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Tego Inc and TSC Printronix Auto ID Partner to Offer Complete Edge to Cloud Solution

The Partnership Serves Digital Transformation Initiatives in the Aviation, Automotive, Rail, and Healthcare Industries

 

WALTHAM MA SEPTEMBER 23, 2020 – Tego Inc announces partnership with TSC Printronix Auto ID, a global leader in the AIDC barcode printer industry. With this partnership, Tego’s Asset Intelligence Platform (AIP) is validated and proven for use across Printronix Auto ID RFID enabled printers. Together, the companies will serve manufacturers across several key industrial market sectors, including aerospace, automotive, life science, energy and healthcare.

Tego is the leading provider for commercial aerospace supply chain visibility solutions and co-author of the ATA Spec 2000 Ch.9-5 standard. As an automated identification aerospace authority, Tego’s validation of Printronix Auto ID RFID enabled printers means they are capable to encode and print UHF high-memory integrated labels to meet compliance with the ATA’s aerospace initiatives. Printronix Auto ID announces immediate availability of printers for sale to aerospace manufacturers, airlines and maintenance, repair and overhaul (MRO) organizations.

The Printronix Auto ID T800, T4000, and T6000e series provide a full portfolio of desktop and industrial four-inch and six-inch RFID enabled printers supporting both standard and on-metal RFID labels and tags. Designed for different print volumes, form-factors, and environmental conditions, all models support automatic RFID label calibration and the high-memory encoding functionalities to work with Tego’s software.

This partnership also offers industrial customers in automotive, rail and healthcare a complete end-to-end software solution via Tego’s award winning platform for asset tracking, supply chain visibility, and real-time location and traceability edge analytics. Tego’s platform solution integrates with enterprise software applications (e.g., SAP) and is configurable and scaleable supporting all major mobile and desktop operating systems including iOS, Android, Windows, and OS X. Lastly, since Tego has the only UHF RFID chip technology that is both gamma and e-beam sterilization proof, this partnership brings an end-to-end offering for both med tech and clean-room pharmaceutical manufacturing companies.

“Tego, together with Printronix Auto ID, provides a complete digital solution to track and trace industrial assets in both manufacturing and logistics supply chain” said Timothy Butler, CEO of Tego, Inc.

“In forging this strategic alliance we’ve enhanced our entire RFID printer portfolio to encode Tego’s high-memory RFID tags. This not only enables us to support Tego with their ATA 2000 commercial aerospace projects, but also gives us access to other markets that demand high-memory tags, such as automotive and healthcare,” said Sam Wang, President and CEO of TSC Printronix Auto ID.

 

About Tego Inc

Tego provides a complete asset tracking, supply chain and lifecycle management solution, providing edge intelligence in both disconnected and inhospitable environmental conditions. With thirty granted patents, Tego’s platform is an interoperable system for building rugged IoT solutions.

Tego, founded in 2005, is based in Waltham, MA. SAP, IOS, Android, ATA Spec 2000 are trademarks of their respective owners. Follow Tego on LinkedIn, Twitter and YouTube.

For more information, visit www.tegoinc.com

About TSC Printronix Auto ID

TSC Printronix Auto ID is a leading designer and manufacturer of innovative thermal printing solutions. The company is comprised of two-industry-leading brands, TSC and Printronix Auto ID with over 65 years of combined industry experience, strong local sales engineering support, continuous investment in new product development and is capable of quickly adapting solutions to meet the needs of small business customers to Fortune 500 companies. TSC and Printronix Auto ID are proud members of the TSC Auto ID Technology Company family. To learn more, visit TSC Auto ID at www.tscprinters.com and Printronix Auto ID at www.printronixautoid.com

Media contact:

LaVerne Cerfolio

Aseptic Tracking and Foolproof Quality Control

Digitized and Automated Chain of Custody and

Audit Information at Your Fingertips – Anywhere

For pharmaceutical manufacturers, product safety is non-negotiable. Violations could mean front-page news, lawsuits, or worse. Current aseptic environmental monitoring quality assurance practices rely heavily on labor-intensive paper-based methods, with only 15 percent of the market utilizing more automated methods like bar codes. Digital solutions can improve manufacturing effectiveness and facilitate reporting for environmental monitoring.

Learn how Tego helps to:

  • Automate data collection from devices and people.
  • Eliminate redundant data entry and transcription errors.
  • Improve worker efficiency.
  • Improve regulatory compliance.
  • Enable sound product and quality release decisions.
Download Brochure

Sterilization Supply Chain

Rugged Tracking for Harsh Conditions:

Sterilization-Proof Supply Chain Tracking

The sterilization processes undertaken in life science supply chains, healthcare companies, biopharmaceutical manufacturers, nuclear laboratories and sterile processing industries are too harsh for typical RFID chips and tags. Tego’s sterilization-proof asset tracking solution is the only ultra-high-frequency solution to stand up to the brutality of gamma and e-beam sterilization.

Learn how Tego helps to:

  • Allow information to flow freely from the point of manufacture through a product’s entire lifecycle.
  • Uncover usage patterns, link outcomes to products and practices, identify waste, and reallocate and reduced working capital.
Download Brochure

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.

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.

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.

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.

Smart Asset Solution in Complex Manufacturing Setting

Life science companies and medical device manufacturers can maximize operational efficiencies when critical product data and information is readily available throughout their value chain — from manufacture to distribution to end use. Tego’s AIP solution benefits pharma, medical device manufacturers and healthcare service providers by providing unprecedented manufacturing visibility and availability of product and regulatory compliance data.

Tego Platform captures product data rugged enough to survive sterilization and other manufacturing processes, while enabling aseptic manufacturing. This breakthrough technology is bringing the benefits of the Industrial Internet of Things (IIoT) to new industries such as life sciences and healthcare. As demonstrated in the solution brochure, the benefits come in many forms, including dramatic increases in process efficiencies and reduced production costs.

The Internet of Things UDI and Medical Device Compliance

For medical device companies, information will become the foundation for their manufacturing, and it will be augmented by more data about the product’s distribution, condition, and directions for use, re-use, and upkeep. In other words, devices will ship with a pedigree and become embedded with a digital record of their entire life history. That local information will be the benefit made available for all stakeholders.

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