The Australian Government is responsible for regulating the quality of therapeutic goods, including medicines. In respect of therapeutic goods other than medical devices, this is principally achieved by specifying ministerial standards for the goods which may relate to a range of matters (e.g. the quality of the goods and the procedures to be carried out in their manufacture), and otherwise by applying default standards specified in the international pharmacopoeias that are defined in the Act.
Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) 2019 (the Order) is designed to support the quality, safety and efficacy of therapeutic goods that are disinfectants, sterilants and sanitary fluids and powders.
The Order does so in relation to disinfectants by, in part, specifying a number of important performance requirements. These performance requirements principally require that disinfectants comply with specified microbiological tests, such as the TGA Disinfectant Test, to support the claims for bactericidal activity. Additional testing is required where a claim is made for a disinfectant in relation to the product having a sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use.
This document sets out for the purpose of identifying and explaining these testing requirements, the TGA Disinfectant Test (Part 1) and specific testing requirements (Part 2), principally for the purposes of the Order.
A number of terms used in this document, for instance 'sporicide', 'tuberculocide' are defined in the Therapeutic Goods Regulations 1990. A link to these regulations on the Federal Register of Legislation can be found at https://www.legislation.gov.au/Details/F2019C00136.
Part 1 - The TGA disinfectant test
Sterile hard water
Medium for growth of test organisms
Preparation of inoculum
Enumeration of inoculum
Recovery broth contamination
Procedure in case of invalid controls
Part 2 - Disinfectant performance tests 11
Division 1 – Tests for the physical stability, chemical stability, and shelf life of disinfectants
Stability testing frequency
Packs for stability testing
Prediction of shelf life
Division 2 – Microbial efficacy general requirements
Specific tests for hospital grade disinfectants and household / commercial grade disinfectants
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.