What is a physical containment (PC) facility?
Physical containment facilities are designed to ensure that infectious microorganisms are safely contained inside the laboratory.
This protects the surrounding environment and the workers inside the facility from any risk of contamination. All procedures involving the manipulation of infectious materials are conducted within the physical containment facility.
Physical containment facilities are strictly controlled to ensure that they can only be accessed by those who have been properly trained and authorised, as well as those who require access for their work. Physical containment may include barriers such as doors, windows, biological safety cabinet, and laminar airflow cabinets – all of which can be accessed with a combination of keycard and password.
A PC facility is an area that provides basic safeguards for both humans working with hazardous materials and the environment. In many cases, a PC facility must be up-to-date with the latest safety standard. For a company or institution to have physical containment facilities that meet the requirements, an engineering firm must be hired to provide designs and calculations that show compliance with the standard laboratory practice.
Creating physical containment facilities for different types and sizes of equipment and experiments can be a complicated process, as much consideration must be put into factors such as room dimensions and type of ventilation needed.
The facility must ensure that if there is a release of hazardous materials, it will be contained within the room and not escape into the surrounding environment or building to avoid creating an unsafe work environment for those insides, as well as reducing risks to those outsides. In some cases, multiple levels of containment are used in Physical Containment facilities. These levels of physical containment are based on the requirements set forth by employers or regulators for a given PC level facility.
A physical containment facility can be divided into three groups:
Laboratory Containment Facilities
A laboratory containment facility is a place that houses biohazardous materials and dangerous waste. It also creates a barrier between the hazardous environment and the work area, enclosing them in a room or other enclosures where there are physical barriers to prevent contamination, as well as equipment designed for safety.
It is built so that any leak of gas or material would not present a threat to workers outside the containment room, minimising the risk associated with its use. The main aim of such laboratories is because those who work with these harmful agents can contact them and become infected, which can lead to serious health problems and even death.
Biocontainment
The term “Biocontainment” refers to the physical containment of infectious materials in a way that prevents the spread of pathogens. All biological laboratories should be built with this in mind, and precautions are taken. Biocontainment is important for high-containment laboratories (BSL-4 facilities), where there is the lowest risk of agents escaping and causing outbreaks, and for other laboratories where it’s unnecessary because the likelihood of having such agents is extremely low.
For high containment laboratories or BSL-4 laboratories, the law requires the laboratory is built with a sufficient biocontainment system. The laboratory must be either contained in a single building or physically divided, so that spills do not cross between areas.
Animal Facility Containment
Animal Containment Facilities are places used for holding or housing animals, whether wild or domesticated, including birds and other aquatic life. Animal Containment facilities have physical barriers designed to ensure animal-human separation, while allowing qualified personnel to access them for study, administration of care, feeding, and maintenance activities.
Most animal containment facilities use physical barriers to separate humans and animals. These include walls, fences, and distance as practical methods to separate animals from people.
Understanding facility types
The physical containment area can determine this facility type and the types of organisms in its environment. Below is a brief overview of the facilities.
What is a Physical Containment Level 1 laboratory?
Physical Containment Level 1 is used to perform tasks using biological agents or agents that are low-risk in their use. Personnel working in containment level 1 laboratories must have BSL-2 facility certification.
They require general knowledge of safety precautions related to the risks associated with their work, but do not need specific training above and beyond normal laboratory procedures (for example, using personal protective equipment like gloves or lab coats).
These laboratories do not require any special containment equipment. For certain tasks, such as cultivation of low pathogenic agents, the containment level 1 laboratory can be a room in a building with normal environmental controls and safety precautions.
Level 1 laboratories can also be used for work with moderate risk biological agents or laboratory procedures that do not require special containment equipment.
These would include microbiological specimen processing and biohazardous medical waste handling. All these tasks, however, must be performed under the supervision of a scientist trained to properly handle the biological agent(s) in question.
What kind of work may need to be done in a physical containment facility 2?
In physical containment level 2, work that must be conducted in the laboratory with an EPA Level 2 physical contamination level (PC level 2) certification, genetically modified organisms (GMO), which present little to moderate risk of infection (National Institutes of Health, 2014).
Research facilities have shown that GMO materials pose less risk of infection than naturally occurring infectious agents. The Department of Energy (DOE) states that “activities with recombinant DNA or living genetically modified organisms must be performed in facilities designed to contain these hazards” (2014), including laboratories at PC level 2 facilities.
Facilities classified as PC level 2 must contain a single source of the GMO for twelve hours. This is because “if a facility containing recombinant DNA was opened to the environment, it is unlikely that any living modified organism would survive under natural conditions for more than a few days” (National Institutes of Health, 2014). For this reason, facilities classified as PC level 2 must include a specialised suite of safety controls and features.
What is a containment level 3 laboratory?
Physical Containment Level 3 is used in the work environment of organisms genetically modified by humans, or organisms thought dangerous (e.g., Ebola, Anthrax). Containment level 3 labs should provide the highest level of protection to workers and surrounding populations, while allowing work to be performed with organisms that are reasonably safe to handle under some supervision.
A containment level 3 facility is a laboratory in which experiments are conducted on agents that may cause serious or potentially causing disease through human infection, or have the potential for aerosol production and inhalation by humans. There must be provisions to protect personnel conducting the work from exposure by ensuring containment through either primary (e.g. sealed glove boxes) or secondary (e.g. breathing protection, biosafety cabinet) barriers. In the event of a loss-of-containment accident, it is important not only to protect staff from exposure, but also to prevent environmental damage and contain or eliminate all organisms used in the work.
What is Physical Containment Level 4 Facility?
Physical Containment level 4 facilities provide biocontainment for agents that may cause serious or lethal human health disease for which no vaccine or therapy exists, and for which the etiologic agent is potentially transmissible via the aerosol route in a contained laboratory setting. Facilities are maintained under negative pressure relative to surrounding spaces, using special HVAC systems. Access is limited to authorized persons. Containment level 4 facilities have multiple tiers of physical containment, including but not limited to biocontainment secondary barriers, such as personnel suits with self-contained breathing apparatus, engineered safety cabinets, or other primary containment devices, and tertiary containment systems such as autoclaves and sealed centrifuges.
Work in a containment level 4 facility involves the handling of organisms that pose a high individual risk of aerosol-transmitted laboratory infections, and may also involve animals infected with highly virulent pathogens or the culture of unusually dangerous organisms. Instances requiring work at this level include studies of (highly virulent) strains of influenza virus, pathogenic mycobacteria, and the organisms causing plague and rabies.
How are Physical Containment Facilities legalised and regulated in Australia?
Physical containment facilities are highly regulated in Australia, with strict requirements imposed to ensure the safety of staff and other members of the public. An Australian government agency must authorise physical containment facilities, ensuring that all activities within these facilities are compliant with national laws regarding biosafety, biosecurity, and animal welfare. Physical containment facility workers are also required to have a facility certification to work within a Physical Containment Facility.
Physical containment facilities operated by a university or public health organisation, including those located on a university campus, maybe self-licensed. Physical containment facilities operating as private facilities must be registered for one of three available types of licensure: low-risk containment level 1 (LC1), high-risk containment level 2 (HC2), or high-risk containment level 3 (HC3) facilities.
Purpose of Licensing Physical Containment Facilities
The licensing requirements ensure that the construction, equipment, facility operations and procedures are appropriate for their containment level. The requirement to be licensed also ensures that staff working within physical containment facilities are appropriately trained and supervised. Both site managers and PCC directors must renew the facility certification annually. The renewal process includes an external audit to ensure that the facility meets standards.
What is Genetically Modified Organisms?
A genetically modified organism is a living thing that has had changes to its DNA using the techniques of genetic engineering. This creates combinations of plant, animal, bacteria, and virus genes that would not exist naturally. These organisms are sometimes called “GMOs”, “genetically engineered” (GE), or “genetically modified organisms” (GMOs).
In many countries, different terminologies are used, and the same terminology can even be used for different things in different countries. For example, “genetically modified organisms” (GMOs) is often used to refer to crop plants specifically bred for agricultural purposes, i.e. crops improved through breeding, selection, and genetic material engineering to make them better suited for human or animal consumption. However, in some countries, “genetically modified organisms” (GMO) may also refer to any organism with its genes altered. For example, algae and bacteria used as food ingredients could be considered GMOs under this wider definition.
What is the Office of the Gene Technology Regulator (OGTR)?
The Office of the Gene Technology Regulator (OGTR) is an independent Commonwealth Government statutory agency responsible for regulating the use of gene technology in Australia. The OGTR administers the National Gene Technology Scheme (the Scheme), which is aimed at ensuring that the use of gene technology regulator in Australia is conducted safely, securely, and ethically.
Classification of Risk group
The risk primarily determined them based on the severity of illness caused by an unintentional exposure to a select agent.
What is Risk Group 1?
Risk Group 1 is a category assigned to select agents associated with past use or threats of use for acts of terrorism or violence. The term historically used for this risk group was a dangerous biological agent. These are biological agents or toxins that can pose a severe threat to public health and safety.
The few organisms in this group were chosen because of the high risk associated with an unintentional release, inadvertent transfer, or deliberate misuse of these agents and toxins. The current members of Risk Group 1 include:
- Bacillus anthracis,
Francisella tularensis, and
Variola major (smallpox virus)
What is Risk Group 2?
Risk Group 2 is a category assigned to select agents that have been associated with past use or threats of use for acts of terrorism or violence. The term historically used for this risk group was a dangerous biological agent.
The purpose of Risk Group 2 is to protect those agents and toxins where the public health risk would be greater than the security risk. These are biological agents, toxins, or vector(s) of concern associated with past use or threats of use for acts of terrorism, and where:
- A public health risk would be considered to exist if exposure is limited (i.e., availability of a vaccine or treatment is limited);
The individual may be easily isolated; and/or
Significant production would not be feasible in most instances.
Currently, the criteria for Risk Group 2 are met by any biological agent or toxin that can cause serious health effects with symptoms including fever, headache, muscle aches, shortness of breath, skin rashes, vomiting, weakness, or fatigue.
What is Risk Group 3?
Risk Group 3 is a category assigned to select agents associated with past use or threats of use for acts of terrorism or violence. The term historically used for this risk group was a dangerous biological agent.
The purpose of Risk Group 3 is to protect those agents and toxins where the public health risk would be small relative to the security risk. These are biological agents, toxins, or vector(s) of concern associated with past use or threats of use for acts of terrorism, and where:
- The individual may be easily isolated;
Significant production would not be feasible in most instances; and/or
A public health risk would be considered to exist only in the event of prolonged, close contact between an individual and an infected or contaminated source.
Currently, the criteria for Risk Group 3 are met by any biological agent or toxin that can cause serious health effects in humans, but would not be expected to result in many deaths or casualties.
