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The Link Between Asset Management and Skills Gap Mastery: A Q&A with Tim Butler

“… there really is a sociological aspect to all of this, where some companies will spend tens of millions of dollars on a new system that ultimately fails because the workers on the edge won’t use it.”

In a ranging conversation with Ian Wright at Engineering.com, Tego’s CEO Tim Butler touches a litany of vital considerations when it comes to building an APM strategy that drives business metrics that matter. From quality assurance, to productivity, to workforce engagement, it is not just about connecting assets together. It is about making them smart.

In other words, enabling things to be smart means putting data about a given asset on the asset itself. This can be its birth records, maintenance history, operating instructions, or any other information about how, when and why employees have interacted with it. The asset becomes a repository for information, not just an endpoint that’s flowing information to the cloud. Instead, information can be read from and written to the asset throughout its life, without requiring any cloud connectivity.

That is what makes an asset smart.

Highlights from the conversation include:

The real change with the introduction of PCs was an increase in flexibility. Does that apply in this case as well?

Yes. Think about what we learned in the last 30 years: suddenly, we’re walking around with tablets and phones that have levels of connectivity that were unheard of a few decades ago. Now, I can walk up to an asset and interact with it using my phone or tablet. I can query it and get information from it or write information to it; I’m using the functional and analytic capabilities of those tools to actually do analytics right there at the edge.

Cybersecurity is a major concern associated with the IoT. Does the kind of pervasive asset intelligence you’re talking about introduce new security risks?

From our perspective, it actually provides a new layer of security because all these assets are off the grid. We can enable up to 16 different types of access, where some employees have read/write access, others can only read some types of information and still others can only access  a different set of information. So, you can partition the information in ways you couldn’t before. The technologies we’re familiar with—in terms of password protection, encryption and authentication—can all be applied here, now that we have the storage to be able to do it.

Do you believe this technology can help address the skills gap in manufacturing? If so, how?

If you’re wondering how manufacturers are going to get the next generation of workers—who typically don’t use pen and paper—to actually use digital information, one of the critical elements is having that information at the source, or the edge.

It’s all about automating the process so that people can do it more easily and efficiently—which brings training costs down—making the information as accessible as possible, and it’s about making the information transferable and usable across the organization.

If you’re giving your workers something that basically turns them into automatons, you’re going to have trouble. The flip side is that you still need to replace them in the next ten years. But, if you enable real data on the edge, you’re starting that digitalization, but the knowledge and experience of your technicians feeds that. Now the older workers are saying, ‘Oh, this isn’t going to replace me. I’m actually going to be able to show people how smart I am, because now it’s much easier for me to broadcast that across the company.’

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 about Tego’s role in local data strategy, contact us here.

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.

“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.

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.

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.

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