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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.


“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.


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