Claims for Patent: 6,468,472

Summary for Patent: 6,468,472

Title:	Cleaning and decontaminating dialyzers by per-compound solutions
Abstract:	A composition for cleaning and decontaminating medical devices such as dialyzers. A per-compound oxidant, for example, hydrogen peroxide (H.sub.2 O.sub.2) and/or peracetic acid, is mixed with a buffer such as dipotassium hydrogen phosphate. The pH of the composition is between about 5-11. The composition effectively cleans the device, can achieve high level disinfection and sterilization of the device and is non-corrosive to plastics and adhesives used in the device.
Inventor(s):	Yu; Zhi-Jian (Irvine, CA), Huth; Stanley William (Newport Beach, CA)
Assignee:	Metrex Research Corporation (Orange, CA)
Application Number:	09/397,543
Patent Claims:	1. A composition for cleaning and decontaminating a dialyzer comprising (a) a source of at least one per-compound oxidant and (b) a buffer in amounts to provide said per-compound oxidant at a concentration and pH effective for cleaning and decontaminating. 2. The composition of claim 1 wherein said pH is between about pH 5 and pH 11. 3. The composition of claim 1 wherein said per-compound oxidant is selected from the group consisting of at least one peracid and hydrogen peroxide (H.sub.2 O.sub.2) and at least one peracid. 4. The composition of claim 3 wherein said H.sub.2 O.sub.2 is at a concentration in the range of about 1-50%.sup.w/v. 5. The composition of claim 3 wherein said H.sub.2 O.sub.2 is at a concentration in the range of about 3-20%.sup.w/v. 6. The composition of claim 3 wherein said H.sub.2 O.sub.2 is at a concentration in the range of about 6.5-8%.sup.w/v. 7. The composition of claim 3 wherein said peracid is at a concentration in the range of about 0.0050-10.0%.sup.w/v. 8. The composition of claim 1 wherein said per-compound oxidant is a mixture of peracetic acid at about 0.0050-0.5%.sup.w/v and H.sub.2 O.sub.2 at about 0.5-50.0%.sup.w/v. 9. The composition of claim 1 wherein said per-compound oxidant is a mixture of peracetic acid at about 0.005-0.2%.sup.w/v and H.sub.2 O.sub.2 at about 0.5-8.0%.sup.w/v. 10. The composition of claim 1 wherein said buffer is selected from the group consisting of acetic acid, propanoic acid, glycine, monobasic dihydrogen phosphate, dibasic hydrogen phosphate, bicarbonate, carbonate, and combinations thereof. 11. The composition of claim 10 wherein said buffer contains non-immunogenic counter ions. 12. A method of cleaning and decontaminating a dialyzer comprising (a) producing a solution by combining at least one per-compound oxidant and a buffer in amounts to provide said per-compound oxidant at a concentration and pH effective for cleaning and decontaminating wherein said oxidant and said buffer are mixed prior to use, and (b) contacting said dialyzer with said solution for a period of time effective for cleaning and decontaminating. 13. The method of claim 12 further comprising a step (c) of removing said solution from said dialyzer following step (b). 14. The method of claim 13 wherein said removing in step (c) is by rinsing with a liquid selected from the group consisting of sterile water and sterile saline. 15. The method of claim 14 wherein said removing in step (c) is followed by storing said dialyzer to prevent recontamination. 16. The method of claim 14 further comprising removing soil from said dialyzer before step (b). 17. The method of claim 16 wherein said soil removing comprises contacting said dialyzer with a solution comprising an enzyme. 18. The method of claim 14 wherein said removing in step (c) is followed by storing said dialyzer to prevent recontamination. 19. The method of claim 12 wherein said buffer is selected from the group consisting of acetic acid, propanoic acid, glycine, monobasic dihydrogen phosphate, dibasic hydrogen phosphate, bicarbonate, carbonate, and combinations thereof. 20. The method of claim 19 wherein said buffer contains non-immunogenic counter ions. 21. The method of claim 12 wherein said per-compound oxidant is selected from the group consisting of at least one peracid and hydrogen peroxide (H.sub.2 O.sub.2) and at least one peracid. 22. A method of cleaning and decontaminating a dialyzer having a blood chamber and a dialysate chamber comprising combining at least one per-compound and a buffer in amounts and at a pH effective to form a cleaning and decontaminating solution, and contacting at least said blood chamber with said solution for a time effective for cleaning and decontaminating. 23. The method of claim 22 further comprising venting said dialyzer for escape of a gas formed from said per-compound. 24. The method of claim 22 further comprising contacting said dialysate chamber with said solution. 25. The method of claim 22 wherein said per-compound oxidant is selected from the group consisting of at least one peracid and hydrogen peroxide (H.sub.2 O.sub.2) and at least one peracid. 26. The method of claim 22 wherein said blood chamber contains fiber bundles having two ends and said contacting is by filling said fiber bundles with said solution, thereafter capping one of said ends with a gas- and solution-impermeable cap and capping the other of said ends with a gas-venting cap. 27. A method for cleaning and high level disinfecting a dialyzer comprising (a) producing a solution by combining at least one per compound oxidant and a buffer in amounts to provide said per-compound oxidant at a concentration and pH effective for cleaning and high level disinfecting wherein said oxidant and said buffer are mixed prior to use, and (b) contacting said dialyzer with said solution for a period of time effective for cleaning and high level disinfecting. 28. A method for cleaning and sterilizing a dialyzer comprising (a) producing a solution by combining at least one per compound oxidant and a buffer in amounts to provide said per-compound oxidant at a concentration and pH effective for cleaning and sterilizing wherein said oxidant and said buffer are mixed prior to use, and (b) contacting said dialyzer with said solution for a period of time effective for cleaning and sterilizing. 29. A composition for cleaning and decontaminating a dialyzer consisting essentially of (a) a source of at least one per-compound oxidant and (b) a buffer in amounts to provide said per-compound oxidant at a concentration and pH effective for cleaning and decontaminating.

Details for Patent 6,468,472

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2039-09-23