Systems, methods, and devices for sterilizing antiseptic solutions

Abstract

A method for sterilizing an antiseptic solution includes providing a container containing the antiseptic solution, the antiseptic solution having an initial purity, selecting a sterilization temperature from about 85° C. to about 135° C. and an sterilization time from about 1 minute to about 19 hours, heating the antiseptic solution to the selected sterilization temperature, maintaining the temperature for the selected sterilization time, and terminating the heating of the antiseptic solution when the sterilization time expires. After terminating the heating, the antiseptic solution has a post-sterilization purity. The sterilization temperature and the sterilization time are selected such that after terminating the heating, the antiseptic solution is sterile and has a post-sterilization purity of at least about 92% and the percentage point change in purity from the initial purity to the post-sterilization purity is at most about 5%.

Description

CROSS-REFERENCE TO RELATED APPLICATION[0001]This application is a Continuation of U.S. patent application Ser. No. 14 / 150,488, filed Jan. 8, 2014. The disclosure of the priority application is hereby incorporated in its entirety by reference.FIELD OF THE INVENTION[0002]Aspects of the present invention relate to the field of sterilization, and in particular, to sterilization of topical antiseptic solutions.BACKGROUND OF THE INVENTION[0003]In the United States there are currently no regulations regarding the sterilization requirements of topical antiseptic solutions. Therefore, antiseptic solutions currently sold in the United States generally do not undergo a sterilization process. In other jurisdictions, however, such as European Union (EU) countries, some degree of sterilization is required. A known antiseptic solution containing 2% w / v chlorhexidine gluconate in 70% v / v isopropanol in water, manufactured by CareFusion Corp., is sterilized for EU countries using a known sterilizati...

AI Technical Summary

Benefits of technology

[0007]Aspects of the present invention overcome the above identified problems, as well as others, by providing systems, methods, and devices for efficiently sterilizing antimicrobial solutions while maintaining antimicrobial efficacy as an antiseptic and purity of the active drug moiety to comply with regulatory requirements.

Problems solved by technology

Degrading the antimicrobial molecules creates undesired impurities as well as lowers the overall concentration of the active drug moiety.

Furthermore, a convection oven, which utilizes air to conduct heat, is an inefficient process because the initial heating of the solution from room temperature (also referred herein as “ramp up” time) and eventual cooling down of the solution back to room temperature (also referred herein as “cool down” time) is relatively long.

It is the industry belief that high temperature sterilization is not suitable due to the expected degradation.

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