Tara Olivo, Associate Editor02.01.22
As the world enters into the third year of the coronavirus pandemic, face masks and respirators continue to be pervasive, especially as new variants, like the contagious Omicron, continue to emerge. As cases of the virus climb, in the U.S. the Biden Administration continues to recommend wearing a mask in public indoor settings in areas of high transmission, along with getting vaccinated.
In fact, just last month, the White House announced the U.S. will begin distributing 400 million N95 respirators to Americans for free, to protect against the Omicron variant. The high-quality face coverings will come from the National Strategic Stockpile and will be issued through thousands of pharmacies and community health centers.
This move comes after the Centers for Disease Control and Prevention admitted in mid-January that cloth masks aren’t as effective against the coronavirus as surgical masks and respirators.
The CDC clarified its position on masks, saying: “Masks and respirators (i.e., specialized filtering masks such as N95s) can provide different levels of protection depending on the type of mask and how they are used. Loosely woven cloth products provide the least protection, layered finely woven products offer more protection, well-fitting disposable surgical masks and KN95s offer even more protection, and well-fitting NIOSH-approved respirators (including N95s) offer the highest level of protection.”
Meanwhile, legislation was recently reintroduced to manufacture and distribute highly-protective N95 masks to every person in America. Under Senator Bernie Sanders’ (I-VT) Masks for All Act—first introduced in 2020—every person in the U.S. would receive a free package of three N95 respirator masks.
“As we face the rapidly spreading Omicron variant, we should remember that not all face masks are created equal,” says Sen. Sanders. “Congress must demand the mass production and distribution of N95 masks, one of the most effective ways to stop the spread of the Covid virus.”
This legislation would require the federal government to use all available authorities, including the Defense Production Act, to eliminate shortages of N95 respirator masks and distribute them to the public as soon as possible. The proposal would use the U.S. Postal Service for distribution and set up pick-up sites at convenient community locations that are already providing essential services, such as Post Offices, pharmacies, schools, public transportation stations, and Covid-19 testing sites. It would also end the U.S. reliance on China and other countries for this essential lifesaving equipment.
Made in America
Throughout 2020 and 2021, the unprecedented usage of face masks, which had mainly been made in Asia previously, led to an extraordinary rate of investment in face masks and respirators, as well as their main raw material component meltblown nonwovens.
During a press briefing last month, White House Covid-19 Response Coordinator Jeff Zients reiterated that one of the first things the Biden Administration did when it entered office was to significantly improve the U.S.’s manufacturing and stockpile of all personal protective equipment (PPE). “Today, N95 masks are widely available and the government has a strong stockpile of over 750 million masks for healthcare workers and first responders,” he told reporters.
In the early days of the pandemic, INDA, the Association of the Nonwoven Fabrics Industry, was deeply involved with the government and various agencies in ramping up production of PPE. “One of the first things the government addressed was respirators,” says Brad Kalil, INDA’s Director of Market Intelligence & Economic Insights. “Early on the government provided a fair amount of money—around $280 million—to increase the domestic production of respirators in 2020. It primarily went to a few companies to increase respirator converting, but the money also went to new meltblown lines.”
Prior to the pandemic, around 30% of the respirator demand was produced in the U.S., Kalil says, citing information from the U.S. Department of Health and Human Services (HHS). Based on his estimates, there were around five respirator producers in the U.S., with 3M being the largest. This number went up to around 40 producers at some point in 2021, including Honeywell reshoring, at one point, two locations in the U.S. “Even though all those producers were added, the original five producers, plus Honeywell, still had about three-quarters share of the respirator production,” Kalil adds.
Many of these new companies had a hard time getting into the medical respirator market. “They all found this out later, but if a hospital buys a new respirator, they have to train all their staff on how to wear it, even though it could be exactly the same,” he says. “I think that was a big hurdle for some of these companies, and we’re not near 40 producers anymore.”
Something that’s expected to help safeguard some of the new investments companies made in the U.S. is a bipartisan provision that was signed into law by President Biden in November as a part of the Infrastructure Investment & Jobs Act. This provision, which is based on U.S. Senators Gary Peters (D-MI) and Rob Portman (R-OH)’s Make PPE in America Act, will strengthen efforts to onshore production of PPE in the U.S. by requiring federal agencies to issue long-term contracts for American-made PPE. Reshoring production will ensure American workers, health care professionals, and more have the PPE they need as the economy continues to reopen. Domestic production of PPE supplies also will create American manufacturing jobs and ensure that America is better prepared for the next pandemic.
The provision will require federal agencies including the Department of Homeland Security, HHS, and the Department of Veterans Affairs, to purchase American-made PPE. The bill also requires federal agencies to issue long-term contracts to U.S. manufacturers.
U.S. manufactures of PPE and meltblown nonwovens, like US Meltblown, say the signing of the bill will help protect the investments companies have made to locate new production in the U.S., and it will also ensure a steady, ongoing supply of quality PPE from domestic producers throughout the U.S.
“We have done our part by establishing a reliable, domestic source for this vitally important PPE material,” says US Meltblown founder and CEO Robert Sires. “We are asking others to do their part by purchasing PPE products from companies here in the U.S., thereby supporting the economy and better protecting American citizens.”
US Meltblown installed a new meltblown production line, which was fully operational six months after Covid-19 and able to make materials that qualified for ASTM F2100 Level 1, 2, 3 and NIOSH 42 CFR 84 Subpart K (N95). In anticipation of the Make PPE in America Act, the company recently doubled production capacity and plans to quadruple capabilities within the 90-day period after the signing of the Infrastructure Bill.
“The Make PPE in America Act came from efforts led by INDA, as well as groups like the National Council of Textile Organizations, the Industrial Fabrics Association and a number of others who came together in the early days of the pandemic in order to address the shortages of PPE that were being experienced across the country and across the world,” says Jessica Franken, INDA’s director of Government Affairs. “That coalition was very aggressively working to address those shortages in the early days, and in that process noted that when it comes to the procurement part of the problem that left the government somewhat shorthanded when crisis emerged was the fact that manufacturers didn’t have a lot of certainty in dealing with the federal government.”
This crisis called to mind a situation between a face mask manufacturer that was supplying face masks to hospitals during the H1N1 outbreak in 2009. “Once the crisis passed, they basically dropped him,” says Franken. “He had to lay people off. That example really highlights that there’s a need for government procurement to offer certainty to those companies that are manufacturing these types of items.”
In the early days of the pandemic, Franken says the federal government’s Defense Logistics Agency, which is responsible for procuring PPE, was getting whatever they could get their hands on. While they imposed requirements such as a preference for domestic manufactured goods, if a company couldn’t find what they needed in the U.S., the agency would provide a waiver.
Through the Make PPE in America Act, a number of products will be impacted, including face masks, she adds. “I think it’s going to be beneficial for our members who are sourcing materials that are made here in the U.S. right now, as well as domestic manufacturers of these finished goods.”
Kalil believes the Make PPE in America Act will have more of an impact on the medical apparel market rather than respirators and face masks because there is already so much domestic capacity in place by the established companies. He estimates that the U.S. is currently making more than 400 million respirators per month, and says there’s also a significant amount of meltblown that’s been added. On the face masks side, he assumes the Make PPE in America Act might allow some of the smaller companies to get some additional business. “But no one is going to add meltblown, face mask or respirator capacity because of the act. It’s already been put in place.
It’s much more about medical apparel.”
Mark Siebert, GM Healthcare & Specialties, US & Canada, for Berry Global’s Health, Hygiene & Specialties division, says there are a number of government bids that support replenishment of the strategic stockpile of isolation gowns that are expected to consume a substantial amount of nonwoven domestic production over a 12-24-month period. “A major supply constraint is the availability of domestic gown converting,” he says. “A combination of new converting capability from the apparel industry combined with leveraging the existing domestic nonwovens capacity is expected to support high consumption as early as March of this year into 2023.”
Entrepreneurs Step Up
As hospitals and other healthcare facilities face shortages of PPE in the early months of the Covid-19 pandemic, manufacturers that hadn’t previously manufactured items like respirators and face masks stepped up to the plate.
In March 2020, Advanced Concept Innovations (ACI), a Lakeland, FL-based company that has had capabilities as a medical device packager and manufacturer since 2004, was contacted by Lakeland Regional Hospital with an emergency request for PPE of all types. ACI’s engineering and manufacturing teams were quickly able to respond with a face shield design, which it was able to start producing within a week of the request.
ACI was also asked if it could fill the desperate need for face masks. As a nonwoven converter since 2005, ACI had expertise in the conversion and assembly of nonwoven materials into consumer products, but did not have equipment designed for face mask manufacturing.
“Our engineering team reviewed the different styles of face masks, and determined within 24 hours that we could redesign, retool and rebuild several of our converting lines into a new ultra-high-speed line, to be able to manufacture a duckbill style N95 respirator,” says Matt Muller, president of ACI.
ACI’s internal teams, along with its external vendors, immediately started disassembling the existing equipment and designing, manufacturing and programming a high speed N95 respirator line. “We started producing general purpose respirators in May 2020, 45 days after beginning the equipment redesign, with NIOSH approved N95 Respirator production following up in June, approximately 60 days after the start of the redesign,” Muller says.
ACI’s respirators are a 10-layer design, comprised of four layers of meltblown, four layers of spunbond and two elastomeric headband layers. Today, its capacity is in excess of 70 million N95 surgical respirators per month—840 million annually.
“Domestic supply and manufacturing of surgical N95 respirators provide a secure supply chain for our healthcare workers and first responders,” says Kevin Pulcini, senior vice president, Business Development. “We cannot rely on other countries, whose self-interest is contrary to ours, to hold us hostage during emergency situations. Even when foreign product is available, supply chain logistics are extremely cumbersome and time consuming.”
Another newcomer to the respirator market is Brookshire, TX-based Aegle Corporation. The domestic manufacturer of NIOSH-approved N95 respirators was founded by a team of social impact investors in response to catastrophic shortages of PPE caused by the global Covid-19 pandemic. The company’s manufacturing facility installation was completed in January 2021 and production began in May 2021 following NIOSH approval.
“Like the 1918 flu pandemic and with vaccine inequality around the world, we may see more waves of this pandemic and we need to be prepared to help out,” says Aegle co-founder Andrew Moy. “Not only are we working on N95 respirator production, but we are also focused on vertical integration to secure the supply chain.”
The company has more than 90,000 square feet of manufacturing space across two facilities and is equipped with 15,000 square feet of ISO 7 and ISO 5 cleanroom space for manufacturing and sterile packaging. The remaining space will be used for expansion of the company’s vertical integration platform—Aegle is working on producing nonwoven materials internally.
Aegle produces two styles of NIOSH-approved N95 respirators: Cup (C100) and foldable (F100). It has a total of 12 production lines operational, and has the production capacity to manufacture over 10 million respirators per month.
Moy says it’s critical to differentiate between face masks and N95 masks, typically called N95 respirators. “N95 respirators offer a much higher level of protection as compared to typical face masks. N95 respirators require NIOSH approval, follow stringent guidelines and quality processes. NIOSH approved N95 respirators require 95% or better particle filtration efficiency (85 lpm flow rate) and breathability (inhalation and exhalation resistance). NIOSH approved respirators also require head-strap design, and ear-loop style design is not acceptable.”
Nonwovens Suppliers Respond
Manufacturers of meltblown, spunmelt and SMS nonwovens, significantly ramped up production of these materials throughout 2020 and 2021 in order to keep up with high demand for medical gowns, face masks and other PPE. Meltblown—a key layer in N95 respirators and face masks—certainly saw the biggest surge in demand during this time.
According to a recent report from Smithers, the global market for meltblown nonwovens has been fundamentally reshaped by the experience of Covid-19. Demand for vital products like face masks and medical PPE saw meltblown sales rise from $809 million in 2019 to $1.68 billion in 2020.
In the first days of the pandemic, professional and medical-grade PPE—especially N95 medical face respirators—became a vital commodity. Smithers’ data show how demand increased nearly 10-fold from 14,400 tons in 2019 to 121,800 tons in 2020, while other medical meltblown applications rose five-fold. This led to meltblown production sites running at near or overcapacity; and other production facilities, like SMS, being switched over to meltblown manufacture. A host of new lines have been commissioned worldwide to raise capacity and ensure domestic availability.
Some of these new lines came from Fitesa. The Brazilian nonwovens producer has been in investment mode since the early days of the pandemic, partnering with Reicofil to install state-of-the-art equipment spanning multiple technologies and targeting the health and hygiene markets, making products for medical gowns, surgical face masks and N95 respirators, diapers and sanitary products.
In Latin America, Fitesa added a multibeam Reicofil line in Cosmoplis, Brazil. In Gravatai, Brazil, Fitesa upgraded and redesigned one existing meltblown line and added a second state-of-the-art meltblown line to this site in spring 2020. Together, the two investments increased Fitesa’s production capacity in the region by 30,000 metric tons and tripled the company’s pure meltblown supply availability, fulfilling the rising demand from the healthcare and hygiene markets.
Fitesa also added meltblown capacity in Trezzano Rosa, Italy; Peine, Germany; and Simpsonville, SC, which came onstream in late 2020 and early 2021. These lines also contributed to Fitesa’s product portfolio for surgical masks and respirators.
The company was able to react so quickly to the urgent need for these materials due to its ability in identifying opportunities and executing new projects, supported by a governance structure that allows the company to have a swift decision-making process, according to Mariana Mynarski, corporate marketing, Fitesa.
On the innovation side, in early 2021 Fitesa developed an antiviral product line with a material that inactivates 99% of coronavirus within 15 minutes of contact. Within 30 minutes, the test samples show the virus to be inactivated. Tests were conducted by UNICAMP in November 2020 with the MHV strain of coronavirus, the same genus and family of SARS-CoV-2, SARS-CoV-1 and MERS.
Fitesa Shield AV nonwovens have silver ions in its structure. The process technology secures lasting effect throughout the product’s lifecycle. The treatment is non-toxic, meets all FDA and EU requirements and does not impact any other physical or chemical properties.
The Fitesa Shield product line consists of antiviral spunbond and multilayer SMS that can be used in various applications such as the production of surgical gowns and drapes, sterilization wraps, head covers, shoe covers, bed linens and laminates including important respiratory protection equipment like N95 masks and respirators.
“As we usually say, we are here for the long run,” says Mynarski. “This means that our investments not only target to take advantage of immediate opportunities but also position ourselves as long-term partners and reliable suppliers for the global hygiene and healthcare markets. Therefore, we continue to develop innovative solutions for face masks and other PPE, such as the Fitesa Shield product line of antimicrobial fabrics and our range of elastic films and laminates.”
Describing the face mask and respirator market as a whole, Mynarski recognizes that because entrepreneurs went above and beyond to guarantee the supply of much needed PPE items to fight the pandemic, a significant capacity for the production of meltblown and face mask has been added. “It is natural that with a slowdown in contamination and the release of restrictive measures demand will reduce,” she says. “We believe that demand will stabilize at higher levels than before Covid-19 as people will maintain the habit of wearing face masks in some public situations or when sick. Nevertheless, governments’ actions, such as the U.S. Infrastructure Bill, will play a key role in determining the economic sustainability of this industry in the long term.”
Berry Global, the world’s largest producer of nonwoven fabrics, quickly and aggressively expanded its global footprint in response to demand for face mask material during the pandemic. According to Siebert, Berry was approached by multiple converters and government entities across Europe, Latin America, and the U.S. to support filtration media and the production of non-surgical masks.
“With tremendous support of Berry leadership, our commercial teams secured contractual agreements supporting the investment in five new meltblown lines in Europe and Latin America,” he says. “We transitioned existing hygiene lines to run exclusive meltblown materials in Asia, Europe and Latin America.”
Berry was also able to rapidly retrofit several existing pilot lines in the U.S. to produce meltblown material in six months from the decision point. Berry also agreed to invest in multiple industrial face mask lines to produce protective masks for its internal operations team members to maintain uninterrupted operations through the pandemic. “As a result of that later investment, we maintained production across our company through good manufacturing practices, social distancing and mask mandates in our almost 300 plants around the world, which remain in place today,” Siebert says.
Describing the supply and demand picture, Siebert says face mask supply has certainly normalized in the last 12 months. “Substantial face mask production assets particularly in Asia throughout 2020 ultimately outpaced demand as we entered into 2021. With this additional supply, face mask prices adjusted back to pre-pandemic levels. As a result of ample supply and pre-pandemic pricing, the majority of the remaining face mask supply has migrated back to Asia.”
Meanwhile, the assets that were brought on specifically in the U.S. for industrial masks have been idled including Berry’s production, he adds. “Our assets in Europe and Latin America continue to operate in support of specific multi-year government commitments. We would expect that dynamic to remain unchanged in 2022. For respirators and surgical masks, the leading U.S. producers have seen a resurgence in requests for supply very recently driven by the Omicron Covid variant. The outlook will be largely influenced by government requirements through calendar year 2022.”
In Italy, a new nonwovens producer that launched in response to the coronavirus pandemic benefited from the 30-year experience of its parent company Ramina Srl, a manufacturer of industrial machinery and turnkey plants for the nonwovens industry. Graziano Ramina Industries Srl (GR Industries) began producing meltblown nonwovens in 2020, and today produces 400 tons of the material per month. The company also manufactures spunbond nonwovens.
“The Covid-19 pandemic has and continues to have a strong impact on the Italian economic and entrepreneurial fabric,” says Gilberto Faggion, sales manager, GR Industries. “Our sector has witnessed an increase in requests for the production of nonwoven fabric for PPE, inextricably linked to the new challenges and needs born and developed within a pandemic situation that has continued for over two years. The challenge taken up by GR Industries was to be able to satisfy an increasingly pressing request, managing to maintain high quality standards for its Made in Italy products.”
Ramina’s Leonardo 1.0 machine, operating in a continuous cycle in the production of the filtering nonwoven fabric that constitutes the internal filter of the masks, has given GR Industries the possibility of satisfying the growing demand, accelerating production times, responding to the clear distribution of difficulties at the national level caused by the pandemic with widespread sales, which are increasingly developed.
For its part, Ahlstrom-Munksjö has been focused on supporting the healthcare industry with its entire nonwoven protective apparel fabric product portfolio since the beginning of the pandemic. It has expanded production, increased capacity and adapted current technology to meet the demand globally.
“We have been and continue to monitor the risks related to the supply chain to ensure our manufacturing needs can be met,” says Lionel Bonte, global VP of Medical Business, Ahlstrom-Munksjö. “We have frequent calls with the global medical team to update and align on manufacturing lead and production times and requirements, raw material pipeline and supply chain flow.”
Over the past two years, the company’s Medical and Filtration Business has tripled its legacy face mask capacity by redistributing allocations, looking outside its traditional manufacturing footprint, repurposing existing product originally not meant for face mask applications, outsourcing non-essential businesses, qualifying external like capabilities that were available and restarting dormant assets.
After nearly three years, Bonte says the supply has caught up with demand for Ahlstrom-Munksjö’s customers, and therefore production has slowed down a bit. Nevertheless, the company believes medical nonwovens and PPE will most likely be required and needed for the foreseeable future, therefore demand will not diminish quite yet. “Once (if) herd immunity is achieved, public requirements will most likely loosen,” he says. “Increased awareness on self-protection against viruses resulting from the Covid-19 pandemic supports a higher level of medical nonwovens/PPE usage.”
Currently there’s an overabundant supply of face masks in the market, and it is important to note that they are all not created equally, he adds. “Having the right type of protection and filtration is critical to have in a face mask.”
To serve its customers and the market even better during the pandemic, Ahlstrom-Munksjö decided to use its sustainable product offering to further develop its face mask materials. The company advanced product functionality and sustainability within its TenderGuard face mask product portfolio. TenderGuard now offers a full suite of fabrics for medical and civil use face masks. The civil use face mask materials, TenderGuard BioBased and BioFilter, are sustainable, renewable and biodegradable. Meanwhile, TenderGuard Natural and Smooth fabrics are designed for medical face masks. They are soft, protective, hypoallergenic and environmentally friendly.
In fact, just last month, the White House announced the U.S. will begin distributing 400 million N95 respirators to Americans for free, to protect against the Omicron variant. The high-quality face coverings will come from the National Strategic Stockpile and will be issued through thousands of pharmacies and community health centers.
This move comes after the Centers for Disease Control and Prevention admitted in mid-January that cloth masks aren’t as effective against the coronavirus as surgical masks and respirators.
The CDC clarified its position on masks, saying: “Masks and respirators (i.e., specialized filtering masks such as N95s) can provide different levels of protection depending on the type of mask and how they are used. Loosely woven cloth products provide the least protection, layered finely woven products offer more protection, well-fitting disposable surgical masks and KN95s offer even more protection, and well-fitting NIOSH-approved respirators (including N95s) offer the highest level of protection.”
Meanwhile, legislation was recently reintroduced to manufacture and distribute highly-protective N95 masks to every person in America. Under Senator Bernie Sanders’ (I-VT) Masks for All Act—first introduced in 2020—every person in the U.S. would receive a free package of three N95 respirator masks.
“As we face the rapidly spreading Omicron variant, we should remember that not all face masks are created equal,” says Sen. Sanders. “Congress must demand the mass production and distribution of N95 masks, one of the most effective ways to stop the spread of the Covid virus.”
This legislation would require the federal government to use all available authorities, including the Defense Production Act, to eliminate shortages of N95 respirator masks and distribute them to the public as soon as possible. The proposal would use the U.S. Postal Service for distribution and set up pick-up sites at convenient community locations that are already providing essential services, such as Post Offices, pharmacies, schools, public transportation stations, and Covid-19 testing sites. It would also end the U.S. reliance on China and other countries for this essential lifesaving equipment.
Made in America
Throughout 2020 and 2021, the unprecedented usage of face masks, which had mainly been made in Asia previously, led to an extraordinary rate of investment in face masks and respirators, as well as their main raw material component meltblown nonwovens.
During a press briefing last month, White House Covid-19 Response Coordinator Jeff Zients reiterated that one of the first things the Biden Administration did when it entered office was to significantly improve the U.S.’s manufacturing and stockpile of all personal protective equipment (PPE). “Today, N95 masks are widely available and the government has a strong stockpile of over 750 million masks for healthcare workers and first responders,” he told reporters.
In the early days of the pandemic, INDA, the Association of the Nonwoven Fabrics Industry, was deeply involved with the government and various agencies in ramping up production of PPE. “One of the first things the government addressed was respirators,” says Brad Kalil, INDA’s Director of Market Intelligence & Economic Insights. “Early on the government provided a fair amount of money—around $280 million—to increase the domestic production of respirators in 2020. It primarily went to a few companies to increase respirator converting, but the money also went to new meltblown lines.”
Prior to the pandemic, around 30% of the respirator demand was produced in the U.S., Kalil says, citing information from the U.S. Department of Health and Human Services (HHS). Based on his estimates, there were around five respirator producers in the U.S., with 3M being the largest. This number went up to around 40 producers at some point in 2021, including Honeywell reshoring, at one point, two locations in the U.S. “Even though all those producers were added, the original five producers, plus Honeywell, still had about three-quarters share of the respirator production,” Kalil adds.
Many of these new companies had a hard time getting into the medical respirator market. “They all found this out later, but if a hospital buys a new respirator, they have to train all their staff on how to wear it, even though it could be exactly the same,” he says. “I think that was a big hurdle for some of these companies, and we’re not near 40 producers anymore.”
Something that’s expected to help safeguard some of the new investments companies made in the U.S. is a bipartisan provision that was signed into law by President Biden in November as a part of the Infrastructure Investment & Jobs Act. This provision, which is based on U.S. Senators Gary Peters (D-MI) and Rob Portman (R-OH)’s Make PPE in America Act, will strengthen efforts to onshore production of PPE in the U.S. by requiring federal agencies to issue long-term contracts for American-made PPE. Reshoring production will ensure American workers, health care professionals, and more have the PPE they need as the economy continues to reopen. Domestic production of PPE supplies also will create American manufacturing jobs and ensure that America is better prepared for the next pandemic.
The provision will require federal agencies including the Department of Homeland Security, HHS, and the Department of Veterans Affairs, to purchase American-made PPE. The bill also requires federal agencies to issue long-term contracts to U.S. manufacturers.
U.S. manufactures of PPE and meltblown nonwovens, like US Meltblown, say the signing of the bill will help protect the investments companies have made to locate new production in the U.S., and it will also ensure a steady, ongoing supply of quality PPE from domestic producers throughout the U.S.
“We have done our part by establishing a reliable, domestic source for this vitally important PPE material,” says US Meltblown founder and CEO Robert Sires. “We are asking others to do their part by purchasing PPE products from companies here in the U.S., thereby supporting the economy and better protecting American citizens.”
US Meltblown installed a new meltblown production line, which was fully operational six months after Covid-19 and able to make materials that qualified for ASTM F2100 Level 1, 2, 3 and NIOSH 42 CFR 84 Subpart K (N95). In anticipation of the Make PPE in America Act, the company recently doubled production capacity and plans to quadruple capabilities within the 90-day period after the signing of the Infrastructure Bill.
“The Make PPE in America Act came from efforts led by INDA, as well as groups like the National Council of Textile Organizations, the Industrial Fabrics Association and a number of others who came together in the early days of the pandemic in order to address the shortages of PPE that were being experienced across the country and across the world,” says Jessica Franken, INDA’s director of Government Affairs. “That coalition was very aggressively working to address those shortages in the early days, and in that process noted that when it comes to the procurement part of the problem that left the government somewhat shorthanded when crisis emerged was the fact that manufacturers didn’t have a lot of certainty in dealing with the federal government.”
This crisis called to mind a situation between a face mask manufacturer that was supplying face masks to hospitals during the H1N1 outbreak in 2009. “Once the crisis passed, they basically dropped him,” says Franken. “He had to lay people off. That example really highlights that there’s a need for government procurement to offer certainty to those companies that are manufacturing these types of items.”
In the early days of the pandemic, Franken says the federal government’s Defense Logistics Agency, which is responsible for procuring PPE, was getting whatever they could get their hands on. While they imposed requirements such as a preference for domestic manufactured goods, if a company couldn’t find what they needed in the U.S., the agency would provide a waiver.
Through the Make PPE in America Act, a number of products will be impacted, including face masks, she adds. “I think it’s going to be beneficial for our members who are sourcing materials that are made here in the U.S. right now, as well as domestic manufacturers of these finished goods.”
Kalil believes the Make PPE in America Act will have more of an impact on the medical apparel market rather than respirators and face masks because there is already so much domestic capacity in place by the established companies. He estimates that the U.S. is currently making more than 400 million respirators per month, and says there’s also a significant amount of meltblown that’s been added. On the face masks side, he assumes the Make PPE in America Act might allow some of the smaller companies to get some additional business. “But no one is going to add meltblown, face mask or respirator capacity because of the act. It’s already been put in place.
It’s much more about medical apparel.”
Mark Siebert, GM Healthcare & Specialties, US & Canada, for Berry Global’s Health, Hygiene & Specialties division, says there are a number of government bids that support replenishment of the strategic stockpile of isolation gowns that are expected to consume a substantial amount of nonwoven domestic production over a 12-24-month period. “A major supply constraint is the availability of domestic gown converting,” he says. “A combination of new converting capability from the apparel industry combined with leveraging the existing domestic nonwovens capacity is expected to support high consumption as early as March of this year into 2023.”
Entrepreneurs Step Up
As hospitals and other healthcare facilities face shortages of PPE in the early months of the Covid-19 pandemic, manufacturers that hadn’t previously manufactured items like respirators and face masks stepped up to the plate.
In March 2020, Advanced Concept Innovations (ACI), a Lakeland, FL-based company that has had capabilities as a medical device packager and manufacturer since 2004, was contacted by Lakeland Regional Hospital with an emergency request for PPE of all types. ACI’s engineering and manufacturing teams were quickly able to respond with a face shield design, which it was able to start producing within a week of the request.
ACI was also asked if it could fill the desperate need for face masks. As a nonwoven converter since 2005, ACI had expertise in the conversion and assembly of nonwoven materials into consumer products, but did not have equipment designed for face mask manufacturing.
“Our engineering team reviewed the different styles of face masks, and determined within 24 hours that we could redesign, retool and rebuild several of our converting lines into a new ultra-high-speed line, to be able to manufacture a duckbill style N95 respirator,” says Matt Muller, president of ACI.
ACI’s internal teams, along with its external vendors, immediately started disassembling the existing equipment and designing, manufacturing and programming a high speed N95 respirator line. “We started producing general purpose respirators in May 2020, 45 days after beginning the equipment redesign, with NIOSH approved N95 Respirator production following up in June, approximately 60 days after the start of the redesign,” Muller says.
ACI’s respirators are a 10-layer design, comprised of four layers of meltblown, four layers of spunbond and two elastomeric headband layers. Today, its capacity is in excess of 70 million N95 surgical respirators per month—840 million annually.
“Domestic supply and manufacturing of surgical N95 respirators provide a secure supply chain for our healthcare workers and first responders,” says Kevin Pulcini, senior vice president, Business Development. “We cannot rely on other countries, whose self-interest is contrary to ours, to hold us hostage during emergency situations. Even when foreign product is available, supply chain logistics are extremely cumbersome and time consuming.”
Another newcomer to the respirator market is Brookshire, TX-based Aegle Corporation. The domestic manufacturer of NIOSH-approved N95 respirators was founded by a team of social impact investors in response to catastrophic shortages of PPE caused by the global Covid-19 pandemic. The company’s manufacturing facility installation was completed in January 2021 and production began in May 2021 following NIOSH approval.
“Like the 1918 flu pandemic and with vaccine inequality around the world, we may see more waves of this pandemic and we need to be prepared to help out,” says Aegle co-founder Andrew Moy. “Not only are we working on N95 respirator production, but we are also focused on vertical integration to secure the supply chain.”
The company has more than 90,000 square feet of manufacturing space across two facilities and is equipped with 15,000 square feet of ISO 7 and ISO 5 cleanroom space for manufacturing and sterile packaging. The remaining space will be used for expansion of the company’s vertical integration platform—Aegle is working on producing nonwoven materials internally.
Aegle produces two styles of NIOSH-approved N95 respirators: Cup (C100) and foldable (F100). It has a total of 12 production lines operational, and has the production capacity to manufacture over 10 million respirators per month.
Moy says it’s critical to differentiate between face masks and N95 masks, typically called N95 respirators. “N95 respirators offer a much higher level of protection as compared to typical face masks. N95 respirators require NIOSH approval, follow stringent guidelines and quality processes. NIOSH approved N95 respirators require 95% or better particle filtration efficiency (85 lpm flow rate) and breathability (inhalation and exhalation resistance). NIOSH approved respirators also require head-strap design, and ear-loop style design is not acceptable.”
Nonwovens Suppliers Respond
Manufacturers of meltblown, spunmelt and SMS nonwovens, significantly ramped up production of these materials throughout 2020 and 2021 in order to keep up with high demand for medical gowns, face masks and other PPE. Meltblown—a key layer in N95 respirators and face masks—certainly saw the biggest surge in demand during this time.
According to a recent report from Smithers, the global market for meltblown nonwovens has been fundamentally reshaped by the experience of Covid-19. Demand for vital products like face masks and medical PPE saw meltblown sales rise from $809 million in 2019 to $1.68 billion in 2020.
In the first days of the pandemic, professional and medical-grade PPE—especially N95 medical face respirators—became a vital commodity. Smithers’ data show how demand increased nearly 10-fold from 14,400 tons in 2019 to 121,800 tons in 2020, while other medical meltblown applications rose five-fold. This led to meltblown production sites running at near or overcapacity; and other production facilities, like SMS, being switched over to meltblown manufacture. A host of new lines have been commissioned worldwide to raise capacity and ensure domestic availability.
Some of these new lines came from Fitesa. The Brazilian nonwovens producer has been in investment mode since the early days of the pandemic, partnering with Reicofil to install state-of-the-art equipment spanning multiple technologies and targeting the health and hygiene markets, making products for medical gowns, surgical face masks and N95 respirators, diapers and sanitary products.
In Latin America, Fitesa added a multibeam Reicofil line in Cosmoplis, Brazil. In Gravatai, Brazil, Fitesa upgraded and redesigned one existing meltblown line and added a second state-of-the-art meltblown line to this site in spring 2020. Together, the two investments increased Fitesa’s production capacity in the region by 30,000 metric tons and tripled the company’s pure meltblown supply availability, fulfilling the rising demand from the healthcare and hygiene markets.
Fitesa also added meltblown capacity in Trezzano Rosa, Italy; Peine, Germany; and Simpsonville, SC, which came onstream in late 2020 and early 2021. These lines also contributed to Fitesa’s product portfolio for surgical masks and respirators.
The company was able to react so quickly to the urgent need for these materials due to its ability in identifying opportunities and executing new projects, supported by a governance structure that allows the company to have a swift decision-making process, according to Mariana Mynarski, corporate marketing, Fitesa.
On the innovation side, in early 2021 Fitesa developed an antiviral product line with a material that inactivates 99% of coronavirus within 15 minutes of contact. Within 30 minutes, the test samples show the virus to be inactivated. Tests were conducted by UNICAMP in November 2020 with the MHV strain of coronavirus, the same genus and family of SARS-CoV-2, SARS-CoV-1 and MERS.
Fitesa Shield AV nonwovens have silver ions in its structure. The process technology secures lasting effect throughout the product’s lifecycle. The treatment is non-toxic, meets all FDA and EU requirements and does not impact any other physical or chemical properties.
The Fitesa Shield product line consists of antiviral spunbond and multilayer SMS that can be used in various applications such as the production of surgical gowns and drapes, sterilization wraps, head covers, shoe covers, bed linens and laminates including important respiratory protection equipment like N95 masks and respirators.
“As we usually say, we are here for the long run,” says Mynarski. “This means that our investments not only target to take advantage of immediate opportunities but also position ourselves as long-term partners and reliable suppliers for the global hygiene and healthcare markets. Therefore, we continue to develop innovative solutions for face masks and other PPE, such as the Fitesa Shield product line of antimicrobial fabrics and our range of elastic films and laminates.”
Describing the face mask and respirator market as a whole, Mynarski recognizes that because entrepreneurs went above and beyond to guarantee the supply of much needed PPE items to fight the pandemic, a significant capacity for the production of meltblown and face mask has been added. “It is natural that with a slowdown in contamination and the release of restrictive measures demand will reduce,” she says. “We believe that demand will stabilize at higher levels than before Covid-19 as people will maintain the habit of wearing face masks in some public situations or when sick. Nevertheless, governments’ actions, such as the U.S. Infrastructure Bill, will play a key role in determining the economic sustainability of this industry in the long term.”
Berry Global, the world’s largest producer of nonwoven fabrics, quickly and aggressively expanded its global footprint in response to demand for face mask material during the pandemic. According to Siebert, Berry was approached by multiple converters and government entities across Europe, Latin America, and the U.S. to support filtration media and the production of non-surgical masks.
“With tremendous support of Berry leadership, our commercial teams secured contractual agreements supporting the investment in five new meltblown lines in Europe and Latin America,” he says. “We transitioned existing hygiene lines to run exclusive meltblown materials in Asia, Europe and Latin America.”
Berry was also able to rapidly retrofit several existing pilot lines in the U.S. to produce meltblown material in six months from the decision point. Berry also agreed to invest in multiple industrial face mask lines to produce protective masks for its internal operations team members to maintain uninterrupted operations through the pandemic. “As a result of that later investment, we maintained production across our company through good manufacturing practices, social distancing and mask mandates in our almost 300 plants around the world, which remain in place today,” Siebert says.
Describing the supply and demand picture, Siebert says face mask supply has certainly normalized in the last 12 months. “Substantial face mask production assets particularly in Asia throughout 2020 ultimately outpaced demand as we entered into 2021. With this additional supply, face mask prices adjusted back to pre-pandemic levels. As a result of ample supply and pre-pandemic pricing, the majority of the remaining face mask supply has migrated back to Asia.”
Meanwhile, the assets that were brought on specifically in the U.S. for industrial masks have been idled including Berry’s production, he adds. “Our assets in Europe and Latin America continue to operate in support of specific multi-year government commitments. We would expect that dynamic to remain unchanged in 2022. For respirators and surgical masks, the leading U.S. producers have seen a resurgence in requests for supply very recently driven by the Omicron Covid variant. The outlook will be largely influenced by government requirements through calendar year 2022.”
In Italy, a new nonwovens producer that launched in response to the coronavirus pandemic benefited from the 30-year experience of its parent company Ramina Srl, a manufacturer of industrial machinery and turnkey plants for the nonwovens industry. Graziano Ramina Industries Srl (GR Industries) began producing meltblown nonwovens in 2020, and today produces 400 tons of the material per month. The company also manufactures spunbond nonwovens.
“The Covid-19 pandemic has and continues to have a strong impact on the Italian economic and entrepreneurial fabric,” says Gilberto Faggion, sales manager, GR Industries. “Our sector has witnessed an increase in requests for the production of nonwoven fabric for PPE, inextricably linked to the new challenges and needs born and developed within a pandemic situation that has continued for over two years. The challenge taken up by GR Industries was to be able to satisfy an increasingly pressing request, managing to maintain high quality standards for its Made in Italy products.”
Ramina’s Leonardo 1.0 machine, operating in a continuous cycle in the production of the filtering nonwoven fabric that constitutes the internal filter of the masks, has given GR Industries the possibility of satisfying the growing demand, accelerating production times, responding to the clear distribution of difficulties at the national level caused by the pandemic with widespread sales, which are increasingly developed.
For its part, Ahlstrom-Munksjö has been focused on supporting the healthcare industry with its entire nonwoven protective apparel fabric product portfolio since the beginning of the pandemic. It has expanded production, increased capacity and adapted current technology to meet the demand globally.
“We have been and continue to monitor the risks related to the supply chain to ensure our manufacturing needs can be met,” says Lionel Bonte, global VP of Medical Business, Ahlstrom-Munksjö. “We have frequent calls with the global medical team to update and align on manufacturing lead and production times and requirements, raw material pipeline and supply chain flow.”
Over the past two years, the company’s Medical and Filtration Business has tripled its legacy face mask capacity by redistributing allocations, looking outside its traditional manufacturing footprint, repurposing existing product originally not meant for face mask applications, outsourcing non-essential businesses, qualifying external like capabilities that were available and restarting dormant assets.
After nearly three years, Bonte says the supply has caught up with demand for Ahlstrom-Munksjö’s customers, and therefore production has slowed down a bit. Nevertheless, the company believes medical nonwovens and PPE will most likely be required and needed for the foreseeable future, therefore demand will not diminish quite yet. “Once (if) herd immunity is achieved, public requirements will most likely loosen,” he says. “Increased awareness on self-protection against viruses resulting from the Covid-19 pandemic supports a higher level of medical nonwovens/PPE usage.”
Currently there’s an overabundant supply of face masks in the market, and it is important to note that they are all not created equally, he adds. “Having the right type of protection and filtration is critical to have in a face mask.”
To serve its customers and the market even better during the pandemic, Ahlstrom-Munksjö decided to use its sustainable product offering to further develop its face mask materials. The company advanced product functionality and sustainability within its TenderGuard face mask product portfolio. TenderGuard now offers a full suite of fabrics for medical and civil use face masks. The civil use face mask materials, TenderGuard BioBased and BioFilter, are sustainable, renewable and biodegradable. Meanwhile, TenderGuard Natural and Smooth fabrics are designed for medical face masks. They are soft, protective, hypoallergenic and environmentally friendly.