Overview

On January 31, 2020, the Secretary of Health and Human Services (“HHS”) declared a public health emergency related to the COVID-19 pandemic. Shortly thereafter, hand sanitizer began to disappear from U.S. retailers’ shelves, as anxious consumers (and, unfortunately, opportunistic hoarders and resellers as well) swept up all available stock. In the ensuing months, traditional hand sanitizer producers have found it impossible to keep up with the greatly elevated demand for their products, which are now considered indispensable items in efforts to control the pandemic’s spread.

Seeking to address the supply-demand imbalance currently existing within the hand sanitizer industry, the Food and Drug Administration (“FDA”) issued several industry guidance documents in March of this year (with updates later that month and in April) permitting, within specified parameters, entities not previously engaged in sanitizer manufacturing to produce, on a temporary basis (i.e., for the duration of the public health emergency declaredby the HHS Secretary in January of this year) either alcohol-based sanitizers themselves or the ethanol typically used a s a key pharmaceutical ingredient in such sanitizers.

The industry guidance documents (all of which can be found on the FDA’s website and should be read in their entirety) contemplate that such new, albeit temporary, producers of hand sanitizers (or ethanol for hand sanitizers) might include pharmacists/drug compounders and alcohol production firms (that is, distillers of alcoholic spirits for human consumption), as well as certain other businesses capable of meeting the FDA’s stringent conditions regarding hand sanitizer ingredients and manufacturing processes, as well as its registration and product listing requirements.

Since the FDA first issued its industry guidance documents in March, numerous entities and individuals have begun production of hand sanitizers (or ethanol for hand sanitizers) to address the supply gap resulting from the COVID-19 pandemic. New (albeit temporary) industry participants include manufacturing enterprises, licensed pharmacists, and distillers of alcoholic beverages. Reportedly, over 200 American distilleries (which, obviously, have deep experience in working with ethanol) have registered their facilities with the FDA pursuant to the relevant industry guidance documents.

Ethanol(a/k/a Ethyl Alcohol)

Ethanol is a clear, colorless, and (according to most people) relatively pleasant-smelling liquid made from a variety of feedstocks, including grains and crops high in sugar content, such as sorghum, corn, barley, sugar beets, and sugar cane. While it may be best known as the alcohol found in alcoholic beverages, when ethanol has been denatured (that is, made unfit for human consumption by adding certain other chemicals to it, which also make the odor unappealing), it also has many other commercial applications, including as a fuel additive, industrial solvent, key component of cosmetics and personal care items, and as the active pharmaceutical ingredient in certain disinfecting products, including hand sanitizers.

Keeping Safe While Working with Ethanol

Ethanol is highly combustible, with a low flash point, making leaks (including vapor emissions) potentially quite dangerous, and threats from accidental ignition very serious indeed. To detect, and protect against, risks emanating from leaks or excessive concentrations of ethanol, best practices include placing gas detection monitors, containing visual and audible alarms, in areas where ethanol is used or stored.

PureAireMonitors

PureAire Monitoring Systems’Combustible Gas Monitor (LEL) offers continuous readings of ethanol (and can also be programed to detectisopropyl alcohol, ethane, ethylene, and methyl alcohol). The monitor features an easy to read screen, which displays current ethanol levels for at-a-glance observation by employees, who derive peace of mind from the monitor’s presence and reliable performance. In the event of a leak or buildup of gas to an unsafe level, the monitor will set off an alarm, complete with horns and flashing lights, alerting personnel to evacuate the area. At the same time, the monitor can be programmed to turn on the ventilation system.

PureAire’s Combustible GasMonitor (LEL) is housed in a NEMA 4 explosion proof enclosure suitable for Class1, groups B, C, and D.The enclosure is specifically designed to prevent an explosion. The monitor is well suited for facilities that produce alcohol-based hand sanitizers, as well as alcohol distilleries, ethanol refineries, chemical plants, and any location where monitoring is required for combustible gases.

PureAire’s durable, long-life LEL catalytic sensor will last 5-6 years in a normal environment without needing to be replaced.

Sterilizing and Reusing N95 Respirators

Overview
Personal protection equipment (“PPE”)includes the gloves, gowns, N95 respiratory masks, and other items required by doctors, nurses, andother healthcare personnelresponsible for treating patients, including those suffering from infectious diseases.  As has become evident in the current COVID-19 emergency affecting the globe, during a crisis, these critical items may not always be available in the quantities needed to meet the challenge of treating large numbers of sick people.

Among the most sought after PPE items today are N95 respirators. According to the U.S. Food and Drug Administration (“FDA”), N95 respirators are essential gear to protect the wearer from airborne particles and to keep liquid materials from contaminating the wearer’s face. Now, more than ever, there is a need for readily available, sterile N95 respirators.

Challenge/Solution
Thus far, during the COVID-19 pandemic, we have witnessed a desperate struggle by public and private sector entities to keep up with the huge increasein N95 respirator usage which, in turn, has at times left healthcare workers and other front-line personnel without the equipment necessary to safely do their jobs. Traditionally, N95 respirators have been discarded after a single use and, while on-shore production has recently ramped up, demand for the masks far outstrips supply during the present period in which the number of COVID-19 cases surges daily.

Fortunately, as medical providers and first responders scramble to procure the safety products required to attend to the patients in their care, businesses are innovating to meet the significant challenge posed by the current respirator supply/demand mismatch.

For instance, in late March of 2020, Battelle, a Columbus, OH-based nonprofit research and development firm, received FDA approval for its Critical Care Decontamination System (“CCDS”) process for decontaminating, on a very large scale, the N95 face masks used by healthcare providers. The CCDS process involves pumping concentrated hydrogen peroxide vapor (H₂O₂) into so-called decontamination chambers (20-foot shipping containers fitted with racks on which the N95 masks are hung) for a 2 ½ hour decontamination cycle. So long as the masks have not been heavily soiled, the CCDS process will allow each N95 respirator to be sterilized and reused up to 20 times. The system is highly scalable, and Battelle, which intends to deploy CCDS as needed throughout the U.S., believes that its larger versions should be capable of sterilizing up to 80,000 N95 masks per day.

Additionally, in early April, the FDA granted STERIS, another Ohio-based company, an Emergency Use Authorization (“EUA”) to begin, on a temporary basis, small-scale N95 sterilization, pursuant to which certain of the company’s V-PRO Low Temperature Sterilization System machines are approved to sterilize up to 10 masks apiece per 28 minute vaporized hydrogen peroxide sterilization cycle. STERIS reportedly has 100 such V-PRO machines across the State of Ohio which have the capacity to sterilize N95 respirators as provided for in the EUA, and each re-sterilized mask is reusable up to 10 times by repeating the V-PRO process.

Hydrogen Peroxide Vapor
Hydrogen peroxide vapor (“H₂O₂”)is a widely used gaseous sterilant that has been shown to be effective in killing viruses, fungi, bacteria, and other pathogens, and H₂O₂ decontamination is a standard process used in pharmaceutical, research, and medical facilities.H₂O₂ vapor works by breaking apart the outer membranes of the pathogen to which it is applied, thereby destroying thedangerous microorganism.

Hydrogen peroxide is a colorless gas with a sharp odor. Exposure to H₂O₂ can irritate the eyes, nose, throat and skin, as well as cause headaches, dizziness, nausea, and vomiting. Long-term exposure can negatively affect the lungs, producing coughing and shortness of breath, and elevated levels of hydrogen peroxide may result in a build-up of fluid in the lungs (a dangerous condition known as pulmonary edema). The current OSHA permissible exposure limit (PEL) standard is 1 part of hydrogen peroxide parts per million(ppm).

Gas Detection is Crucial for Personnel Safety
Facilities using concentrated hydrogen peroxide vapor to decontaminate PPE or other medical equipment needto ensure that employees are not exposed to H₂O₂ at levels greater than OSHA’s PEL of 1ppm. Since it is always present, the odor from H₂O₂ vapor does not provide warning that hazardous H₂O₂ concentrations may exist. Therefore, in the absence of appropriate monitoring, it is impossible to determine whether hydrogen peroxide concentrations are approaching dangerous levels.

Best practices call for installation of hydrogen peroxide monitors anywhere H₂O₂ is stored or used.

PureAire Monitors

PureAire Monitoring Systems’ Universal Gas Detectors use “smart” sensor cell technology to continuously track levels of ammonia, bromine, hydrogen, hydrogen chloride, and other toxic gases, including hydrogen peroxide. The sensor cell is programmed to monitor for a specific gas and measurement range, as required by the user.

PureAire’s Universal Gas Detectors allow operators of medical decontamination facilities and systems to detect elevated hydrogen peroxide levels before employee health is put at risk. In the event that H₂O₂ is elevated to an unsafe level, the Universal Gas Detector will set off an alarm that includes horns and flashing lights, alerting staff to vacate the affected area.

The Universal Gas Detector’s easy to read screen makes it simple for employees to monitor hydrogen peroxide levels at a glance, providing them with the assurance that their health is not jeopardized while they perform their important work.