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Zero PM – Pipe Dream or Edging Toward Reality?

A recent article in Pharmaceutical Online on aseptic processes caught our attention, where the Parenteral Drug Association dared to ask the question, “What can be done to achieve zero particulates in parenteral manufacturing?”

The headline took us down a few veins of an important thought-exercise:

1) By presenting the query in these terms, does the PDA know something the rest of of us do not know about the prospects for such a standard?

2) Does discussion of this topic by a high-profile organization portend stricter regulations to come for PM threshold limits?

3) Is the PDA going to provide exact specifications for steps manufacturers can take to achieve zero particulates and sterility assurance?

When reading the piece in its entirely, however, none of these threads received the attention we believed they might. In fact, in the end, the author lands on the most predictable conclusion possible: detection and removal of all particulate matter is not a particularly feasible target for pharmaceutical manufacturers. (See what we did there?).

It is the causes she cites, however, that ended up being the greater surprise.

She seems to pin the core of the issue on the presence of significant variation in manufacturing processes, inspection methods (visual and subvisible), and risk assessments across the industry, and even among multiple sites within a single organization. This “lack of consistency in manufacturing processes,” she says, is what most impedes the effort.

To that, we’d argue it is not necessarily a simplified manufacturing process that will create better knowledge, awareness and protection against the presence particulate matter. Rather, it is a realized digitization of process and safety controls related to environmental monitoring, both within the facility and up and down the value chain, which can serve to materially mitigate the risk of a sterility breach, and limit damage if it occurs.

The author goes on to call out an urgent need to identify defects “at the time of manufacture,” as this can provide valuable insight about where particulates came from, and how to reduce them in the future. To us, this advice stems from a misguided assumption. Aseptic manufacturers aiming to exclude contaminants already do a pretty good job of identifying the presence of impurities. The trouble, it could be said, is they do this job too well.

Paradoxically, whenever an operator handles passive air monitoring equipment such as agar collection media, it opens the door to the possibility of needlessly wasted product, by way of false-positive contamination reports. It is unrealistic to expect a process that does not require humans to complete the job but, in an environment as critically sensitive as aseptic manufacturing, it may be time to move on from a multi-touch workflow that inherently sets the stage for frequent non-conformance alarms. (In this case, post-manufacture contamination of cleanroom monitoring equipment).

The reasons for this are clear. Every time a manufacturing run has a flagged concern, it costs a cool $16,000 just to launch an internal investigation. And the cost of sending a batch to waste that would otherwise be of good quality but for a post-production non-sterility event is $500,000.

Beyond the hard costs, any batch that gets held for investigation, whether it’s contaminated or not, goes to extend the time-to-market timeline. Anything that can be done to limit the chances of contamination during the collection process will reduce the instance of false-positives, remove an entire cost center, and allow products to be released sooner. There are simply fewer flagged batches to contend with.

Going touchless alters the workflow to reduce the number of steps human operators have to take in the course of their job that might lead to a contamination event. It’s that simple. But, how?

Tego’s entire raison d’etre is to allow progressive data to be placed directly onto physical, static assets so that industries can solve long-standing challenges. In aseptic manufacturing, the idea is for passive viable air monitoring equipment to come to life with computing power so that staff members can complete plate collection through a more streamlined procedure, which means they don’t have to touch as many of the plates, or touch them as many times.

In keeping with the PDA’s call for a more uniform approach, better internal collaboration, and open communication between manufacturers, suppliers, and regulatory agencies, touchless environmental monitoring could indeed “increase the feasibility of products being manufactured essentially free of particulate matter.” But, even if such a vision remains aspirational, reduced instance of false-positive contamination is not a bad outcome, either.

How efficient is your process of particulate-spotting?

To learn more about Tego’s touchless monitoring solutions for cGMP environments, please visit this page.

To schedule a demo of Tego’s gamma-proof technology for your aseptic facility, 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.


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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