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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.


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.


Simplify Complex Biologics Supply Chain with RFID Smart Asset Management

RFID technology has been adopted for diverse applications in a wide range of industries. However, for many years, the life sciences and healthcare fields missed out on the full benefits that RFID delivers because they did not have a solution that could survive their specific rugged supply chain needs. Traditional RFID chips and tags are not capable of surviving sterilization by gamma and e-beam radiation.

Fortunately, Tego has the first UHF RFID technology proven to withstand gamma, ebeam, ethylene oxide, and autoclave sterilization methods, as well as cold storage to -80C. This enables an entire industry to incorporate RFID into medical device manufacturing and labelling, biologic processing and healthcare supply chain processes.

In one particular application, Tego is working with a large life sciences provider that uses gamma and e-beam sterilization in its manufacturing process. Their products are processed and stored in bottles, which have been fitted with Tego’s passive UHF tags. The provider maintains a running inventory of more than 20 million bottles, which are kept in a deep freeze for up to 60 days before final processing and delivery.

A key challenge is the need for cradle-to-grave traceability, in the event that manufacturing problems should trigger recalls. Tracking each and every bottle with a high level of efficiency – and without disrupting their entire business operation – is a formidable task that was previously addressed with an elaborate barcode system. However, the barcode reading process was labor-intensive and susceptible to reading errors due to the extreme cold.

Additionally, the company maintains a supply chain that’s spread across several hundred locations worldwide, making it cost prohibitive to create a company-wide, global database of inventory. The Tego solution enables radiation-resistant RFID tags to be applied to each pharmaceutical bottle and to store unique identifying numbers, as well as separate information about the bottle’s contents and whereabouts throughout the supply chain.

To allow end-to-end visibility of the data throughout the healthcare supply chain, Tego tailored their TegoView software for this particular application to enhance overall productivity and efficiency. The company is seeing significant benefits with the Tego RFID system fully deployed.

When the company used barcode labels to track products, shipping pallets often had to be broken down and cases opened so that workers could manually scan bottles one at a time. Now with the Tego solution, all the bottles inside a case can be read without opening the lid. As a result, a shipment that used to take eight hours to process can now be received in roughly 30 minutes.

Furthermore, the Tego solution eliminated the need to build a costly corporate network for sharing data collected at each location throughout the global supply chain. The high-memory TegoTag allows collected information to be stored directly with the asset, allowing each location to maintain a local database for a smaller, more secure and more cost-efficient solution. When bottles are inspected, either by quality assurance personnel or by government agencies, they can simply read the RFID tag to get the entire history of the bottle and its contents.

To learn more about how radiation-resistant RFID technology is benefitting the life sciences and healthcare field, and to read more details about this application, click here.

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