COVID-19 response: Personal protective equipment and sterilization

 

N95 respirators and surgical face masks are important examples of personal protective equipment (PPE) used to keep airborne particles and droplet hazards from contaminating the user's face and potentially exposing them to COVID-19. The NRC is working to ensure the safety and effectiveness of PPE in Canada by lending its expertise to develop PPE and the capability to test its performance, providing testing services for PPE and decontamination equipment, and funding research and development for innovative, made-in-Canada solutions to keep Canadians safe.

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Ensuring safe, effective N95 respirators

When worn properly, certified N95 respirators reduce the risk of inhaling hazardous airborne particles and aerosols. The N95 designation means that, when subjected to careful testing, the respirator blocks at least 95% of very small test particles that are representative of pathogens.

The importance of testing

As part of the National Research Council of Canada's (NRC) COVID-19 response, the Metrology Research Centre is developing unique-in-Canada capability to test the performance (i.e., particulate filter efficiency level) of N95 respirators and respirator material, according to the TEB-APR-STP-0059 (PDF) test standard.

This testing is important to determine whether N95 respirators meet the mandatory performance standards to protect the wearer, and assess how new materials and manufacturing processes perform so manufacturers can produce safe, effective N95 respirators in Canada.

Developing N95 testing capability in Canada

The Metrology Research Centre is engaged in a number of areas to develop the capacity and expertise necessary to test N95 respirators and respirator material in Canada:

  • Direct testing: We perform testing for federal government partners and in support of  COVID-19 challenge programs at NRC facilities in Ottawa
  • Capacity building: We are working with partners in industry and government to help modify existing testing infrastructure and expertise to meet the test standard
  • Information sharing: We facilitate connections between organizations requiring testing and qualified testing facilities across Canada
  • Long-term support: We will continue working with regulators, industry, organizations, and other stakeholders within Canada's national quality infrastructure to distribute and solidify N95 respirator testing nationwide

Accessing this testing service

Due to the urgent need for N95 respirators for front-line workers, the NRC's N95 respirator testing service is strictly accessible at this time to the NRC's COVID-19 response programs only. The Metrology Research Centre is working to expand its testing capacity to meet more demand, and will advise how to access these services as they become available.

We are also supporting our partners with an interest in developing this testing capability by providing advisory services, expertise, and—once available—our standard test apparatus. To speak to an expert about developing N95 testing capability at your organization, please contact us at PPE-EPI@nrc-cnrc.gc.ca.

 

Testing COVID-19 decontamination equipment (Clēan Works Inc.)

The NRC purchased 20 decontamination devices from Beamsville, Ontario company Clēan Works Inc. to send to hospitals as part of a Pandemic Response Challenge Program study that will evaluate the use of this technology in Canada's health care system. The device, called the Clēan Flow Healthcare Mini, decontaminates personal protective equipment such as N95 respirators, masks, and medical gowns, so they can be safely reused by medical professionals.

Clēan Works Inc. originally manufactured a version of this device, Clēan Flow, as a food safety solution. With business advisory support and R&D funding from the NRC Industrial Research Assistance Program (NRC IRAP), Clēan Works Inc. modified its existing solution to help the Government of Canada in its efforts against COVID-19.

"Working with NRC IRAP enabled us to respond quickly to the COVID-19 pandemic. Using our combined expertise we were able to retool our existing solution to increase the availability of medical PPE for Canadian healthcare and front-line workers. We are very fortunate we are able to make such a meaningful contribution to the health and safety of our fellow Canadians."

Mark VanderVeen, President, Clēan Works Inc.

The Clēan Flow Healthcare Mini has been proven to kill 99.99% of a surrogate for the novel coronavirus on disposable filtering face masks. The Healthcare Mini received Class 2 medical device certification from Health Canada and now meets the requirements for use in hospitals and other healthcare organizations.

At present, 10 Clēan Flow units have either been delivered to clinical sites, or are expected to be in place shortly.

Is your organization interested in participating in this study? Find out how to get involved.

 

Funding innovative made-in-Canada solutions for alternative filtration material

To help create and maintain capacity to manufacture essential PPE items in Canada, the NRC, facilitated by NRC IRAP and Innovative Solutions Canada, challenged small and medium-sized businesses to come up with innovative solutions for alternative filtration material that could be sourced and made in large quantities here in Canada, and used to produce N95 respirators and surgical masks for our many front-line workers across the country. Now, NRC IRAP is investing over $200,000 to support 3 companies working on solutions to this important challenge:

  • Stedfast Inc. is receiving $32,570 to develop washable masks with barrier properties, and a prototype N95 respirator, surgical mask, and community mask
  • Roswell Downhole Technologies is receiving $70,253 for rapid reconfiguration of plastic extrusion equipment to manufacture N95 filter material
  • Performance BioFilaments Inc. is receiving $102,524 to develop novel cellulose-based filtration material for N95 respirators and surgical masks that are either recyclable or compostable

This funding will help these companies further their research and development to prove the feasibility of their ideas. The projects will then be evaluated for Phase 2 funding to develop a working prototype, with the goal of scaling up the production of filtration materials for respirators and masks by late summer.

 

All hands on deck - responding to Canada's need for sanitizer (Acenzia Inc.)

With support from NRC IRAP, Acenzia Inc. of Tecumseh, Ontario, was able to quickly respond to COVID-19 supply shortages by producing much-needed hand sanitizer. Already well versed in product development and advanced manufacturing for the nutraceutical industry, the company turned to NRC IRAP for strategic advice to quickly expand their product line and source an ethanol producer to secure their supply chain.

As a result, the company was able to secure accelerated funding from NRC IRAP to ramp up their hand sanitizer production. With this support, Acenzia has increased its production from 12,500 litres per month up to 400,000 litres per month and is investing in additional equipment to increase manufacturing capacity. Acenzia now has over $5 million in pre-orders for their product and are in talks with major Canadian grocery and pharmacy retailers and distributors.

"Strategic advice and funding from NRC IRAP has enabled us to quickly adapt our operations to join the fight against COVID-19. With this support, we have been able to significantly ramp up production of much-needed hand sanitizer to help keep Canadians safe and expand into a new market."

Indrajit Sinha Ph.D., Co-President/Co-Founder Acenzia Inc.
 

Expanding production to include health and medical personal protective equipment (Top Dog Manufacturing)

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A long-time producer of protective clothing for the food manufacturing industry, Top Dog Manufacturing (TDM), Prince Edward Island's 2018 Exporter of the Year, looked to NRC IRAP for advisory services and funding to expand its operations to add a line of certified health and medical personal protective equipment for frontline health care workers.

With NRC IRAP's support, the firm has been able to hire additional expertise, connect with technical and regulatory experts, validate the structural integrity of their products, and adopt new manufacturing processes to expand their operations. Advice from the company's NRC IRAP industrial technology advisor allowed TDM to prepare a business model for financial growth and explore new opportunities to test their products. TDM is now focussing on producing medical gowns which meet Health Canada regulations for use in the context of COVID-19, and they've added more shifts to address demand for their product.

"Support from NRC IRAP and its experts has been invaluable, providing us with the right advice and contacts as we branch out and expand into the manufacturing of medical gowns to help Canada respond to the COVID-19 pandemic."

Doug LeClair, Chief Executive Officer, Top Dog Manufacturing
 

Producing face shields for health care workers (MacKenzie Atlantic)

As an expert in precision manufacturing, design and metal fabrication, MacKenzie Atlantic of Musquodoboit Harbour, Nova Scotia, was well positioned to answer the call for Canadian-made products to help in the fight against COVID-19. In only a few shorts weeks, the company expanded its operations to include the design and manufacture of face shields for healthcare workers. NRC IRAP played a role in facilitating this journey, providing guidance on safety and effectiveness testing, as well as the process of applying for a medical device establishment license (MDEL)—a necessary step for any company to sell or import any class of medical device in Canada. This support was provided through 2 NRC IRAP subject expert teams (SET)—the Regulatory SET and the Personal protective equipment SET—which were established to help Canadian businesses respond to COVID-19 in key priority areas. MacKenzie Atlantic received Health Canada approval and is now ready to deliver on supply contracts for up to 1.5 million face shields to Canadian health care workers.

"Thanks to the support of NRC IRAP, we were able to easily navigate the regulatory requirements needed to expand our operations and quickly produce Canadian-made solutions to protect front-line health care personnel working through the COVID-19 pandemic."

Matthew MacKenzie, Owner, MacKenzie Atlantic
 

Made-in-Canada N95 masks that are lightweight, environmentally friendly and fit like a glove (Dorma Filtration)

3D printer

The NRC is joining forces with Dorma Filtration to help make N95 masks using 3D printing, injection moulding and digital technology. N95 masks represent essential and effective PPE to minimize exposure to airborne particles that can contain viruses such as SARS-CoV-2, which is responsible for the outbreak of COVID-19. This project will not only allow the NRC and Dorma Filtration to increase the availability of PPE for Canadians and the international market, but it will help reduce production costs and speed up manufacturing of this new line of N95 masks.

"With more than 30 years of experience in polymer processing, including in injection moulding and 3D printing, NRC researchers have developed an important expertise in polymers. Using our unique facilities and high-level technologies in Boucherville, Quebec, our team will provide valuable expertise to optimize the use of 3D printing and injection moulding processes for the manufacturing of N95 masks," says Dr. Mihaela Mihai, the NRC's lead researcher for this project.

Dorma Filtration, a Montreal-based health care service company founded in 2016 by a team of medical doctors, started producing and distributing 3D-printed customized N95 masks to local hospitals and clinics in response to the COVID-19 pandemic in March 2020.

Dorma Filtration's masks are made using an innovative mobile application based on facial scanning and generative design, which enables the creation of personalized and well-fitted masks for health care workers as well as for all Canadians. Once the user's facial dimensions have been scanned and measured by the app, the data is immediately transmitted to 3D printers, which then employ laser power to process polymers into a form-fitting comfortable mask with superior sealing efficiency that can be sterilized and reused multiple times.

"Being a health care worker myself, once COVID-19 hit, I was immediately attuned to the lack of reliable supply of personal protective equipment on the front lines," said Dr. René Caissie, co-founder of Dorma and Montreal-based maxillofacial surgeon. "Without delay, we teamed up with leading domestic designers and suppliers of the raw materials needed to build these masks, as well as great scientific minds from the NRC, to rapidly develop this innovative line of lightweight masks that fit like a second skin."

By working with the NRC, Dorma Filtration will manufacture and commercialize cost-effective, environmentally friendly and reusable N95 masks that are fully sourced and made in Canada through the use of additive manufacturing and on a larger scale by injection moulding. Dorma is also collaborating with the NRC to fine-tune the manufacturing process and to run these injection-moulded masks through a gamut of tests for the purpose of obtaining Health Canada approval.

 

Personal protective equipment for front-line workers

Picture showing 10 palettes of needed Personal protective equipment

Beyond carrying on with the critical tasks across the NRC during the pandemic, we are proud to have made donations of urgently needed PPE for frontline workers.

On March 27, we put the call out to our researchers and branches, asking them to identify surplus stock of unopened PPE that could be spared. On April 3, The NRC collected 10 pallets of urgently needed PPE, including:

  • N95 masks
  • nitrile gloves
  • disposable coveralls with integrated boots and hood

The majority of the PPE was collected on our Ottawa campus and shipped to the Ottawa Hospital, Riverside Campus.