BiosafetyDr Rosaleen Devery

School of Biotechnology

Biological Safety Advisor

Biosafety : Keeping lab workers, the community and environment safe• 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 FDAhttps://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 centreshttps://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

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.

Biological Safety of huge importance in biotechnology facilitiesCauses of biological diseases.

• Is this a known human pathogen?

• What is history of lab use?

• Recognised risks?

• Is it associated with LAI?

• Is there an effective treatment? Vaccine?

• Does it cause allergies?

• What is my susceptibility potential based on age, sex, medical condition?

• How can I limit my exposure ?

• Recommended safety precautions ?

• Are they practiced in this lab?

• Is risk acceptable to me?

Virus Bacteria /

ToxinsFungi Parasites Prions

Know how you can get exposed Know what strategies to implement to prevent exposure

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).

Good Lab Practices & Containment

PPE

GLP

Biosafety: basic practices in risk reduction

Personal protective equipment (PPE)

Risk Awareness

Personal protective equipment (PPE)

• Laboratory coats are to beworn in the laboratoryONLY.

• Do not wear around officeor eating areas.

• Laboratory reagents canspill 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

There are many routine lab procedures that generate aerosols.Shaking and mixing liquids, pouring liquids, pipetting liquids, removing cap , opening a sealed tube

Good practices like using a BSC will reduce exposure to aerosols. Wait a few minutes to allow aerosols to settle before you open a container you have shaken, centrifuges etcFill and open centrifuge tubes in BSC, disinfect rotors and tubes.

• All labs/areas where, for example, blood orblood products are used will be identified withBiological Hazard Sign(s) and/or the floor areawill 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

Containment is the control of biohazards by isolation and separation of the organism from the worker. Biohazard boxes provide primary containment

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

No special handling

Biohazard warningsigns, Sharps precautions,Waste managementpolicies are needed

Controlled access, Decontaminationof waste, Negativeair flow, baseline healthmonitoring

Separate building,dedicated air supply, positive pressure personnel suit.

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/treatmentavailable

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 theenvironment

Slight net inflow of air

Depends for its efficacy on laminar airflow 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 easilybreached

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 andenvironment from potentially dangerous microbiologicalagents.

They are designed to control airborne contamination of thework and reduce risks of exposure of the operator to anyairborne particles dispersed within the cabinet from thework 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 forthe operator and are suitable for extreme bio-hazard work.

Inflow air is HEPA filtered before entering via a side-mountedinlet filter chamber. Exhaust air is HEPA filtered before leavingthe 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 andSafety at Work acts.

• Faculty - Biosafety overseen by Faculty Biological Safety Committee

Primary Contact: Dr. Rosaleen Devery, School of Biotechnology.

Email: rosaleen.devery@dcu.ie

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

LiklihoodRating

Risk Rating

…..

……

Hazard Context

Reasons Considered a

Hazard

Hazardous Procedures/Activities Persons at Risk

Potential Injury/Loss

Current Controls/Precautions

Waste management

strategiesAre 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

11

12

13

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

14

15

16

17

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?

26

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?

29

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 materialIdentify the

hazards?

39

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, Healthand Welfare at Work (BiologicalAgents) Regulations 2013.

In summary: How do have a safe system for work?

Safe Workplace

Safe Procedures

Safe People

40

Safe Plant