Abstract
In recent months, the world has been dealing with an outbreak of a novel coronavirus, designated COVID-19. Requirements have been established for facial masks, social distancing, gloves, and 20 second handwashing, and the like as a part of everyday life. As our everyday life has a new standard for protection from contamination, we also need to consider the effects of this pandemic upon the production of pharmaceutical products and the personnel who produce them. Viruses are not new to many biotech and vaccine products. We have seen requirements for viral clearance studies for many years, however; it is not clear whether traditional contamination control programs are appropriate for today. This article discusses some concerns with contamination control in the COVID-19 era.
Background
The Centers for Disease Prevention and Control (CDC) has identified a number of emerging infections in the 2000s. (Note: Data is presented through 2016) Some of these items are depicted in Table 1.
President George W. Bush (Bush, 2005) gave a speech regarding concerns about preparing for a pandemic. He recognized that it was not if a pandemic would occur but when. At that time, he requested money from Congress to support this program. He laid out a program to prepare for a pandemic including detection of outbreaks that occur anywhere in the world (Surveillance), stockpile vaccines and anti-viral drugs, and improve the ability to produce new vaccines against a strain. Unfortunately, the project was not funded. In Mr. Bush’s speech he indicated that a pandemic could continue spreading destruction for a year or more. He also explained that waiting until a pandemic occurs is too late. (Bush, 2005)
Three novel highly pathogenic human coronaviruses have been found in the last two decades, COVID-19, MERS, and SARS. Many deaths were associated with all three occurrences. There are descriptions for person-to-person transmission in both hospital and family settings. (Kampf et al., 2020) The COVID-19 pandemic has changed how we live life and has forced us to be concerned with contamination control.
Concerns for Contamination Control
In most pharmaceutical facilities there are specific procedures in place for control of microbiological contamination, i.e., bacteria and fungi. However; except for some biotechnology and vaccine production facilities, there has not been a major concern with the potential for viral contamination. At this time, it may be appropriate to rethink some of these contamination control programs both for risks to the product and to the individuals working in the areas.
Viral Contamination in the Air
One way in which the COVID-19 virus spreads between people is related to individuals sneezing or coughing. When they sneeze or cough droplets are released into the air. Other people breathe in the droplets and can catch the virus. (Anonymous, 2020) According to Valkin (2020) the SARS-CoV-2 v (which causes COVID-19) remains viable for 3 hours. (Valkin, 2020)
One might determine that this is not a risk in a pharmaceutical plant due to the various air handling systems and gowning procedures. However, not all pharma operations are for sterile products. Many operations are conducted without individuals being gowned and/or the gowning does not include a face mask. While it is common in many SOPs to require that individuals be healthy to work in the production line, it is not universally required. While contamination in the air may not be likely to survive the production and packaging processes for long periods of time, this can be a concern for the health of workers in the facility. There are reports of meat packaging plants closing or being severely hampered due to coronavirus infections. USA TODAY reports that “Operators [of the meat packing stores] may have to chose between worker health or meat in stores.” (Bagenstose et al., 2020) This same issue could occur in a pharmaceutical facility unless additional controls are established. The problem is exacerbated by the significant training required for individuals to work in production areas. It is unlikely that sufficient back-up personnel are appropriately qualified to maintain operations at current or elevated levels if 10% or more of the population is affected.
Another concern is that often individuals with allergies are not considered “sick” and are allowed to work, even if they are sneezing. It would be difficult to control what sneezes do and do not need additional control.
Viral Contamination of Surfaces
We touch numerous surfaces every day. Different parts of the car to drive to work, gowning materials when changing clothes, cell phones, equipment, credit cards, gas pumps, door handles and the list goes on and on. It is likely that viral contamination can happen on many different surfaces. (Whitney, 2020) There is not one specific time period that describes how long viruses can survive on a surface. The length of viral survival is dependent upon many factors including the specific virus, the surface material, environment (e.g., temperature and humidity), and the concentration of virus on the surface. (Whitney, 2020)
Touching a surface that is contaminated with virus does not mean you will get the virus. When a virus is outside of a host (remember it is an obligate parasite), it degrades quickly. As a result, it becomes less potent over time. (Whitney, 2020)
The length of time the virus can live on surfaces varies among authors depending upon the strain of virus actually tested. Table 2 identifies some of the cited surface survival times.
Additionally, the length of time the viruses survive on surfaces are affected by other factors like temperature, relative humidity, sunlight, type of surface, whether the virus does or does not have an envelope, and so forth. (Anonymous, 2020; Newman, 2020; Woodward and Gal, 2020) It is not sufficient to know how long the virus can survive on a surface. There must also be a sufficient quantity present to be infectious. In many cases, this level was not present at the end of the “survival time.” (Volkin, 2020)
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The survival on surfaces impact to the pharmaceutical industry varies based upon the room classification and cleaning/disinfection methods used in the area. Most cleaning and disinfection procedures used for aseptic manufacturing are likely to be effective in virus inactivation. However, we need to look at potentially contaminated items being discarded from the room and ensure that the proper personal protection equipment is used for the personnel handling these items, after use. For example, a “dirty” stainless steel item that is to be cleaned will always need to be handled with protective equipment for at least as long as the virus can survive on the surfaces.
Another concern is the effectiveness of the cleaning and disinfection procedures used. It can be difficult with many of these types of procedures to ensure that all of the surface is decontaminated, e.g., when wiping a surface, how do you ensure all the surface is contacted with the disinfectant. However, for non-aseptic operations and non-sterile products care procedures may need to be updated to reduce the risk of virus contamination.
Personnel Safety
The gowning used in many classified areas likely provides protection from many sources of contamination. Gowning in “non-sterile” classified and non-classified areas may need additional changes to ensure personnel safety. Volkin states “…researchers believe people can carry high viral loads of the SARS-CoV-2 in the upper respiratory tract without recognizing any symptoms, allowing them to shed and transmit the virus while asymptomatic.” It can become very difficult to protect individuals from contamination when you cannot detect who carries the virus.
Other Concerns
There are several other considerations in developing your contamination control program. Some examples are provided below.
- Since social distancing is to be used for protection of employees, how will we implement these actions in small areas like change rooms, airlocks, and the like?
- With social distancing (including masks and potentially gloves) will you continue to allow smoking breaks? If so, how will they be controlled?
- One of the major controls for this contamination is handwashing. Since many different papers indicate that individuals fail to properly wash their hands for the required 20 seconds, should we install ozonated water sinks since use of ozonated water inactivates viruses in a shorter time period?
- How do we better monitor handwashing procedures?
- Should we implement tighter temperature and humidity controls to reduce contamination risks?
- WHO (2012) reports “Recognizing these concerns, some of the more scientifically advanced vaccine manufacturers have begun to develop sampling, recovery, and automated analytical methods capable of detecting a wide range of viruses or other microorganisms likely to be the major environmental contaminants found in biologics production sites.” Should we consider monitoring for viral contamination on a routine basis?
- Should controls be implemented to monitor personnel temperatures for each shift?
- Should coronavirus testing (the short time results methods) be implemented for all personnel on a daily or periodic basis?
Conclusion
The COVID-19 pandemic is likely to have a significant influence on contamination control procedures and strategies.
Literature Cited
Anonymous (2020) How long does the coronavirus live on surfaces? WebMD. WebMD Medical Reference Reviewed by Hansa D. Bhargava, MD on April 23, 2020.Downloaded from: https://www.webmd.com/lung/how-long-covid-19-lives-on-surfaces on April 24, 2020.
Bagenstose, K.; Chadde, S.; and Wynn, M. (2020) Coronavirus at meatpacking plants worse than first throught, USA TODAY investigation finds. USA TODAY. Downloaded from: https://www.usatoday.com/indepth/news/investigations/2020/04/22/meat-packing-plants-covidmay-force-choice-worker-health-food/2995232001/ on April 24, 2020.
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Kampf, G.; Todt, D.; Plaender, S.; and Steinmann, E. (2020) Persistence of coronavirus on inanimate surfaces and their inactivation with biocidal agents. Journal of Hospital Infections 103: 246 -251. DOI:https://doi.org/10.1016/j.jhin.2020.01.022.0
Newman, T. (2020) Coronaviruses: How long can they survive on surfaces? Medical News Today. Downloaded from: https://www.medicalnewstoday.com/articles/coronaviruses-how-long-can-theysurvive-on-surfaces on April 23, 2020.
Volkin, S. (2020) How long can the virus that causes COVID-19 live on surfaces? Johns Hopkins Hub Downloaded from: https://hub.jhu.edu/2020/03/20/sars-cov-2-survive-on-surfaces/ on April 23, 2020.
Whitney, C. (2020) How Long Can Viruses Live on Surfaces? How Stuff Works. Downloaded from: https://science.howstuffworks.com/life/cellular-microscopic/long-can-viruses-live-on-surfaces.htm on April 23, 2020.
WHO (2012) Environmental Monitoring of Clean Rooms in Vaccine Manufacturing Facilities – Points to consider for manufacturers of human vaccines. World Health Organization. Vaccine Quality and Regulations (VQR), Quality, Safety, and Standards (QSS) Essential Medicines and Health Products (EMP) Department World Health Organization (WHO), Geneva, Switzerland. Downloaded from: file:///C:/DocLib/Literature/Environmental%20Monitoring/env_monitoring_cleanrooms_vaccines.pdf on April 24, 2020.
Woodward, A. and Gal, S. (2020) One chart shows how long the coronavirus lives on surfaces like cardboard, plastic, wood, and steel. Business Insider. Downloaded from: https://www.businessinsider.com/coronavirus-lifespan-on-surfaces-graphic-2020-3 on April 24, 2020.