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US 11,939,259 B2Granted
Pharmaceutical glass coating for achieving particle reduction
AssigneeCorning Incorporated
InventorsJohn Frederick Bayne, Dana Craig Bookbinder, Theresa Chang, Steven Edward DeMartino, Andrei Gennadyevich Fadeev, Kyle Christopher Hoff, Jamie Lynne Morley, Santona Pal, John Stephen Peanasky, Chandan Kumar Saha, Christopher Lee Timmons
Life of this patent
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Abstract
Embodiments of the present disclosure are directed to coated glass articles which reduce glass particle formation caused by glass to glass contact in pharmaceutical glass filling lines.
Claims22
A coated glass container comprising:
- a glass body formed from an alkali aluminosilicate glass having a Class HGA 1 hydrolytic resistance when tested according to the ISO 720-1985 testing standard or a borosilicate glass that meets the Type 1 criteria according to USP <660>, the glass body having a first surface and a second surface opposite the first surface, wherein the first surface is an exterior surface of the glass body;
- and
- a coating disposed on at least a portion of the exterior surface of the glass body, the coating comprising a polymer and a coupling agent, wherein the polymer comprises a polyimide, the coupling agent comprises a silsesquioxane, and the coated glass container reduces particle generation when the coated glass container undergoes processing,
- wherein the coated glass container demonstrates at least a 50% reduction in average glass particle count for generated glass particles compared to an average particle count of generated glass particles by an uncoated glass container that undergoes the processing, wherein the average glass particle count is computed for glass particles equal to or greater than 10 μm and glass particles equal to or greater than 25 μm using light obscuration according to United States Pharmacopoeia Standard 788 and the % reduction is determined for the sum of the average glass particle count for glass particles equal to or greater than 10 μm and the average glass particle count for glass particles equal to or greater than 25 μm.
1 more element
A coated glass container comprising:
- a glass body formed from an alkali aluminosilicate glass having a Class HGA 1 hydrolytic resistance when tested according to the ISO 720-1985 testing standard or a borosilicate glass that meets the Type 1 criteria according to USP <660>, the glass body having a first surface and a second surface opposite the first surface, wherein the first surface is an exterior surface of the glass body;
- and
- a coating disposed on at least a portion of the exterior surface of the glass body, the coating comprising a polymer and a coupling agent, wherein:
- the polymer comprises a polyimide;
- the coupling agent comprises a silsesquioxane;
- the coated glass container reduces glass particle formation caused by non-breakage inducing glass contact in pharmaceutical glass filling lines, the reduction in glass particle formation being defined as follows:
- wherein an average glass particle count of generated sub-visible glass particles having a size of equal to or greater than 10 μm and equal to or greater than 25 μm is below allowable levels defined by United States Pharmacopoeia Reference Standard 788, the average particle count being computed using light obscuration;
- and
- wherein the coated glass container demonstrates at least a 50% reduction in average glass particle count for generated glass particles compared to an average glass particle count of generated glass particles by an uncoated glass container in the pharmaceutical glass filling lines, wherein the average glass particle count is computed for glass particles equal to or greater than 10 μm and glass particles equal to or greater than 25 μm using light obscuration according to United States Pharmacopoeia Standard 788 and the % reduction is determined for the sum of the average glass particle count for glass particles equal to or greater than 10 μm and the average glass particle count for glass particles equal to or greater than 25 μm.
6 more elements
Dependencies are inferred from the claim text.