US 12,228,555 B2
Self-contained biological indicator
Francois Ahimou, Woodbury, MN (US); Kelvin J. Witcher, Hudson, WI (US); Naiyong Jing, Saint Paul, MN (US); Tonya D. Bonilla, Woodbury, MN (US); and G. Marco Bommarito, Stillwater, MN (US)
Assigned to Solventum Intellectual Properties Company, Maplewood, MN (US)
Appl. No. 17/261,084
Filed by Solventum Intellectual Properties Company, Maplewood, MN (US)
PCT Filed Jul. 26, 2019, PCT No. PCT/US2019/043590
§ 371(c)(1), (2) Date Jan. 18, 2021,
PCT Pub. No. WO2020/023833, PCT Pub. Date Jan. 30, 2020.
Claims priority of provisional application 62/711,007, filed on Jul. 27, 2018.
Prior Publication US 2021/0311002 A1, Oct. 7, 2021
Int. Cl. C12Q 1/22 (2006.01); A61L 2/28 (2006.01); G01N 21/64 (2006.01); G01N 31/22 (2006.01)
CPC G01N 31/226 (2013.01) [A61L 2/28 (2013.01); C12Q 1/22 (2013.01); G01N 21/6428 (2013.01); G01N 2021/6439 (2013.01)] 7 Claims
 
1. A self-contained biological indicator comprising:
a housing;
a source of biological activity, the source comprising and/or capable of producing an enzyme capable of catalyzing a cleavage of an enzyme substrate; and
an actuatable container comprising a liquid composition, comprising the enzyme substrate, wherein the enzyme substrate comprises a fluorophore component that, when separated from the enzyme substrate by the enzyme, comprises 7-hydroxy-2H-chromen-2-one or a derivative thereof;
wherein the actuatable container can be actuated to allow the liquid composition to contact a bacterial spore; and
wherein the source of biological activity and/or the liquid composition comprises an effective amount of an acidic component and/or a basic component such that, when the source of biological activity and the liquid composition are combined, a resulting mixture of the source of biological activity and the liquid composition has an initial pH greater than or equal to a pKa of a hydroxyl group of the fluorophore component.