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Webinar: Leveraging Smart Assets/ IoT for Smarter ​MRO Across Industries

Webinar: Leveraging Smart Assets/IoT
for Smarter ​MRO Across Industries

In this 30 minute joint webinar by industry leaders
Lufthansa Industry Solutions (LHIND) and Tego, you will discover:

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Viable use cases for IoT and smart assets for MRO processes
Real-life examples and the lessons learnt from them
How to eliminate major process inefficiencies and drive double-digit improvements in MRO economies 
Specifically learn…

1. How Lufthansa Industry Solutions is leveraging IoT to enable its customers’ MRO activities.

2. How intelligent information at the edge has benefited the aerospace industry.

3. How Tego’s smart asset solutions are capturing digital lifecycle information and the MRO benefits they drive.

4. How LHIND and Tego are pairing up to offer smarter integrated solutions.

Ready to watch the webinar?
Click below to register and get a copy!

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REGISTER FOR WEBINAR

Can gamma-proof data stem the tide of aseptic manufacturing deficiencies?

In news that’s starting to sound like a broken vinyl record, instances of voluntary recall and FDA warnings continue to plague the aseptic manufacturing industry. To wit:

Baxter issued a voluntary recall for more than 427,000 units of sodium chloride injection and 54,528 containers of dextrose injection, citing “a lack of assurance of sterility” as the driving mechanism. (Read more on FiercePharma).

The FDA cited Tubilux for “deficiencies that include improper equipment use, insufficient laboratory controls, and problems with the company’s sterility assurance program.” (Read more on PharmTech.com).

And most recently, Rugby Laboratories just issued a major voluntarily recall for Diocto Liquid and Diocto Syrup. (Read more on Pharmaceutical Processing).

Even as the global market for environmental monitoring is estimated to reach $19.56 Billion by 2021, factors such as high costs of current proposed solutions, complicated implementation procedures, and high export barriers across emerging countries are restraining market growth.

How can gamma-survivable digital intelligence help? In an aseptic manufacturing environment, it transforms the very assets already in place into smart aids that keep better track of moment-by-moment conditions and process controls, to produce a more complete and verifiable record of sterility assurance.

The assets we’re talking about are those that monitor airborne particulates, active viable air, passive viable air and equipment surfaces, and facility personnel themselves. Whenever a drug or biologic goes through a given process or stage of production, these components gather digital records and time-stamped details about the manufacturing procedure, location or condition of the environment, which of course includes chain-of custody and information needed for regulatory compliance. These assets become embedded with a literal digital thread, to help downstream operators collect, manage, and report every stage of production including initial sterilization. The data then feeds the manufacturing clinical laboratory database and, quite simply, personnel are put in position to perform their jobs better. Operators, laboratory technicians, managers — even executives — can digitally access and sync component data, and call up production or sterility details about any individual unit at any time, even after a batch has been released to the market.

To learn about Tego’s gamma-proof intelligent solutions for pharmaceutical manufacturing, please visit this page.

To schedule a demo and see how Tego can improve your aseptic manufacturing processes, contact us here.

IoT Data’s Human Component: A Q&A with Tim Butler

“…for companies who are grappling with IoT integration … edge computing is becoming a prime opportunity for enhanced employee performance and contribution to the whole.”

Thus begins Tim Butler’s Q&A session with the incomparable David Marshall of VM Blog, who knows quite a bit about the important technology trends and what they mean to business practitioners.

Pegged to the recent AWS launch of Greengrass, an initiative that takes on many of the same issues that Tego’s been working for years to solve, Tim provides ranging perspective on the value that edge computing stands to unlock. Highlights from the session include:

Why did AWS choose to launch on-premises compute solution?

Greengrass seems to explicitly acknowledge that constant data connectivity on edge devices isn’t easy, and it isn’t cheap. Instead, an approach that focuses on the “T” in the IoT (i.e. the “Thing”), which turns parts, components and other objects into smart conveyors of information, does not require constant connectivity or complex software integrations. The trick is in finding an easier way for these things to share their data, which is where AWS appears to be devoting its attention.

Does Greengrass give the IoT a boost to “cross the chasm” into large-scale digitization initiatives?

Wider recognition of the value of placing intelligence on the “T” in the IoT is analogous to companies realizing in the 1980s and 90s that moving away from mainframe computing architectures to desktop PCs could empower their companies to accomplish more. Instead of being locked into singular work streams from their “dumb green” digital terminals, employees could now read, write and store data locally, further their knowledge and understanding, broaden their work context, and produce more powerful daily outcomes.

How do you see the human dynamic changing as edge computing gains steam?

In today’s work environment, it is not uncommon for an employee at the edge to start to feel disconnected, or to feel like they’ve been made into an automaton. However, when data travels with an object, and that object becomes progressively more informed each time it interacts with a human, a funny thing happens. Humans can suddenly absorb and contribute to the organization’s intelligence in ways that add more meaning and context to their roles.

We believe edge computing will yield a better sense of engagement for employees at the edge, empower them to more personally contribute more often to a final outcome. It may just become the perfect expression of man and machine working together.

Read the full article here.

To learn about Tego’s asset intelligence platform for high-value edge computing, visit this page.

To schedule a demo for how Tego can improve your local data strategy, contact us here.

Tego Named a 2017 “All-Star Innovator” by Pharma Manufacturing

We are thrilled to report that Tego’s touchless, digital environmental monitoring solution for cGMP manufacturers was named an “All-Star” Innovation for 2017 by the editors of Pharmaceutical Manufacturing magazine. The program recognizes standout companies who produced technological innovation in pharma over the course of the prior year.

PM calls out Tego’s exemplary use of IIoT technology to enable precise tracking and verification of contaminant exposure on product, material or equipment across the production steps for aseptic pharmaceuticals. The promise of automated and touchless detection reduces the possibility of contamination, limits the potential for costly wasted batches, and allows for much more selective, granular recall procedures. All types of environmental monitoring – for airborne particulates, active viable air, passive viable air, surfaces, water and personnel – benefit from this sterilization-proof, digital solution.

Read the full article here.

To learn about Tego’s RFID chip and platform solutions for aseptic pharmaceutical manufacturers, visit this page.

To schedule a demo for how Tego can improve your aseptic operation, contact us here.

Tego CEO Tim Butler Featured in Aviation Week’s InsideMRO

“A smart-asset approach is about putting extensive digital product information and life-cycle history onto components themselves. Meaningful data simply becomes part of the things’ DNA, ripe to divulge wisdom everywhere they go across their entire life cycle.”

Tego’s CEO Tim Butler was a featured columnist in Aviation Week’s InsideMRO, discussing the mindset shift to the ‘things’ versus the ‘internet’ in ‘IoT,’ which simply must occur in order to bring about true digital transformation in aviation and MRO.

Tim likens the new mentality to the moment when companies realized that moving away from mainframe computing architecture to desktop PCs would liberate the the business to accomplish more than was ever thought possible.

That is a stunning consideration, when you really stop to think about it.

From the article:

Granting intelligence to an asset at its physical layer is a novel approach, a departure from typical IoT thinking that centers upon the “I” part of the IoT. It is our belief the focus has skewed too heavily toward connecting everything with a sensor all the time, to send streaming information to a database or cloud repository or enterprise system. When this happens, the value proposition for the IoT tends to get lost amid concerns of conducting a large-scale, expensive system rollout. It can engender a “where do we start” mentality among fragmented operational teams already struggling to define time lines, returns-on-investment and ownership schemes for digital adoption. This predicament already is holding many airlines back from putting digital technologies into place, despite the vast potential they hold for value creation.

…

After each service or inspection, new maintenance information is added to the asset’s digital history, and it retains a permanent, progressive record for all workers with authorized permission to access and perform local analysis. This is done via a local smartphone and connected reader and enables faster, safer and more precise decision-making in the field. If need be, the field worker can sync the latest data record back to the enterprise systems of the airline operator, OEM, or third-party maintenance provider, providing thorough visibility into how a part is being used and its performance over time.

…

In short, every asset becomes a node of distributed intelligence, with data available at the point of need to guide maintenance, prompt compliance activity for life-limited parts, ensure the authenticity of parts, verify part performance and even provide maintenance instructions directly. The asset becomes so smart that employees asks it what needs to be done!

Read the full article here: Pulling The IoT Out Of Its “Dumb Green Screen” Rut

To learn about Tego’s radio frequency asset intelligence platform for transforming aviation operations, visit this page.

To schedule a demo and see if Tego can improve the performance and interaction among your organization’s assets, contact us here.

“Lack of sterility assurance” in CGMP strikes again: Hospira issues a recall

We learned late last week that Pfizer subsidiary Hospira issued a nationwide recall of its vials used to inject sodium bicarbonate, citing sterility concerns. Not only will this cause undue financial damage to the company, but more critically it removes a volume of potentially lifesaving drug from the market.

There’s a downstream impact, as well. PharMEDium Services had to recall a full run of its products that had been compounded using the affected Hospira lots. One sterility monitoring mix-up upstream creates a domino effect across the entire value chain.

Again, the difficulty manufacturers have with proving sterility across the entirety of their processes creates an outsized burden, not only for the manufacturer itself, but also for its partners and the healthcare community at-large. Unfortunately, the Hospira recall is but a time-stamped snapshot into how bioburden incidents add up annually, outlined in early Q2 2017 by Bioprocess Online.

Most importantly, this instance is a harsh reminder that a solvable issue continues to present a significant challenge. The good news is, there are new ways to overcome it. By storing digital data directly on a facility’s manufacturing components, monitoring processes can become automated and touchless, and manufacturers are more able to account for the possibility of contamination before lots are released to the market. This goes to mitigate against the potential for costly, brand damaging situations to occur. There’s much less chance for sterility to be compromised because operator touches have been reduced and digital information has been made readily available for easy access. If something’s askew, it is much more likely to be caught before final product leaves the building.

To learn about Tego’s sterilization-proof monitoring solutions for pharmaceutical manufacturing, please visit this page.

To schedule a demo and see if Tego can improve your aseptic manufacturing processes, contact us here.

Tego Inc. Recognized in MassTLC IoT Report for Innovation and Cutting-Edge Technology

In the recent MassTLC IoT Report, Tego was featured as a key IoT-driven company in  Massachusetts. We are proud of our team at Tego and the work they’ve done to develop and manage a smart, functional technology that has proven success across numerous vertical use cases.

It is an honor to be recognized among some of the most cutting-edge technology companies in Massachusetts, and to be a part of a local tech economy that is at the forefront of IoT innovation. Thank you, MassTLC!

To access MassTLC’s IoT 2017 report: http://www.masstlc.org/iot-dl

With Greengrass launch, Amazon validates market readiness for IoT data processing and enhanced edge computing

By Timothy Butler, CEO

 

With its introduction last week of Greengrass, AWS paid a huge favor to anyone seeking to extract more value from IoT data. In his blog, AWS’s CTO Werner Vogels describes three “laws” that define why localized data processing (a.k.a., edge computing) is important:

Physics. It takes time to send data to the cloud, and networks don’t have 100% availability. Customers in physically remote environments, such as mining and agriculture, cannot afford to let these issues affect their operations.

Economics. The IoT creates a lot of data, much of it low-value. Businesses need to be able to keep and conduct analysis only the high-value data.

Regulations. Legal requirements often call for data to be isolated, duplicated or handled in a very specific way. Some governments even impose restrictions on where data may be stored or processed. (I.e., data cannot be transported physically or electronically at all).

On several fronts, Amazon sees the same opportunity as Tego. Both organizations are truly endeavoring to break down barriers for IoT adoption that stem from a need for always-on connectivity. The company also reinforces much of what Tego has understood for years, that there is tremendous power in getting data closer to assets, so that decision-making can be made by workers who are in the fray. Sometimes, the most important decisions can only be informed from short-lived data, and at a precise moment in time. Once that moment’s passed, the data loses its value, and the opportunity is lost.

Even still, Amazon seems to lack real understanding about where the transformative effects of edge computing lie. Where does the data originate? Is it able to share a unique historical context with employees? Does it allow on-site personnel to improve downstream outcomes? This is where putting data onto assets becomes the missing link. When data travels with an object, and is able to become progressively more detailed at every point of human interaction, humans can absorb and contribute to the organization’s intelligence in ways that add meaning to their roles. Edge computing is not just about creating faster, quicker, data. It’s about finding better ways to use data, and that requires active employees who are enabled to own the process.

Greengrass appears destined to help with decisions at the point of read, but another question lingers: can it likewise make human assets more valuable? Big, enterprise value has to start with a small, specific improvements in job roles and performance. That’s what will drive positive, enterprise-level outcomes. An airline empowers its ground crews to reduce time on the tarmac and thus improve overall profitability; medicines prove their authenticity to an aftermarket caregiver through an embedded, digital signature with NSA-level encryption, and expand trust for a brand; line workers in an aseptic pharmaceutical plant use data to protect the company against batch-level contamination and the specter of a vast recall. Focus on solving small issues, and they will add up to BIG!

Amazon, please show us the path for Greengrass to “go big.”

To learn more about why data at an asset’s physical layer matters, schedule a demo here.

Cleanroom Technology – Tego unveils touchless EM tracking for cGMP

“Tego’s Asset Intelligence Approach survives gamma sterilization, reduces risk of contamination and streamlines compliance processes for cGMP pharmaceutical facilities.”

Cleanroom Technology magazine spotlights Tego’s ability to enable digital data on critical gamma and eBeam-sterilized components used during aseptic (sterile) manufacturing, to solve for visibility and traceability mandates in FDA-regulated cGMP manufacturing environments.

Tego continues to redefine the use case for RFID data.

From the article:
Tego, a leading provider of smart asset solutions based in Waltham, MA, US, has produced an automated, touchless, digital solution for environmental monitoring within FDA-regulated pharmaceutical manufacturing facilities.

Tego’s Asset Intelligence Platform makes businesses smarter by embedding digital information in assets and components for the life sciences, healthcare, aerospace and manufacturing industries. Insights about assets’ lifecycle history, regulatory compliance and integrity can help to drive operational excellence and new revenue models.

Built on this platform, the latest solution applies advances in Industrial Internet of Things (IIoT) technology to precisely track and verify contaminant exposure on product, material or equipment used during production of aseptic pharmaceuticals.

The solution ensures that data is stored directly on environmental monitoring components; processes become automated and touchless so that manufacturers greatly reduce the possibility of contamination and limit the potential for costly wasted batches.

“Tego’s approach to progressive data on assets is gaining attention from pharmaceutical manufacturers because it helps minimize the potential for contamination and batch loss, and provides more complete traceability and visibility data as required by the FDA,” said Timothy Butler, founder and CEO of Tego.

Pharmaceutical manufacturers who perform aseptic processing are required to deliver meaningful information about the quality of the manufacturing environment during production. They must demonstrate to regulators that proper controls are in place, quickly discover problems or put themselves at risk of significant financial loss (one lost batch can cost $500,000 or more), and always have the right data at hand to support root cause analysis procedures.

All types of environmental monitoring – for airborne particulates, active viable air, passive viable air, surfaces, water, and personnel – benefit from this aseptic-proof, digital solution.

Staff are able to receive digital validation about the status of monitoring componentry and instantly update a component’s documentation as it changes across multiple prescribed points during CGMP manufacturing.

The digital environmental monitoring solution was born out of Tego’s work in the aerospace industry, where putting data on critical airplane parts and components has dramatically improved decision-making in the field, supported far more accurate reporting, extended products’ lifecycles, and produced significant cost savings.

Read the full article here.

To learn about Tego’s RFID chip and platform solutions for pharmaceutical manufacturing, visit this page.

To schedule a demo and see if Tego can improve your aseptic operation, contact us here.

Intelligent Aerospace – The Transformational Effect of Asset Intelligence for MRO and FBO organizations

“The day will come when every serialized, repairable, replaceable and maintainable part — numbering 10,000 on a typical airframe, will carry its own data.”

Intelligent Aerospace magazine puts asset intelligence into context for aviation MRO organizations and Fixed-base Operators (FBOs).

From the article:

The product lifecycle visibility challenge is largely a product of limited information, and it can utterly hamstring maintenance processes. At best, products and components today may carry a serial number, a barcode, or perhaps a digital ID tag, but they often exclude the finer details about the product’s specifications, configuration, maintenance history, and usage that are so central to efficient operation, maintenance, and even regulatory compliance in many industries. Instead, this information is typically kept on paper logs, in centralized Enterprise Asset Management (EAM) systems, or in some cases nestled within the “tribal knowledge” of an experienced workforce.

Each of these modus operandi is complicated, expensive to maintain, and has inherent limitations. Paper logs can get misplaced or become unreadable, and data within enterprise systems can erode during IT consolidation and upgrade cycles; worse yet, it can become inaccessible if workers are in remote locations or stationed at a third-party aviation maintenance, repair, and overhaul (MRO) supplier. The factors contributing to “tribal knowledge” are hard to pinpoint and information is perpetually at risk, due to workforce churn. The end result: In many situations, MRO workers are left at the mercy of incomplete or non-existent product history information.

Read the full article here.

To learn about Tego’s RFID chip and platform solutions for smarter aviation MRO operations, visit this page.

To schedule a demo and see if Tego can improve your organization’s asset performance management, contact us here.

Resource Engineering & Maintenance – Achieving Next-generation MRO through Smart Asset Performance Management

“… rugged high-memory passive RF data chips (and sensors) enable next generation MRO by allowing product data and its entire, granular lifecycle history to easily and inexpensively become part of the product itself.”

Tego Executive Director Bill Stevenson writes for Resource Engineering & Maintenance magazine to describe what asset intelligence can do to bring about a next generation of asset performance management and MRO operations.

From the article:

The term digital thread is sometimes used to describe an integrated view of an asset’s data throughout its lifecycle. The digital thread is intended to deliver “the right information to the right place at the right time.” In a distributed asset intelligence scenario, a given asset’s “as-maintained” data resides on the asset itself, thus providing an information platform for improving asset performance management and MRO. “Smart assets” make detailed specification and configuration data available at the point of use to facilitate maintenance, precisely track compliance of life-limited parts, ensure the authenticity of parts and avoid counterfeits, confirm part performance, and even incorporate maintenance instructions into the part itself. The part tells the employee what needs to be done!

More importantly, data on each part can be updated with each service or inspection activity, and a permanent record of all entries gets maintained locally. Multiple data partitions requiring security credentials allow certain data to be selectively available to users based on their rights and role. A local smartphone reader can connect right back to the enterprise systems of the operator, OEM, or third-party maintenance provider, providing thorough visibility into how a part is used and its performance over time, and fueling better decision making for management.

In addition to storing lifecycle history data on the product itself, RF data chips can be configured to provide power to a sensor, and then record its data whenever the chip is interrogated with an RF signal. Typically, this activity would not be carried out to collect continuous real-time data, but rather to provide periodic trend data that could inform further maintenance decisions.

Read the full article here (Go to Page 16).

To learn about Tego’s platform solutions for product lifecycle management and MRO and how Tego enables smarter asset performance management, contact us here.

RFID Journal – Touchless Environmental Monitoring for Pharmaceuticals

“The tags are designed for rugged environments and sustain temperatures that can vary widely from sub-freezing to gamma and electronic beam sterilization.”

Tego’s VP of Marketing LaVerne Cerfolio sat down with Claire Swedberg at this year’s RFID Journal Live to discuss our new, sterilization-proof solution for touchless environmental monitoring in pharmaceutical manufacturing facilities.

Tego continues to redefine RFID for high-value use cases.

RFID platform solution provider Tego, Inc. has released an RFID-based solution for tracking environmental-monitoring components to manage the presence of contaminants in places where vaccines or medications are being made. The Touchless Environmental Monitoring Solution is aimed at providing a history of each component and its chain of custody to better manage use and location, as well as what items or products were located around it in the event of a contamination. Items being tracked include agar exposure plates, cleanroom airflow monitoring filters, finished drug components, and raw materials and components used to monitor the environment.

Tego’s environmental-monitoring solution includes a passive ultrahigh-frequency UHF RFID tag that stores data written directly to it, as well as fixed or handheld readers from a variety of vendors, and Tego’s Asset Intelligence Platform (AIP) software to manage the collected read data. By using the solution with high-memory Tego tags, multiple entities can have access to the data written on the tag itself, even if they lack access to the software, explains LaVerne Cerfolio, Tego’s marketing VP.

The technology was developed as a solution for pharmaceutical companies to track such assets as the hundreds or thousands of agar exposure plates that they use to prevent contamination while making medications and vaccines. The U.S. Food and Drug Administration (FDA) mandates that companies follow Current Good Manufacturing Practices (CGMP) by certifying that every vaccine, drug or biologic product is produced in a safe and controlled environment. The plates are used to identify if any mold or other contamination takes place, thereby identifying a problem before it can reach a finished product or a patient.

RFID enables the tracking of those plates. However, because they are often moved from one workstation, lab or manufacturing facility to another, the plates can be the responsibility of multiple parties, who may or may not have access to a single software platform.

For this reason, Cerfolio explains, Tego provides tags with high-memory chips—24 kilobytes of memory—that store a unique device identifier (UDI), GS1 manufacturing information about the product itself, and any data written by those inspecting or handling the test sample.

Tego’s environmental-monitoring solution tag can be securely read and written to for use downstream, Cerfolio says, “by authorized personnel when critical supply chain events occur, or if changes in the products’ status are necessary.” Such changes may be required in such scenarios as a soft recall.

The tags are designed for rugged environments and to sustain temperatures that can vary widely from sub-freezing to gamma and electronic beam sterilization. Tego’s solution consists of the cloud-based Asset Intelligence platform with its Hub software dashboard, as well as the Tego Narrator App, which users can download on their reading device. “The software doesn’t favor any one device,” Cerfolio notes. “Rather, its power is that it enables the exchange of lots of information at the edge, between the operator and the asset, that has been made intelligent with Tego’s solution.”

In the case of agar exposure plates, tags are affixed to the plate’s exterior, and production data can be written to the tag and stored with its unique ID number, both on the tag itself and in the software. From that point forward, other information can also be added or stored, such as the identity of the culture in the plate, the due date or expiration date, the name of the manufacturing center or the identity of the test station within that facility, as well as the operator’s ID.

“Tego’s AIP is limitless,” Cerfolio says, “as far as the type of data that can be written and stored. Data could be structured or unstructured, an Excel file or an image.”

According to Cerfolio, companies will use the solution to automate the collection of data, thus ensuring that the agar plate does not need to be touched to access its ID or data, and to capture a history about the item itself and the people who have interacted with it. “In this way,” she states, “they can prove, batch by batch, compliance with FDA contaminant regulations.”

The solution follows Tego’s digital environmental-monitoring solution for the aerospace industry, in which critical airplane parts and components must be tracked and require high-memory tags, as well as software to store and interpret data

Read the full article: http://www.rfidjournal.com/articles/view?16136

To learn about Tego’s RFID chip and platform solutions for pharmaceutical manufacturing, visit this page.

And if you want to see Tego in action, contact us here.

From RFID to IoT — Radio-free wattage energy harvesting

“Like anemones on the sea floor, [devices] have to sustain themselves on what streams by.”

In another example of how Tego is redefining RFID in an IoT world, CTO Bob Hamlin spoke with IoT Agenda about the role of harvesting ambient RF energy to spur innovation in IoT and IIoT.

From IoT Agenda:

“All FM stations transmit power from antennae at 50 to 100 kilowatts,” he noted. “By the time it gets to your FM radio, it’s only a few milliwatts. These days those few milliwatts are enough to do all kinds of interesting things with electronic circuits.”

The RFID devices Tego makes take the carrier signal of the RFID reader and rectify it into a DC voltage. Tego uses that power — as little as 4 milliwatts — to power the processor that is the heart of its RFID chip. Tego’s combination RFID chip and antenna add writeable, readable, encryptable data to any kind of asset — moving intelligence to the very edge of the IoT edge.

Originally, those chips could operate only five or 10 feet from the reader. “These days, traditional passive RFID — just identification tags — can work 50 to 100 feet away. These things operate in the microwatts of power,” Hamlin said. But Tego’s goal isn’t stretching the distance between RFID scanner and, say, retail RFID tag, which might just hold 96 bits to identify the make and price of a bathing suit. Instead, it’s adding storage and processing workload to the chip. Obviously, it’s not doing this to tag bathing suits, but to track and document parts and devices in aerospace, oil and gas exploration, life sciences, and similarly weighty applications.

Tego’s roots and wireless protocols are in RFID, but it’s also looking at Wi-Fi and other radio transmissions as power sources. “When most people hear IoT, they think of their phone and their laptop,” Hamlin said. “We think of that as the first ring on the outside of the network. But further out, there are other rings where devices are no longer plugged into the wall, no longer running Windows or iOS. They’re smaller, don’t have full-blown OSes, have more dedicated processing and, by their nature, consume much less power.” In addition, they may be so remote from power sources that they have to operate “autonomously.” Like anemones on the sea floor, they have to sustain themselves on what streams by.

A version of Tego’s tags has a serial interface on its chip, suitable for connection to sensors or microprocessors. One client is working on a new highway; installing these tags every 300 feet into pavement being laid across a bridge so they can monitor temperature as the pavement cures, as a step toward improving durability.

To learn about Tego’s RFID chip and platform solution, visit this page.

And if you want to see Tego in action, contact us here.

In Anaheim, Optimism Abounds for Continuous Pharma Manufacturing

Highlights from the Parenteral Drug Association Annual Meeting: pharma is in high hopes that flexible and continuous manufacturing will help them meet sterile production standards. 

By LaVerne Cerfolio

Last week we had the honor to attend and exhibit at the Parenteral Drug Association’s Annual meeting in Anaheim, Calif. Not only was it a great chance to escape the Northeast’s extended winter, but there was also a great deal to learn from an industry that is amid rapid change and innovation.

For example, I was utterly surprised to learn that pharmaceuticals still … STILL … stand out as the “last remaining industry to continue with batch manufacturing as opposed to flexible or continuous manufacturing.” I suppose it comes with the territory; when you’re manufacturing highly sensitive, high-efficacy drugs you need the buffer, so to speak, that batch manufacturing affords to limit risk. Nonetheless, a good portion of the Meeting’s content focused on the promise of continuous flexible manufacturing, and how the parenteral drug industry can put it into play.

More importantly, these conversations signaled that manufacturing is catching up to the real clinical needs for certain oncology patients: personalized drugs. “One dose, one patient” is the future of medicine, but to execute safe manufacturing of these therapeutics, the entire approach to production must change. And it is changing.

Novartis, for example, gave a very insightful presentation on this score, related to its CAR-T (Chimeric Antigen Receptor- T cell) leukapheresis drugs. The company explained that in order to manufacture these personalized therapeutics, it had to move away from legacy linear, large batch manufacturing processes to a single patient, single batch, single dose model. Moreover, the patient-centricity inherent in leukapheresis drugs means that manufacturing, logistics and clinical care must work more collaboratively and more flexibly throughout a global supply chain.

Along with Novartis’ innovation, Merck is also delivering tangible results. In a presentation, the company reported that one of its facilities has incorporated a flexible manufacturing process, and seen a boost in productivity that astounds: a 45 percent reduction in bulk production end-to-end lead time, down to 149 days from 270.

Amidst all the buzz about new or streamlined continuous manufacturing practices, there are still many lingering questions about how to attain — and maintain — sterility standards. In batch processing, if contaminants find their way into production, damage will be limited to the batch, by default. The real challenge comes with putting into place a scheme for continuous environmental monitoring, where rigorous controls and detection must occur on an ongoing basis. How can a facility easily do this without necessitating additional steps that might increase the chance of exposure?

You can imagine our elation when PDA President and CEO Richard Johnson himself expressed his excitement about Tego’s work to bring Industry 4.0 innovation to aseptic drug manufacturing. He easily grasped how the realized benefits of distributed asset intelligence in industries like aerospace translate to the CGMP environment, to support facilities’ transition to continuous aseptic manufacturing.

To learn more, set up a review of Tego’s touchless Environmental Monitoring solution at https://tegoinc.com/contact/, or give us a call.

Tego Announces Touchless Environmental Monitoring Solution for CGMP Manufacturers

Tego’s Asset Intelligence Approach Survives Gamma Sterilization, Reduces Risk of Contamination and Streamlines Compliance Processes for CGMP Pharmaceutical Facilities

WALTHAM, MA, April 13, 2017 – Tego, Inc., a leading provider of smart asset solutions to produce meaningful operational intelligence from any asset, anywhere, today announced availability of an automated, touchless, digital solution for environmental monitoring within FDA-regulated pharmaceutical manufacturing facilities. The solution is built on the company’s award-winning Asset Intelligence Platform and leverages advances in Industrial Internet of Things (IIoT) technology to enable precise tracking and verification of contaminant exposure on product, material or equipment used during production of aseptic pharmaceuticals.

“Tego’s approach to progressive data on assets is gaining attention from pharmaceutical manufacturers because it helps minimize the potential for contamination and batch loss, and provides more complete traceability and visibility data as required by the FDA,” said Timothy Butler, founder and CEO of Tego, Inc. “Tego’s core platform turns otherwise inanimate things into living, breathing sources of critical business information, and it is exciting to see indispensable industries like pharmaceuticals recognize the value of putting dynamic data on their assets.”

Pharmaceutical manufacturers who perform aseptic processing are required to deliver meaningful information about the quality of the manufacturing environment during production. They must demonstrate to regulators that proper controls are in place, quickly discover problems or put themselves at risk of significant financial loss (one lost batch can cost $500,000 or more), and always have the right data at hand to support root cause analysis procedures.

When data gets stored directly on environmental monitoring components, processes become automated and touchless so that manufacturers greatly reduce the possibility of contamination, and limit the potential for costly wasted batches. Staff are able to receive digital validation about the status of monitoring componentry, and instantly update a component’s documentation as it changes across multiple prescribed points during CGMP manufacturing. All types of environmental monitoring – for airborne particulates, active viable air, passive viable air, surfaces, water, and personnel – benefit from this aseptic-proof, digital solution.

Tego’s digital environmental monitoring solution is a direct transference of the company’s heritage in the aerospace industry, where putting data on critical airplane parts and components has dramatically improved decision-making in the field, supported far more accurate reporting, extended products’ lifecycles, and produced significant cost savings.

CGMP manufacturers who want to explore how asset intelligence can both help with compliance to zero contaminant mandates, and eliminate burdensome post-sterilization labeling processes, can visit https://tegoinc.com/contact/ to set up a demo, or contact Tego at (781) 547-5680.

About Tego
Tego powers assets with intelligence. Tego’s Asset Intelligence Platform makes businesses smarter by embedding digital information in assets and components for the aerospace, life sciences, healthcare and manufacturing industries. Insights about assets’ lifecycle history, regulatory compliance and integrity drive operational excellence and new revenue models. Smart asset data is available for the right people and systems, including IoT, EAM, ERP, and Analytics applications.

Tego is an architect and co-author of the aerospace Spec 2000 Ch9-5, has 30 granted patents, serves dozens of global customers including Honeywell, Parker Aerospace, and B/E Aerospace, and is a healthcare leader with the Industrial Internet Consortium (IIC).

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Digitized Solution for Environmental Monitoring of FDA regulated cGMP Facilities

The FDA requires manufacturers operating under Current Good Manufacturing Practices (CGMP) to certify that every batch of drug, vaccine, or biologic be produced in a high quality controlled environment.

Digital Environmental Monitoring (EM) removes human factors and provides significant process improvement opportunities. These digital, data-driven solutions must survive sterilization. However, digital EM with sterilization-proof technology allows CGMP manufacturers to write data directly onto a) products and materials that must be tracked and verified before, during, and post-production and b) products and materials that monitor sterility. More importantly, digitized environmental monitorying makes data available via touchless, sightless procedures.

The digital traceability and visibility provides a full GMP compliance solution as well as an early warning system.

Tego’s environmental monitoring solution provides increased assurance of sterility for aseptically produced pharma and medical products.

Learn more about the solution here.

Pharmaceutical Processing: Counterfeits on the Move

Globally, counterfeit medication is a major issue for public health and international trade, not to mention a threat to the bottom line of any pharmaceutical company. Thousands of people worldwide die every year from ingesting fake drugs — and it costs the pharmaceutical industry between $70 billion and $200 billion per year in lost profits, by various estimates. In the latest edition of Pharmaceutical Processing, Tego CEO Tim Butler looks at how counterfeiters are affecting the pharmaceutical industry, and what the market can learn from measures put into place by aerospace to tackle the challenge.

The key challenge lies in maintaining a drug’s “connectivity” throughout its journey, even through sterilization or other necessary harsh environmental conditions, so as to create an accurate, accessible log of data about a drug’s every move.

See the full article here

 

Supply Chain World: Fighting Counterfeit!

It is an issue that plagues many of today’s most sensitive and highly-regulated industries: unauthorized product still makes its way into the supply chain in place of high-value, authentic products. In the latest edition of Supply Chain World, Tego CEO Tim Butler looks at how counterfeiters are affecting the pharmaceutical industry, and what the market can learn from measures put into place by aerospace to tackle the challenge.

In short, it comes down to digitization. Embedding progressive digital information onto products themselves is becoming a tried and true method to shore up supply chains, and help prevent counterfeiters from gaining a foothold.

View the full article here.

 

Aviation Week – “Slow Adoption” of Digital Technologies, Despite Vast Potential for Value Creation

In the February issue of Aviation Week, aerospace corporate performance thought leader Dirk de Waart comments on an ongoing trend in aviation: airlines have been slow to adopt digital technologies, despite the promise these new approaches hold to improve equipment uptime and squeeze new efficiencies out of day-to-day operations. The digital focus, he notes, has been largely centered on customer experience matters by leveraging the surge of smartphones to offer what is perceived to be a more personalized level of service. Understandably, airlines are locked into the business of winning customers over, given the tremendous choice air travelers have, and the cutthroat competition that now exists over cost.

Dirk goes on to highlight several specific issues that are holding digitization back:

  • Fragmentation among operational functions and lack of singular, focused ownership to define and implement a cross-functional digital strategy.
  • No articulated return-on-investment in terms the finance organization can understand.
  • Change management challenges that stand in the way of productivity improvements.
  • A perceived chasm between OEMs’ digital promises and what they can deliver. Airlines are asking manufacturers to collaborate more tightly on the digital challenge, hone their understanding of airlines’ operations and develop downstream, value-add solutions that will “talk” to the legacy airline infrastructure.

It is his final point that really caught our attention. At Tego, we have worked with aerospace OEMs for years to digitize information, data and records directly on the parts and components of an aircraft, turning them into smart assets. Such digitization is already allowing for tighter, more accurate supply chain collaboration and pre-delivery inspection upstream, as well as much more efficient maintenance programs downstream. MRO organizations are thus able to effortlessly, digitally read and add data to OEM parts as those parts move through their lifecycles. MROs use these digital records to speed up overhaul processes, drive significant efficiencies and cost savings, and get better visibility into the service life of a plane’s parts and components, thus maximizing their useful life. (Early asset retirement is a perennial drag on the bottom line).  Airlines also take advantage of these digitized smart assets. They are now able to digitally inspect and monitor components and parts to drive significant process efficiencies and address compliance, safety and operational requirements.

There’s a larger inference to be made here about what it is that’s creating barriers to digital technology adoption: basing the IoT discussion on the “I” in the IoT, as opposed to the “T” seems to be one of the major stumbling blocks. A fully connected infrastructure requires large-scale, expensive systems roll-outs and could very well be fueling much of the “where do we start” mentality that Dirk references. We see it as bit ironic, however, when you step back to realize the value from digitization does not require sensors or IP connections. Instead, an approach that focuses on the “T” (i.e. the “Thing”), and turns the parts and components into smart assets carrying their own information, does not require constant connectivity or complex integrations. It enables real transformation from simply making information and intelligence available for consumption by humans and various systems at the asset level, without the significant investments or process disruptions.

What we have seen occur by way of personal computing in the past 30 years for people and processes, is now happening to Things. Embedding information and documents directly into things creates smart assets and distributed intelligence, where data can freely flow to — and be pulled off — of objects. This is the real linkage toward enabling people to do their jobs better, faster, and with greater situational awareness. When that happens, the concept of “disruption management,” where airport, fleet, crew and passenger data come together simultaneously to fully optimize airline operations, may just start to see the light of day.

Read the full Aviation Week article here.

Inside Big Data: Staying Agile by Focusing On the “T” in the IoT

Unlike traditional IoT (Internet of Things) solutions, edge computing looks to bring the power of the data closer to the asset itself so that decision making is quicker and data is nearer the hands of the right folks who can take the right actions. In practice, it’s called, “Decision making at the point of read.”

Read full article here

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