The Food and Drug Administration’s newest guidelines on elemental impurities will have significant implications for drug product and pharmaceutical makers — as well as their suppliers.
Despite renewed attention to leachables, experts at sight glass maker L.J. Star Inc. believe that inferior quality sight glass is leaching impurities into process media, but the industry has yet to focus on it.
"It’s not enough for suppliers to say their sight glass is made with leach-resistant borosilicate glass," said L.J. Star Director of Business Development, Michael Curnutte. "They should provide documentation of compliance with the DIN 7080 standard."
The latest FDA guidelines list 24 elemental impurities to test for in the recently published ICH Q3D guidelines, which go into effect at the end of the year. United States Pharmacopeia, or USP, lists 15 elemental impurities to test for. Curnutte and others in the pharmaceutical industry believe that all elemental impurities are suspect.
"The industry experts I talk to are concerned with not only the elemental impurities on the list, but all elemental impurities because there are many unknowns that could have negative effects on the drug quality, the yield strength of the drug, and the shelf life of the drug."
"While sodium silicate and calcium leached from inferior sight glasses have been found in toxicology testing, they’re not sounding major alarms at this point because they’re not yet on the list of targeted elemental impurities," Curnutte said. "The industry experts I talk to are concerned with not only the elemental impurities on the list, but all elemental impurities because there are many unknowns that could have negative effects on the drug quality, the yield strength of the drug, and the shelf life of the drug."
To be certain that its sight glass does not leach the unknown impurities, L.J. Star, of Twinsburg, Ohio, has long taken the extra step to manufacture its sight glass in adherence to DIN 7080 standards, which assures the use of borosilicate glass, the same type used in USP Type I glass that is required for parenteral drug manufacturers.
"The DIN 7080 standard makes sure the glass formulation has the right amount of each ingredient to make a leach resistant glass," Curnutte said. "The current industry focus on elemental impurities is a timely opportunity to eliminate impurities leaching from inferior quality sight glasses, which many pharmaceutical companies have installed, but they don’t know it."
For more information about leach-resistant sight glass products, click here.
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