Biosafety and Security Flashcards
– Most important concept/ strict adherence
– Aware of potential hazard
– Trained and proficient in techniques
– Supervisors responsible for appropriate laboratory facilities, personnel and training
standard practices
any microbiological entity, cellular or non cellular, naturally occurring or engineered, capable of replication or of transferring genetic material that may be able to provoke infection, allergy, toxicity or other adverse effects in human, animals, or plants (eg. HIV, SARS-COV 2)
biological agent
- any material comprised of, containing, or that may contain biological agents and/or harmful products such as toxins and allergens (eg. blood in test tube, sputum in the mask)
- microorganisms that cause infection
biological material
potential source of harm caused by biological materials
biohazard
containment principles, technologies, and practices implemented to prevent unintentional / accidental exposure to pathogens and toxins, or their unintentional / accidental release
laboratory biosafety
institutional and personal security measures designed to prevent the loss, theft, misuse, diversion, or intentional release of pathogens and toxins
laboratory biosecurity
recapping of needles
biosafety concern
medtech is a member of terrorist group
biosecurity concern
lab personnel not provided with PPE
biosafety concern
disgruntled staff
biosecurity concern
work overload
biosafety concern
waste from the lab are not segregated
biosafety concern
lack of staff training
biosafety concern
staff with a huge dept
biosafety concern and biosecurity concern
most important concept and requires strict adherence
standard practices
responsible for appropriate laboratory facilities, personnel and training
supervisors
its purpose is to protect the laboratory worker
safety equipment
- primary containment barrier
- minimize exposure to hazard
safety equipment
engineering controls, equipment, PPE, Biosafety cabinet, Covered animal cage system, sealed centrifuge rotors are examples of which principles of biosafety?
safety equipment
- second barrier
- protects outside the laboratory
facility design and construction
Building and lab design, ventilation, autoclaves, cage wash facility, sealed laboratory walls/floors, HEPA filters are examples of which principles of biosafety?
facility design and construction
biosafety levels are aka?
containment levels
it is the combination of lab practices and procedures, safety equipment (primary barriers) and lab facilities (secondary barrier)
biosafety levels
- student training and teaching lab
- no harm to humans
- nonpathogenic organism
- relies on standard microbiology practices
- wear of PPE
biosafety level 1
in this level of biosafety, standard microbiological practices are followed and work can be performed on an open lab bench or table
biosafety level 1
facility construction
- a sink must be available for handwashing
- the lab should have doors to separate the working space with the rest of the facility
what level of biosafety is this?
biosafety level 1
- in this biosafety level, clinical, diagnostic, and teaching laboratories handling moderate risks agents
- lab personnel should have specific training in handling pathogens
biosafety level 2
- access to the laboratory is restricted when work is being conducted
- COMPLETE PPE is worn
- all procedures that can cause infection from aerosols or splashes are performed within a biological safety cabinet (BSC)
- An autoclave or an alternative method of decontamination is available for proper disposals
Biosafety level 2
facility construction
- lab has self-closing doors
- a sink and eyewash is readily available
what level of biosafety is this?
biosafety level 2
- Builds upon the containment requirements of BSL-2
- Clinical, research and production laboratories: Indigenous or exotic agents, Potential for respiratory transmission (Mycobacterium tuberculosis, St. Louis encephalitis, Coxiella)
- Primary hazard: infectious aerosol
- Emphasis on primary (protective clothing) and secondary barriers
- Emphasis on procedures, must have written and validated Standard operating procedures
Biosafety Level 3
- Laboratorians are under medical surveillance and might receive immunizations for microbes they work with.
- Access to the laboratory is restricted and controlled at all times
- Safety equipment
- Appropriate PPE must be worn, and respirators (N95) might be required.
- All work with microbes must be performed within an appropriate BSC
BSL-3
- hands-free sink and eyewash
- entrance to the lab: 2 sets of self-closing and locking doors
- active security (cctv, id cards)
- provides “zone of control” of hazards and odors
BSL-3
- dangerous/ exotic agents: via aerosol route, no vaccines or treatment, ebola and marburg viruses
- extreme containment
- maximum containment
BSL-4
- Change clothing before entering
- shower upon exiting
- decontaminate all materials before exiting
- Class 3 Biosafety Cabinet
- Full body, air supplied positive air pressure suits
BSL-4
- Separate buildings or completely isolated zone complex, specialized ventilation requirements
- Special waste management
BSL-4
- Laboratories where work with microorganisms is conducted in a BSL2 lab with biosafety practices and procedures typically found in BSL3
-Risk assessment based - Challenging since it is not a recognized level in biosafety guidance documents.
Biosafety Level 2+
- protection of sensitive sample from contaminant exposure
- positive pressure areas
- protection of personnel and the environment from biological exposure
- negative pressure area
Biosafety Level 2+
- a microorganism that is unlikely to cause human/ animal disease
risk group 1
- a pathogen that can cause disease but is unlikely to be a serious hazard to lab workers, the community, livestock or the environment.
- lab exposures may cause serious infection, but effective treatment and preventive measures are available and the risk of spread of infection is limited
risk group 2
no or low individual and community risk
risk group 1
moderate individual risk, low community risk
risk group 2
high individual risk, low community risk
risk group 3
- a pathogen that usually causes serious disease but does not ordinarily spread from one infected individual to another
- effective treatment and preventive measures are available
risk group 3
high individual and community risk
risk group 4
a pathogen that usually causes serious disease and that can be readily transmitted from one individual to another, directly or indirectly
- effective treatment and preventive measures are not usually available
risk group 4
- is the assurance of safety from physical intrusion
- graded layers of protection
physical security
- assurance that the people are given access to sensitive biological materials should have that access
- reduce the risk of theft or fraud, reduce scientific misconduct
personnel management
assurance that there is an awareness of what exists in the lab, where it is and who is responsible for it
material control and accountability
- Protect biological materials in the laboratory and track those materials when they are transported outside of laboratory areas.
- Utilize triple packaging for transporting biological materials.
- Follow chain of custody principles and establish end-user agreements.
transport security
- Ensure that sensitive and valuable information stored in the laboratory is protected from theft or diversion.
- Protect information that is too sensitive for public distribution.
- communication and network security.
information security
research that could be used for malevolent purposes
Dual Use research of concern (DURC)
Monitor and assess the scientific, ethical, and social implications of certain biotechnologies. When necessary, monitor the development and integration of these technologies into scientific and clinical practice (e.g., gene editing, human gene transfer, recombinant technologies).
EMERGING BIOTECHNOLOGY
