AMSJ » Australian respirator manufacturer at the forefront of COVID-19

Australian respirator manufacturer at the forefront of COVID-19

CleanSpace Technology

CleanSpace Technology is delivering a revolution in respiratory protection for the healthcare sector.

CleanSpace® Technology, an Australian company that designs and manufactures next-generation respirators, has found itself at the forefront of the COVID-19 pandemic. The proprietary technology at the heart of all CleanSpace Respirators was designed by ex-ResMed biomedical engineers; ResMed is a world leader in CPAP devices. The engineers had a vision to make respirators which deliver high-level protection in a comfortable, easy-to-use system. The company has been successfully protecting workers in a wide range of sectors for the past ten years.

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Until CleanSpace, the technology for masks had not changed in 30 years. Traditional devices were typically uncomfortable, hot and provided low levels of protection. Industries such as mining, metal works and stonemasonry, where workers are exposed to harmful contaminates such as coal dust, silica and welding fumes, welcomed an alternative.

“Our technology was seen as a game-changer – and it still is. One of the main reasons people go unprotected is because of low compliance. If masks are uncomfortable or not quick and easy to put on then it simply doesn’t get used,” says CleanSpace Technology CEO Dr Alex Birrell. “CleanSpace is unique: it’s a Powered Air Purifying Respirator (PAPR) without the heavy and cumbersome belt and hoses associated with PAPRs. Its simplicity, with fresh air on the face, makes it far preferable to the N95 disposable.”

The clear silicon mask is comfortable and soft; and allows for easy communication. In combination, these features mean that healthcare workers are more likely to wear CleanSpace Respirators for a full shift than traditional medical masks: disposable masks are well known for causing fogging of eyewear and discomfort, leading to low compliance. Compared to disposable masks, CleanSpace Respirators offer more protection and are more economical, as the cost of replacing disposables stacks up.

CleanSpace HALO

Following the Ebola outbreak in 2014, the WHO and CDC put out a call for highly protective lightweight PAPRs specifically designed for healthcare workers. CleanSpace Technology was confident, with its medical device background and a commercially proven technology, that it could develop a healthcare respirator. 30% lighter, smaller and more ergonomic that its predecessors, CleanSpace HALO was the first respirator to be designed in consultation with healthcare.

Well before the COVID-19 crisis, CleanSpace HALO was protecting the lives of thousands of frontline healthcare workers globally. Since the outbreak, this unique system has become the ‘standard of care’ for the protection of high-risk healthcare teams in anaesthetics, surgery and general care. The advantages of reusable systems with superior protection and a secure supply chain make this Australian manufacturer an attractive and reliable vendor for many Australian and international hospitals.

Since the onset of COVID-19, with the rapid depletion of disposable masks and reliance on lean supply chains, hospitals were suddenly desperately seeking alternatives to disposable masks. “The need is very real and very urgent; we have had to quickly adapt our manufacturing to respond to the need,” Dr Birrell says. “Like many businesses, COVID restrictions are creating a shift change in our training delivery platform. In introducing a new technology, this had challenges but during an outbreak, healthcare workers around the world were – and still are – overwhelmed. Our deployment had to be reliable and fast for frontline workers. One thing that remains constant is the confidence we have in the technology and its ability to protect workers facing airborne contaminates that risk their health and safety.”

Respirators: positive and negative pressure

PAPRs and N95 disposable respirators are two of the respiratory protection options available to protect workers from dangerous or hazardous airborne contaminants such as crystalline silica, but the design and means by which these two types of respirators function are very different.

Disposable N95 respirators: negative pressure

N95 disposable respirators are specifically manufactured to be able to filter particles that are above 0.3 microns in size with 95% filtration efficiency. They achieve this level of filtration by using a filter layer in the mask that is created from non-woven fibre or material, such as a form of polypropylene.

N95s are negative pressure masks, which means air is drawn in through the mask. However, in order to be effective, N95 respirators are designed to be worn with a tight seal against the wearer’s face. This ensures that when the wearer inhales, the air being drawn in is coming through the mask’s filtration layers, and not from leakage around the edges of the mask where it meets the face. The procedures for proper use of an N95 mask require that the mask be correctly fitted and properly donned.

Powered Air Purifying Respirators: positive pressure

Powered Air Purifying Respirator systems consist of a battery-powered air handler or blower which draws ambient air through a filter cartridge, directing the purified air into headgear such as a mask, hood or helmet. The power unit generates positive pressure inside the mask, which serves to keep unfiltered ambient air from entering the headgear and potentially being inhaled by the user.

This positive pressure feature means that the fit of the headgear used with PAPRs need not form a tight seal, unlike the N95 mask where the tight fit to the face is a key requirement. This capability means that users with facial hair are able to wear the respirators, because if there is a break in the seal the air is pushed outwards, preventing any contaminated air from entering.

PAPRs are capable of filtering anywhere from 96% of contaminants at the low end to upwards of 99.9% at the higher end of the filtration metric.

CleanSpace Respirators

CleanSpace Respirators are PAPRs, but they are seen as a revolution in the area of respiratory protection because while they provide all the protection of a PAPR, they are free from belts, battery packs and hoses, making them more comfortable and easier to deploy.

Compared to disposable masks, CleanSpace Respirators offer more protection and are more economical as the cost of replacing disposables stacks up. With the current COVID-19 crisis, securing a reliable supply has also been an issue. When used in hot or humid conditions, CleanSpace Respirators provide cool, clean air to the user and eliminate fogging and moisture. CleanSpace Respirators are light, easy to put on, reliably safe and comfortable. These smart powered devices are easily operated using a one-button smart system.

Comfort equals compliance

CleanSpace offers both half-face and full-face masks. The full-face mask also has a high impact rating. CleanSpace Respirators are compact systems with a runtime of up to six hours and fast top-up charging.

“The feedback we get from teams wearing CleanSpace Respirators with the full face mask for mining, is that the mask is comfortable to wear all day; and the cool fresh air on the face is a dramatic improvement on disposable or reusable half-masks,” Dr Birrell says. “They have also told us there is no fogging or hot moisture on their face.”

To guard against silica exposure, state regulators have moved to recommending staff wear respiratory protection using a minimum of a P2 filter. CleanSpace Respirators meet and exceed these requirements with a P3 filter. CleanSpace Respirators are CE, NIOSH and AS/NZS 1716 approved.

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