Tanks
Designed for Risk Group 4 micro organisms:
Dangerous/exotic agents and high risk of life threatening nature, transmitted by aerosol or transmission unknown
All work done in a class III & II cabinet or positive pressure personnel suit
Facility is separated from other work areas Access is strictly control
Lassa fever virus, Ebola virus, Marburg virus, Rift Valley Fever, smallpox
BSL-4 Laboratories
BSL-4 Laboratories (continued…)
In Addition to BSL-3 requirements:
The Sign-in procedures to monitor personnel Clothing change before entering Shower upon exiting All material is decontaminated Other requirements as required by the risk assessment
BSL-4 Laboratories (continued…)
BSL-4 Design Special engineering and design features to prevent microorganism from escaping into environment Overheard floor(s) – contain ventilation systems with HEPA-filtered
supply and exhaust Underlying floor(s) - contain plumbing and effluent collection /
treatment system
Laboratory entrance and exit through: Clean change room, personal shower, dirty change room, suit Chemical shower room, enter laboratory
More strict access control (e.g., 24-hour guard and check in/out logbooks)
BSL-4 Laboratories (continued…)
Suit Laboratory
BSL-4 Laboratory
BSL-4 Laboratories (continued…)
BSL-4 Laboratory
Cabinet Laboratory
BSL-4 Laboratories (continued…)
BSL-4 Laboratory
BSL-4 Laboratories (continued…)
Laboratory Facilities Work in positive pressure suits Bioseal “submarine” doors Antechamber with suit room and chemical decontamination
shower
BSL-4 Laboratories (continued…)
Physical Laboratory Design
Double Exhaust HEPA Exhaust HVAC system Plumbing Vent Vacuum Lines Supply HVAC System (Single HEPA)
Verification of Biosafety Level 3 & 4
It is recommended that BSL-3 and BSL-4 lab design and operation be recertified, at least annually, to verify the design and operational parameters.
Laboratory Facilities
Activity: Laboratory Planning Exercise
Group Exercise Instructions: In your groups read through the Laboratory Planning Exercise scenario write-up. Develop a laboratory layout diagram for the equipment provided and present to the class. Take 40 minutes
Activity: Post-Presentation Questionnaire
Instructions: Individually, complete the Post-Presentation Questionnaire in your guide. Take 5 minutes
Summary & Key Messages
When designing a laboratory or organizing workflow, ensure that patients and patient samples do not have common pathways.
Safety is dependent on: A responsible supervisor A safety manual and sops Trained personnel Assessment of risks Laboratory design
Neglecting laboratory safety is costly, as the lives and health of employees and patients, laboratory reputation, equipment, and facilities are put at risk.
Summary & Key Messages (continued…)
Biosafety (prevention of the unintentional exposure to pathogens) and Biosecurity (prevention of the intentional release of pathogens) are both elements of Biorisk (risks associated with biological materials)
The main elements of biosafety are standard microbiological practices, special practices, safety equipment and facility design and construction
Risk assessment is the foundation and basis of BSLs and involves a comprehensive hazard evaluation of the hazard posed by the infectious agent
Acknowledgements
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The presentation on Biosafety and Biosecurity is modeled in part around the Define Biosafety & Biosafety Levels 1-4 module of the ACILT Strengthening Biosafety and Biosecurity course. This presentation was developed with the assistance of Mr. Ken Ugwu, P.Eng, Public Health Agency of Canada. Global Biorisk Management Curriculum (GBRMC) courses used for reference material. The Centre for Emerging and Zoonotic Diseases (CEZD)
Guidelines & Standards
References
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Laboratory Biosafety Manual, 3rd Edition Biosafety in Microbiological and Biomedical Laboratories, 5th Edition Laboratory Biosafety Guidelines, 3rd Edition Canadian Biosafety Standards and Guidelines, 1st Edition; WHO – TB Laboratory Safety Manual, 2012 ANSI/ASSE Z9.14 – 2014: Testing and Performance-Verification Methodologies for
Ventilation Systems for BSL3 and ABSL3 Facilities, 2014 The National Institutes of Health (NIH) Design Requirements Manual for Biomedical
Laboratories and Animal Research Facilities (DRM), 2008 CWA 15793: Laboratory Biorisk Management Standard; 2008
References
Wrap Up
Participants are now be able to: Explain general safety requirements for the laboratory; Discuss the concept of biosafety and biosecurity (as elements of Bio-risk
Management); Describe the main elements in bio-containment; Identify the differences between biosafety levels 1-4 and discuss the
classification of existing and planned facilities ; Describe the criteria and requirements for determining the appropriate
biosafety; Discuss the different laboratory equipment used in bio-containment
facilities; Describe the selection of PPE and laboratory equipment;
Questions