[PA-NJ Glassblowers] A brief appreciation of borosilicate glass
Tony Patti
gaffer at glassblower.info
Sat Aug 15 21:40:17 EDT 2020
https://www.bloomberg.com/features/2020-covid-vaccine-manufacturing-essentials/
Bloomberg BusinessWeek named the current (August 17, 2020) issue as “The Vaccine Issue”.
This is on page 61 (full page):
Vials: A brief appreciation of borosilicate glass
The invention of borosilicate glass is part of corporate lore at Schott AG. In 1880 the German chemist Otto Schott, a window maker’s son, set about experimenting with glass, trying to fulfill the stringent needs of a telescope observatory in the town of Jena. Methodically he worked his way through the then-new periodic table, adding one element after another to glass mixes and testing the results. Boron <https://www.bloomberg.com/features/2019-periodic-table-elements-issue/?sref=e7AVYjZR#boron> , until then, had been used mostly in detergent, but it turned out to make glass containers more resistant to temperature changes and far less reactive to the chemicals they held.
I asked Fabian Stöcker, Schott’s vice president for global strategy and innovation, what makes borosilicate glass so different from the glass out of which I’ve just taken a sip of water. “That glass of water you’re holding—it’s a soda-lime glass,” he says. If it held a more potent chemical, he explains, small particles of glass would gradually leach into the liquid. That doesn’t happen with borosilicate glass, making it ideal for containing drugs and vaccines, which must avoid contamination. Schott makes long glass tubes out of borosilicate mixes—7% to 13% boron, the rest mostly silicon dioxide—at four melting facilities: two in Germany and one each in India and Brazil. The company is the world’s largest manufacturer of medical borosilicate. “Around the world, roughly 25 billion injections every year—or 1,200 a second—are drawn out of vials made with our borosilicate glass,” Stöcker says. About 11 billion of these are vials made by Schott itself; the rest are made by other vial manufacturers to whom Schott sells its borosilicate tubes.
In the early weeks of the pandemic, vaccine developers still couldn’t forecast the kind of vials they’d need, but as prospects grew brighter and clearer, a tide of inquiries came Schott’s way. To commission and test all-new factories, Stöcker says, would have taken a couple of years. Instead, Schott freed up manufacturing capacity in its existing factories, giving over more and more production lines to vials. The company had already planned to invest €320 million ($376 million) across its operations, including for plant machinery; it ordered still more machines as vaccine development progressed. “We can supply vials for 2 billion vaccine doses, when the time comes,” Stöcker says.
Several challenges of physics and logistics remain. The final step in the process of vaccine manufacturing is known as the “fill and finish,” in which vaccines and other chemicals are piped into vials, which are then sealed and checked. Many plants today can fill and finish tens of thousands of vaccine doses per hour, but when the immediate need is for billions of doses, even the fastest robotic filling arm can be too slow. For this reason, says Blayer at Path, the first wave of vaccines will likely have multiple doses in each vial. And the urgency of the demand may mean these multiple-dose vials won’t contain preservatives, which normally have to undergo extensive testing to ensure the chemicals don’t react adversely. In that case, Blayer says, “all the doses in a vial will have to be used up six or so hours after the vial has been opened, according to WHO [World Health Organization] requirements.” An analyst at investment adviser Evercore Inc. also warned in April that the glass industry will face shortages of the kind of high-purity sand that goes into borosilicate glass, though Stöcker insists Schott isn’t expecting a sand crunch.
Bright warned the U.S. government early in the pandemic that all the borosilicate tubes on the global market were either sold out or spoken for. It wasn’t until May, when the U.S. government finally began to prepare for a vaccine, that it tried to secure a supply. Barda has invested $204 million in Corning Inc. to expand its production of glass vials, and the government is also trying to secure alternatives to the classic vial in its attempt to make up for lost time. A company in Connecticut, ApiJect Systems Corp., has received $138 million to make 100 million prefillable plastic syringes by the end of the year. Another company, SiO2 Materials Science in Auburn, Ala., manufactures a patented vial out of plastic coated with a thin layer of glass. It looks just like a glass vial but is stronger and won’t be affected by sand shortages, according to Lawrence Ganti, the company’s chief business officer. In June, after extensive presentations to Barda and the U.S. Department of Defense, SiO2 won a $143 million investment to accelerate its production—from 14 million vials to 120 million by December. “Basically they’ve called dibs on our entire production, should they need it,” Ganti says.
If you went to the SiO2 campus in Auburn, he adds, you’d see “our first 165,000-square-foot plant, with people running around in cleanrooms, wearing PPE bunny suits, and just down the road, diggers and machinery that are building a second plant. We’re having to hire like crazy.” (By July, SiO2 had started work on a third plant.) Every kind of vial has to undergo stability testing with vaccine candidates to make certain the container and its contents don’t react with each other. Ganti says SiO2 has been conducting this testing with Moderna Inc. and three other vaccine developers.
In June, Schott’s chairman, Frank Heinricht, told Reuters <https://ca.reuters.com/article/topNews/idUSKBN23J0SN> he’d rejected requests from pharma companies to reserve stocks of vials in advance, lest Schott end up committing a major supply to a vaccine developer that fails to bring its product to market. The company has instead forged agreements with a number of big companies—“hot tickets,” as Stöcker calls them—that are working on Covid-19 vaccines, so its newly added capacity can best support production. “Then, in case one of them gets to make the successful vaccine,” Stöcker says, “we are ready and there.”
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