US 12,268,793 B2
Liquid-chemical sterilization system with biological indicator
Yan Fang, Irvine, CA (US); Prabhakaran Jayabalan, Lake Forest, CA (US); and Benjamin M. Fryer, Lake Forest, CA (US)
Assigned to ASP Global Manufacturing GmbH, (CH)
Filed by ASP Global Manufacturing GMBH, Schaffhausen (CH)
Filed on Oct. 13, 2023, as Appl. No. 18/379,843.
Application 18/379,843 is a division of application No. 16/717,735, filed on Dec. 17, 2019, granted, now 11,850,320.
Claims priority of provisional application 62/782,949, filed on Dec. 20, 2018.
Claims priority of provisional application 62/782,931, filed on Dec. 20, 2018.
Prior Publication US 2024/0033385 A1, Feb. 1, 2024
Int. Cl. A61L 2/18 (2006.01); A61L 2/28 (2006.01); C12M 1/00 (2006.01); C12M 1/12 (2006.01); C12M 1/32 (2006.01); C12M 1/34 (2006.01); C12M 3/00 (2006.01); C12Q 1/22 (2006.01)
CPC A61L 2/18 (2013.01) [A61L 2/186 (2013.01); A61L 2/28 (2013.01); C12M 1/34 (2013.01); C12M 23/12 (2013.01); C12M 23/34 (2013.01); C12M 23/38 (2013.01); C12M 23/40 (2013.01); C12M 23/48 (2013.01); C12M 37/06 (2013.01); C12Q 1/22 (2013.01); A61L 2202/24 (2013.01)] 20 Claims
OG exemplary drawing
 
1. A method of determining a sterility of a medical device sterilized by a sterilization system, comprising:
inserting a vial into a cavity, the vial containing a carrier of microorganisms;
penetrating a needle into the vial;
introducing a liquid-chemical sterilant into the vial through the needle;
incubating the vial with the liquid-chemical sterilant disposed therein;
withdrawing the liquid-chemical sterilant from the vial through the needle;
introducing a neutralizer into the vial through the needle;
withdrawing the neutralizer from the vial through the needle;
introducing a growth medium into the vial through the needle; and
incubating the vial with the growth medium disposed therein.