The new silicone elastometric half-piece respirator, VJR-NMU: A novel and effective tool to prevent COVID-19

Abstract

Filter facepiece respirators (FFRs) are critical for preventing the transmission of respiratory tract infection disease, especially the dreadful coronavirus 2 (SARs-CoV-2). The N95 mask is a prototype, high-efficiency protective device that can effectively protect against airborne pathogens of less than 0.3 μm. The N95 mask is tightly fitting and has high filtration capacity. The ongoing COVID-19 pandemic has led to a greater requirement for FFR. This rising demand greatly exceeds current production capabilities and stockpiles, resulting in shortages. To address this, our team has invented a new type of half-piece respirator made from silicone and assembled with HEPA or elastostatic filter. A variety of methods have been used to evaluate this new device, including a qualitative fit test with the Bitrex® test kit and filtration test. The preliminary results showed that the new elastometric respirators pass the fit test. The filtration tests also confirmed the superiority of the new respirator over traditional N95 masks, with a mean performance of protection greater than 95%. For the filters, we used two types: SafeStar, which is a kind of HEPA filter; and CareStar, which is considered an elastostatic filler. CareStar was developed to filter virus and bacteria in the operating room, with a limit duration of use up to 24 h, while the safe star was designed for 72 h use and has the quality equivalent to a HEPA filter. Our study demonstrated superior filtration efficacy of both filters, more than 98% even after 24 h of use. CareStar has significantly more filtration efficacy than a safe star (p < 0.001). In conclusion, the development of our new N99 half-piece respirator should ultimately be applicable to healthcare workers with at least non-inferiority to the previously used N 95 respirators. As a universal masking policy is generally implemented, health care workers who are at risk must be protected with appropriate devices. Currently, the adequate supply of such equipment is not feasible. The advent of the new protective device will help protect healthcare workers and replenish the shortage of N95 respirators during the COVID-19 pandemic.

Fig 1. Silicone elastometric half- piece respirator.

Fig 2. Components of the silicone mask.

The respirator consists of a silicone mask and filter.

Fig 3. Health care workers wearing silicone elastometric half-piece respirator (with permission from the personnels).

Fig 4. Filter Tester model 8130A.

Ref: https://www.tsi.com/getmedia/05b5cb92-d6bb-4bb7-862f-59587ba52ffd/8127-8130_5001474_A4_WEB?ext =.pdf.

Fig 5. Diagram of the filtration test.

dx.doi.org/10.17504/protocols.io.bnr2md8e.

Fig 6. Comparison between the percentage performance of the SafeStar and CareStar filters.

Fig 7. New version of silicone mask with exhalation valve.