Claims for Patent: 5,346,889

Summary for Patent: 5,346,889

Title:	Process for extracting endotoxin
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.
Inventor(s):	Tsuchiya; Masakazu (Amagasaki, JP), Takaoka; Aya (Amagasaki, JP), Harada; Kazuaki (Amagasaki, JP)
Assignee:	Wako Pure Chemical Industries, Ltd. (Osaka, JP)
Application Number:	07/991,214
Patent Claims:	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. 2. A process according to claim 1, wherein the solution comprises albumin. 3. A process according to claim 2, wherein the albumin is human serum albumin. 4. A process according to claim 3, wherein the human serum albumin is contained in an amount of 0.0001 to 0.5% w/v. 5. A process according to claim 2, wherein the solution comprising albumin is a plasma solution or serum solution. 6. 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. 7. A process according to claim 1, wherein the albumin and globulin are previously autoclaved to remove endotoxins. 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. 9. A solution according to claim 8, which contains albumin. 10. A solution according to claim 9, which contains albumin is human serum albumin. 11. A solution according to claim 10, which contains human serum albumin is contained in an amount of 0.0001 to 0.5% w/v. 12. A solution according to claim 9, which contains solution containing albumin is a plasma solution or a serum solution. 13. A solution according to claim 8, wherein the albumin and globulin are previously autoclaved to remove endotoxins. 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. 15. A process according to claim 14, wherein the solution contains albumin. 16. A process according to claim 15, wherein the albumin is human serum albumin. 17. A process according to claim 16, wherein the human serum albumin is used in an amount of 0.0001 to 0.5% w/v. 18. A process according to claim 15, wherein the solution containing albumin is a plasma solution or serum solution. 19. 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. 20. A process according to claim 14, wherein the albumin and globulin are previously autoclaved to remove endotoxins. 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. 22. A cleaning agent according to claim 21, which is a solution containing albumin. 23. A cleaning agent according to claim 22, wherein the albumin is human serum albumin. 24. 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. 25. A cleaning agent according to claim 22, wherein the solution containing albumin is a plasma solution or serum solution. 26. A cleaning agent according to claim 21, wherein the albumin and globulin are previously autoclaved to remove endotoxins.

Details for Patent 5,346,889

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138	10/21/1942		2011-12-24
Baxalta Us Inc.	BUMINATE, FLEXBUMIN	albumin (human)	Injection	101452	03/03/1954		2011-12-24
Csl Behring Ag	ALBURX	albumin (human)	Injection	102366	07/23/1976		2011-12-24
Grifols Biologicals Llc	ALBUTEIN	albumin (human)	Injection	102478	08/15/1978		2011-12-24
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	02/17/1995		2011-12-24
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	06/11/2003		2011-12-24