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VIRACLEAN® Leads the Way with a SARS-C0V-2 (COVID-19) Approved Label Claim

Following recent changes to the Guidelines for Disinfectants under Therapeutic Goods Order 104, Whiteley Corporation can confirm VIRACLEAN® has the first newly approved label claim for killing the SARS-CoV-2 (COVID-19) virus on contaminated hospital surfaces.

The Australian Therapeutic Goods Administration (the TGA), has confirmed that Viraclean® [AUSTL 69000], which is manufactured by Whiteley Corporation, has “Kills Coronavirus, SARS-CoV-2 (COVID-19)” added to it’s 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 the first product approved in Australia with this disinfection label claim against the SARS-CoV-2 (COVID-19) virus. It is important to note that this product is a surface disinfectant and not intended for use directly on people, or for treating a patient.

Viraclean® is a Hospital Grade Disinfectant intended for use on a wide range of hospital surfaces which may be contaminated. Viraclean® 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.

Dr Greg Whiteley, Chairman of Whiteley Corporation, says “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 Whiteley continued, “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 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.

Dr Whiteley said “The hospital surfaces around a patient who is infected with this virus will be contaminated by the patient shedding the virus. Viraclean® is suitable for use in these hospital situations“. Viraclean® and Instrumax® Pink complement each other for this purpose. Instrumax® Pink is ideal where there is a lot of very sensitive medical equipment that could be corroded or destroyed by harsh disinfectants

Dr Whiteley added, “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.”

As a more technical comment Dr 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."

Dr Whiteley concluded, “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.”

For more information on Viraclean® visit - https://www.whiteley.com.au/our-products/viraclean
 

 

 

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