At the onset of the COVID-19 pandemic, Canada was faced with a significant challenge—trying to source the necessary personal protective equipment (PPE) to help keep frontline workers safe. In particular, there was a large surge in demand for N95 respirators. With no existing domestic N95 producers, Canada was reliant on uncertain and overburdened global supply chains. In an effort to ensure that Canada could produce its own PPE, a new company was born in Burnaby, British Columbia.
Founded in 2020, Vitacore Industries Inc. (Vitacore), brings together the collaborative expertise of Canadian doctors, scientists, engineers and business leaders with the aim of manufacturing high-quality "made-in-Canada" health care products and PPE. Among the company's first priorities was the production of a safe and reliable N95 mask for frontline workers. With support from the National Research Council of Canada (NRC) along the way, Vitacore became the first authorized manufacturer of N95 respirators made in Canada.
The NRC Industrial Research Assistance Program (NRC IRAP) supported Vitacore through its PPE Subject Expert Team (SET) by providing guidance on testing requirements and how to navigate new regulatory environments. The team also provided the company key connections to expertise like the NRC's Metrology Research Centre for performance testing, and recommendations for sourcing filter materials used in respirators from domestic manufacturers.
NRC IRAP also helped Vitacore navigate the process of obtaining ISO 13485:2016 certification—the standard that lays out the requirements for a comprehensive quality management system (QMS) for the design and manufacture of medical devices and is the most common path to meet the QMS medical device requirements in Europe, Canada and Australia; it also serves as the basis for QMS compliance in other countries like Japan, Korea and Brazil.
In August 2020, Vitacore became the first Canadian company to receive Health Canada authorization to produce N95 equivalent respirators—the CAN95. In March 2021, the company then went on to receive Health Canada authorization for a secondary respirator with an improved design—the CAN99—the first Canadian-made N99-equivalent single-use respirator. This success was soon followed by a string of domestic and international certifications including CSA Group certification and certification to the European EN149:2001 standard, exceeding requirements for the highest protection class, filtering facepiece 3, (FFP3) for its N99 mask.
The company also recently received its Medical Device Single Audit Program (MDSAP) certification—a process that was facilitated through NRC IRAP guidance along the way and will enable the firm to satisfy regulatory audit requirements across multiple authorities with a single regulatory audit—supporting the regulatory authorization of its respirators in different countries.
Today, Vitacore has grown to over 80 employees and has manufactured more than 15 million masks and respirators. With further encouragement and support from NRC IRAP, the company has also looked for opportunities to expand the use of its technologies through recycling to reduce the environmental impact of PPE in landfills. As a result, Vitacore is now collaborating with partners such as McMaster University and the University of British Columbia on how to use recycled masks to create new materials and applications in other industries.
Vitacore serves as a good example of how Canada's scientific community, government and industry have come together to solve some of the nation's most pressing pandemic needs. Not only are these Canadian-made masks helping in the ongoing fight against COVID-19, they also provide Canada with a domestic supply and capacity to meet future needs.
"As a new company forged to respond to an emergency, we needed guidance to quickly understand and navigate the complex testing and regulatory requirements for respirator production in Canada. Thankfully, the NRC offered a significant amount of expertise which was vital to our success in producing Canada's first N95 and N99 respirators. We are grateful for the professionalism and support of the NRC which aided us in providing the best protection to Canadians. Our success is a testament to the importance of community and partnership in times of need."
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