# US 5,346,889 A · Process for extracting endotoxin

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- Number: US 5,346,889 A
- Document ID: US5346889A
- Status: Granted
- Kind: A
- Application number: 07/991,214
- Filed: 1992-12-15
- Granted: 1994-09-13
- Earliest claimed: 1991-12-24
- Assignees: Wako Pure Chemical Industries, Ltd.
- Inventors: Masakazu Tsuchiya; Aya Takaoka; Kazuaki Harada
- Web page: https://patentgrep.com/patent/US5346889A

## CPC

- A61L 2/18: Liquid substances
- 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)

## Abstract

A solution containing at least one of albumin and globulin is effective for extracting endotoxin adhered to or adsorbed on a surface of a solid such as containers, medical devices, disposable needles, etc., and thus useful as a cleaning agent for these containers, medical devices, etc.

## Claims

### Claim 1

A process for extracting endotoxin adhered to or adsorbed on a surface of a container or device, which comprises contacting the container or device with a solution comprising at least one of albumin and globulin.

### Claim 2 (depends on 1)

A process according to claim 1, wherein the solution comprises albumin.

### Claim 3 (depends on 2)

A process according to claim 2, wherein the albumin is human serum albumin.

### Claim 4 (depends on 3)

A process according to claim 3, wherein the human serum albumin is contained in an amount of 0.0001 to 0.5% w/v.

### Claim 5 (depends on 2)

A process according to claim 2, wherein the solution comprising albumin is a plasma solution or serum solution.

### Claim 6 (depends on 1)

A process according to claim 1, wherein at least one of albumin and globulin is contained in the solution in a concentration of 0.0001 to 6 mg/ml in terms of protein concentration.

### Claim 7 (depends on 1)

A process according to claim 1, wherein the albumin and globulin are previously autoclaved to remove endotoxins.

### Claim 8

A solution for extracting endotoxin adhered to or adsorbed on a surface of a solid, which comprises an endotoxin-free water or buffer solution and at least one of albumin and globulin in a concentration of 0.0001 to 6 mg/ml in terms of protein concentration.

### Claim 9 (depends on 8)

A solution according to claim 8, which contains albumin.

### Claim 10 (depends on 9)

A solution according to claim 9, which contains albumin is human serum albumin.

### Claim 11 (depends on 10)

A solution according to claim 10, which contains human serum albumin is contained in an amount of 0.0001 to 0.5% w/v.

### Claim 12 (depends on 9)

A solution according to claim 9, which contains solution containing albumin is a plasma solution or a serum solution.

### Claim 13 (depends on 8)

A solution according to claim 8, wherein the albumin and globulin are previously autoclaved to remove endotoxins.

### Claim 14

A process for cleaning containers or devices contaminated with endotoxin, which comprises rinsing the containers or devices using a solution comprising at least one of albumin and globulin.

### Claim 15 (depends on 14)

A process according to claim 14, wherein the solution contains albumin.

### Claim 16 (depends on 15)

A process according to claim 15, wherein the albumin is human serum albumin.

### Claim 17 (depends on 16)

A process according to claim 16, wherein the human serum albumin is used in an amount of 0.0001 to 0.5% w/v.

### Claim 18 (depends on 15)

A process according to claim 15, wherein the solution containing albumin is a plasma solution or serum solution.

### Claim 19 (depends on 14)

A process according to claim 14, wherein at least one of albumin and globulin is contained in the solution in a concentration of 0.0001 to 6 mg/ml in terms of protein concentration.

### Claim 20 (depends on 14)

A process according to claim 14, wherein the albumin and globulin are previously autoclaved to remove endotoxins.

### Claim 21

A cleaning agent for cleaning containers or devices contaminated with endotoxin, which comprises an endotoxin-free water or buffer solution and at least one of albumin and globulin in a concentration of 0.0001 to 6 mg/ml in terms of protein concentration.

### Claim 22 (depends on 21)

A cleaning agent according to claim 21, which is a solution containing albumin.

### Claim 23 (depends on 22)

A cleaning agent according to claim 22, wherein the albumin is human serum albumin.

### Claim 24 (depends on 23)

A cleaning agent according to claim 23, wherein the human serum albumin is used in an amount of 0.0001 to 0.5% w/v.

### Claim 25 (depends on 22)

A cleaning agent according to claim 22, wherein the solution containing albumin is a plasma solution or serum solution.

### Claim 26 (depends on 21)

A cleaning agent according to claim 21, wherein the albumin and globulin are previously autoclaved to remove endotoxins.