- List
- Australia Group – Dual-Use Biological Equipment and Related Technology and Software – Version of 1 October 2025
- Corresponding EU entry
- 2B352
Cross (tangential) flow filtration equipment capable of separation of microorganisms, viruses, toxins or cell cultures having all the following characteristics:
a) a total filtration area equal to or greater than 1 square metre; and
b) having any of the following characteristics:
i. capable of being sterilized or disinfected in-situ; or
ii. using disposable or single-use filtration components.
(Note - This control excludes equipment designed for reverse osmosis or for filtration of blood for medical applications (e.g. hemodialysis or plasmapheresis), as specified by the manufacturer.)
Cross (tangential) flow filtration components (eg modules, elements, cassettes, cartridges, units or plates) with filtration area equal to or greater than 0.2 square metres for each component and designed for use in cross (tangential) flow filtration equipment as specified above.
Technical note: In this control, ‘sterilized’ denotes the elimination of all viable microbes from the equipment through the use of either physical (eg steam) or chemical agents. ‘Disinfected’ denotes a process to reduce the number of microorganisms but not usually of bacterial spores, through the use of chemical agents, without necessarily killing or removing all organisms.
a) a total filtration area equal to or greater than 1 square metre; and
b) having any of the following characteristics:
i. capable of being sterilized or disinfected in-situ; or
ii. using disposable or single-use filtration components.
(Note - This control excludes equipment designed for reverse osmosis or for filtration of blood for medical applications (e.g. hemodialysis or plasmapheresis), as specified by the manufacturer.)
Cross (tangential) flow filtration components (eg modules, elements, cassettes, cartridges, units or plates) with filtration area equal to or greater than 0.2 square metres for each component and designed for use in cross (tangential) flow filtration equipment as specified above.
Technical note: In this control, ‘sterilized’ denotes the elimination of all viable microbes from the equipment through the use of either physical (eg steam) or chemical agents. ‘Disinfected’ denotes a process to reduce the number of microorganisms but not usually of bacterial spores, through the use of chemical agents, without necessarily killing or removing all organisms.