It’s been widely reported that Clorox doesn’t expect store shelves to be fully stocked with its disinfecting wipes until 2021. CEO Benno Dorer told Reuters last month that the company has been unable to keep up with a six-fold surge in demand for many of its disinfectant products.
As wipes makers continue to tackle this challenge and work around the clock to meet unprecedented demand, they’re also seeking SARS-CoV-2 EPA label claim approval to verify that the virus is being inactivated on surfaces.
On March 5, the U.S. Environmental Protection Agency (EPA) released a list of EPA-registered disinfectant products that have qualified for use against SARS-CoV-2. Products appearing on EPA’s list of registered disinfectant products, called “List N: Disinfectants for Use Against SARS-CoV-2,” have qualified for use against Covid-19 through the agency’s Emerging Viral Pathogen program. This program, according to EPA, allows product manufacturers to provide EPA with data, even in advance of an outbreak, that shows their products are effective against harder-to-kill viruses than SARS-CoV-2. It also allows additional communications intended to inform the public about the utility of these products against the emerging pathogen in the most expeditious manner.
According to EPA, disinfectants can qualify for inclusion on List N in three ways: The product has been tested against the coronavirus SARS-CoV-2 (Covid-19); the product has demonstrated efficacy against a different coronavirus similar to SARS-CoV-2 (Covid-19); and the product has demonstrated efficacy against a pathogen that is harder to kill than SARS-CoV-2 (Covid-19).
As of the printing of this issue, the EPA announced that 15 products on List N have completed laboratory testing for use specifically against SARS-CoV-2, the novel coronavirus that causes Covid-19. The specific products approved include three Lysol products from Reckitt Benckiser and 12 unique products from the manufacturer Lonza. While these products were already on List N, the EPA says they now carry additional weight against the virus that causes Covid-19 based on testing performed by the manufacturer and confirmed by EPA.
Lonza’s range of disinfectant wipes are used in the household retail, institutional, healthcare and food processing/food service markets. Among the products that were recently approved by the EPA to kill SARS-CoV-2 are four wipe registrations including Lonza Disinfectant Wipes (EPA Reg. No. 6836-313); Lonza Disinfectant Wipes Plus (EPA Reg. No. 6836-336); Lonza Disinfectant Wipes Plus 2 (EPA Reg. No. 6836-340); and NUGEN Low Streak Disinfectant Wipes (EPA Reg. No. 6836-382), according to Lonza marketing manager Kiran Kulkarni.
In addition to having wipes products tested against SARS-CoV-2, since the start of the pandemic Lonza has also gradually ramped up production by optimizing its product mix. “[The] pandemic has triggered significant demand surge,” Kulkarni says. “We expect the demand to continue into 2021 and beyond. Supply is being prioritized for healthcare and food processing markets.”
Sister wet wipes companies Nice-Pak and PDI have been testing products for efficacy against SARS-CoV-2. In July, Nice-Pak announced that it has generated data showing its products (EPA Reg. No. 9480-5) demonstrated efficacy against SARS-CoV-2. Nice-Pak’s wipes are sold under the Grime Boss brand, as well as under private labels.
The testing was conducted in early May by Microbac, a testing laboratory that offers antimicrobial/antiviral testing for disinfectants, antiseptics, sanitizers and medical devices, and was completed in line with EPA test methods and guidelines. The data is being sent to the EPA for review and approval. If approved, Nice-Pak will update its products’ labels, providing consumers with a proven effective solution to kill the SARS-CoV-2 virus, when used according to label instructions.
Meanwhile, PDI announced its Super Sani-Cloth wipes are effective against SARS-CoV-2. The data have been submitted to the EPA for review. This is one of several of the company’s hospital-grade disinfecting products being tested for efficacy against SARS-CoV-2 for submission to the EPA for approval. Testing of the additional disinfecting products is still underway and results are expected in the upcoming months, the company says.
According to the data, PDI’s Super Sani-Cloth wipes demonstrated a 3-log reduction against the virus. The wipes were tested in compliance with “Disinfectants for Use on Environmental Surfaces, Guidance for Efficacy Testing,” the EPA’s threshold for deeming a disinfectant effective.
“This was an important step in furthering our mission to protect patients and those on the front lines of preventing the transmission of Covid-19,” says Sean Gallimore, senior vice president and general manager for PDI Healthcare. “We are seeking SARS-CoV-2 EPA label claim approval for Super Sani-Cloth wipes to officially verify that the virus is being inactivated on surfaces, and ultimately protecting caregivers, patients and communities.”
Microbac Laboratories performed the efficacy testing using a multi-step process, PDI says. First, the lab applied the virus to a surface and let it dry. Then, they wiped the surface with a Super Sani-Cloth wipe, recovered the residual liquid, and applied the liquid to cells in culture. How viable the cells remained told Microbac how effective the cloth was in inactivating the virus.
“This is an important step in understanding how SARS-CoV-2 responds to hospital-grade disinfectants,” says James Clayton, director of Laboratory Sciences for PDI. “The ability to reduce surface transmission of the virus is an important tool in the growing arsenal of preventative measures.”
Clayton says the EPA’s review process would normally take six months, but PDI is hopeful that the timeline will be expedited given the continued urgency of the pandemic.
“Being in the infection prevention space, we knew a global pandemic was always a possibility (if not an inevitability),” he says. “As such, we had an emergency preparedness plan in place, drawing on lessons from past outbreaks such as H1N1. One of our big advantages was that we manufacture in the U.S., so the early global supply issues didn’t affect us as acutely.
“That said, no one was fully prepared for the surge in demand caused by this pandemic.,” he adds. “We had facilities using in excess of 200% of their normal inventory, so there were some major decisions that we had to make early on.”
In response to the pandemic, PDI quickly transitioned to around-the-clock manufacturing, adding shifts and line capacity to increase output. The company also shifted resources to manufacture high-priority products, on the EPA’s List N, while pausing other product lines not relevant to SARS-CoV-2. It also prioritized healthcare facilities and limited the size of new orders to prevent stockpiling.
“Our team has been working incredibly hard to fill in any gaps that arise,” Clayton adds. “We’ve helped with education and training customers. And, while we ship seven days per week, there have been times when a member of our team has personally delivered products to a hospital to cover them during the upcoming shifts.”
PDI disinfectant wipes are designed for use in healthcare settings. While there has definitely been interest from other sectors and even consumers, Clayton confirms the company’s priority remains protecting healthcare workers and people on the frontline of the pandemic.
“For us, SARS-CoV-2 has highlighted the importance of taking a layered approach to infection prevention,” he explains. “It’s not enough to use one product and hope that it will eliminate both existing and emerging pathogens. There are a range of threats and areas where an infection can creep in. So, to be safe, we need multiple layers of defense. That includes having the proper staff training, evidence-based policies and procedures and, where possible, no-touch room decontamination via UVC light. We have these amazing technologies, so let’s use them.”
Diversey, Inc., a manufacturer of healthcare and infection prevention products and solutions, makes products that are effective against many enveloped and small, non-enveloped viruses. Many of its products have been tested for efficacy against SARS-CoV-2, which causes Covid-19, and these results will be or have been submitted to the EPA for approval, according to Larinda Becker, healthcare marketing, Diversey.
“The EPA has announced that this test data will not replace the EPA List N and guidelines for disinfectants for use against SARS-CoV-2 at this time,” she says. “All products on this list meet EPA’s criteria for use against SARS-CoV-2, the virus that causes Covid-19. The testing will provide added assurance for specific efficacy against this virus. Until there is further EPA guidance, disinfectants found on the EPA’s List N should continue to be used according to their label instructions.”
Diversey has several wipes in its offering, including prewetted and dry wipes. The prewetted wipes are offered with a variety of disinfectant technologies, including Accelerated Hydrogen Peroxide (AHP), quat alcohol and sodium hypochlorite (bleach). The company offers several size and packaging options based upon the application, including 6" x 7" wipes for clinical application and 11" x 12" wipes for cleaning larger surfaces, such as beds and operating room tables.
Among Diversey’s products on List N are Oxivir Disinfectant Wipes, using its AHP technology. These wipes offer fast and effective disinfection in one minute, helping reduce turnover time. Effective against a broad spectrum of pathogens, including bacteria, viruses, TB, and fungi, Oxivir disinfectants provide excellent cleaning action and stay wet for the required label contact time, ensuring disinfection compliance with one easy pass.
“The Oxivir family of disinfectants has the best possible safety rating (category IV), and the one-step solution, designed for use in healthcare environments, is tough enough to clean and disinfect surfaces and equipment in one pass while being gentle on staff and surfaces,” Becker says.
This range of disinfectants is non-irritating to skin, eyes and respiratory tracts, making it pleasant for use by staff and around patients, Becker adds. “Oxivir wipes raise the bar by reducing turnover time while keeping costs in line. Staff can safely increase efficiency and effectiveness, streamlining the process,” she adds.
In response to increasing demand for wipes, over the past several months Diversey has increased its wipes supply capacity by adding shifts, increasing line efficiency and deploying new manufacturing lines. Additionally Diversey has launched several of its market leading disinfectants in larger formats to address the significant increase in demand during the pandemic. An expansion of its offering of dry wipe solutions are also helping address shortfalls in supply, offering customers an on-demand solution that can be mixed on site.
“We recognized that due to component constraints, new solutions would be required, which lead to several of our new launches, including the larger formats and dry wipe offering expansion,” Becker says. “We want to do everything possible to help our customers.”
CleanWell is another company that holds EPA registrations for products that are on EPA’s List N. Its wipes, sold as CleanWell Botanical Disinfecting Wipes, can be used against SARS-CoV-2, the virus that causes Covid-19, by following the disinfection directions for Rhinovirus. In addition to Rhinovirus, CleanWell Botanical Disinfecting Wipes are registered to kill Influenza A virus, H1N1, Pseudomonas aeruginosa, Salmonella enterica, Staphylococcus aureus, Methicillin Resistant S. aureus (MRSA), and Enterobacter aerogenes on hard, nonporous surfaces, as documented by third-party testing.
Since third-party testing against the SARS-CoV-2 pathogen only recently became available for commercial products, CleanWell is in the queue to begin this testing as soon as possible, according to Stew Lawrence, CEO of CleanWell.
CleanWell’s active ingredient is thymol, a plant-based antibacterial derived from the essential oils of thyme and other herbs. Third-party testing data that is registered with the EPA proves the disinfecting effectiveness of the company’s proprietary 0.05% thymol formula. CleanWell’s products can be used on any hard, nonporous surface, and—unlike most conventional disinfectants—they do not require special PPE or ventilation during use or rinsing after use, Lawrence adds.
“CleanWell’s Botanical Disinfectant Wipes kill 99.99% of germs and viruses botanically without the use of bleach or harsh chemicals that can have negative health and/or environment impacts,” says Lawrence.
CleanWell sold through nearly a year’s worth of planned product in the first four months of 2020. “Like all disinfectant wipe manufacturers, we are doing our best to increase production runs and shipments to keep up with demand,” he says. “The challenge has been exacerbated by the duration of the Covid-19 outbreak as well as supply issues associated with the wipe fabric and packaging.”
The fabric challenge, he says, is compounded by the time and resources the company must invest to qualify any potential alternative fabrics. “Though the EPA is working with manufacturers to lessen the required registration burden during the pandemic, we still have to ensure that any new material passes stability testing and is compatible with production filling lines,” he explains. “We continue to work with our suppliers to address these issues in an attempt to replenish our inventory as quickly as possible.”
CleanWell recently left the personal care category, so it is no longer making hand sanitizers and soaps. It’s now focusing entirely on the disinfecting side of the business—both wipes and sprays—“because we believe that is where we can make the biggest difference,” Lawrence says. “The overwhelming majority of products in the household cleaning space are made with bleach or other harsh chemicals that present increased health and environmental risks. CleanWell provides a less toxic alternative (based on EPA toxicity category ratings) and is one of only a handful of botanical-based products on the EPA’s List N. This gives us a strong differentiator at a time when Covid has prompted consumers to pay closer attention to personal and household hygiene and dramatically increased the use of household cleaning products.”