The SafeTraces Podcast – Episode #4

Date: November 17, 2020

Episode #4
Ron McMahan, Dir. Business Development at SGS Galson

CEO Erik Malmstrom speaks with Ron McMahan, Director of Business Development and Innovative Solutions at SGS Galson, the largest occupational health lab in the world, with whom SafeTraces is collaborating to deliver the SafeTraces veriDART solution. For over 30 years, Ron has been at the forefront of applying burgeoning technology to real-time applications and currently leads a team in developing innovative ways to make sampling simpler. They discuss his experience in the indoor air arena, the changes he has seen in the EHS space as it pertains to new technologies, and some of the solutions SGS is providing to help protect spaces from COVID-19.

The SafeTraces Podcast – Episode #3

Date: November 4, 2020

Episode #3
Lisa Kay, Chief Operating Officer at NV5

For this episode, CEO Erik Malmstrom speaks with Lisa Kay, the COO of Health and Safety at NV5, with whom SafeTraces is collaborating to deliver the SafeTraces veriDART solution. Lisa leads a team of high-performing environmental, health, and safety (EHS) consultants with the mission of making businesses cleaner, stronger, and safer. She sheds light on NV5’s EHS practice, her perspective on the impacts of COVID-19 on the built environment, and the kind of work NV5 has been doing to help clients navigate challenges since the pandemic began.

Managing Indoor Air Quality Amid COVID-19

Featured in Restoration & Remediation

Written by Mark Drozdov | October 7, 2020

As we seek to return to normalcy without a vaccine, COVID-19 confronts us with a troubling reality. We spend 90% of our time indoors in the U.S. and Europe, and scientific evidence indicates we are nearly 20 times more likely to be infected by the virus indoors than outdoors. COVID-19 has impacted many indoor settings such as schools, offices, churches, restaurants and bars, with prisons, meatpacking plants, and long-term care facilities being most affected due to high occupancy, poor ventilation and vulnerable populations.

Increasingly, scientists believe airborne transmission is a major route for the spread of COVID-19. Viral respiratory droplets released from coughing, sneezing, talking, and breathing can aerosolize into smaller particles, stay suspended in the air for hours, and travel significantly farther than six feet. A key scientific debate has been whether the virus is infectious in aerosols.

Though the virus is clearly detectable in aerosols, no one had been able to provide evidence  that it is “live” until the University of Florida. Skeptics of airborne transmission have been using this lack of evidence to challenge the importance of this mechanism. As the prominent aerosol scientist Linsey Marr said about the UF study, “If this isn’t a smoking gun, then I don’t know what is.” Even those who acknowledge aerosol’s infectiousness debate the relative importance of different viral transmission routes, including airborne or fomite, droplet or aerosol, direct or indirect contact, or a combination of mechanisms.

The role of airborne transmission of COVID-19 has a huge bearing on infection control in the built environment in two important respects. First, common approaches characterized by deep cleaning are incomplete and possibly misguided altogether. Second, masking and social distancing by themselves might be insufficient for mitigating airborne transmission.

Lisa Brosseau, a retired professor of public health, says that masks can limit larger particles’ spread, but they are less helpful for smaller particles. Aerosol mobility of over 30 feet, and suspension in air for hours can reduce the efficacy of six-foot social distancing mandates.

Image via Restoration & Remediation Magazine Online.

The fundamental question is what can and should we do to mitigate airborne transmission and create “safe” indoor environments amid COVID-19? One critically important and often overlooked area is engineering and Heating, Ventilation, and Air Conditioning (HVAC) controls. The American Industrial Hygiene Association (AIHA) states, “Engineering controls that can keep infectious aerosols at very low levels indoors offer the greatest promise to protect non-healthcare workers and other vulnerable populations as we reopen our businesses and workplace.”

Similarly, the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) states, “Changes in building operations, including the operation of heating, ventilating, and air conditioning systems can reduce airborne exposures.” It highlights the following HVAC strategies based on evidence-based literature:

  • Enhanced filtration that includes higher Minimum Efficiency Reporting Value (MERV) filters over code minimums in occupant-dense and/or higher-risk spaces
  • Upper-room UltraViolet Germicidal Irradiation (UVGI), with possible in-room fans, as a supplement to supply airflow
  • Local exhaust ventilation for source control
  • Personalized ventilation systems for certain high-risk tasks
  • Portable, free-standing High-Efficiency Particulate Air (HEPA) filters
  • Temperature and humidity control

ASHRAE is careful to qualify its recommendations with the caveat that the system’s impact will depend on the source location, strength, and distribution of the released aerosol, droplet size, temperature, air distribution, humidity, and filtration. Each indoor environment is unique; conditions within each indoor environment are dynamic, and there is not a one-size-fits-all strategy for infection control.

Emerging technology by SafeTraces to evaluate engineering and HVAC systems for infection control. Image via Restoration & Remediation Magazine Online.

The complex and evolving nature of the airborne transmission risk has resulted in two broad categories of responses for engineering and HVAC controls. The first is that owners and operators, particularly those responsible for mission-essential businesses, have spent significant financial resources on many of ASHRAE’s recommended strategies and beyond. The second category is many other owners and operators have done little due to being overwhelmed, confused, resource-constrained, or merely taking a wait-and-see approach.

Empirical data that allows people to understand the current level of risk and remediation usefulness is absent from most decision-making processes. ASHRAE, AIHA, IICRC and other leading authorities base their recommendations on evidence-based methodologies and peer-reviewed research.

Extrapolating academic studies results to any specific indoor environment has significant challenges and limitations, especially for a novel virus like SARS-CoV-2. ASHRAE and AIHA acknowledge as much, urging the involvement of knowledgeable mechanical engineers and industrial hygienists familiar with a building and, in some cases leveraging computational fluid dynamics (CFD) modeling.

However, mechanical engineers and industrial hygienists have candidly and consistently shared with us their concerns around infectious aerosols. Simply put, existing diagnostic solutions for indoor air quality, including tracer gases, smoke or bubble testing, and monitors or sensors may be insufficient for assessing the risk posed by an airborne pathogen like SARS-CoV-2.

The good news is that emerging technologies at the cutting edge of building, health, and data science are posed to fill this gap. One notable solution is veriDART, developed by the Bay Area-based technology company SafeTraces with the National Institutes of Health (NIH) support. This groundbreaking technology safely mimics the airborne pathogen’s mobility with proprietary tracers based on the chemical composition, fluid dynamics, and detection methods of human saliva and aerosols that comply with OSHA, NIOSH, and ACGIH exposure limits. The key is to enable owners and operators to identify hotspots, assess filtration and ventilation, and inform remediations with empirical data, heatmap visualizations, and time-series analyses.

The challenge is how it efficiently support safer office reopening and emergency response at sites, yielding valuable data for what could be very costly engineering and HVAC control decisions. For example, a Fortune 500 company used veriDART for both a survey risk assessment of their 500,000 square foot office building and targeted risk assessments of their restrooms, conference rooms, and other perceived high-risk locations. A major focus area of testing was dilution ventilation, which ASHRAE and AIHA cite as an important engineering control for reducing an occupant’s exposure to airborne viruses.

It was established by veriDART data-driven time and condition parameters for tracer dilution to the diagnostic indicator level of low risk. Interestingly, the number of effective air changes per hour had a uniform effect on tracer dilution within a room, but non-uniform across rooms of similar size, HVAC configuration, and test conditions. The customer’s implication was clear: they needed to be careful about not over-generalizing their engineering and HVAC controls across the entire building.

veriDART solution measures time and HVAC setting parameters for dilution ventilation of aerosol particles. Image via Restoration & Remediation Magazine Online.

Additionally, test results indicated mechanical issues, including exhaust systems not functioning properly and unexpected airflow between high-trafficked areas. In many cases, test results confirmed engineering and HVAC controls performed as expected. Ultimately, the user leveraged data to baseline their risk and inform tactical decisions regarding space utilization SOP’s, filtration enhancements, and procurement of airborne interventions prior.

Engineering and HVAC controls represent one of the most important opportunity areas for mitigating viral spread. However, there is no silver bullet strategy given each building’s uniqueness and constantly evolving conditions within the building. As management guru Peter Drucker famously said, “If you can’t measure it, you can’t improve it.” Assessing your risk through regular environmental monitoring and data-driven technology solutions will be hugely consequential for occupant health and safety, organizational productivity and liability, and development of infection control strategies that are both effective and financially sustainable.

This article originally appeared on Restoration & Remediation Magazine Online. Read it here.

References:

  1. https://www.medrxiv.org/content/10.1101/2020.02.28.20029272v2
  2. https://www.pnas.org/content/117/26/14857
  3. https://jamanetwork.com/journals/jama/fullarticle/2763852
  4. https://www.medrxiv.org/content/10.1101/2020.08.03.20167395v1
  5. https://www.technologyreview.com/2020/07/11/1005087/coronavirus-airborne-fighting-wrong-way/
  6. https://aiha-assets.sfo2.digitaloceanspaces.com/AIHA/resources/Guidance-Documents/Reducing-the-Risk-of-COVID-19-using-Engineering-Controls-Guidance-Document.pdf
  7. https://www.ashrae.org/file%20library/about/position%20documents/pd_infectiousaerosols_2020.pdf
  8. Ibid.
  9. https://cdn.ymaws.com/www.iicrc.org/resource/resmgr/images/resources/COVID-19_Professional_Cleani.pdf

Welcome to a New Era of Food Safety

Written by Thomas Skernivitz | October 1, 2020

This article originally appeared on Growing Produce. Read it here. 

The miniDART technology from SafeTraces applies edible, invisible, DNA-based tags directly to fruit and other produce. Photo courtesy of SafeTraces

Food traceability companies will remember the summer of 2020 for more than the coronavirus and lockdowns.

On July 13, the FDA announced its new approach to food safety, the goal of which is to bend the curve of foodborne illness in the U.S. by reducing the number of illnesses. The organization had planned to announce the initiative in March but was forced to turn its attention to addressing the public health emergency posed by the COVID-19 pandemic.

The New Era of Smarter Food Safety leverages technology and other tools to create a safer and more digital, traceable food system. The blueprint seeks out simpler, more effective, and modern approaches and processes.

Tasked with educating growers on the FDA program and its significance are food traceability companies such as iFoodDecisionSciences (iFoodDS), rfxcel, and SafeTraces.

“Produce growers, packers, and shippers need to meet and exceed the performance of conventional packaging and requirements of the initiative,” Ulrike Hodges, the COO of SafeTraces, says. “As consumers and regulators demand higher food safety standards and visibility into supply chain practices, on-product traceability can provide them and their customers much needed assurance of the safety and authenticity of food products.”

The FDA is focusing on four core elements that it believes could significantly reduce foodborne illness in the country: tech-enabled traceability; smarter tools and approaches for prevention and outbreak response; new business models and retail modernization; and food safety culture.

“Industry- and regulator-led efforts and standardization will set the rules of the road for the key data elements (KDEs) and critical tracking events (CTEs) that must be captured,” John McPherson, Director of Global Solutions with rfxcel, says. “For the growers/harvesters, we think that data-capture innovations will allow field-level/harvest data to be leveraged for traceability, data analytics, and many other business uses. Growers who adopt digital strategies today will be not just ahead — they will be the ones that survive. “There will be a new era of food safety.”

THE NEED FOR SPEED

Every shipper’s traceability data should be in the cloud, according to iFoodDS Vice President Minos Athanassiadis.

“The PTI (Produce Traceability Initiative) standard of ‘one up one back’ traceability is too slow to respond to future outbreaks because the fresh fruit supply chain is complex, and the traceability data is locked up in data silos within each organization across the supply chain,” Athanassiadis says.

Hodges concurs: “The lack of complete, rapid, and accurate traceability systems significantly impedes the speediness and effectiveness of traceback investigations during outbreaks and recalls. They also fail to effectively support global sustainability initiatives and prevent food fraud, undermining the public’s faith in global and even domestic food supply chains and creating financial harm to growers and manufacturers.”

Growers should realize that digital supply chains and the benefits they offer are within their reach, McPherson says. New innovations in product labeling, Internet of Things (IoT), mobile, radio frequency identification (RFID), and Bluetooth are being built to scale at the levels that growers work in. “Such innovations mean that the cost and implementation are easier to see as an investment, not as an expense,” McPherson says.

iFoodDS is working with packer/shippers to not just be PTI case-labeling compliant but also be PTI compliant in tracking their pallet shipments with Serial Shipping Container Code (SSCC) pallet tags and submitting advance ship notices (ASNs) to their customers for instantaneous trace forward.

“We are also encouraging the grocery retailers to make the most of our industry’s investments in PTI traceability by tracking cases at the DC (distribution center) and on to the store level,” Athanassiadis says.

END GOAL

Growers continue to make strides in digitizing their supply chains, McPherson says, but they need to continue evolving their operations to meet new demands of the marketplace. This includes complying with the PTI as well as potential new requirements from the FDA under the Food Safety Modernization Act (FSMA).

“The FDA has been candid about wanting supply chains to be more digital and transparent, and growers will need to consider breaking down supply chain data from current silos and having a unified approach to that data,” McPherson says.

Adds Hodges: “Without incorporating end-to-end traceability back to the source in the produce industry, produce growers, packers, and shippers fail to meet consumers’ needs for food transparency, legal requirements, and potentially increase their risk in the event of an outbreak or recall.”


TECH ROUNDUP

iFoodDS (Kenmore, WA) — The company on May 6 acquired Trimble’s food traceability and quality inspection business, HarvestMark. “We now provide growers and shippers with comprehensive real-time food safety records along with the state-of-the-art traceability,” Athanassiadis says. “This means that, for the first time, we’re linking real-time food safety information, not annual or quarterly audits, with every case of fruit going out the door, to be able to instantaneously access and respond to food safety and trace requests.”

rfxcel (Reno, NV) — The company boasts products that growers can use to digitize — from mobile and web to sensor/IoT tech — all run from the cloud, McPherson says. “We have deep experience creating a single-source of truth for every item in a supply chain, then sharing that data with trading partners to be compliant with current and future needs, such as blockchain integration,” he says. “Our experience working with federal regulatory bodies is another big advantage we bring to our customers.”

SafeTraces (Pleasanton, CA) — The company’s miniDART technology speaks to the problem of packaging that bears conventional barcodes and other digital identifiers being removed or damaged during normal supply chain transactions. The product uses unique edible, invisible DNA-based tags (FDA-GRAS) that are applied directly to the fruit during normal processing and can be read by a downstream purchaser with a rapid, inexpensive, onsite test to verify product source and authenticity in 25 minutes.

 

This article originally appeared on Growing Produce. Read it here.

The SafeTraces Podcast – Episode #2

Date: September 28, 2020

Episode #2
Glenn Fishler, MS

For the second episode, CEO Erik Malmstrom connects with Glenn Fishler, who was a Board Certified Industrial Hygienist for 32 years (1985-2017) and now sits on the Boards of Directors for McMillen Jacobs Associates and Citadel EHS, and is an executive advisor for SafeTraces. They discuss the ongoing pandemic and Glenn offers his perspective on airborne virus transmission as it relates to the environmental, health, and safe space.

The SafeTraces Podcast – Episode #1

Date: September 8, 2020

Episode #1
John Martin, ScD, CIH, CHMM

In the first episode, SafeTraces CEO Erik Malmstrom speaks with veriDART advisor John Martin – a leading industrial hygienist and aerosol scientist – about airborne transmission of COVID-19, engineering and HVAC controls, and the urgent need for data-driven validation and verification solutions.

Corvium and SafeTraces Launch Partnership

Corvium and SafeTraces Partner to Automate Management of Sanitation Verification Diagnostic Testing for Food Supplier Organizations

Date: June 29, 2020

RESTON, VA. (PRWEB) 

Corvium Inc., the leader in automation of food risk intelligence, announced today that it is partnering with SafeTraces, Inc. leaders in next-generation DNA-based technology solutions. The partnership will enable food suppliers and processors to schedule, manage and deliver diagnostic testing and results from SafeTraces groundbreaking rapid sanitation verification solution, saniDART™, through CONTROL-PRO™– Corvium’s automated environmental monitoring platform.

Available today, SafeTraces customers can seamlessly integrate their current EMP process into Corvium’s award-winning solution that is used by more than 100 food supplier operations in North America. The integration will allow customers to schedule, manage and analyze results collected with the saniDART solution — the first rapid solution for verifying sanitation effectiveness at a microbial level to receive certification from the AOAC Research Institute (AOAC-RI). Corvium’s CONTROL-PRO manages the entire process, from scheduling and mapping test locations, to automatically collecting results and presenting sanitation verification results within a single web-based platform that can be accessed through any browser-enabled device.

“The key to enabling a new era of smarter food safety is technology” says Erik Malmstrom, SafeTraces CEO. “SafeTraces has responded to the food industry’s need for better, faster, and more cost-effective solutions for sanitation verification and traceability by harnessing the power of DNA technology. Similarly, Corvium has delivered best-in-class software and data technology for environmental monitoring. Our two platforms together provide tremendous value to customers and make the new era of smarter food safety a reality.”

“The food safety, quality and sanitation functions within the food and beverage industry are experiencing a digital transformation”, states David Hatch, Corvium’s Chief Growth & Partnership Officer. “Organizations are seeking to integrate and consolidate the technologies and devices that help streamline their environmental testing processes. The partnership with SafeTraces meets this need with the integration of SafeTraces saniDART™, the most innovative sanitation verification solution available today, to Corvium’s food risk intelligence platform, and the CONTROL-PRO EMP workflow and analytics application. This provides customers with one system on which all of their EMP, Product Testing and Sanitation workflows can be managed, visualized and analyzed.”

About Corvium Inc.
Corvium’s mission is to use data to make the world a safer place to eat. Our food risk intelligence platform continuously aggregates and analyzes risk and quality data generated during food production and distribution. Corvium’s fully integrated solution is used by food safety professionals and executives to streamline and optimize product testing, environmental sampling, and sanitation workflows. Our workflow and analytics technology helps food producers and processors prevent pathogenic contamination, comply with federal regulations and internal safety and quality programs, while reducing food safety risks and food waste. To learn more about corvium, visit their website: https://corvium.com.

About SafeTraces, Inc.
Founded in 2013, SafeTraces is a mission-driven team of entrepreneurs, scientists, engineers, and food safety practitioners dedicated to using nature’s DNA to make food production safer, more transparent, and more sustainable. Our rapid, easy-to-use, and cost-effective testing solutions for sanitation verification and traceability build on groundbreaking and patented DNA-based technology. We developed the first and only on-food traceability solution, the miniDART, which leverages natural, edible, invisible, DNA-based barcodes (FDA-GRAS) that are applied directly to the product and that downstream purchasers can read with a rapid, inexpensive test in order to verify product source, authenticity, and purity in minutes. Additionally, we developed the first rapid solution for verifying sanitation effectiveness at a microbial level, the saniDART, that uses FDA-GRAS, AOAC-certified abiotic bacterial surrogates in order to enable in-process corrective actions, evaluate sanitation crew accuracy and proficiency, and support environmental monitoring, continuous improvement, root cause analysis, in-house validation, and FSMA and SQF audits. To learn more, visit their website at https://www.safetraces.com

 

###

The Role of Aerosols in COVID-19 Transmission

Aerosols in COVID-19 Transmission

Written by Erik Malmstrom, CEO of SafeTraces |  May 27, 2020

Initial Answers to the “Trillion-Dollar Question”: The Role of Aerosols in COVID-19 Transmission and Implications for Safely Reopening Shared Spaces

In an April 14 New York Times article titled “Stay 6 Feet Apart, We’re Told. But How Far Can Air Carry the Coronavirus,” Dr. Michael Osterholm, Director of the Center for Infectious Disease Research and Policy at the University of Minnesota, posed a question with enormous implications for global health and safety as we return to shared spaces in the absence of a vaccine and reliable rapid testing: 

“The question is what does it take for you to get infected? And that I think is the trillion-dollar question we have…maybe all it takes is an aerosol. You don’t need any droplets at all.” 

Dr. Osterholm highlights one of the critical “known unknowns” of COVID-19 – the transmission role of aerosols, or particles under five microns in diameter that are emitted while talking and breathing, that can stay suspended in air for hours, and that can travel over 20 feet.

Currently, guidance from the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) of six feet separation in public assumes that large droplets from coughing and sneezing are the principal means of COVID-19 transmission and that most large droplets drop to the ground within six feet.

However, a chorus of prominent experts have emphasized the role of aerosols and air flow as a potentially important transmission vehicle for COVID-19, with emerging scientific research lending credence to their argument:

What does the potential for airborne transmission of COVID-19 via aerosols mean for the air that we breathe in shared spaces that many of us will be returning to? 

On this matter, the American Society of Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE), a leading professional association whose guidance is widely referred to by facility managers, published a position document on infectious aerosols in April stating:

“Transmission of SARS-CoV-2 through the air is sufficiently likely that airborne exposure to the virus should be controlled. Changes in building operations, including the operation of heating, ventilating, and air-conditioning systems, can reduce airborne exposures.”

Given the complexity, urgency, and our evolving understanding of the risk presented by COVID-19 aerosols, practical application of ASHRAE’s guidance is easier said than done. In our experience, the airborne transmission risk is not always well-understood by facility managers and therefore insufficiently accounted for in reopening plans. Moreover, there is a notable gap in diagnostic tools available for assessing the risk of airborne transmission of COVID-19 indoors.

Based on groundbreaking technology developed with the support of the National Institutes of Health (NIH), our veriDART solution for verifying safe indoor airflows fills this gap. veriDART leverages proprietary airborne tracers that safely mimic the mobility of airborne pathogens like COVID-19 in order to identify high-risk transmission vectors, assess the efficacy of filtration, ventilation, and anti-microbial solutions, and instill public trust and confidence in buildings for safe occupancy.

Joseph Allen, Director of the Healthy Buildings program at Harvard T.H. Chan School of Public Health said, “The evidence suggests that mitigating airborne transmission should be at the front of our disease-control strategies for COVID-19.” As facility managers gradually reopen buildings while preparing for a potential second wave of viral outbreak this fall, veriDART is a powerful tool in the fight against COVID-19  – and gets us a step closer to answering the trillion-dollar question.

Please follow up to learn more and become an early adopter.   

Safety & Traceability in New Industries

Expanding Traceability to New Industries

Date: May 18, 2020

We hope that you and your loved ones are staying safe amidst the ongoing COVID-19 pandemic.

We wanted to provide an update on exciting developments at SafeTraces. At our core, our company is a mission-driven organization committed to solving the biggest, toughest safety challenges in the world. Until recently, we have been exclusively focused on food and agriculture-based applications of our technology. And for good reason. There is tremendous need for technology-enabled solutions for food safety and authenticity – consumers demand it, regulators mandate it, and food companies invest in it as a key source of value and competitive advantage.

Our miniDART and saniDART solutions represent major technological breakthroughs for food safety. miniDART is the first and only on-food traceability solution, leveraging edible, invisible DNA-based barcodes (FDA GRAS) that are applied directly to the food or ingredient and that a downstream purchaser can read with a rapid, inexpensive, on-site test to verify product source and authenticity. saniDART is the first rapid solution for verifying sanitation effectiveness at a microbial level to receive approval from AOAC-International, the gold standard for proprietary testing methods in food safety.

However, in recent months, opportunities beyond food and agriculture have increasingly demanded our attention for three important reasons. First, COVID-19 has created seismic global health and economic challenges that our technology is uniquely suited to help mitigate. Second, many companies outside of food and agriculture have sought our support, seeing our technology as a valuable solution to safety and security challenges confronting their operations. Third, our technology is highly versatile, enabling deployment in a wide variety of applications at scale. And that is why we have been compelled to support two other global industries facing enormous, urgent challenges:

Verifying Safe Airflow in the Built Environment

COVID-19 represents an unprecedented threat to public health and the global economy. As of mid-May 2020, Johns Hopkins counts nearly 300,000 deaths and four and a half million confirmed cases of COVID-19 globally in less than six months, sadly with these statistics forecasted to continue increasing until a vaccine is successfully developed.

Ranging from office buildings to nursing homes to food processing plants, the virus presents a major safety and health risk to the built environment given the complexity of airflows and the risk of airborne transmission. Currently, property managers lack adequate tools for assessing and mitigating this risk safely.

In response, we are excited to launch veriDART, our groundbreaking solution that leverages airborne tracers that safely mimic the mobility of pathogens like COVID-19 in order to verify safe airflows for building occupancy and re-occupancy. veriDART empowers property managers with a powerful tool to identify high-risk transmission vectors, ensure effective filtration, ventilation, and other protective measures, and target remediation actions. veriDART draws on SafeTraces’ deep expertise in surrogate particle development, built over years with support from leading institutions like the National Institutes of Health (NIH).

Anti-Counterfeiting for Pharmaceuticals & Nutraceuticals

The World Health Organization (WHO) estimates that the $200 billion global market for counterfeit drugs, touching nearly every therapeutic class, kill hundreds of thousands of people annually. Additionally, counterfeit nutraceuticals pose a serious threat to consumers as more than 50% of FDA Class I recalls between 2004 and 2012 were for dietary supplements. Product security stops at the unit of sale level, enabling significant risk of fraud, adulteration, and diversion during manufacturing and distribution.

To meet this growing need, we have introduced our on-dose traceability solution that leverages edible, invisible, FDA-GRAS, DNA barcodes that are mixed with coating or ingredients and applied to directly to pharmaceutical and nutraceutical pills during regular production. In turn, downstream supply chain partners can verify the authenticity, origin, and safety of a dose or its ingredients within 25 minutes more accurately and reliably than with traditional packaging-based serialization.

In closing, broadening our mission to ensure the highest safety standards of the food we eat, the medicine we take, and the air we breathe is an exciting and natural evolution of our company. Now more than ever, people demand transparency and assurances from food companies, drug manufacturers, and property managers regarding their safety practices. We are honored to tirelessly support our customers in making a better, safer world.

Sincerely,

Erik

 

 

Erik Malmstrom


Erik has been a leader at the intersection of agriculture and technology in senior roles at Farmers Business Network, Cargill, and the White House. He is a co-founder of CrossBoundary, a leading frontier market investment advisor, and is a combat veteran and graduate of U.S. Army Ranger and Airborne Schools. He received his undergraduate degree from the University of Pennsylvania and a joint M.B.A. – M.P.P. from Harvard Business and Kennedy Schools.

 

SafeTraces saniDART™ Receives AOAC Approval

saniDART Receives AOAC Approval

Date: April 2, 2020

PLEASANTON, Calif.April 2, 2020 /PRNewswire/ — SafeTraces, Inc. announced today that it has received approval from the AOAC Research Institute (AOAC-RI) for its groundbreaking rapid sanitation verification solution, saniDART™.

SafeTraces’ saniDART™ is the first rapid solution for verifying sanitation effectiveness at a microbial level to receive AOAC certification. saniDART addresses major shortcomings of two commonly used methods for verifying sanitation effectiveness in food production, the Adenosine Triphosphate (ATP) test and the Aerobic Plate Count (APC) test. The ATP test measures the effectiveness of the sanitation processes in removing organic matter but is not a reliable indicator of bacterial inactivation. Meanwhile, the APC test is a reliable indicator for bacterial inactivation, however the 48-hour wait period for results precludes making in-process corrective actions. saniDART is a powerful tool for monitoring bacterial inactivation with APC-like test quality and results available at a speed closer to that of ATP tests.

“Now more than ever, consumers and regulators are demanding high standards and visibility into food safety practices throughout the supply chain,” said Erik Malmstrom, SafeTraces Chief Executive Officer. “There is a significant unmet need in the food industry for a better, faster, and cheaper solution for sanitation verification at a microbial level. SafeTraces responded and innovated, which is what we do best. Receiving AOAC validation, the gold standard for proprietary testing methods in food safety, is a major milestone for saniDART™. We look forward to delivering this groundbreaking solution to the food industry in a big way.”

Results in the AOAC validation report (Performance Tested Method #032001) provided evidence that saniDART is effective at detecting the presence of saniTracers™, proprietary abiotic bacterial surrogates and a key component of saniDART, on stainless steel surfaces representative in food processing and manufacturing facilities. saniTracers are manufactured by encapsulating short, non-coding DNA sequences within food-grade material particles and are applied on food contact surfaces in processing facilities, including Zone 1. saniTracers are degraded and removed in a similar manner as microbes during cleaning and chlorine-based sanitizing. saniTracers levels can be quantified by a simple swabbing and on-site qPCR test that provides results in 25 minutes. By measuring saniTracers levels before and after sanitation, saniDART provides powerful, actionable information in a pass/caution/fail format for verifying sanitation effectiveness.

The saniDART rapid sanitation verification solution includes saniTracers consumables, test kits, an off-the shelf qPCR reader, and a tablet with a cutting-edge augmented reality (AR) feature to identify sampling points in food processing facilities. saniDART is supported by market-leading environmental monitoring software to manage floor plans, scheduling, corrective actions, reporting, and analytics.

AOAC International (formerly the Association of Analytical Chemists) is an independent, third-party, not-for-profit organization that develops standards on measuring and determining the safety and integrity of food and other products worldwide. An AOAC-Research Institute (AOAC-RI) validation means that the manufacturer’s claims have been verified by a trusted third-party laboratory.

Founded in 2013, SafeTraces is a mission-driven team of entrepreneurs, scientists, engineers, and food safety practitioners dedicated to using nature’s DNA to make food production safer, more transparent, and more sustainable. Our rapid, easy-to-use, and cost-effective testing solutions for sanitation verification and traceability build on groundbreaking and patented DNA-based technology. We developed the first and only on-food traceability solution, the miniDART, which leverages natural, edible, invisible, DNA-based barcodes (FDA-GRAS) that are applied directly to the product and that downstream purchasers can read with a rapid, inexpensive test in order to verify product source, authenticity, and purity in minutes. Additionally, we developed the first rapid solution for verifying sanitation effectiveness at a microbial level, the saniDART, that uses FDA-GRAS, AOAC-certified abiotic bacterial surrogates in order to enable in-process corrective actions, evaluate sanitation crew accuracy and proficiency, and support environmental monitoring, continuous improvement, root cause analysis, in-house validation, and FSMA and SQF audits. To learn more, contact us at https://www.safetraces.com/product-inquiry.

SOURCE SafeTraces, Inc.

This post originally appeared on PRN Newswire. Read it here.

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