Emerging Pathogens Require Emerging Solutions

Chun-Yin Or, Jackson Tse, and Jeanne – Moldenhauer, C-POLAR Technologies, Inc.

Background

Companies today face many new challenges following the COVID pandemic. One common challenge is determining whether to allow employees to continue working remotely. Alternatively, an assessment must be made regarding the kind of safety procedures to be established to allow for safe return to working in the office. It becomes important to balance the safety regulations that should be implemented versus violating civil rights laws. (Pazzanese, 2021)

Pharmaceutical companies generally need people to be available to support their manufacturing processes. Few, if any, are so automated that workers are not needed. During the pandemic, many companies struggled to keep the employees who were working in the office or manufacturing area healthy. Employee absences and sicknesses resulted in some of the product shortages and delays in shipping/releasing products. In addition to personnel calling in sick, presenteeism also occurs. This is the practice of coming to work, even though one is sick. The most recent strains of coronavirus have raised concerns about the transmissibility of the virus as well as, the effectiveness of vaccines against these viruses. (Salo, 2021)

As such, it has become more important for businesses to look at appropriate safety precautions to implement to keep their employees safe. While vaccines were highly recommended to provide complete protection against the coronavirus causing COVID-19, current data indicates an inability of the vaccine to work on newer strains. The information gained from COVID-19 experiences can also apply to other viruses and microbiological pathogens.

Transmission of SARS-CoV-2

The Centers for Disease Control (CDC) has identified three main ways in which exposure to respiratory fluids carrying SARS-CoV-2 occur. They include inhalation (breathing in air which has small droplets and aerosol particles that contain the virus; the greatest concentration is within three to six feet of the infectious person); deposition(contaminated droplets are splashed or sprayed on mucous membranes, e.g., coughing), and touching (surfaces or inanimate surfaces which are contaminated with virus). (Anonymous, 2021)

There are two basic methods to determine the concentration of virus exposure that occurs from the air or by touching a surface. The concentration of virus in the air deceases from the initial location of the contamination and the further the air is from the initial location. Larger and heavier droplets fall to the ground or surfaces due to gravity. The smaller droplets and aerosol particles mix in the airstream and become diluted. Mixing typically is not uniform. It can be affected by thermal layering and the initial jetting of exhalations. There is a progressive loss of the virus’ viability and infectious-ness over time. Environmental conditions like temperature, humidity and ultraviolet radiation influence the loss of viability and infectiousness. (Anonymous, 2021)

In a work situation, data has shown that infections due to inhalation can occur at distances greater than six feet from the infectious source. For example, an infectious person working indoors and exhaling for an extended time period (greater than 15 minutes) led to virus concentrations in the air sufficient to be infectious more than six feet away. Some have also been infected walking through these areas, even after the infectious person left the area. The factors identified affecting an increased risk of infection were: enclosed spaces with inadequate ventilation or air handling, increased exhalation of respiratory fluids (e.g., loud talking, physical activity, shouting, or singing), and prolonged exposure to these conditions. (Anonymous, 2021)

Prevention Methods

There are numerous prevention methods that can be implemented to aid in keeping employees healthy. One of the important methods is frequent and appropriate handwashing. Unfortunately, as much as this procedure is encouraged and taught, individuals often choose not to implement this method, even though individuals who work in cleanrooms have been trained in the importance of these procedures. (Bottone, et al., 2004)

For aerosol contaminants, masks and/or respirators may be used. However, for them to work properly, they must be fitted and worn in accordance with the manufacturer’s instructions. There are also major differences between masks, e.g., cloth masks, coated masks, antiviral/antibacterial masks, and masks designed for chemical smells or dust. The antiviral/antibacterial masks have advantages in reducing contamination risks. Falcon (2021) advocated the use of masks based upon 49 peer-reviewed studies that indicated that masks are valuable in reducing contamination risks. Kelly (2020) reported, “Measures to reduce the spread of COVID-19 through non-pharmaceutical interventions (NPIs) such as mask wearing and social distancing are a key tool in combatting the impact of the ongoing coronavirus pandemic. These actions also have greatly reduced incidence of many other diseases, including influenza and respiratory syncytial virus (RSV).”

It is important to understand that wearing a mask, with no instruction, is not really appropriate. For example, cloth masks that are worn for many days at a time without washing or disinfectant may not be effective. Newer masks are available that are antibacterial and/or antiviral. Within this category, it is important to know what technique was used to make the masks antimicrobial and/or antiviral. For example, some coatings utilize nanoparticles or metal ions which may have their own toxicity issues. (See Figure 2) The associated risks may be different depending upon the technique used. There are also concerns with how employees wear the masks and the associated effectiveness.

The need to breathe clean air became a significant concern during the COVID-19 pandemic. It resulted in a worldwide interest and concern over air quality, due to the transmission of the disease. As the pandemic progressed and there was an interest in allowing people to return to work or school (following the stay-at-home mandates) a concern arose over the ability to have a safe working/ school environment. (Laake, 2022)

Various regulatory agencies including the World Health Organization (WHO), the Environmental Protection Agency (EPA) in the USA, and the Centers for Diseases Control (CDC) identified ventilation procedures and air fi ltration methods to reduce the spread of the virus. Manufacturers used these recommendations to identify products that were available to combat or eradicate the virus, making it a safer workspace. Depending upon the technology selected, the safety features may be providing a false sense of security, i.e., there still is a high risk of infection. Other technologies may be “helping” the reduction of virus contamination while making other risks higher, e.g., release of ozone, volatile organic compounds (VOCs), or releasing other dangerous chemicals into the air. (Laake, 2022)

There are several types of air systems that have been developed which claim to improve air quality. Some representative technologies are included in Figure 3.

Brief Technology Overviews

Cationic Polymerization

The key mechanism of action in this technology is the use of positively charged ions to attract and eradicate the negatively charged microorganisms and viruses.

Often, the positively charged ions associated with this technology are nanoparticles. There are properties of nanoparticles that influence toxicity including size, surface area, shape, aspect ratio, surface coating, crystallinity, dissolution, and agglomeration. (Egbuna, et al., 2021)

Nanoparticles come in different shapes, which can affect toxicity. The following figure (Figure 4) shows the typical shapes of nanomaterials.

Toxicity of metallic oxide nanoparticles, when attached to nanoparticles is based upon the properties of the nanoparticles (as described previously) and the properties of the nanoparticle combined with the metal oxide ion and its proclivity to induce reactive oxygen species (ROS). This causes toxicity to cells, genes, and neurons. (Egbuna, et al., 2021)

There are various toxicities associated with different types of metallic ions. The following literature provides details of these human toxicities associated with nanoparticles and metallic ions, Egbuna, et al. (2021), Woodcock, et al. (2021), Jeremiah, et al., (2020), Hanson and Ranney, (2020), Smith, et al. (2018), Grass, et al. (2011), and EMA (2021).

Cationic Polarization Matrix (CPM)

The main mechanism of action for this technology is the use of positively charged polarity and a space charge electret to attract and eradicate viruses and microorganisms. One major difference in this technology is that metal ions are not used to create the cationic charge.

HEPA Filters

HEPA filters utilize ultra-dense fabric to capture harmful particles, including viruses and microorganisms.

This type of filter cannot be utilized with Fan Coil Units (FCU).

ULTRAVIOLET-C (UVC)

UVC utilizes radiation to disrupt the DNA of viruses and pathogens. They do so by damaging molecules like nucleic acids and proteins, inactivating them.

According to ASHRAE, the UVC used in HVAC applications can result in filter material degradation. This can result in potential safety concerns, including the spread of pathogens from the filter. This document states, “Material degradation can result in decreased filtration efficiency, defective seals, and damaged system components, causing a possible loss in system performance and/or potential safety concerns” (Ashrae, 1973). The FDA indicates, “UVC can degrade certain materials, such as plastic, polymers, and dyed textile” (FDA, 2021).

Bipolar Ionization

Ionizers work by splitting molecules in the air into positive and negative ions. Theoretically, the positive ions cluster around viruses and microorganisms, either altering or rupturing their protein structure.

The following testing data was excerpted from the Boeing Report (Laake, 2022), which shows very low efficacy for killing of various microorganisms and bacteriophage.

Conclusion

There have been significant advances in technologies available to aid in significantly improving masks to be used in pandemic situations as well as, improved air ventilation systems. It is important for one to consider costs, and associated safety issues when selecting systems to us.

Regardless of methods to implement, these technologies are only useful if we plan and implement them now, before we get into another pandemic situation.

Literature

1. Anonymous (2021) Scientific Brief: SARS-CoV-2 Transmission. Covid-19. CDC. Downloaded from: https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/sars-cov-2- transmission.html on February 15, 2023.
2. Ashrae (1973) Chapter 62: Ultraviolet Air and Surface Treatment. Ashrae Standard 62. Downloaded from: I-P_A19_Ch62.fm (ashrae.org) on February 21, 2023.
3. Bottone, E.; Cheng, M.; and Hymes, S. (2004). Ineffectiveness of Handwashing With Lotion Soap to Remove Nosocomial Bacterial Pathogens Persisting on Fingertips: A Major Link in Their Intrahospital Spread. Infection Control & Hospital Epidemiology, 25(3): 262-264. doi:10.1086/502388
4. CDC (2023) UV Lights and Lamps: Ultraviolet-C Radiation, Disinfection, and Coronavirus. Downloaded from: https://www.fda.gov/medical-devices/coronavirus-covid-19- and-medical-devices/uv-lights-and-lamps-ultraviolet-c-radiation-disinfection-and[1]coronavirus Downloaded on February 21, 2023.
5. Egbuna, C., Parmar, V.K., Jeevandam, J., Ezzat, S.M., Patrick-Iwuanyanwu, K.C., Adetunji, C.O., Khan, J., Onyeike, E.N., Uche, C.Z., Akram. M., Ibrahim, M.S., El Mahdy, N.M., Awuchi, C.G., Saravanan, K., Tijjani, H., Odoh, U.E., Messaoudi, M., Ifemeje, J.C., Olisha, M.C., Ezeofor, N.J., Chickweeds, C.J., and Ibeabuchi, C.J. (2021) Review Article Toxicity of Nanoparticles in Biomedical Application: Nanotoxicology. Hindawi Journal of Toxicology. Volume 2021. Article ID 9964443. 21 pages. https://doi.org/10.1155/2021/9954443.
6. EMA (2021) Final feedback from European Medicine Agency (EMA) to the EU Commission request to evaluate the impact of the removal of titanium dioxide from the list of authorised food additives on medicinal products. European Medicines Authority. EMA/504010/2021. Downloaded from: https://www.efsa.europa.eu/en/news/titanium-dioxide-e171-no-longer-considered-safe-when-used-food-additive on February 7, 2022.
7. EPA (2021) Notice of Receipt of Requests to Voluntarily Cancel Certain Pesticide Registrations. Federal Register 77(35). 22 February, 2012, p. 10516.
8. Falcon, R. (2021) Coronavirus: Do Face Masks work? Here are 49 studies that explain why they do. KWAN In depth Investigation (NBC). Downloaded from: https://www.kxan.com/ news/coronavirus/do-face-masks-work-here-are-49-scientific-studies-that-explain[1]why-they-do/ on February 15, 2023.
9. FDA (2022) Personal Protective Equipment EUAs. Downloaded from: https://www.fda.gov/ medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas#appendixaremoved on February 6, 2022.
10. Grass, G., Rensing, C., and Solioz, M. (2011) Metallic Copper as an Antimicrobial Surface. Applied Environmental Microbiology. 77(5):1541-1547. DOI: 10.1128/AEM.02766-10 Downloaded from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3067274/ on February 6, 2022.
11. Hanson, J. and Ranney, J. (2020) Know the Health Risks Before Investing in an Antimicrobial Nano-Silver Mask (and What to Buy Instead!). Center for Food Safety. Downloaded from: https://www.centerforfoodsafety.org/blog/6201/know-the-health-risks-before on February 6, 2022.
12. Jeremiah, S.S., Miyakawa, K., Morita, T., Yamaoka, Y., and Ryo, A. (2020) Potent Antiviral Effect of Silver Nanoparticles on SARS-CoV-2. Biochemical and Biophysical Research Communication. 533. Downloaded from: https://www.sciencedirect.com/science/article/ pii/S0006291X20317575 on February 6, 2022.
13. Kelly, M. (2020) Large, delayed outbreaks of endemic diseases possible following Covid-19 controls. Princeton University News. Downloaded from: https://www.princeton.edu/ news/2020/11/09/large-delayed-outbreaks-endemic-diseases-possible-following-covid-19-controls#:~:text=Measures%20to%20reduce%20the%20spread%20 of%20COVID-19%20through,diseases%2C%20including%20influenza%20and%20 respiratory%20syncytial%20virus%20%28RSV%29. On February 15, 2023.
14. Laake, L. (2022) Air Filtration Trends That Don’t Work. Camfil. Downloaded from: https:// cleanair.camfil.us/2022/03/18/air-filtration-trends-that-dont-work/ on February 21, 2023.
15. Li, R., Jia, Z., and Trush, M.A. (2016) Defining ROS in Biology and Medicine. React Oxyg Species (Apex). 2016;1(1):9-21. doi:10.20455/ros.2016.803.
16. Licht, S.; Hehor,A.; Trent, S.; Dunlap, D.; Bosunane, K.; Wilson, M.; and Smith, K. (2021) Use of Biopolar Ionization for Disinfection with Airplanes. Downloaded from: Use of Bipolar Ionization for Disinfection within Airplanes (boeing.com) on February 21, 2023.
17. Pazzanese, C. (2021) How COIVD Experiences Will Reshape the Workplace. The Harvard Gazette. Downloaded from: https://news.harvard.edu/gazette/story/2021/02/how[1]covid-experiences-will-reshape-the-workplace/ on February 15, 2023.
18. Salo, J. (2021) What to know about the Covid-19 variants. New York Post. Downloaded from: https://nypost.com/article/covid-19-strains-variants-what-we-know/ on February 15, 2023.
19. Smith. J.N., Thomas, D.G., Julley, H., Kodali, V.K., Littke, M.H., Munusamy, P., Baer, D.R., Gaffrey, M.J., Thrall, B.D., and Teeguarden, J.G. (2018) All that is silver is not toxic: silver ion and particle kinetics reveals the role of silver ion aging and dosimetry on the toxicity of silver nanoparticles. Particle and Fibre Toxicology 15:47. https://doi.org/10.1186/s12989- 018-0283-z.
20. Uzialko, A. (2023) The Problem of Presenteeism: Employees Coming to Work Sick Costs Businesses. Business News Daily. Downloaded from: https://www.businessnewsdaily. com/11323-cost-of-coming-to-work-sick.html on February 15, 2023.
21. Woodcock, J., Regan, M.S., and Thomas, T.A. (2021) Engineered nanomaterials in masks claimed as protection against COVID-19. Downloaded from: Institute for Agriculture & Trade Policy on February 6, 2022

 

Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special
offers from American Pharmaceutical Review delivered to your inbox!
Sign up now!