Whiteley Corporation’s hospital grade surface disinfectant Viraclean has been named as the first product approved in Australia with the disinfection label claim against the SARS-CoV-2 (COVID-19) virus.
It follows changes by the Australian Government regulator to the TGA guidelines under Therapeutic Goods Order 104, 2019 to allow listed disinfectants to make validated claims to kill the COVID-19 virus on surfaces. The new arrangements were uploaded to the Australian Therapeutic Goods Administration (TGA) website on Monday, 23 March 2020.
The TGA has confirmed Viraclean [AUSTL 69000], which is manufactured by Whiteley Corporation, has “Kills Coronavirus, SARS-CoV-2 (COVID-19)” added to its label.
The new amendments to the TGA guidelines under Therapeutic Goods Order 104, which allow listed disinfectants to make validated claims to kill the SARS-CoV-2 (COVID-19) virus on surfaces, will be complemented by approval under Section 42(d)(k) of the Therapeutic Goods Act.
Viraclean is a hospital grade disinfectant intended for use on a wide range of hospital surfaces which may be contaminated. It is an infection prevention technology which allows the healthcare sector to better protect hospital patients and staff from the risk of SARS-CoV-2 (COVID-19) virus cross infection via inanimate high touch objects and surfaces.
“We are delighted to announce this new claim for our product Viraclean, which is a truly Australian invention, developed, manufactured and proven in Australia,” Dr Greg Whiteley, chairman of Whiteley Corporation, said.
“This new label claim for Viraclean against the virus responsible for the current pandemic will add to certainty around the level of hygiene in hospitals, particularly in Intensive Care Units, Emergency Departments, and a range of other clinical, medical and dental applications.
These claims will also be applied to the company’s Instrumax Pink, which is used for disinfection of non-critical medical devices in the hospital and healthcare sector.
“We know that this virus does have the capacity to survive on hard and relatively soft surfaces for a prolonged period of time, therefore, cleaning and disinfecting those surfaces is incredibly important to limit the spread of the virus.
“We applaud the TGA for their efficiency in passing the amendments incorporated under Therapeutic Goods Order 104 (TGO 104). The TGA regulatory framework outlines the various requirements for documentary and complying evidence of disinfecting performance,” Whiteley said.
“The testing against coronavirus in the case of this SARS-CoV-2 (COVID-19) relies on a number of surrogate viruses. This is important because using a surrogate protects the laboratory staff but allows a scientifically accurate representation of the disinfectant performance against all of the Coronaviruses including SARS-CoV-2 (COVID-19) virus. This approach allows the TGA to manage the regulatory aspects of both the approval and also market performance to ensure public health standards are maintained.”
“We also express our thanks to the team at Accord Australasia for their collaboration with the TGA in achieving the timely outcome in amendments to the guidelines under TGO 104.
“This new Viraclean label claim against SARS-CoV-2 (COVID-19) through use of surrogate virus testing will allow our company to provide our Australian and New Zealand healthcare community with certainty around cleaning and disinfecting of health care surfaces and non-critical medical devices.”
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