Importing Biological Materials
Page Contents
Include: Australian Quarantine and Inspection Service (AQIS) | Definition of Biologicals | Awareness of potential problems associated with the import of biological materials | Decontamination of infectious microorganisms by pressurised steam | Disposal of potentially infectious animals | Transfer of imported biological material
Australian Quarantine and Inspection Service (AQIS)
The Australian Quarantine and Inspection Service (AQIS) provides quarantine inspection services for the arrival of international passengers, cargo, mail, animals and plants or their products into Australia, and inspection and certification for a range of animal and plant products exported from Australia.
Import permits are required from AQIS to import biological materials from outside Australia. You will need a permit if you are obtaining material from overseas suppliers or from overseas colleagues, laboratories, hospitals, etc. See Departmental Safety Officer if you are unsure of what to do.
Definition of Biologicals
Biologicals are products containing biological material of either animal, human, plant or microbial origin and include diagnostic kits, reagents and media used in research, medical or associated fields. Local suppliers will have import permits, but you will need a permit if you are obtaining material from overseas suppliers or from overseas colleagues, laboratories, hospitals, etc.
Awareness of potential problems associated with the import of biological materials
Imported diagnostic reagents and other biological products manufactured from human, animal or plant material may be contaminated with pathogens including viruses. Processing methods do not always ensure freedom from contamination. Information concerning the multi-country origin, processing and innocuity testing of biological products is frequently difficult to obtain.
While most imported biological products for in-vitro use pose only a minimal risk of introduction of exotic diseases into Australia, certain products, e.g. sera, are a high risk. When products, even many low risk products, are used in-vivo, they may become very high risk.
An example of AQIS concerns are the slow viruses, "Scrapie" and "Bovine Spongiform Encephalopathy" which can withstand extreme temperatures (dry heat of 160ºC for 24 hours or autoclaving at 134ºC for 18 minutes). Provided products containing animal material are only used in-vitro and are safely disposed of (e.g. by incineration), there is little risk of introducing these or other exotic pathogens. Should this type of material be used in-vivo, the risk is magnified many fold.
A quarantine policy has therefore been developed requiring the safe use and disposal of these products in Australia.
It is, therefore, our responsibility to ensure that the import of materials and the methods of disposal in place in the Department of Microbiology and Immunology are such that potential risks are eliminated.
Decontamination of infectious microorganisms by pressurised steam
Moist steam under pressure is the method used in the Department of Microbiology and Immunology for both sterilization and decontamination of infectious materials and waste.
The basic essential in steam sterilization is that the whole of the load of material to be sterilized shall be in contact with saturated steam at the required temperature for the necessary length of time. Each of these criteria is important. Saturated steam must be used, otherwise the process virtually becomes a dry heat treatment for which different temperature-time relationships hold. There is also a well established temperature-time relationship that must be observed if reliable decontamination is to be achieved.
Implicit in the specifications for steam sterilization is the need for sufficient time for the whole of the load to reach the required temperature for the actual sterilizing period to commence. This varies considerably with the nature and size of the load and the size and type of the sterilizer. That the required temperature for each autoclave has been reached can be determined by the placement of a thermocouple, a biological indicator (spore strip) a chemical indicator or a combination of all three in the centre of the load.
Steam sterilization of micro-organisms requires a temperature of 121ºC for 15 minutes or 134ºC for 3 minutes. The actual time allowed must be determined for each autoclave by testing with the maximal desirable load. Once this time-temperature relationship has been determined for a particular autoclave these values are used, subject to monitoring.
Disposal of potentially infectious animals
Potentially infectious animals are killed using humane procedures in compliance with the NH&MRC Code of Practice for the Care and Use of Animals for Scientific Purposes and are placed in appropriate sealed biosafety bags which are collected by Mediwaste, a registered biomedical waste contractor, for incineration in an EPA approved incinerator. Carcasses are collected weekly and are kept frozen in a dedicated freezer pending collection, located in the animal unit.
Bedding, cages and waste are autoclaved at 121ºC prior to disposal.
Transfer of imported biological material
Before transferring imported biological material to another AQIS registered laboratory the Manager of the Department must be provided with name of institution, name of recipient, date, AQIS number, material details and quantity if applicable.
No imported material shall be transferred to a non AQIS registered laboratory unless a permit has been obtained by that laboratory from AQIS.