Since the onset of the COVID-19 pandemic, there’s been a lot of talk about Physical Containment Facilities, also known as PC Facilities. But what are they? What is their purpose? Why are they so important? In this article, Dr Carie-Anne Logue, Senior Operations Manager at the Institute for Glycomics, answers all our questions and more.
As a starting point, however, it’s important to first gain an understanding of pathogens and Pathogen Risk Groups.
Pathogens and Pathogen Risk Groups
A pathogen can be simply defined as an infectious agent capable of causing disease in humans, animals or plants. Pathogens can be bacteria, viruses, parasites or other microorganisms that cause disease. Pathogens are classified into 4 groups based on the risk they pose, called Pathogen Risk Groups where Risk Group 1 poses the least risk and Risk Group 4 poses the most risk. Let’s talk about each Pathogen Risk Group to get a better understanding of each:
- Risk Group 1 (RG1)
Pathogen Risk Group 1 poses the lowest risk to individuals and the environment; a microorganism that is unlikely to cause disease. Examples include Non-pathogenic Escherichia coli (E. coli) and environmental organisms (those occurring naturally in the environment).
- Risk Group 2 (RG2)
Pathogen Risk Group 2 poses a moderate risk to individuals and a low risk to the environment. In other words, a microorganism that could cause disease but that is not serious. Typically, treatment is available, and the risk of spread is limited. Some examples of pathogens that fall within this group include Campylobacter, Salmonella, Shigella, Ross River virus, Rotavirus, and Influenza.
- Risk Group 3 (RG3)
Pathogen Risk Group 3 poses a high risk to individuals and a moderate risk to the environment. This describes a microorganism that will cause disease that is potentially serious; treatment is available but can be expensive, and the risk of spread is moderate. Some examples of RG3 pathogens include SARS-CoV-2 (the virus that causes COVID-19), Lyssavirus, and Chikungunya.
- Risk Group 4 (RG4)
Pathogen Risk Group 4 poses a high risk to individuals and the environment; microorganisms that cause life-threatening disease, readily spread, and where treatment is usually not available. Common examples of RG4 pathogens include Ebola and Hendra virus.
As a side note, and in contrast to a pathogen, you may also have heard of a genetically modified organism (a GMO) and wondered what that is. A GMO is any organism whose genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination.
Now that we have this handy background information, let’s jump into Physical Containment Facilities.
Physical Containment Facilities
A physical containment facility (PC facility) is a facility that involves the combination of building, engineering, equipment and practises to handle microorganisms safely. PC facilities are necessary as they reduce, or prevent, the release of pathogens into the environment.
You would have heard a lot about ‘PPE’ in the media over the last few months. PPE is Personal Protective Equipment and sometimes may also be referred to, informally, as personal protective clothing. Essentially, PPE is any device or equipment used to protect against health and safety hazards. Examples of PPE include gloves, respiratory protection, lab coats/gowns, safety glasses, etc. PPE is important as it protects the researcher from the pathogens they are handling or from the hazards of the process they are conducting.
Just as pathogens are classed into 4 different groups, PC facilities are also classed into 4 groups, which we describe in more detail below. Now you’ll see how Pathogen Risk Groups and PC Facilities are connected.
- Physical Containment Level 1 Facility (PC1 Facility)
This level of facility is suitable for work with microorganisms where the hazard is low and the researchers can be protected by the procedures that are in place. Pathogens used in this level of facility are Risk Group 1 organisms, or pathogens of a higher Risk Group that have been inactivated. This level of facility is typical for undergraduate or teaching laboratories. In terms of access, anyone who has been trained in the practices for PC1 or higher is allowed entry. PPE in this level of facility is dependent upon the risk of the process being conducted, but at a minimum would include closed shoes and lab coat/gown.
The Institute for Glycomics has one PC1 laboratory. This laboratory is where researchers will prepare samples for structural studies using a variety of techniques.
- Physical Containment Level 2 Facility (PC2 Facility)
A PC2 facility is suitable for work with Risk Group 2 microorganisms including research and diagnostic practices. Entry is restricted to those researchers who have been trained in the techniques and practices for this level of facility and have approved projects to work on in the laboratory.
PPE in this level of facility is dependent upon the risk of the process being conducted but at a minimum would include closed shoes, lab coat/gown, and eye protection. If the organism is transmissible by the respiratory route, procedures with the organism must be conducted in a Biological Safety Cabinet. All PPE that needs to leave the facility must be decontaminated prior to departure, usually by heat inactivation in an autoclave. Equipment that needs to leave the facility or requires a contractor to service, must be decontaminated, usually by chemical disinfectant.
The majority of laboratories at the Institute for Glycomics are certified to PC2 level. Some of the pathogens researched in the Institute’s PC2 laboratories include Neisseria species, influenza viruses, parainfluenza viruses, malaria parasites, Campylobacter, Streptococcus, as well as many others.
- Physical Containment Level 3 Facility (PC3 Facility)
A PC3 facility is suitable for research and diagnostic practices with organisms that are classified as Risk Group 3. A PC3 facility has additional building features and services to aid in minimising the risk of infection to people, the community, or the environment. Entry is highly restricted to researchers with extensive PC2 laboratory experience and are trained and assessed as competent for PC3 procedures and techniques.
PPE in this level of facility at a minimum would include closed shoes, lab coat/gown, eye protection, gloves and any other PPE as determined by a risk assessment. All procedures with the organisms must be conducted in a Biological Safety Cabinet. The specialist design of the facility also adds to the protective environment for the researcher. PPE used in a PC3 facility is disposable, single-use and should be disposed of once it has been heat inactivated by an autoclave prior to leaving the facility. Where heat inactivation is not appropriate, chemical disinfectants are used.
The Institute for Glycomics has one PC3 facility consisting of a laboratory facility and an Animal House facility. Some of the pathogens researched in the Institute’s PC3 facility include HIV, Chikungunya, Ross River virus, and SARS-CoV-2.
- Physical Containment Level 4 Facility (PC4 Facility)
This level of facility is suitable for research with organisms that are classified as Risk Group 4. A PC4 facility is separated from other buildings, has shower in/out facilities, and specialist ventilation and decontamination systems.
There is only one large scale PC4 facility in Australia. However, there are Institutions that have the capability to handle RG4 organisms in a PC3 facility with special precautions.
How are Physical Containment Facilities legalised and regulated in Australia?
The Australian Standards provide detail about how organisms (non-GMOs) can be handled and the building design and work practices. The Office of the Gene Technology Regulator (OGTR) regulate GMOs and the certification of associated facilities, including work practices.
Are the above classes of Physical Containment Facilities & Risk Groups standard all over the world or do they differ from nation to nation?
For PC facilities, generally, yes, although the designation is different. For example, in other areas of the world laboratories are classified as BSL – Biosafety Level – but the classifications align with the 1-4 levels in Australia.
The Risk Groups of organisms can be different around the world, depending on how infectious the organism is or if the organism is endemic to that part of the world. For example, Burkholderia is RG2 in Australia as it is found in the environment but in other parts of the world it is RG3 because it is not found there.