# US 11,027,032 B2 · Systems, methods, and devices for sterilizing antiseptic solutions

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- Number: US 11,027,032 B2
- Document ID: US11027032B2
- Status: Granted
- Kind: B2
- Application number: 14/150,488
- Filed: 2014-01-08
- Published: 2015-07-09
- Granted: 2021-06-08
- Earliest claimed: 2014-01-08
- Assignees: CareFusion 2200, Inc.
- Applicants: Carefusion 2200, Inc.
- Inventors: Satish Degala; Christopher Matthew McGinley; Kenneth Bruce Thurmond, II
- Web page: https://patentgrep.com/patent/US11027032B2

## CPC

- A61L 2/04: Heat (radiation A61L2/08)
- A01N 43/40: six-membered rings
- A01N 47/44: Guanidine; Derivatives thereof
- A61P 31/02: Local antiseptics
- A61L 2103/05: Living organisms or biological materials
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A01N: PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF (preservation of food or foodstuff A23); BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES (preparations for medical, dental or toiletry purposes which kill or prevent the growth or proliferation of unwanted organisms A61K); PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## 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%.

## Claims

### Claim 1

A sterile antiseptic solution comprising:
an antimicrobial molecule selected from the group consisting of: an octenidine salt and a biguanide; and
an alcohol solvent,
wherein the sterile antiseptic solution is sterile and at least about 92% pure,
wherein the sterile antiseptic solution is made sterile by a method comprising the steps of:
providing a container containing an antiseptic solution, the antiseptic solution having an initial purity;
selecting a sterilization temperature from about 85° C. to about 135° C. and a sterilization time from about 1 minute to about 19 hours;
heating the antiseptic solution to the selected sterilization temperature;
maintaining the antiseptic solution at the sterilization temperature for the selected sterilization time; and
terminating the heating of the antiseptic solution when the selected sterilization time expires, thereby providing the sterile antiseptic solution,
wherein after terminating the heating, the sterile antiseptic solution has a post-sterilization purity, and
wherein the sterilization temperature and the sterilization time are selected such that after terminating the heating, the sterile antiseptic solution has a post-sterilization purity of at least about 92% and a percentage point change in purity from the initial purity to the post-sterilization purity of at most about 5%.

### Claim 2 (depends on 1)

The sterile antiseptic solution of claim 1, wherein the selected sterilization time and selected sterilization temperature satisfy the following relationship:
a) 85° C.≤y<125° C.,
y≥−6.14·ln x+123.2 for 1≤x≤552, and
y≤−10.38·ln x+156.9 for 21.5≤x≤1123; or
b) 125° C.≤y≤135° C.,
x≥1 and
y≤−10.38·ln x+156.9 for 9.1≤x≤21.5,
wherein y is the sterilization temperature and x is the sterilization time in minutes.

### Claim 3 (depends on 1)

The sterile antiseptic solution of claim 1, wherein the selected sterilization time and selected sterilization temperature satisfy the following relationship:
a) 85° C.≤y<125° C.,
y≥−6.14·ln x+123.2 for 1≤x≤552, and
y≤−10.37·ln x+154.6 for 17.5≤x≤900; or
b) 125° C.≤y≤135° C.,
x≥1 and
y≤−10.37·ln x+154.6 for 7.3≤x≤17.5,
wherein y is the sterilization temperature and x is the sterilization time in minutes.

### Claim 4 (depends on 1)

The sterile antiseptic solution of claim 1, wherein the selected sterilization time and selected sterilization temperature satisfy the following relationship:
a) 85° C.≤y<125° C.,
y≥−6.14·ln x+123.2 for 1≤x≤552, and
y≤−10.4·ln x+151.7 for 13≤x≤670; or
b) 125° C.≤y≤135° C.,
x≥1 and
y≤−10.4·ln x+151.7 for 5.5≤x≤13,
wherein y is the sterilization temperature and x is the sterilization time in minutes.

### Claim 5 (depends on 1)

The sterile antiseptic solution of claim 1, wherein the selected sterilization time and selected sterilization temperature satisfy the following relationship:
a) 90° C.≤y<125° C.,
y≥−6.14·ln x+123.2 for 1≤x≤552, and
y≤−10.6·ln x+148.3 for 9≤x≤260; or
b) 125° C.≤y≤135° C.,
x≥1 and
y≤−10.6·ln x+148.3 for 3.7≤x≤9,
wherein y is the sterilization temperature and x is the sterilization time in minutes.

### Claim 6 (depends on 1)

The sterile antiseptic solution of claim 1, wherein the sterile antiseptic solution is completely free of microbes.

### Claim 7 (depends on 1)

The sterile antiseptic solution of claim 1,
wherein the antimicrobial molecule is selected from the group consisting of chlorhexidine gluconate and octenidine dihydrochloride; and
wherein the solvent is selected from the group consisting of ethanol, isopropanol, and n-propanol.

### Claim 8 (depends on 1)

The sterile antiseptic solution of claim 1, comprising from about 40% to about 90% v/v of the solvent and from about 0.1% to about 2.5% w/v of the antimicrobial molecule, wherein the solvent is isopropanol and the antimicrobial molecule is chlorhexidine gluconate.

### Claim 9 (depends on 1)

The sterile antiseptic solution of claim 1, comprising about 70% v/v of the solvent and about 2.0% w/v of the antimicrobial molecule, wherein the solvent is isopropanol and the antimicrobial molecule is chlorhexidine gluconate.

### Claim 10 (depends on 1)

The sterile antiseptic solution of claim 1, wherein the sterilization time is from about 6 minutes to about one hour.

### Claim 11 (depends on 1)

The sterile antiseptic solution of claim 1, wherein the sterilization temperature is about 95° C. and the sterilization time is from about 1.5 hours to about 6.5 hours.

### Claim 12 (depends on 1)

The sterile antiseptic solution of claim 1, wherein the sterilization temperature is about 110° C. and the sterilization time is from about 6 minutes to about 90 minutes.

### Claim 13 (depends on 1)

The sterile antiseptic solution of claim 1, wherein the sterilization temperature is about 120° C. and the sterilization time is from about 2 minutes to about 35 minutes.

### Claim 14 (depends on 1)

The sterile antiseptic solution of claim 1, wherein the container comprises glass or plastic.

### Claim 15 (depends on 1)

The sterile antiseptic solution of claim 1, wherein the method further comprises the steps of:
providing a cascading water sterilizer that produces a constant, cascading waterfall,
wherein heating the antiseptic solution to the selected sterilization temperature and maintaining the selected sterilization temperature comprises contacting the container with the cascading waterfall for the duration of the sterilization time.

### Claim 16 (depends on 1)

The sterile antiseptic solution of claim 1, wherein the method further comprises a step of cooling the sterile antiseptic solution after terminating the heating.

### Claim 17 (depends on 1)

The sterile antiseptic solution of claim 1, wherein prior to heating the antiseptic solution to the selected sterilization temperature, the container and the antiseptic solution have a temperature from about 20° C. to about 35° C.

### Claim 18 (depends on 1)

The sterile antiseptic solution of claim 1, wherein the container is sealed prior to heating the antiseptic solution to the selected sterilization temperature.

### Claim 19 (depends on 7)

The sterile antiseptic solution of claim 7, further comprising water.

### Claim 20 (depends on 1)

The sterile antiseptic solution of claim 1, comprising from about 50% to about 80% v/v of the alcohol solvent, from about 0.1% to about 2.5% w/v of the antimicrobial molecule, and from about 10% to about 60% v/v water, wherein the alcoholic solvent and the water do not exceed 100% of a total volume of the solution, and wherein the alcohol solvent is isopropanol and the antimicrobial molecule is chlorhexidine gluconate.

### Claim 21 (depends on 1)

The sterile antiseptic solution of claim 1, comprising about 0.1% of the antimicrobial molecule.

### Claim 22 (depends on 1)

The sterile antiseptic solution of claim 1, wherein the antiseptic solution has an initial purity of at least 98%.

### Claim 23 (depends on 1)

The sterile antiseptic solution of claim 1, wherein the selected sterilization temperature and the selected sterilization time are chosen such that after terminating the heating, the sterile antiseptic solution has a post-sterilization purity of at least about 94% and the percentage point change in purity from the initial purity to the post-sterilization purity is at most about 4%.

### Claim 24 (depends on 1)

The sterile antiseptic solution of claim 1, wherein the selected sterilization temperature and the selected sterilization time are chosen such that after terminating the heating, the sterile antiseptic solution has a post-sterilization purity of at least about 96% and the percentage point change in purity from the initial purity to the post-sterilization purity is at most about 3%.

### Claim 25 (depends on 1)

The sterile antiseptic solution of claim 1, wherein the selected sterilization temperature and the selected sterilization time are chosen such that after terminating the heating, the sterile antiseptic solution has a post-sterilization purity of at least about 98% and the percentage point change in purity from the initial purity to the post-sterilization purity is at most about 2%.

### Claim 26 (depends on 1)

The sterile antiseptic solution of claim 1, wherein the sterile antiseptic solution maintains 7-day sterility in accordance with U.S. Pharmacopeia Convention (USP) 36, Chapter 55, Biological Indicators—Resistance Performance Tests.