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