Wednesday, 10 July 2019

Standard for Disinfectants and Sterilants (TGO 54)


Previously in this blog we mentioned the Australian TGA consultation for its Standard for Disinfectants and Sterilants (TGO 54). The consultation period has now been completed and the TGA has made the new Therapeutic Goods Order 104: Standard for Disinfectants (TGO 104) to replace the previous TGO 54 'Standard for Disinfectants and sterilants' which sunsets on 1 April 2019.

The TGA has incorporated stakeholder feedback from consultation, about the proposed new TGO:

  • Updated sections of the previous TGO 54 'Standard for Disinfectants and Sterilants' and clarifies the requirements for hard surface disinfectants;
  • The labelling requirements of the previous and TGO 37 'General Requirements for Labels for Therapeutic Devices' (which sunset on 1 October 2018); and
  • Standards and requirements within the Guidelines for the evaluation of disinfectants.
  • As a result, these regulatory requirements are now contained within one TGO. 

Stakeholder feedback will also inform TGA's review of:
  • the disinfectants pages of the TGA website, to ensure the application processes for inclusion in the Australian Register of Therapeutic Goods (ARTG) are clear for all current and potential sponsors of disinfectants; and
  • the guidance documents for exempt and listed disinfectants (which will be published in late April in response to requests from stakeholders for further amendments). In the interim, the previous guidance documents provide support to sponsors for understanding the TGO.
  • In response to requests from stakeholders, the TGA intends to consult separately on a Standard for sterilants and disinfectants of medical devices during 2019. In the interim, sponsors may continue to comply with the appropriate sections of TGO 104 (which refers to the Guidelines for the evaluation of disinfectants) as 'state of the art'.



The TGA also intends to amend the definition of hospital grade disinfectant to more accurately reflect these products are used outside of a medical setting, at the next review of the regulations.

For details see – TGA https://www.tga.gov.au/therapeutic-goods-order-54-standard-disinfectants-and-sterilants-tgo-54

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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