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Biosafety Dr Rosaleen Devery
Biosafety
Dr Rosaleen Devery
Biosafety : Keeping lab workers, the community and environment safe • Incentive for development of advanced Biotechnologies
• Mosquito control, agriculture, pollution remediation, mining, biofuels, medications that use synthetic organisms, recreation of extinct animals
• Prevent accidents/lab failures
• Biosafety training is not yet championed (contrast to biological research)
• How can biosafety advice get to people who need it?
• Lab accidents with highly transmissible agents have potential to become a public health emergency of international concern
Multiple high profile safety failures reported to date • Discovery of glass vials containing live variola (smallpox) virus at US FDA https://www.washingtonpost.com/national/health-science/smallpox-vials-found-in-storage-room-of-nih-campus-in-bethesda/2014/07/08/bfdc284a-06d2-11e4-8a6a-19355c7e870a_story.html?utm_term=.e64fae93aefe
• Poor inventory management
• Samples of live anthrax shipped to unregistered centres https://www.sciencealert.com/pentagon-admits-it-accidentally-sent-live-anthrax-to-nearly-200-labs-across-the-world
• Bio-errors may occur more frequently if more people are able to work on
infectious diseases
Intrinsic biosafety
• Biosafety is built into the organism • Synthetic organisms can’t escape boundaries • Engineer organisms so that they are not able to survive without specific human intervention
(supply nutrient essential for life)
• How can we reduce and prevent accidents in the lab? • Set up a no fault reporting system (as in aviation industry)
• Need for procedural studies • Proper protocols to inactivate anthrax spores, which equipment works best? which PPE?)
• Need for behavioural studies • How best to instill a safety culture in lab? What is best training material for each skill level of
scientist? How can lab be inspected in such a way as to be supportive and improve safety over time? How to promote safe practices in routinized biological lab environments?
• Comparative Studies • Determine safety level for different lab practices, engineering, lab set ups, equipment
All organisms (especially animals and humans) are incubators for disease-causing organisms.
Causes of biological diseases.
Virus Bacteria /
Toxins Fungi Parasites Prions
Biosafety: an introduction
Risk Awareness
• Biosafety – “safety measures taken with respect to the effects of biological research on humans, animals, plants and the environment”
• Keeping you and others safe from biological hazards and meeting statutory requirements.
Biosafety: definition
• Contact with human products, e.g. blood, saliva, urine, tissue.
• Contact with humans.
• Contact with human/animal cells/microbes.
Exposure to biohazards
Organism must get onto/into body in sufficient amount and begin to grow.
Mechanisms
• Ingestion.
• Inhalation – aerosol.
• Puncture wounds –needles/glass ware.
• Direct contact.
• Mucous membranes – especially eyes and nose.
Mechanisms of introduction
Hazard Awareness
Risk Management (Biosafety).
PPE
GLP
Biosafety: risk reduction
Personal protective equipment (PPE)
Risk Awareness
Personal protective equipment (PPE)
• Laboratory coats are to be worn in the laboratory ONLY.
• Do not wear around office or eating areas.
• Laboratory reagents can spill onto toes.
• Never eat or drink near samples/laboratory environment.
• Wash your hands thoroughly before and after laboratory procedures.
• Ensure you have appropriate vaccination (e.g. tetanus, hepatitis, TB).
• Manage the use of sharps.
• Appropriate waste handling (labelling, autoclaving, incineration).
• Be aware of the location of your nearest first-aid box.
Universal precautions
Risk Awareness
Good laboratory practice
• All labs/areas where, for example, blood or blood products are used will be identified with Biological Hazard Sign(s) and/or the floor area will be identified with tape.
• Ensure that bags are stored appropriately.
• Please hang coats in the correct places!
• Ensure all material is correctly labelled.
Housekeeping
Containment
Engineering controls
Risk Awareness
Vaccination policy
http://www.dcu.ie/sites/default/files/safety/pdfs/vacination_policy.pdf
Hazard Groups (HG)
A biological agent unlikely to cause
human disease to employees
HG / Class 1:
Environmentally-Common
A biological agent that
can cause human disease and might be
a hazard to employees
HG / Class 2:
Hazardous through unusual exposure
A biological agent that
can cause severe human disease and presents a serious
hazard to employees and which may present
a risk of spreading to the community
HG / Class 3:
Known to cause serious human or
animal disease
A biological agent that causes severe human
disease and is a serious hazard to
employees and which may present a high risk of spreading to
the community
HG / Class 4:
Known to cause fatal human or animal
disease
Working with Pathogens
Hazard Group
1 2 3 4
Pathogenic to humans
Unlikely Can be Yes, can be severe
Severe
Hazard to workers
n/a May be Yes, may be serious
Serious
Transmission to the community
n/a Unlikely May be Likely
Effective prophylaxis/ treatment available
n/a Usually Usually Not Usually
Classification Guideline: http://www.hsa.ie/eng/Publications_and_Forms/Publications/Codes_of_Practice/Code_of_Practice_Biological_Agents_SI_572.pdf
• Major risk – hepatitis B (1/4 world population infected).
• Main pathogen of interest.
• Highly infectious (infections with very low pathogen numbers).
• Can produce self-limiting disease but also can be fatal.
• Hep C, D, E, F and G.
• Impact varies patient to patient and dependent on underlying
health status
Blood-borne pathogens.
Containment
Biological Safety Cabinets
Not to be confused with Fume Hoods
• Protects the operator
• No protection for contents
• Class I cabinets are not fantastic!!
• Quite robust
• Watch out for positive-pressure cabinets !
• These are NOT Biosafety Cabinets !
Class I Biological Safety Cabinets.
Class II Biological Safety Cabinets.
Protects the operator and the environment
Slight net inflow of air
Depends for its efficacy on laminar air flow within the cabinet and a protective “curtain” of air at the front
Not very robust
Laminar air flow is easily disrupted
Protective air curtain is easily breached
Class II Biological Safety Cabinets.
HEPA
HEPA
Fan
HEPA High-Efficiency Particulate Air/Arrestance
Class II Biological Safety Cabinets are the most in use bio-containment devices protecting worker, product and environment from potentially dangerous microbiological agents. They are designed to control airborne contamination of the work and reduce risks of exposure of the operator to any airborne particles dispersed within the cabinet from the work procedures. http://www.biologicalsafetycabinet.co.uk/
Class II Biological Safety Cabinets.
Class II Biological Safety Cabinets.
Class III Biological Safety Cabinets.
Very robust
Completely enclosed
Provides total protection for the operator, the environment and the contents
Cumbersome to use
Class III Biological Safety Cabinets.
HEPA
HEPA
Glove Port
Class III Safety Cabinets provide total barrier protection for the operator and are suitable for extreme bio-hazard work. Inflow air is HEPA filtered before entering via a side-mounted inlet filter chamber. Exhaust air is HEPA filtered before leaving the safety cabinet via a single or double HEPA filter, dependant on the customer’s specific technical requirements. • Total enclosure of the working area • User separated from the work by a physical barrier • Filtered air continuously supplied to the safety cabinet • Exhaust air treated to prevent contamination • Creates total protection for user and materials
http://www.biologicalsafetycabinet.co.uk/
Tips When Using BSCs.
DO:
Allow air flow to stabilise prior to commencing work.
Prepare thoroughly for your work.
Reduce the risk of contamination by bringing all materials into the cabinet prior to disinfection/stabilisation.
Have appropriate disinfectants.
Ethanol/IMS
Ensure the laboratory door is closed.
Work as close to the centre of the hood as possible.
DO NOT:
Overcrowd or obstruct air flow.
Mix sterile and non-sterile materials.
Use safety cabinets for storage.
Rely on the cabinet to compensate for poor practice!
Tips When Using BSCs.
Risk Assessment
DCU Process: Biological Agents
• “It is the duty of every employer to ensure the safety, health and welfare of his or her employees”
And requires the employer to:
• Identify hazards.
• Assess risks.
• Eliminate or control exposure to risks.
• Protect human health and safety.
Safety, Health and Welfare at Work Act (2005).
Legislation.
• Biological safety is covered in general and specific terms in the Health and Safety at Work acts.
• Faculty - Biosafety overseen by Faculty Biological Safety Committee
Primary Contact: Dr. Rosaleen Devery, School of Biotechnology.
Email: [email protected]
1. Visit the DCU Faculty of Science & Health webpage.
http://dcu.ie/science_and_health/index.shtml
2. Click on Safety Information
DCU Process: Biological Agents
1. View the section entitled: GMO & Biological Hazards.
DCU Process: Biological Agents
Primary Recommendation: FAQ Section
Biological Agent Risk assessment
Slightly Harmful
Harmful Very Harmful
Unlikely Trivial Acceptable Medium
Likely Acceptable
Medium Substantial
Very Likely Medium Substantial Intolerable
Agent Name/ Hazardous Procedure
Potential Injury loss
Severity Rating
Liklihood Rating
Risk Rating
…..
……
Hazard Context
Reasons Considered a
Hazard
Hazardous Procedures/Activities Persons at Risk
Potential Injury/Loss
Current Controls/Precautions
Waste management
strategies Are All Risks Acceptable? Risk assessment Date
Lab safety Audit Check
Research Lab Name and No.: Auditors:
Lab Safety Rep: Date of Inspection:
No Question Yes
No
NA
BIOLOGICAL AGENTS
1 Do you have a complete inventory of biological agents
2 Has the HSA/EPA been notified of your biological agents. Show the
documentation?
3 Are risk assessments available for all biological agents?
CHEMICALS
4 Chemicals stored by compatibility?
5 Chemicals not stored on floor?
6 Are containers of chemicals clearly labelled and dated?
7 Are chemicals kept in appropriate storage areas?
8 Are chemical spill kits available?
9 Are solvents stored appropriately?
10 A current complete inventory of chemicals should be in the lab?
RISK ASSESSMENTS AND SDS’S
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Are SDS’s available for all chemicals?
Are SDS’s easily accessible?
Are risk assessments sheets available for all chemicals? Are risk
assessment sheets easily accessible?
EQUIPMENT
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Does the lab have a fume cupboard?
Does the sash move freely?
Does the fume hood contain only working equipment/experiments.
Date last tested:
18 Does the lab have a biosafety cabinet?
Class:
Date last tested:
Type/size:
19 Is Bunsen tubing checked regularly for breaks and cracks?
SAFETY EQUIPMENT
20 Is a washbasin available?
21 Is there an eyewash station checked on a weekly basis?
22 Emergency phone numbers posted?
23 Are emergency showers available?
24 Is the first aid cabinet sufficiently stocked?
25 Personal protective equipment available?
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Are lab coats and safety glasses worn during work and removed
before leaving?
27 Are suitable nitrile/butyl gloves available for spills?
28 Are face masks available for a biohazard spill?
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Is there a balance sited in the fume hood for the weighing of
hazardous substances?
No Question Yes
No
NA
WASTE
30 Is hazardous waste contained and labelled?
31 Waste segregation appropriate?
32 Is waste removed regularly?
33 Is biological and chemical waste stored correctly?
34 Is there an SOP for waste management?
35 Have you completed a waste management form for disposal of
biological waste?
36 Is broken uncontaminated glassware stored and disposed of in a safe
manner?
37 Are sharps containers available?
FIRE
Are fire safety checks completed weekly?
39 Are emergency exit lights lighting?
40 Are fire extinguishers in place and fully charged?
41 Are flammable combustible materials stored in appropriate locations?
1. 42 Are fire doors fully closed?
2. 43 Are fire exits, corridors, escape routes and stairwells accessible?
MISCELLANEOUS
44 Is there a list available of those who attended the Safe lab Module
45 Is there a list available of lab members who attended the yearly safety
statement lecture.
46 Are out of hours sheets easily retrievable?
47 Are there accident report forms available?
48 Are accident report forms held on file?
HOUSEKEEPING
49 Is there good general housekeeping in the laboratory?
50 Are constant temperature rooms used? Where?
51 Examine constant temperature rooms for cleanliness and
organization.
Q
No.
Comments
Source: Safety Statement for School of Biotechnology. Compiled by Dr Patricia Carty
Invaluable reading material Identify the
hazards?
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http://www.hsa.ie/eng/Publications_and_Forms/Publications/Chemical_and_Hazardous_Substances/Guidelines_to_the_Safety_Health_and_Welfare_at_Work_Biological_Agents_Regulations_2013.html
Guidelines to the Safety, Health and Welfare at Work (Biological Agents) Regulations 2013.
In summary: How do have a safe system for work?
Safe Workplace
Safe Procedures
Safe People
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Safe Plant
