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3D-Printed Respirator Masks Below N95 Standards, Says Virginia Tech Team

We’ve been cautious and careful about promoting 3D-printed COVID safety equipment here at 3DPrint.com. We talked about a general principle of first doing no harm and also discussed safety recommendations for 3D-printed medical devices. Specifically, we addressed safety concerns related to 3D printing masks and provided some recommendations.

It was notable that, in this current crisis, the U.S. Food and Drug Administration (FDA) and other authorities relaxed their existing standards for face shields but did not do so for respirators. A respirator is a close-to-the-skin device that is worn over one’s mouth for hours per day and can impede breathing or could lead to foreign particles in the wearer’s lungs. Even at their most inventive and creative, health authorities would not budge from keeping it a Class II medical device that would have to be made in a good manufacturing practice environment and subject to strict FDA regulation.

Initial findings point to the regulator’s findings being borne out by research. A paper by a team at Virginia Polytechnic Institute and State University (Virginia Tech) points to a decided lack of effectiveness on the part of 3D-printed respirators. We must point out that the paper itself is in the preprint stage. Preprint means that it has not yet been peer reviewed. This means that we are now forming our opinion about a hasty engineering effort to make life-saving devices through a paper that itself has been presented to us earlier (and one would expect more error-prone) than usual.

Just to be clear, we celebrate everyone’s engineering and maker efforts to make COVID devices of all kinds. We think this is truly one of the brightest and best moments in our industry’s history. We have an important role to play in making spare parts, new solutions, and unavailable items in this current crisis. Furthermore, it is becoming clear to us and many more people that 3D printing has a real role to play in many supply chains and in future crises, whatever they may be. We are now much more relevant than at the start of the year to any further breakdown of the very fabric of the global supply chain or as some kind of magical duck tape solution to a shortage.

This expectation and interest is, of course, a double-edged sword and we could squander it by over-claiming and underdelivering. Or we could meet the challenges of the future with forthrightness and honesty. Yes, we are an interesting shape-making technology. This does not mean that all of our shapes are functional for all of the applications now, in all materials.

The paper is by Bezek, L.B.; Pan, J.; Harb, C.; Zawaski, C.E.; Molla, B.; Kubalak, J.R.; Marr, L.C.; Williams, C.B.  and is titled “Particle Transmission through Respirators Fabricated with Fused Filament Fabrication and Powder Bed Fusion Additive Manufacturing“. The summary is as follows (the text is quoted but formatted by me for readability):

  • “Results from this study show that respirators printed using desktop/industrial-scale fused filament fabrication [FFF] processes and industrial-scale powder bed fusion [PBF] processes have insufficient filtration efficiency at the size of the SARS-CoV-2 virus, even while assuming a perfect seal between the respirator and the user’s face.

  • Almost all printed respirators provided <60% filtration efficiency at the 100-300 nm particle range.

  • Only one respirator, printed on an industrial-scale fused filament fabrication system provided >90% efficiency as-printed.

  • Post-processing procedures including cleaning, sealing surfaces, and reinforcing the filter cap seal generally improved performance, but no respirator sustained the filtration efficiency of an N95 respirator, which filters 95% of SARS-CoV-2 virus particles.

  • Instead, the printed respirators showed similar performance to various cloth masks.

  • While continued optimization of printing process parameters and design tolerances could be implemented to directly print respirators that provide the requisite 95% filtration efficiency, AM processes are not sufficiently reliable for widespread distribution and local production of N95-type respiratory protection without commensurate quality assurance processes in place.

  • Certain design/printer/material combinations may provide sufficient protection for specific users, but the respirators should not be trusted without quantitative filtration efficiency testing. It is currently not advised to expect printed respirators originating from distributed designs to replicate performance across different printers and materials.”

Generally, a lot of the conclusions that the paper has made are what we have previously pointed out and what many in the industry were saying, as well. It seems that, once again, we’re shadowboxing overinflated claims that the media (and some of us) have made.

The paper points out that

  • “One concern about the efficacy of using AM to produce direct replacements for N95 respirators is the intrinsic porosity in FFF and PBF-produced parts, which can affect filtration efficiency, accuracy, and reliability of the printed respirators. In FFF processes, porosity can result from adjacent layers not fully fusing, gaps left from changing direction and stopping/starting melt extrusion, and/or gaps left from adjacent extruded paths failing to fuse together”
  • “Such inherent, process-induced defects have been shown to cause up to 32% porosity in FFF parts, with 200-800 Mu diameter pores , which could render them ineffective in protecting against 0.3 mu virus particles.”
  • “Similarly, parts produced via PBF can be up to 30% porous [16] due to insufficient delivery of energy, recoating defects, and/or the use of heavily recycled powder.”
  • One solution to mitigate porosity in printed polymer parts is to seal them in a post-processing step.
  • “Another anticipated challenge in the use of AM to directly fabricate PPE through shared digital designs is the inherent variability between AM machines, materials, and build parameters, which can affect the mechanical properties of the printed materials and the accuracy of the printed geometries.”

That final issue is also a potential limitation to testing how effective these masks are, since individual machine settings, materials, material handling, toolpaths and local variables could have interfered with the test parts themselves. The paper goes on to look at the parts where the mask could fail through insufficiently covering the face or through gaps.

The masks chosen were the Montana mask by Make the Masks, the Factoria mask, and the Stopgap Surgical Face Mask. They printed these masks on a Sinterstation (polymer powder bed fusion), Fortus 400mc (industrial FFF) and an Afinia (desktop FDM). We have made some progress since the venerable Sinterstation and porosity has been reduced in current generation sintering machines with better software and processing so that we would expect less porosity than with a machine that was released in 1998. On the one hand, it’s amazing that these machines last so long, but it is perhaps slightly unfair to use a 22-year-old 3D printer as the industrial sintering system for this important test.

The paper states that, “the PBF models were de-powdered and bead blasted to remove adhered powder and improve surface finish,” but, crucially, it is unclear if “rinse parts with water to remove remaining media and dry parts using compressed air” was done as per the general instruction attached to the file. Also, they state that the powder used was “Nylon-12 (Factoria: 100% recycled; Montana/Stopgap: 50% recycled / 50% virgin).” It’s unclear whose powder it was. Now, its not apparent why they would use different mixes between virgin and recycled powder for different masks but a 100 percent recycled material is not really something I’d recommend. I think it’s also unfair to compare a 100 percent recycled mask to anything.

I also have concerns about the filament materials printed. I also thought that ULTEM 9085 printed at 350°C? I’m confused about the ABS print that has 15-20% infill. To me, for a day-to-day use part, I’d use a much higher infill percentage of 30 percent at least. I also don’t understand why the PLA part has 15 percent infill either. I couldn’t find the machine settings or the name of the filament supplier either. There could be a lot of variability in their nozzle temperature as per indicated and actual also. We all know that we can get a lot of layer adhesion differences in prints from speed, material, temperature. So this is one caveat. I’d really like for the Cura profile and the machine settings to be included in this kind of research. If we’re going to be testing parts then we should know how they were made.

This isn’t a gripe specific to this paper however; no papers have this. I personally can’t really get ABS to work at all below a 100°C bed temperature and most recommend 110°C, so that seems low, while 260°C sounds like it could be rather too fume-y. I’d never recommend that you print ABS above 250°C and, most of the time, I’d expect the right temperature to be far lower than that, much lower than 260°C anyway. Also, each test part was only printed once (apart from the stopgap that they tried in two orientations). That to me is putting rather a lot of stock in the five-year-old Afinia’s accuracy and I would have much rather seen a number of parts printed and tested.

The team then shows us that they had visible defects in the prints.

“(a) The Stopgap respirator in ABS oriented with the filter cap face down on the build plane has a few mislaid layers; (b) The Stopgap respirator in ABS in an alternate orientation also suffers from periodic sparsity; (c) The Stopgap respirator in PLA is visibly thin across most surfaces; (d) The Stopgap respirator in ULTEM shows porosity on the surface parallel to the filter.”

“Figure 4c shows the Stopgap respirator fabricated with PLA held up to a light to enable observation of several regions of thin material along the shell (as in Figure 4a and b), along the seal to the face, and on the surface flush with the filter cap. Figure 4d displays the Stopgap respirator fabricated with ULTEM held up to a light. Macroscale pores across the entire surface flush on the build plane are observed despite this part being printed in 100% infill on an industrial-scale FFF system,” the authors write. The team does say that the Stopgap respirator was made for powder bed fusion ,so that it was not meant to be printed with FFF/FDM. They go on to test the Stopgap FFF/FDM prints and I think that this is rather unfair.

I have a real issue with the authors changing the roll of filament for build orientation prints “a” and “b” and not mentioning that this is a different material. Even if it was from the same vendor and the handling was the same, then the different colorants mean that there is a different optimal print temperature there. It’s strange to me to both change print orientation and material and then compare those prints. Also, the authors say that this is an adhesion issue, but is it? Is it digging by the nozzle? The “c” part is a great example why you should not have letters on your part. The hatched pattern on the “d” print made from ULTEM is very strange. Is that the Sparse Double Density infill pattern? Did it not print because they didn’t support the part well?

The team went on to test the results of the different filter designs:

“The particle analyzer simply counts the frequency of detected nanoparticles; it does not distinguish between nanoparticles resulting from the generated aerosol and residual nanoparticles resulting from stray particulates shed from the shell,”  was an issue that they identified.

They go on to treat the masks, saying that the “FFF respirators were rinsed thoroughly with tap water and dried with compressed air. Since water could cause aggregation among dry powder, the cleaning step for PBF respirators involved additional compressed air followed by the application of two coats of acrylic paint to form a sealant.”

I’m confused about this since I know that water can have effects on porous sintered parts long-term, but am not sure why the researchers didn’t just wash them in water, which would be fine short-term. Also, painting it changes the part and makes it less flexible. I don’t understand the “aggregation among dry powder” part at all really and am not sure why they’d need to paint the model. I especially worry that the coats of paint will effect how the different parts of the mask fit together. I may have read it wrong but why then in the table above do they say that they rinse and dry the PBF parts? Also I’m pretty sure that the PLA models were made more brittle by the water, but perhaps that’s a limitation of the mask that’s good to include.

The paper goes on to show that, “none of the printed respirators provided the requisite 95% filtration efficiency.”

“Montana respirator results (Figure 5a) show filtration efficiency consistently under 60% for the ABS, PLA, and nylon materials, which is far from the baseline performance of the ULPA filter medium. The ULTEM variant of the Montana respirator could not be tested as printed because the filter cap was too loose to adequately secure the filter.”

The team makes the following determination:

“The Factoria respirator results are provided in Figure 5b. The PLA and ABS respirators filter out more particles than in the Montana respirator design, but both still only protect against ~75% of particles. The ULTEM Factoria respirator provides the highest observed performance, with a filtration efficiency between 90-95%, depending on particle diameter; however, it falls slightly less than the tested ULPA filter (99% efficiency). Similar to the Montana respirator results, the PBF-printed respirator presents the lowest filtration efficiency (~45%).”

“Montana and Factoria respirators are nearly identical in shell design, it is expected that the difference in filter cap design is the cause for the consistently worse performance of the Montana respirator compared to the Factoria respirator. The press-fit cap of the Montana respirator may have allowed particles around the filter (which correlates to the loose-fitting filter cap printed in ULTEM), whereas the larger cap of the Factoria respirator completely encloses the filter.”

Another thing that I don’t get is this: “It is observed in Figure 6a that cleaning the ABS Montana respirator increases the filtration efficiency measurement by ~20%, but the ABS Factoria measurement decreases in efficiency by ~10%. The ABS Stopgap efficiency measurements significantly improve, with both print orientations offering similar performance once cleaned. In Figure 6b, it is seen that the ULTEM Factoria respirator decreases by ~15% efficiency following cleaning.”

I’m quite surprised that there would be such a huge difference in filtration efficiency just from cleaning the parts? To me, this points to the fact that the testing apparatus is picking up loose powder and particles on the masks themselves from before, or that they are created or released through cleaning. But, I don’t know enough about the filtration side of things to know.

The team concedes, “These results highlight the inherent variability in results due to the testing method and testing conditions, which is why it was critical to use the same respirators for repeat tests. The testing environment was kept as close to the same conditions each time, yet the Factoria respirators somehow declined in filtration efficiency. It is believed that a coupling of the failure modes identified in Section 1.2 could be contributing to the erratic trends.”

They go on to look deeper, “Application of the epoxy sealant to the shell increases efficiency to peak at ~75%. This indicates that the porosity of the PLA material drops filtration efficiency by ~20%.” And “Residual powders from printing, post-process, or handling are likely to blame for the poor performance of the respirators as-printed. This also corroborates the reason why the as-printed nylon Montana and Factoria respirators had such low filtration efficiency. While testing some intermediate modifications were forgone, it is evident that the dominant failure mode is the filter cap/shell interface.”

Their conclusions are the following:

“As printed, most of the respirators performed poorly, with almost all providing less than 60% filtration efficiency (significantly below the requisite 95% efficiency of a N95 respirator). This result is especially discouraging when considering that the testing was done with the approximation of a perfect seal between the respirator and user’s face (a common failure mode for standard N95 textile respirators, and likely a significant failure mode for the rigid printed polymers). When printed in ULTEM on an industrial-scale FFF system, the Factoria respirator provided the best filtration efficiency of those evaluated, consistently exceeding 90% efficiency for all particle sizes.”

They also say that, “For example, while the Factoria respirator in ULTEM reached >90% filtration efficiency in the as-printed state, its measured efficiency was reduced to ~80% following cleaning. No tested design with modifications was able to consistently attain 95% filtration efficiency, although the nylon Stopgap respirator with modifications was able to filter ~85% of particles at the size of 300 nm.”

“The results from this study do not completely discount AM from being appropriate for making an effective N95 respirator,” the authors write. “The ULTEM Factoria’s performance suggests that (i) high quality, repeatable printing technology with (ii) proper process settings, and (iii) tolerancing of the filter cap/shell interface that is aligned with a specific machine/material combination could provide an effective solution.”

Further on they, say, “In the case of the Montana and Stopgap respirators, the as-printed performance falls below that of many simple textile materials. The as-printed Factoria respirators and post-process modified Stopgap respirators provide equivalent protection to these textile materials and surgical masks, with the ULTEM Factoria and modified PBF Stopgap respirators providing slightly enhanced performance to these materials.” This was a result that many of us would actually have been happy with, I believe.

Also, “The modified PBF Stopgap respirators can perform better than the surgical mask, high-threaded cotton, and N95 respirator from the study by Konda [33]. This study shows AM respirators are capable of achieving competitively high filtration efficiency on par with non-medical use masks only when assuming a perfect seal to the face.” This is a very good result however and one that we’d be very happy with. But, as the paper rightfully states, this perfect seal is illusory and is probably not the case for these relatively rigid parts. The inability to make a good seal, especially when compared to a home-sewn mask has always to me been the Achilles heel of 3D-printed respirators.

On the whole, it is very good that this kind of research is being done. I’m a little confused by some of the printing and parameters involved. I would have liked to have seen more consistency there. But assembly and print-related issues in experiments only cause me to consider how such variability precludes us from making respirators. On the whole, we can conclude that it will be difficult to make a respirator that works well with 3D printing. This does not mean that we should be dissuaded from trying to improve these designs but rather that we should welcome scientific rigor and analysis to our endeavors.

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3D Printing and COVID-19 Update, June 23, 2020: General Motors, Simplify3D

Companies, organizations and individuals continue to attempt to lend support to the COVID-19 pandemic supply effort. We will be providing regular updates about these initiatives where necessary in an attempt to ensure that the 3D printing community is aware of what is being done, what can be done and what shouldn’t be done to provide coronavirus aid.

Among the companies tasked by the federal U.S. government to tackle medical supply shortages was General Motors, which was contracted under the Defense Production Act to build 30,000 ventilators. As of June 1, the company—which has struggled as an automaker over the years—delivered the first 6,132, with the rest expected to be delivered by the end of August.

To produce the ventilators, GM leaned heavily on 3D printing. In addition to personal protection equipment, the auto company 3D printed nearly all of the tooling necessary to build the ventilator systems with its partners Ventec Life Systems and Hamilton Medical. Many of these are fixtures that were reverse engineered from Ventec and Hamilton part data and were meant to hold parts in place during assembly. In order to have the 3D printing capacity necessary, GM had 3D printers shipped from its Additive Innovation Lab and Additive Industrialization Center in Warren, Michigan to its manufacturing plant in Kokomo, Indiana.

Fixtures 3D-printed for holding parts into place during assembly. Image courtesy of GM.

Dominick Lentine, senior manufacturing engineer of additive applications at GM, said of the technology’s use in ventilator production, “3D printing allows us to make constant, rapid changes to fixtures based on feedback from the assembly teams. We can receive feedback from Hamilton, improve a part and have it flown back to Reno in less than 24 hours.”

SME has published an account of some of the challenges to 3D printing PPE in the current environment, touching on many of the topics that we have already discussed in previous stories and some that we have not. For instance, the post highlights the overabundance of designs now available for producing PPE and how some actually don’t work, while others do. Another issue is the creation of one-size-fits-all designs that may not actually work for every wearer. Material shortages have also been a problem for some efforts to 3D print PPE. Perhaps most importantly, the fear of liability still hangs over all of those involved in the 3D printing of medical devices who may not have the proper facilities, equipment, training and certifications.

Additive software developer Simplify3D has begun publishing a series detailing research dedicated to 3D printing PPE amid the COVID-19 pandemic. Titled “Lessons from the Field,” the work combines experience from Simplify3D engineers who spent hundreds of hours producing PPE equipment and feedback from over 40 organizations that were engaged in similar operations. Every post in the series will cover a different piece of PPE, including 3D model recommendations based on testing and feedback from healthcare professionals, sourcing, print optimization advice, assembly instructions and tips on distribution.

3D printing isn’t the only technology being used to deal with the new normal of life under COVID-19. As with AM, other technologies meant to address the crisis can seem either opportunistic or truly innovative.

As states and municipalities begin to reduce quarantine requirements, businesses operations are attempting to restart with new measures in place to reduce the possibilities of infection. Looking to capitalize on that process, British wearables firm Equivital has developed a social distancing device called eqWave, which alerts workers if they’re within 2 meters of one another. The product uses ultra wide band radio and Bluetooth to detect other eqWaves to provide 360-degree coverage around the wearer, alerting them with an LED light and haptic vibration.

Singapore-based robotics manufacturer Otsaw Digital Pte. has developed what it calls an autonomous disinfection robot. The system, dubbed O-RX, uses UV-C LED technology kill microbes, such as bacteria and COVID-19. The company suggests that, unlike UV-A and UV-B emitting mercury lamps, the machine’s UV-C LED light is safe and non-carcinogenic. Otsaw also claims that the O-RX has a disinfection rate of over 99.999%. Developed in just eight weeks, the O-RX uses a 360-degree camera and LiDAR sensors to allow it to drive automatically and avoid obstacles.

The O-RX robot from Otsaw. Image courtesy of Otsaw.

As the pandemic continues to grip the world, we will continue to provide regular updates about what the 3D printing community is doing in response. As always, it is important to keep safety in mind, remain critical about the potential marketing and financial interests behind seemingly good humanitarian efforts from businesses, and to do no harm.

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NP Swabs Prove 3D Printing’s Scalability and Speed-to-Market Advantages

A year ago, if you would have asked anyone in our industry what they thought might be a future killer application, it’s highly doubtful that anyone would have replied with, “nasopharyngeal swabs.” Until recently, it was a niche product and the entire market was serviced by a few dominant industry players.

While there are now other protocols, the main test for COVID-19 testing involves gathering virus from deep in a person’s nasal cavity. The SARS-CoV-2 virus is collected using a nasopharyngeal (NP) swab. Traditionally, these swabs are made in two parts, including a polyester handle and a tip with tiny rayon fibers called flock.

A 3D-printed NP swab developed by Carbon. Image courtesy of Carbon.

The two primary companies that make them, Purtian Medical Products Co. and Copan Diagnostics, bulk manufacture them in multiple steps, which include production, assembly, sterilization and packaging, among others. Their process requires customized machinery and a sizable group of relatively skilled people.

When the global pandemic struck, the demand for COVID-19 test kits skyrocketed, far outpacing the combined capacity of these two companies. For several reasons, they had difficulties scaling their businesses. They both produce many other products for the medical industry and adding new equipment is a timely endeavor. To make matters worse, Copan which is located in Italy (a hotspot for the virus) was challenged with maintaining the health of its own workforce.

3D Printing to the Rescue

As it became apparent that the normal suppliers couldn’t fully meet the need, the additive manufacturing industry began working on the problem. Markforged, a manufacturer of filament-based 3D printers, partnered with Neurophotometrics to produce 3D-printed NP swabs made from their Fiberflex Rayon.

Separately, Northwell Health teamed up with the University of South Florida, Tampa General Hospital and Massachusetts-based Formlabs and worked with physicians to design their own NP swab, which Formlabs recently started printing in its FDA-registered, ISO 13485-certified factory in Ohio.

Results from a clinical trial of 3D-printed NP swabs. Image courtesy of Beth Israel Deaconess Medical Center.

Soon after, a consortium of 3D printing companies was codified. Their goal was to deliver clinically tested, FDA-registered, 3D-printed COVID-19 NP test swab designs with superior or equivalent efficacy to flocked swabs, at scale.

Origin Partners with Henkel

Origin, manufacturer of stereolithography (SLA) 3D printers was one of the founding members of the consortium. It began working with several partners to develop what it is now calling the world’s first FDA-compliant, sterile, 3D-printed NP test swab. 

3D printed NP swabs with detailed lattice structure. (Image courtesy Origin.)

In a new announcement, the startup is providing more detail about the process. Origin collaborated with materials company, Henkel and Beth Israel Deaconess Medical Center (BIDMC) on the swab’s development. Working with generative design software, Origin was able to design a one-piece swab that performed as well as the traditional version. Henkel leveraged its own Albert software platform to specify a material that would meet the requirements for an in-body medical device. Together they tested the design’s clinical capabilities, in addition to validating each step in the sterilizations process, and conducting rigorous mechanical testing and packaging certification.

Scalability and Speed-to-Market

Within weeks they were able to bring a product to market that is classified as a sterile device and is considered a finished medical product, which is regulated by the FDA.

It’s a perfect example of two of 3D printing’s biggest benefits: scalability and speed-to-market. As Chris Prucha, Founder and CEO at Origin noted in the press release, “by working collaboratively and utilizing each other’s technologies, we identified, optimized and scaled the manufacturing process to bring an application to market extremely fast.”

Origin’s sterile NP swabs are currently shipping to leading healthcare facilities, government institutions, and independent testing centers in the U.S. and several other countries. They’re also available for purchase on Amazon.

But beyond the opportunity with NP swabs, this collaboration also further substantiates the industry’s growth into functional part production.  

In the press release, Ken Kisner, Head of Innovation for 3D Printing at Henkel said, “From inception, the vision behind Henkel’s Open Materials Platform was to enable collaboration all along additive manufacturing’s value chain. Working together with Origin, we were able to develop a product which is just as effective as its mass-produced counterpart. With the constraints commercial medical suppliers are facing, this presents a significant opportunity for the 3D printing industry to demonstrate its capabilities, beyond prototyping.”

Innovate Globally, Produce Locally

The problem wasn’t just related to the manufacturing of NP swabs. There were constraints all across the medical supply chain. Some of it had to do with the traditional model of centralized manufacturing and logistics. The healthcare industry relies on a relatively small number of producers and distributors. When they’re impeded, all bets are off. Further, the vast number of products, the niche nature of some of them, and shelf life issues make some medical products difficult to stockpile.

Perhaps more than anything else, this application demonstrates the value of a nimble, distributed manufacturing network, where identical parts can be made as close as possible to the point of need. In some cases, it can be financially beneficial, but in others like this decentralizing production provides an insurance policy in the event the unimaginable happens. We know it can, because it has.

About the Author

John Hauer is the Founder and CEO of Get3DSmart, a consulting practice which helps large companies understand and capitalize on opportunities with 3D printing. Prior to that, John co-Founded and served as the CEO of 3DLT. The company worked with retailers and their suppliers, helping them sell 3D printable products, online and in-store.

As a technology journalist, John focuses primarily on the topics of 3D printing, artificial intelligence, virtual reality and automation. His original content has been featured on Forbes, TechCrunch, Futurism, QZ.com, Techfaster.com, 3DPrint.com and Fabbaloo, among others.

Follow John on Twitter @Get3DJohn

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3D Printing and COVID-19, June 8, 2020 Update: Canon, Creatz3D, Carima, 3D Bioprinting Solutions

Companies, organizations and individuals continue to attempt to lend support to the COVID-19 pandemic supply effort. We will be providing regular updates about these initiatives where necessary in an attempt to ensure that the 3D printing community is aware of what is being done, what can be done and what shouldn’t be done to provide coronavirus aid.

Canon has been in the additive space for some time, dating at least as far back as 2014, when Canon Marketing began reselling 3D Systems technology in Japan. Now, Canon Marketing Japan (Canon MJ) has announced that it will offer contract manufacturing as well, spurred by the medical supply crisis associated with COVID-19. The company is utilizing its 3D printing network to provide on-demand production of medical items, beginning with resin parts. Testing the market further, Canon MJ will expand to offer further materials and printing methods.

3D Bioprinting Solutions (3DBio) is working to address the pandemic by enabling the testing of anti-COVID-19 drugs. The company has developed scalable production of 3D lung tissue spheroids modeled on human lung adenocarcinomas, human colorectal adenocarcinoma and African green monkey kidney cells. The 3D spheroids have been given to virologists to infect with the SARS-CoV-2 virus for testing pharmacological molecules.

U.K. startup Fractory is using sheet metal manufacturing to produce a universal tool made from CZ108, antimicrobial grade brass with 64 percent copper content, that enables the hands-free operation of doors, cabinets, fridges, cash machines, elevators and other objects in public life. Dubbed the SafeKey, it even acts as a bottle opener and wrench.

Alongside such companies as EnvisionTEC, HP, Origin, Carbon and Formlabs, South Korea’s Carima is also 3D printing nasopharyngeal swabs for SARS-CoV-2 testing. Via its partner company ‘T’ in the U.S., the company is making an average of 15,000 swabs daily with a goal of ramping up production to 25,000 per day. Additionally, the company is 3D printing face shields for healthcare professionals.

Nasal swabs being 3D printed with Carima’s continuous DLP technology. Image courtesy of Carima.

While some companies are 3D printing nasal swabs for SARS-CoV-2 testing, Singapore’s Creatz3D is 3D printing models for training personnel in the application of nasal and throat swabs. As many may now well know, this testing procedure involves inserting a very long swab into the nasal cavity, reaching it into the back of the throat, where the swab is gently rotated to collect specimens. A front-line training organization reached out to Creatz3D to 3D print life-sized medical mannequins to simulate swab collection.

A mannequin 3D printed by Creatz3D for nasal swab testing of SARS-CoV-2. Image courtesy of Creatz3D.

Its sister company, AuMed, a bespoke medical simulator company, found models in its CT and MRI library and fused them into a single mannequin using Materialise’s Mimics Innovation Suite (MIS) Medical. The models were refined with feedback from doctors in the field before the final products were realized. Compared to opaque counterparts made with traditional techniques, the resulting, 3D-printed mannequins are partially transparent for improved training. Two varieties can be 3D printed at a lower cost than the $3,000 conventional variety in just five to seven days. Other improvements include a bounceable tongue for simulating the use of a tongue depressor.

As the pandemic continues to grip the world, we will continue to provide regular updates about what the 3D printing community is doing in response. As always, it is important to keep safety in mind, remain critical about the potential marketing and financial interests behind seemingly good humanitarian efforts from businesses, and to do no harm.

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3D Printing and COVID-19, May 25, 2020 Update: DSM, Amazon, Fortify

Companies, organizations and individuals continue to attempt to lend support to the COVID-19 pandemic supply effort. We will be providing regular updates about these initiatives where necessary in an attempt to ensure that the 3D printing community is aware of what is being done, what can be done and what shouldn’t be done to provide coronavirus aid.

Dutch chemical company DSM has launched a platform for connecting healthcare providers and businesses for the supply of personal protection equipment (PPE) and other items. UNITE4COVID acts as a hub in which manufacturers and certifications labs can be linked to medical professionals in order to provide PPE and safety equipment.

Fortify is 3D printing tooling for injection molding meant to produce an adapter that converts a snorkel into a face mask. By making the tooling with its own 3D printing technology, the company believes that it could reduce the lead time for mold production by 75 percent, cutting a 14-day lead time to three days and potentially reducing costs from $2,000 to $300.

Origin has begun shipping its nasopharyngeal swabs, which are now FDA-registered, Class I, 510K medical products. Bulk orders of the swabs can be ordered on the company’s website.

A thirteen-year-old Tennessee student is using his own desktop 3D printer to produce ear savers, meant to reduce chafing caused by facial masks. Printing at a rate of eight ear savers in three-and-a-half hours, Sam Walker is running his printer 17 hours a day, giving them to local doctors, nurses, pharmacists and retirement home employees.

Also making ear savers is a collective of companies including Ultimaker, HP and other businesses, such as ImageNet Consulting, which has made over 10,000 such devices. While we have covered many of HP’s initiatives so far, Ultimaker’s involvement is made up of a two-part endeavor in which hospitals with pre-approved designs and material specifications are connected to 3D printing companies like 3D Hubs and ImageNet, a substantial U.S. reseller of IT technology and 3D printers, to produce the equipment.

Members of Amazon’s Prime Air mechanical design and hardware teams have joined a Washington State initiative that is producing face shields for healthcare workers. Based on feedback from medical professionals, the Amazon team claims to have improved the initiative’s existing face shield design, including material quality, so that they can be reusable and keep the shield in place more effectively. The new design also reduced sharp edges and pressure to the forehead, as well as improved print time. The Prime Air team subsequently made the U.S National Institutes of Health-approved design available for 3D printing and injection molding.

So far, Amazon has donated about 10,000 face shields and aims to deliver 20,000 more, using systems typically used to cut fiber materials for drone manufacturing to cut the face shield screens. Soon, the retail behemoth aims to mass produce face shields, suggesting it will be able to make hundreds of thousands over the next few weeks and have them available through the Amazon website. A recent blog post on the topic states:

“Because of the design innovations and the capabilities of our supply chain, we are confident we will be able to list them at a significantly lower price—almost a third of the cost—than all other reusable face shields currently available to frontline workers. We are looking to prioritize frontline workers and then eventually open up to all Amazon customers.”

During the pandemic, Amazon has faced harsh criticism from employees, including at Amazon warehouses and Whole Foods, who striking for better conditions as they continue to work amid the health crisis. While warehouse workers in multiple cities are demanding that Amazon shut down facilities where employees have been tested positive for COVID-19, CEO Jeff Bezos has grown his wealth by $25 billion since January 1, which the Institute for Policy Studies has described as “unprecedented in modern financial history.”

A leaked memo indicated that, after firing a worker who played a role in organizing a strike at a Staten Island distribution warehouse, company executives would discredit the worker and the larger movement to unionize Amazon workers. The employee was described as “not smart or articulate.”

According to VICE, who received the leaked documents, the company has attempted to cover its labor record in the midst of the pandemic with public relations efforts. Included in those efforts is the possibility of making free masks, with Amazon General Counsel David Zapolsky saying that the corporation should come up with “different and bold” ways for giving away surplus masks.

3D-printed medical supplies have obviously generated a lot of positive PR for companies involved in producing them. What this recent news could indicate is that the move by Amazon to participate in making 3D-printed face shields is part of a larger campaign to generate good publicity in the face of its labor disputes. Because we have seen multiple other companies laying off workers also participate in the production and delivery of medical supplies, such as GE and Boeing, it might not be unreasonable to think that similar campaigns are under way by other entities.

As the pandemic continues to grip the world, we will continue to provide regular updates about what the 3D printing community is doing in response. As always, it is important to keep safety in mind, remain critical about the potential marketing and financial interests behind seemingly good humanitarian efforts from businesses, and to do no harm.

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SmarTech Analysis: Over 1.4 Million Kg of AM Copper Powders to Ship by 2029

SmarTech Analysis has published its most recent report on the copper additive manufacturing (AM) market, “Copper Additive Manufacturing 2020–Market Database and Outlook,” projecting that the segment is growing at a rapid pace. By 2029, we estimate that over 1.4 million kilograms of copper powder, both pure copper and copper alloys, will ship for AM use.

The report is made up of two parts: a market analysis of the copper AM sector and a database forecasting the copper AM segment throughout numerous subsegments and broken out in multiple ways across a 15-year projection period from 2014 to 2029. This includes estimates of how much copper powder (pure and alloy) each metal AM technology family has consumed in the past, does and will consume in the present and future in a range of verticals and geographical regions.

For instance, SmarTech has concluded that copper AM adoption will expand rapidly from now until 2029 at a compound annual growth rate of roughly 43 percent, particularly in the Asia Pacific region. And, while the copper 3D printing market is relatively small compared to titanium, it will represent an increasingly large chunk of the broader copper market.

We also anticipate that the total sales of copper AM systems will grow by 34 percent through to 2029, which will introduce opportunities for copper powder sales across all metal 3D printing families. In particular, powder bed fusion (PBF) and bound metal printing will represent the largest revenue opportunities, though directed energy deposition will also increase its market share, despite its comparatively small size.

3D-printed copper parts, including induction coils, made using Trumpf technology. Image courtesy of Trumpf.

Part of the reason for copper AM’s rapid growth is attributed to improvements in copper 3D printing processes and materials. We know that metal PBF technologies are making advances in the processing of pure copper and copper alloys and that these materials themselves are being formulated in ways that make it easier for PBF systems to 3D print with them. This is demonstrated by work by Trumpf, which is now being expanded via a partnership with Heraeus AMLOY. Additionally, bound metal printing technologies are proving themselves to be increasingly capable of 3D printing copper parts, exemplified by recent news from Markforged.

3D-printed copper parts made using bound metal deposition technology from Markforged. Image courtesy of Markforged.

As far as applications are concerned, the industry is proving valuable the use of copper 3D printing for the production of induction coils—now offered by a variety of service bureaus, including GKN Additive, Phoenix Contact, and GH Induction—and heat transfer components, such as heat exchangers and rocket propulsion parts.

3D-printed copper and stainless steel filters made by ExOne and the University of Pittsburgh.

Interestingly, the COVID-19 pandemic has demonstrated the niche potential of copper 3D printing for producing antimicrobial parts. The report discusses the rise of copper 3D printing for medical applications, including some of the stories that we’ve discussed during our coverage of the disease, such as copper door plates and handles by SPEE3D, antimicrobial filament from Copper3D and reusable copper filters 3D-printed by ExOne.

The report examines the current states of copper 3D printing, across all of the major metal AM technology families. Each present specific obstacles for processing the material using established AM system configurations, due to the metal’s physical characteristics, but each also present unique opportunities.

In addition to the analysis found in the report, the accompanying database has the unique feature of being easily integrated into existing internal market intelligence resources. SmarTech describes it well as an “off-the-shelf resource for market metrics and forecasts,” in that, while the report provides context for the database, the database is a versatile tool for providing actionable intelligence across business units.

Among the companies discussed in the report are EOS, Formalloy, Sandvik, Praxair Surface Technologies, Stratasys Direct Manufacturing, 3T and FIT AG, as well as others already mentioned here.

To learn more about the report and database, view its table of contents, or purchase the two-part resource, visit the SmarTech website.

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Lithoz Ready to “Pull the Trigger” on New 3D-Printed Drug & Vaccine Purification Method

3D printing may potentially have an impact on the way that pharmaceuticals and vaccines are produced, including those for fighting the SARS-CoV-2 virus that causes COVID-19. The E.U.’s NESSIE project is a transnational European initiative that brings together five partners across Austria, Norway, and Portugal to develop a new generation of monolithic columns for separating molecules for biopharmaceutical production. The end result may be a quicker, more efficient and less expensive method for making vaccines. To learn more, we spoke to Martin Schwentenwein, head of materials for ceramics 3D printer manufacturer Lithoz.

A chromatography column 3D printed using Lithoz’s ceramic 3D printing technique. Image courtesy of Lithoz.

The project is dedicated to improving the process of chromatography used to separate and purify molecules for pharmaceutical purification. During chromatographic operations molecules and proteins are separated based on size or selective interactions, such as how well they dissolve in water or fats. This is accomplished by pumping a pressurized liquid solvent with the material being purified through a column filled with a specialized material, which separates impurities or unwanted byproducts. The members of the NESSIE project are working to improve this column component to make the process more efficient.

The group is developing methods for tailor-making these columns to optimize the behavior of the fluid running through them and reduce changes in pressure that occur during the purification process. In particular, the fluid pressure drops as the material interacts with the column, limiting the speed of purification. By reducing this drop in pressure, the entire process can be made more efficient, thus improving speed and reducing cost.

Lithoz was brought into the project due to the fact that existing columns are made using silicon dioxide material. As a specialist in ceramic 3D printing, the company is able to offer its expertise to producing columns with the fine resolution and materials needed for biopharmaceutical purification. Silicon dioxide has the advantage of combining the porosity needed to filter molecules, while maintaining temperature stability. It can also be sterilized, which is often required for processing biopharmaceutical materials.

Depending on the pharmaceutical material that is being researched or manufactured, the purification operation can be made up to 20 percent more efficient. With the processing of easier molecules sped up by up to five minutes per run, this translates into hours or days of work saved in drug R&D or even days or weeks saved in mass production of medications and vaccines. At the moment, the partners have developed a proof-of-concept for improving column designs more generally, but Schwentenwein said that the columns can in principle be tailored for each specific biopharmaceutical product that is studied or produced:

“Of course, improving the speed is the most tangible outcome, but going beyond that, is the vision that the separation mechanics can be improved overall, and you can ideally move significantly beyond this 20 percent times saving. You can move more into the domain where it can really get to half the time that you need. But for that also the whole design has to be optimized, has to be tailored. For now, we’re aiming for this basic proof-of-concept that, by using this 3D printing technique in combination with ceramics, that you can get this improvement for the whole separation process.”

Schwentenwein said that these columns could be used for the purification of basically any molecule, whether it’s during the drug screening and research phase, or for production. This includes the wide array of vaccines and medications being developed to combat the SARS-CoV-2 virus.

Renderings of chromatography columns with different geometries. Images courtesy of SINTEFweb on YouTube.

Currently, there are about 23 companies creating such solutions. This includes more inexpensive drugs for treatment, such as the decades-old antimalarials from the chloroquine family of medications to more potentially costly medicines like remdesivir. As for vaccines, products range from more traditional vaccines derived from the inactivated virus to much newer DNA and RNA vaccines, classes of vaccines that were previously not considered acceptable for human use due to the fact that in some cases they could not provide immunity, may have unpredictable effects and could potentially cause unintended consequences.

Despite the uncertainty about these newer vaccines, several RNA and DNA vaccines, some developed by partners of the U.S. Department of Defense, are undergoing clinical trials. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in March that a vaccine won’t be available for the public for another 12 to 18 months.

Regardless of the timeline for the public availability of a SARS-CoV-2 vaccine, the technology developed from Project NESSIE wouldn’t necessarily aid in production immediately. However, it could be used to purify a vaccine or drug used to prevent or treat the COVID-19 illness.

At the moment, the team is fine-tuning its production process and ensuring repeatability for printed columns, determining that they are able to achieve feature resolutions of well beyond 100 microns very homogeneously throughout across entire batches parts. This is something that has not been available before. The project is set to conclude at the end of October this year, but it won’t likely be ready for commercialization quite yet at that time.

The group is looking for a manufacturer who is ready to manufacture columns in mass, which would require a farm of Lithoz ceramic 3D printers. According to Schwentenwein, using a single printer that has not been optimized for production, it would be possible to produce 50 columns daily. If this were scaled up, it would be possible to manufacture in the numbers necessary for the market.

The columns currently being developed are smaller, meaning that they are more suitable for R&D purposes, but the size can be made larger for biopharmaceutical manufacturing, which would mean fewer columns per print job. The biggest bottleneck at the moment, Schwentenwein says, is the lack of having a user/partner who is able to produce these columns in a quality controlled environment. However, he believes that they have the technology in place so that, once they find this partner interested in mass production, all that would be necessary would be to “pull the trigger.”

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3D Printing and COVID-19, May 14, 2020 Update: Arburg, America Makes, Caracol-AM

Companies, organizations and individuals continue to attempt to lend support to the COVID-19 pandemic supply effort. We will be providing regular updates about these initiatives where necessary in an attempt to ensure that the 3D printing community is aware of what is being done, what can be done and what shouldn’t be done to provide coronavirus aid.

After participating in a simulation of a similar such pandemic, the World Economic Forum has been leveraging its might to shape response to the outbreak. The non-governmental organization has highlighted the work that its corporate partners have performed, including the use of JD drones for delivery of medical supplies in China and data gathering about people’s movements in Norway by the country’s leading telecom company. The Davos group also launched the 3D Printing COVID-19 Rapid Response Initiative, which more or less collates the ongoing projects from its partners, ranging from America Makes and Carbon to Roboze and Royal DSM.

Caracol-AM’s automated 3D printing system featuring KUKA robots. Image courtesy of Caracol-AM.

Caracol-AM, a 3D printing provider in Italy, is manufacturing face shields and masks using both its proprietary extrusion system mounted on a KUKA industrial robotic arm and more traditional fused deposition modeling printers. According to KUKA, the company is producing 1,000 parts daily for use by local healthcare workers.

The “Moldable Mask” from Carnegie Mellon University. Image courtesy of Carnegie Mellon University.

America Makes has announced the winners of its Fit to Face – Mask Design Challenge, hosted with the U.S. Department of Veterans Affairs. The designs had to meet the requirements of five head form datasets shared by the National Institute for Occupational Safety and Health (NIOSH), before being judged on manufacturability, assembly and instruction. The top designs were the “Vader Small Mask” from Alliance PCB Solutions and “Moldable Mask Small and Moldable Mask Large” from Carnegie Mellon University, which will be hosted on the NIH 3D Print Exchange and America Makes websites. Honorable mentions for the challenge were the “Every Mask” from the National Institute of Standards and Technology and the “Flex Fit Small and Flex Fit Large” from Re:3D.

The “Vader Small Mask” from Alliance PCB Solutions. Image courtesy of Alliance PCB Solutions.

Seattle Children’s has 3D printed clips for its supply of Controlled Air Purifying Respirator helmets. The hospital’s Chief Procurement Officer, Greg Beach, along with its Clinical Engineering team feared a shortage of clips necessary to secure face shields to their CAPR helmets. The Radiology department relied on a CT machine to scan existing clips, before Friedman used Materialise’s Mimics Medical & 3-matic Medical software to reverse engineer them. Using an in-house 3D printer, the hospital was able to fabricate the parts and determine that they fit. Stratasys then offered to print batches of the tools using its V650 Flex stereolithography 3D printer.

A medical worker wearing a CAPR helmet, featuring 3D-printed clips to mount a face shield. Image courtesy of Materialise.

After producing protective glasses using its Allrounder injection molding machines, Arburg is making face masks, injection molded from liquid silicone rubber (LSR) and polypropylene (PP). With a goal of making about 3,500 masks daily, the company will begin by distributing them to its own employees and then providing them to hospitals and care facilities in the district of Freudenstadt in Germany. The mask is made up of a soft mouth cover, moulded from a food-safe LSR material, with PP eyelets for attaching elastic bands. FFP2 or FFP3 filters can then be connected to provide filtration for healthcare workers.

Masks made with injection molding from Arburg. Image courtesy of Arburg.

At full capacity, Arburg believes it could make 15,000 masks weekly. If production were kicked up to a 24-hour schedule, this number could feasibly be doubled. The LSR masks are being made using a larger injection moulding machine at the Arburg Training Center while a smaller system creates the PP shields at its Customer Center. Working in tandem with the larger machine, a six-axis Kuka robotic arm removes the masks from the mold and places them onto a conveyor belt. Meanwhile, a linear Multilift Select robotic system handles the PP shields. The PP shields are then manually attached to the LSR masks, connected to elastic bands, and packed.

Four LSR masks are produced per cycle and then removed by a six-axis robot. About 3,500 multifunctional high-tech masks can be produced per day. Image courtesy of Arburg.

As the pandemic continues to grip the world, we will continue to provide regular updates about what the 3D printing community is doing in response. As always, it is important to keep safety in mind, remain critical about the potential marketing and financial interests behind seemingly good humanitarian efforts from businesses, and to do no harm.

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3D Printing and COVID-19, May 12, 2020 Update: Limbitless Solutions, Dunlee, 3DPRINTUK

Companies, organizations and individuals continue to attempt to lend support to the COVID-19 pandemic supply effort. We will be providing regular updates about these initiatives where necessary in an attempt to ensure that the 3D printing community is aware of what is being done, what can be done and what shouldn’t be done to provide coronavirus aid.

Albert Chi, a trauma surgeon from Oregon Health and Science University (OHSU), and the team at Limbitless Solutions, a 3D printed prosthetics company, are creating a ventilator that does not require electricity. Instead of using electronics, the device relies on airflow from an oxygen tank. The design is made up of 3D printed parts, low-cost, off-the-shelf components and can be made with less than $10 in materials, according to its makers. This makes it possible to not only manufacture the product nearly anywhere in the world, but use it in places without electricity.

Using printers at its lab at the University of Central Florida, Limbitless was able to make 10 iterations of Chi’s designs for the device, which were then sent to his lab at OHSU for testing. After seven days of continuous functioning, the team found that there were no issues, leading Chi to file for emergency approval by the U.S. Food and Drug Administration.

The 3D printed ventilator device being tested. Image courtesy of OHSU/Kristyna Wentz-Graff.

Because CT scanning is a crucial technology for examining the respiratory issues caused by severe cases of COVID-19. To deal with the increased use of the technology during this time, Dunlee is ramping up production of anti-scatter grids for CT systems with 3D printing. The grids are used to absorb unwanted scatter radiation, in turn improving the quality of CT scans. Its Cone Beam CT line, for instance, is able to improve the signal-to-noise ration by 1.7 times, according to the company.  Working with EOS, the company is obtaining new printers and using its existing machines to print pure tungsten grids 24 hours a day.

3D printed, tungsten anti-scatter grid from Dunlee. Image courtesy of Dunlee.

3DPRINTUK is helping to provide facial shields to workers at the National Health Institute. Pointing out that some of the existing shield designs are meant for material extrusion systems, the British 3D printing service bureau has optimized a model for large batch printing using selective laser sintering machines.

By nesting the parts, the company is able to print 260 brackets for face shields in a single print in 27 hours on an EOS Formiga P110 system. The bracket is made from PA2200/Nylon 12, features a closed-peak design for greater protection, and can be flat packed in an A4 envelope, according to the company. Managing Director of 3DPRINTUK Nick Allen said:

“That is 6 minutes per shield, which is a game changer. The design that we created clips together in 10 seconds, uses silicone straps for adjustment, can take an acetate sheet with 3 holes, is lightweight at only 42 g, and is sterilisable with IPA, autoclave, or ethylene oxide (Et0). All in all, we believe that this is the most efficient visor design to produce via 3D printing available today.”

Because 3DPRINTUK is currently using its own fleet of printers to produce ventilator parts with the UK cabinet and manufacturers, the company partnered with the Arts University Bournemouth, who used its own P110 machine and laser cutting capabilities to produce 5,000 face shields. The partners are inviting other SLS systems owners to aid in production capacity, as well.

One employee of Thomson Reuters has been producing face shields at the company’s office in Costa Rica, making over 100 such devices for healthcare workers and raising money within the office to buy filament. Given the fundraising effort, it’s worth noting that the multinational media conglomerate has a net income of $4 billion. The company’s chairman, David Kenneth Roy Thomson, is the Lord Baron of Fleet in the U.K. and, as of 2019, was the wealthiest person in Canada with a net worth of $37.8 billion.

Global military members are also producing medical devices. A fighter pilot for the Italian Air Force is 3D printing valves for ventilators at local Italian hospitals, including 50 “Charlotte Valves” and 50 “Dave Valves”. Soldiers from the 20th Chemical, Biological, Radiological, Nuclear, Explosives Command, which has a unique role given the nature of the pandemic, are using their 3D printing capabilities to produce NIH-approved face shield designs for local healthcare workers and beyond. The 10 volunteer soldiers, who met in an Explosive Ordnance Disposal (EOD) Facebook group, aim to make more than 13,500 face shields to send to 28 states and one U.S. territory.

ExOne has posted its Q1 20202 earnings in the midst of the pandemic and has reported total revenue of $13.4 million, a 40 percent increase over Q1 2019. The company also says that it has a record backlog of $33.8 million, with CEO John Hartner tying this strong to new product introductions and the number of orders backlogged from the end of 2019. Like SLM Solutions, which reported a similar pattern of increased revenues and orders from the previous year,  Hartner says that the impact of the virus could be felt in March:

“Despite initial effects of COVID-19 on our business, our execution performance was solid. Globally, our facilities continued to operate in support of our customers in critical industries and essential businesses, subject to social distancing and other procedures to keep our employees safe.” He continued, “However, conditions clearly changed in March. We previously anticipated that growth would continue during 2020, but the COVID-19 pandemic has impacted shipping, travel and installation schedules, as well as the timing of customer capital investments. The uncertainty of our outlook caused by this situation prompted us to reduce our cost structure as we manage through these historic times.”

As the pandemic continues to grip the world, we will continue to provide regular updates about what the 3D printing community is doing in response. As always, it is important to keep safety in mind, remain critical about the potential marketing and financial interests behind seemingly good humanitarian efforts from businesses, and to do no harm.

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