Web
		Analytics
IoT - Tego
Tego Logo
MENU

“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


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.


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.


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


Verified by MonsterInsights