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An Introduction to Biosafety Covering the basic principles of containment and working safely when handling biological materials Phil Walsh and Fiona Harris Biological Safety Advisers Biological Safety Unit Health and Safety Department Information and Reference documents Biosafety Unit website: http://www.ed.ac.uk/schools-departments/healthsafety/biosafety/home Various sections: General, Containment Laboratories, Pathogens, Genetic modification, Work with other materials, Risk assessment forms, Transport In particular read: Good microbiological practice and containment Hazard grouping and containment requirements Preventing injuries from glass and sharps Requirements under the GMO (Contained Use) Regulations Select others depending on nature of your work Safety cabinets, Work with blood and tissues, Work with naked DNA, Work with animals Individual workers responsibilities familiarise yourself with University and School Health and Safety Policies carry out your work safely and in accordance with these policies using all control measures specified exercise care in relation to yourself and others who may be affected by your actions (or inactions) report any safety concerns Legislation Also: the Plant Health (Great Britain) Order 1995 (as amended) Advisory Committee on Dangerous Pathogens Legislation Approved Guidance Biological Agent • Biological agents are included within the COSHH definition of a ‘substance hazardous to health’ • Biological agent defined as: micro-organism, cell culture or human endoparasite, whether or not genetically modified, which may cause infection, allergy or toxicity or otherwise create a hazard to human health Biological agents Micro-organisms bacteria viruses fungi prions Cell Culture Endoparasites Adventitious agents Microscopic endoparasites e.g. malarial parasites, amoebae & trypanosomes Microscopic infectious forms of larger parasites e.g. microscopic ova and infectious larval forms of helminths Duties under the COSHH: Identify hazards and assess risks to human H&S • identify and classify biological agents which will be used • consider all hazards not just infection • first consider substitution with less hazardous agent or alternative method of work or work process • take the nature of the work into account and the route of infection of the particular agents involved • identify any particular groups of people who may be at increased risk Control the risk • prevent exposure wherever possible • if not reasonably practicable then “adequately control” • maintain, examine and test control measures • monitor exposure • provide information, instruction and training • provide health surveillance • make arrangements to deal with accidents & emergencies Schedule 3 COSHH: biological agents • maintain list of employees working with the most hazardous biological agents • notify use and storage of certain agents • notify consignment of certain agents Once systems are in place you must monitor • to ensure control measures are working effectively periodically review • to ensure these are still valid and applicable Also take account of any new information that becomes available that affects the risk assessment Risk assessment considerations • Hazards of the biological materials • Routes of infection • Control measures Hazards of biological materials • Infection • Toxic • Allergenic • Carcinogenic • Other? Routes of infection • Inhalation breathed in • Ingestion by mouth • Injection damaged to skin • Absorption across mucous membranes e.g. splash into eye Basis for control measures Block all routes of infection: • Do not put anything in mouth • Do not create aerosols • Cover damaged skin and minimise risk of puncture wounds • Do not produce splashes and droplets • Do not transfer to any route with hands or other contaminated objects Hazard Group classification system ACDP classifies biological agents which may be a hazard for human health into four Hazard groups based on: A. Ability of the agent to cause infection in healthy humans B. Severity of the disease that may result C. Risk that the infection will spread to the community D. Availability of effective treatment or prophylaxis Hazard Group matrix Approved List of Biological Agents • ACDP classifies biological agents which may be a hazard for human health into Hazard groups 2-4 • Hazard Group 1 agents are not pathogenic but may still cause opportunistic infections • The ACDP classification is approved by the HSE → published as the Approved List of Biological Agents HG1 Disabled E. coli HG2 Listeria monocytogenes HG3 Bacillus anthracis HG4 Ebola virus • Agents not on the Approved List: must seek evidence of pathogenicity- not automatically assign to Hazard Group 1 • all unlisted viruses isolated from humans assigned to not less than Hazard Group 2 - unless evidence that they are not pathogenic • if there is any uncertainty then the higher of the two possible hazard groups should be chosen • GMMs are not on the Approved List but the wild-type species may be listed Other considerations in the risk assessment • Hazard Group does not take account of other hazardous properties e.g. toxic or allergenic • Categorisation is based on the infective hazard to healthy adult workers • It does not allow for any additional risk to individual workers caused by for example • • • • pre-existing disease the effects of medication compromised immunity pregnancy or breastfeeding Containment levels • Working safely with biological agents requires a series of containment measures termed Containment Levels • Four containment levels directly related to each hazard group Hazard Group number = Containment Level number • Laboratories where known biological agents are propagated or concentrated → match hazard group of the agent with the CL e.g. HG3 pathogen, Bacillus anthracis = CL3 Containment levels At each CL, control measures are specified in relation to: • Facilities • Procedures - local laboratory rules & Code of Practice High Specification laboratory Strict Codes of Practice CL4 High risk microbes CL3 CL2 Basic laboratory GMP CL1 Low risk microbes Containment Level 1 Facilities • Easy to clean laboratory • Impervious and resistant benches • Wash basin or sink for hand washing • Appropriate warning signs Containment Level 1 Working practices • No eating, chewing, drinking, smoking, applying makeup • No mouth pipetting • Wear lab coat and remove when leaving lab • Wash hands • Procedures for use, storage & transporting biological agents • Procedures for disinfection & waste disposal • Procedures for accidents & incidents Containment Level 2 all the requirements of CL1 plus Facilities • Restricted access • Dedicated hand wash basin at exit • Adequate space for safe working • Separate storage area for lab coats in the lab • Negative pressure if mechanically ventilated • Microbiological safety cabinet may be required if an infectious aerosol is produced Containment Level 2 all the requirements of CL1 plus Working practices • Same basic working practices but applied to a higher standard • Greater level of information, instruction, training & supervision required • Workers to receive training in handling pathogens Containment Level 2 Additional control measures and precautions • Extras depending on nature of work and route of infection • Avoid using sharps • Gloves • Microbiological safety cabinet • Designated work station • Eye protection • Vaccination Containment Level 3 all the requirements of CL2 plus • Facilities • Self contained facility • Separated from other activities • Operate at negative pressure • HEPA filter on extract • Sealable for fumigation • Microbiological safety cabinet (ducted) • Viewing panel Containment Level 3 all the requirements of CL2 plus Working practices • High standard of training and supervision • All working practices rigorously controlled, documented & recorded • Use dedicated lab coats and autoclave before laundering • When handling infectious materials wear gloves and carry out all manipulations in MSC • No sharps Containment Level 4 • Totally isolated • Complete change of clothes • Shower out • Sterilise all waste and effluent • Double ended autoclave • Very strict air handling arrangements Classification ACDP hazard group 1-4 Pathogenicity Containment level 1-4 Facility & Working Practices SACGM classes 1-4 Project MSC classes I, II, III Type of cabinet Simple system for implementation of risk control measures 1. identify biological agents to be used or those that may be present in the materials to be handled 2. classify each into one of four Hazard Groups 3. the number of the Hazard Group indicates the level of containment under which the work must be carried out 4. identify whether any additional control measures needed Steps in a COSHH risk assessment Use form BA1 (revised 2003 ver2) Available from the biosafety unit website Assessing risk for work with blood & human tissues hazards blood borne viruses hepatitis viruses, HIV other pathogens vary depending on type of material source of material Control measures for work with blood and human tissues Containment Level 2 Gloves Avoid use of glass and sharps Designated work area Guidance on work with blood and human tissues on biosafety unit website Range of Guidance available on the biosafety unit website Blood and human tissues Tissue culture Naked DNA including oncogenes and viral genomes TSEs Animals Plants Separate regulations for GM work The Genetically Modified Organisms (Contained Use) Regulations 2014 Specific requirements for risk assessments need approval from the GM safety committee project is classified as Class 1- 4 notification to HSE Control measures on same principles as for all biological work Microbiological Safety Cabinets An introduction to selection and safe use of MSC Information and Reference documents Biosafety Unit website: http://www.ed.ac.uk/schools-departments/healthsafety/biosafety/home Guidance Microbiological Safety Cabinets Microbiological Safety Cabinets Offer protection to the user and the environment from infectious aerosol hazards Local Exhaust Ventilation (LEV) under COSHH regulations Specification in British Standard BS EN 12469 (2000) 3 different types Class I Class II Class III All protect worker Some also protect work All exhaust air is HEPA filtered Class I Class II Class III Do not confuse with Laminar flow hoods Tissue culture cabinets Anaerobic cabinets Fume cupboards Safe use of MSCs All users must be trained in the correct use of MSC Do not use until the cabinet has warmed up Do not work with the UV light on Do not obstruct the air intake grilles in Class II cabinets Do not use bunsen burners or centrifuges in Class II cabinets Always disinfect the cabinet after use Cabinet selection Select the correct MSC for your work (by risk assessment) Consider whether protection of the work is needed MSC class is not linked to the CL assigned to the work Class Operator Protection Suitable for which biological agents Protects work from contamination I Yes HG2 & HG3 no II Yes HG2 & HG3* yes III Yes HG3 & HG4 yes * Risk assessment required Key Points A cabinet only offers protection against infectious aerosol hazards The level of protection offered by a cabinet relies heavily on good working practices Thank you! http://www.ed.ac.uk/schools-departments/health-safety/biosafety/home IN ORDER TO GET YOUR CERTIFICATE PLEASE SIGN THE REGISTER BEFORE YOU LEAVE