Biosafety / Infrastructures Yann BOURGUIGNON Fondation Mérieux Infrastructures Manager 1
Definition Biosafety is aimed to reduce or eliminate exposition of laboratory staff and the exterior environment to potentially dangerous microorganisms. Universal Precautions is a process of infection control conceived to reduce transmission of infectious agents. It describes a system of precautions. 2
Group 1 biological agent means one that is unlikely to cause human disease. Such as Saccharomyces cereviseae 3
Group 2 biological agent can cause human disease and may be hazard to employees; it is unlikely to spread to the community and there is usually effective prophylaxis or treatment available such as C. difficile, hepatitis A, B, and C, influenza A, Salmonella. 4
Group 3 biological agent can cause severe human disease and may be a serious hazard to employees; it may spread to the community, but there is usually effective prophylaxis or treatment available such as, Mycobacterium tuberculosis*, Bacillus anthracis, SARS coronavirus, Salmonella typhi, yellow fever virus * Culture & DST 5
Group 4 biological agent causes severe human disease and is a serious hazard to employees; it is likely to spread to the community and there is usually no effective prophylaxis or treatment available. such as, Ebola virus, Congo hemorrhagic fever (CCHF) 6
Example: Risks in Laboratory with TB
Risk of TB transmission in laboratories Work location TB incidence rate ratio (relative to population TB incidence rate) Outpatient facilities 4.2 11.6 General medical wards 3.9 36.6 Inpatient facilities 14.6 99.0 Emergency rooms 26.6 31.9 Laboratories 42.5 to 135.3 Joshi R, Reingold AL, Menzies D, Pai M [2006]. Tuberculosis among health-care workers in low- and middle-income countries: a systematic review. PLoS Med 3(12): e494. Menzies D, Joshi R, Pai M [2007]. Risk of tuberculosis infection and disease associated with work in health care settings. Int J Tuberc Lung Dis 11(6): 593-605. 8
Excess occupational risk Type of laboratorian TB incidence rate ratio relative to general population (95% confidence intervals) Microscopy technicians 1.4 (0.2 10.0) Culture/DST technicians 7.8 (1.7 34.9) DST technicians 21.5 (4.5 102.5) Kim SJ, Lee SH, Kim IS, Kim HJ, Kim SK, Rieder HL [2007]. Risk of occupational tuberculosis in National Tuberculosis Programme laboratories in Korea. Int J Tuberc Lung 11(2):138 142. 9
Main Design Requirements for BSL 2, 2+ and 3
REGULATORY FRAME Standard applicable to all projects and accepted by European and US regulatory offices: ISO 14 644-4: clean rooms and related environments: design, building and functioning. Standard used for these specifications to characterize the required level of design classification of air cleanliness: ISO 14 644-1: clean rooms and related environments: classification of air cleanliness.
BSL2 BSL2+ BSL3 Walls & ceiling Floor Lighting Window All laboratory partition walls and ceilings are of type smooth. Use special resin for clean room. Large size tiles with the minimal seals or Plastic floor included in the ceiling classic All laboratory partition walls and ceilings are of type walls "clean room" (sandwich partitions : metal core with internal insulation or compact laminate type) Plastic (PVC) for clean room. Finish by curling up the flexible floor covering to form skirting in the room created. Lighting is flush fitted no opening possible (ventilation) - Glazing is flush fitted. 12
BSL2 BSL2+ BSL3 Furnitures Mobile lab bench (easy clean and disinfection) Airlock chambers yes yes yes - (multiple) Access control no depending on the activity yes 13
HVAC (Heating Ventilation - Air Conditoning) - Absolute filtration BSL2 BSL2+ BSL3 HEPA Filter is not a requirement, but if the lab has air conditioning (split), one must be careful with the condensate (collect and decontaminate). Exhaust Filtration N/A no yes (with secure box) Autoclave verticale or in bench verticale or in bench double doors Water in laboratory yes yes no Waste water must be desinfected before evacuation - using desinfection tank no Safety shower in the lab or in the corridor (if multi-lab) In order to avoid contamination of drinking water, a backflow valve system must be installed between the potable water pipes and the grey water pipes. And the contamined water is storage in the tank before sterilization by autoclave yes yes 14
Design your lab with these 3 words: smooth, curve and flush. The goal is no retention zone
Incident in a BSL 3: roles of anterooms
BSL3 BSL2 17
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Flow and air pressure management BSL 3 BSL2 2100,01-50 Pa 20v/h Refig. Refig. + 40 Pa 20v/h Freezer -85 C incubator incubator +20 Pa 20v/h - 40 Pa 20v/h Autoclave Double entry Pa 20v/h Freezer
No Lab coat potentially contaminated Lab coats Contaminated PPE for BSL3
2100,01 incubator Freezer -85 C incubator incubator Autoclave Double entry 5 Refig.
2100,01 incubator Freezer -85 C incubator incubator Autoclave Double entry 5 Refig. 22
2100,01 incubator Freezer -85 C incubator incubator Autoclave Double entry 5 Refig. 23
2100,01 incubator Freezer -85 C incubator incubator Autoclave Double entry 5 Refig. 24
Aerosol contamination: every 3 min air volume is changed 2100,01 incubator Freezer -85 C incubator incubator Autoclave Double entry 5 Refig. 25
2100,01 incubator Freezer -85 C incubator incubator Autoclave Double entry 5 Refig. 26
2100,01 incubator Freezer -85 C incubator incubator Autoclave Double entry 5 Refig. 27
2100,01 incubator Freezer -85 C incubator incubator Autoclave Double entry 5 Refig. 28
2100,01 incubator Freezer -85 C incubator incubator Autoclave Double entry 5 Refig. Disinfection system by hydrogen peroxide and peracetic acid (misting) 29
2100,01 incubator Freezer -85 C incubator incubator Autoclave Double entry 5 Refig. 30
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Destruction in autoclave 32
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On Ventilation OFF 900,00 900,00 900,00 900,00 37
KEEP IN MIND «MEANS OF PROTECTION MAY BECOME THE CONTAMINANT» ------ «Biosafety is your responsibility, the infrastructures are only a tool that you must manage, as gloves, masks, BSC, lab equipment, GLP training»
Biosafety / Infrastructures Yann BOURGUIGNON Fondation Mérieux Infrastructures Manager 39