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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.


Tego Announces Open, Multi-Platform Operating System for Powering Things with Intelligence

TegoOS Now Supports Major Mobile OS and RF Gateway Protocols

Boston, MA, September 19, 2016Tego, Inc. announced today the release of its open, multi-platform operating system, TegoOS, adding new capability to Tego’s innovative Asset Intelligence Platform, which provides local intelligence on any asset, anywhere. TegoOS now supports all major mobile and desktop operating systems, including iOS, Android, Windows and OS X. The open OS operates across all RF gateway protocols and handheld readers. It also enables distributed data about assets to be easily available to any cloud-based Internet of Things (IoT) platform as well as core enterprise systems such as Enterprise Asset Management (EAM), Enterprise Resource Planning (ERP) and Business Intelligence (BI) and analytics applications.

“In the age of IoT, businesses need operational intelligence about the state and condition of their physical products, components and assets for better and safer business practices, and the use of open standards in IoT is a critical success factor,” shared Andy Mulholland, Vice President and Principal Analyst, Constellation Research. “Tego is among the next generation of IoT companies bringing local data connectivity to assets for operational, maintenance and strategic purposes.”

Using TegoOS, assets can tell their story at the point of use by making their origin, authenticity, lifecycle maintenance history, or chain of custody available to authorized users. TegoOS empowers manufacturers, distributors and maintenance organizations across aerospace, life sciences, healthcare and manufacturing sectors to deploy scalable solutions for lifecycle and service management, regulatory and process compliance, and authenticity management. Out of the box, TegoOS provides encryption, compression and flexible and efficient file management. The process of storing data on a physical asset becomes a simple, one push-button activity.

The three main components of the TegoOS include:

  • A comprehensive software library supporting Tego’s Asset Intelligence Platform functionality and extensibility, securely storing and retrieving structured or unstructured data directly on any asset through a wireless communications protocol
  • A mobile application for AIP administrators and users with one common interface to RF gateway devices such as Motorola, ThingMagic, Intermec, Zebra, Impinj, TSL and LLRP gateways.
  • Integration capabilities for cloud-based IoT and enterprise systems

TegoOS powers Tego’s Asset Intelligence Platform (AIP), backed by a comprehensive portfolio of 30 patents. AIP provides the capability to embed digital information directly in the asset itself. From product specification and configuration, maintenance and use history, and intended use and compatibility, to process instructions or images, Tego’s AIP allows distributed data solutions to be installed quickly within small or large environments—providing line employees with critical operating data and ensuring asset data connectivity to devices and systems. TegoOS greatly simplifies the process of storing, recalling and communicating the information embedded in a product, component or asset.

“TegoOS powers data and insights for the T in the IoT,” said Timothy Butler, CEO of Tego. “It provides data connectivity to assets so businesses have the information they need to take the necessary actions to save money, keep users safe, and continue to build new revenue models.”

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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Smart Approaches to Smart Assets – Use cases and Immediate Benefits

Tego focuses on the T in IoT as distributed data on assets has significant advantages over constant connectivity approaches. Get acquainted with the immediate quantifiable benefits of a smart asset solution and how it is different from the IoT.


Frost & Sullivan Asset Intelligence for Healthcare: New Product Innovation Award

Tego recognized as one of the pioneers in smart asset management solutions, with its proven asset intelligence platform (AIP) solution targeted towards the healthcare industry. Makes every asset smart by bringing intelligence to things that have been unreachable with conventional IoT solutions.

 

 


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