Composition and methods for sterilizing dialyzers
First Claim
1. A method for disinfecting a dual-chamber hemodialyzer having a blood side and a dialysate side separated by a dialysis membrane, wherein the membrane has a blood contact surface and a dialysate contact surface, comprising:
- (a) contacting a blood contact surface and a dialysate contact surface of a dialysis membrane with an effective amount of an aqueous sterilant comprising a protic acid and a metal chlorite, and wherein the sterilant has a pH ranging from about 2.3 to 4.2;
(b) replacing the sterilant in contact with the dialysate contact surface of the dialysis membrane with an aqueous solution such that the pH of the sterilant in contact with the blood contact surface of the dialysis membrane increases to at least about 5.0 to yield a pH-adjusted sterilant; and
(c) subsequently replacing the pH-adjusted sterilant in contact with the blood contact surface of the dialysis membrane with an isotonic saline solution.
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Accused Products
Abstract
Compositions and methods are provided for sterilizing hemodialysis apparatus, particularly for reprocessing dialyzers in a manner that minimizes membrane perforations. The compositions contain a protic acid and a metal chlorite, and have a pH of at least about 2.3 and no greater than 4.2. Methods of this invention include contacting both the blood side and the dialysate side of a dialysis membrane with the composition, followed by first displacing the composition on the dialysate side with water or an aqueous alkali buffer having a pH in excess of about 6.0, such that the pH of the composition on the blood side of the dialysis membrane increases to at least about 5.0. The composition on the blood side is then displaced with saline. In a further embodiment, the composition has a pH ranging from 3.3 to 4.2, and the amount of chlorite ion in the form of chlorous acid ranges from 0.5% to 5.0% by weight of the total amount of chlorite ion in the composition. In this embodiment, the composition may be employed without associated membrane degradation by using existing hemodialysis set-up techniques, except that dialysate displacement on the dialysate side precedes saline displacement of blood side.
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Citations
26 Claims
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1. A method for disinfecting a dual-chamber hemodialyzer having a blood side and a dialysate side separated by a dialysis membrane, wherein the membrane has a blood contact surface and a dialysate contact surface, comprising:
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(a) contacting a blood contact surface and a dialysate contact surface of a dialysis membrane with an effective amount of an aqueous sterilant comprising a protic acid and a metal chlorite, and wherein the sterilant has a pH ranging from about 2.3 to 4.2; (b) replacing the sterilant in contact with the dialysate contact surface of the dialysis membrane with an aqueous solution such that the pH of the sterilant in contact with the blood contact surface of the dialysis membrane increases to at least about 5.0 to yield a pH-adjusted sterilant; and (c) subsequently replacing the pH-adjusted sterilant in contact with the blood contact surface of the dialysis membrane with an isotonic saline solution. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)
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18. A method for disinfecting a dual-chamber hemodialyzer having a blood side and a dialysate side separated by a dialysis membrane, wherein the membrane has a blood contact surface and a dialysate contact surface, comprising:
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(a) contacting a blood contact surface and a dialysate contact surface of a dialysis membrane with an effective amount of an aqueous sterilant comprising a protic acid and a metal chlorite, and wherein the sterilant has a pH ranging from about 2.3 to 4.2; (b) displacing the sterilant in contact with the dialysate contact surface of the dialysis membrane with an aqueous alkali ion-containing solution having a pH greater than about 6.0, such that the pH of the sterilant in contact with the blood contact surface of the dialysis membrane increases to at least about 5.0 to yield a pH-adjusted sterilant; and (c) subsequently displacing the pH-adjusted sterilant in contact with the blood contact surface of the dialysis membrane with an isotonic saline solution. - View Dependent Claims (19, 20)
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21. A method for disinfecting a dual-chamber hemodialyzer having a blood side and a dialysate side separated by a dialysis membrane, wherein the membrane has a blood contact surface and a dialysate contact surface, comprising:
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(a) contacting a blood contact surface and a dialysate contact surface of a dialysis membrane with an effective amount of an aqueous sterilant comprising a protic acid and a metal chlorite, wherein the sterilant has a pH ranging from about 3.3 to 4.2, and wherein the amount of chlorite ion present in the form of chlorous acid ranges from 0.5% to 5.0% by weight of the total amount of chlorite ion in the sterilant; (b) displacing the sterilant in contact with the dialysate contact surface of the dialysis membrane with an aqueous solution, such that the pH of the sterilant in contact with the blood contact surface of the dialysis membrane increases to at least about 5.0 to yield a pH-adjusted sterilant; and (c) subsequently displacing the pH-adjusted sterilant in contact with the blood contact surface of the dialysis membrane with an isotonic saline solution. - View Dependent Claims (22, 23, 24, 25, 26)
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Specification