Image courtesy of Corning
Corning plans to open a new high-volume manufacturing facility, likely in North Carolina, specifically for making Corning Valor Glass. The company launched the new glass for pharmaceutical vials last year, with initial production out of out of its New York operation. Recently, Corning added new jobs to its existing New York production facilities located in Big Flats and in Erwin. The new location will enable the company to “increase capacity to meet market demand,” reports Kyle Hoff, applications engineering manager at Corning. “Two pharma companies are already with us,” he says, referring to Corning’s collaboration with Merck and Pfizer. “And we’ve seen a lot of development in the top 40 pharma.
“We got into the industry to help address patient safety and drug safety and improve efficiency,” he adds.
Known for its specialty glass, Corning began developing a new glass for pharma packaging after FDA’s 2011 advisory on glass delamination. At the same time, the company was working with a crystallizing glass customer that was experiencing problems with cracking vials. “So, we started asking ourselves, what does the industry need for safety and manufacturing?” recounts Hoff.
Hoff’s team set out to develop glass with a new formulation, one that “removed the bad actors,” he tells PMP News. “We thought the composition of glass could be a problem in terms of delamination.”
Corning decided to use a different “network former,” creating an aluminosilicate glass by eliminating boron from the composition. “Boron used in conventional glass volatizes during vial manufacturing creating different glass chemistry in the drug-contacting region of the container, which can lead to chemical attack and glass flake (lamellae) formation," he says. "The aluminosilicate glass does not have boron, so the volatilization mechanism does not occur, leading to a uniform and chemically durable glass chemistry on the entire inside of every Valor container.”
To increase the strength of the container, Hoff says that “treating the glass nicely throughout the manufacturing process is one approach. The high-temperature processes require a lot of metal, so there can be contact damage,” he says. The team decided to design new ways to mitigate damage during processing. However, “we found out that wasn’t enough.”
Corning opted for an “ion exchange” for a stronger glass. “It is a simple concept—ions exchange out of glass into a salt bath to reach equilibrium,” he explains. “We added a large ion, leading to higher compression strength.”
For damage resistance, the team added an external coating with a low coefficient of friction. “The vials slide past each other, and this also improves throughput,” he says. Glass particles shedding from typical vials “end up wearing away components on filling lines.” With the new coating, there would be “fewer interventions and stoppages, improving manufacturing,” he says.
Image courtesy of Corning
Hoff says that at “end-of-line inspections, Valor glass doesn’t have the scratches or damage that high-coefficient-of-friction products do.”
Hoff considers Valor Glass a “drop-in solution” for pharma. “Because we’ve worked with pharma companies with our glass, we knew they wouldn’t want to change their processes, so we didn’t want to add a manufacturing hurdle for them.”
The regulatory filing is up to pharma. “We meet all requirements and expectations for glass, and our Type III DMF is deemed adequate,” he says.
For more details, Hoff points to this article published in the PDA Journal of Pharmaceutical Science Technology: “A new glass option for parenteral packaging.”