Source: http://www.google.com/patents/US5362442?dq=patent:5567455
Timestamp: 2014-07-10 03:07:59
Document Index: 407127826

Matched Legal Cases: ['art.4', 'art.5', 'art.6', 'art.7', 'art 2', 'art 2', 'art 1', 'art 1']

Patent US5362442 - Method for sterilizing products with gamma radiation - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign in<nobr>Advanced Patent Search</nobr>PatentsA method for sterilizing products to remove biological contaminants such as viruses, bacteria, yeasts, molds, mycoplasmas and parasites is disclosed. The method involves providing the product in a form that contains less than 20% solids and subsequently irradiating the product with gamma irradiation...http://www.google.com/patents/US5362442?utm_source=gb-gplus-sharePatent US5362442 - Method for sterilizing products with gamma radiationAdvanced Patent SearchPublication numberUS5362442 APublication typeGrantApplication numberUS 08/095,698Publication dateNov 8, 1994Filing dateJul 22, 1993Priority dateJul 22, 1993Fee statusPaidAlso published asCA2167528A1, CA2167528C, DE69432351D1, DE69432351T2, EP0710124A1, EP0710124B1, US6171549, US6346216, US6635222, US20030059339, US20030143107, US20080176306, WO1995003071A1Publication number08095698, 095698, US 5362442 A, US 5362442A, US-A-5362442, US5362442 A, US5362442AInventorsRandall S. KentOriginal Assignee2920913 Canada Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (8), Non-Patent Citations (10), Referenced by (54), Classifications (13), Legal Events (7) External Links: USPTO, USPTO Assignment, EspacenetMethod for sterilizing products with gamma radiationUS 5362442 AAbstract A method for sterilizing products to remove biological contaminants such as viruses, bacteria, yeasts, molds, mycoplasmas and parasites is disclosed. The method involves providing the product in a form that contains less than 20% solids and subsequently irradiating the product with gamma irradiation over an extended period of time. Generally the product is irradiated for a period of not less than 10 hours. The extended irradiation time in conjunction with the low level of solids in the product substantially reduces the damage to the product. The method is useful in sterilizing sensitive materials such as blood and blood components.
What I claim as my invention is: 1. A method for sterilizing a product comprising:a) providing a product to be sterilized in a form having a solid content of less than 20% by weight and b) irradiating the product with gamma irradiation for a period of time of not less than 10 hours at a rate sufficient to provide a total dose of irradiation of between about 20 to about 32 kGy. 2. A method according to claim 1 wherein said process is carried out at ambient temperature.
FIELD OF THE INVENTION The present invention relates to a method for sterilizing products to remove biological contaminants such as viruses, bacteria, yeasts, molds, mycoplasmas and parasites.
BACKGROUND OF THE INVENTION Several products that are prepared for human, veterinary or experimental use may contain unwanted and potentially dangerous contaminants such as viruses, bacteria, yeasts, molds, mycoplasmas and parasites. Consequently, it is of utmost importance that such products are determined to be contaminant free before they are used. This is especially critical when the product is to be administered directly to a patient for example in blood transfusions, organ transplants and other forms of human therapies.
SUMMARY OF THE INVENTION In view of the above, there is a need to provide a method of sterilizing products that is effective in removing biological contaminants while at the same time having no adverse effect on the product. Examples of contaminants include viruses, bacteria, yeasts, molds, mycoplasmas and parasites.
DESCRIPTION OF PREFERRED EMBODIMENTS The following examples ere provided in order to illustrate the method of the present invention and are not meant to limit the scope of the invention.
EXAMPLE 1 Sterilization of Blood A 200 ml bag of one day old packed red blood cells was used. Ethanol was added to the cells in order to achieve a final ethanol concentration of 0.01%. The red blood cells were diluted by a factor of one in ten using a modified Citrate Phosphate Dextrose (CPD) solution having a pH of about 6.4 to 6.7 and having the following composition in a total volume of 500 ml:
EXAMPLE 2 Sterilization of Dextrose Dextrose (or glucose) containing solutions are used in the treatment of carbohydrate and fluid depletion, in the treatment of hypoglycaemia, as a plasma expander, in renal dialysis and to counteract hepatotoxins. Dextrose is also the preferred source of carbohydrate in parenteral nutrition regimens. In all of the above applications, the dextrose must be sterilized before use. Sterilization of dextrose containing products is generally done by heat sterilization or autoclaving. Unfortunately, these methods have been reported to degrade or caramelize dextrose containing solutions resulting in a color change in the solution. Gamma irradiation of glucose has also been reported to decompose glucose containing solutions. Therefore, there is e need for a method that can sterilize dextrose containing products that does not degrade the product itself. In view of the problems of the prior art, a dextrose solution was treated according to the method of the present invention as follows.
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*Dec 1, 1995Jun 6, 1996Central Biomedia IncPassive transfer immune serum and method of makingWO1998046073A1 *Apr 15, 1998Oct 22, 1998Secondo DottoriImproved storage and maintenance of blood productsWO2001070279A1 *Mar 23, 2001Sep 27, 2001Clearant IncMethods for sterilizing biological materialsWO2001087357A2 *May 16, 2001Nov 22, 2001American Nat Red CrossGamma irradiation of protein-based pharmaceutical productsWO2003020325A2 *Sep 3, 2002Mar 13, 2003Clearant IncMethods for sterilizing preparations containing albuminWO2004009143A1 *Jul 17, 2003Jan 29, 2004Wilson H BurgessMethods for sterilizing biological materials by multiple ratesWO2005030137A2 *Sep 24, 2004Apr 7, 2005Akkus OzanImproving biomechanical performance of irradiated biological materialWO2006048864A2 *Oct 27, 2005May 11, 2006Nanocyte IncSterile preparations and compositions including stinging capsules and methods of producing and using same* Cited by examinerClassifications U.S. Classification422/22, 250/432.00R, 426/240, 435/2, 422/44, 204/158.21International ClassificationA61L2/00, A61L2/08Cooperative ClassificationA61L2/0035, A61L2202/22, A61L2/0029, A61L2/0076European ClassificationA61L2/00P2R2Legal EventsDateCodeEventDescriptionMay 8, 2006FPAYFee paymentYear of fee payment: 12May 28, 2002REMIMaintenance fee reminder mailedMay 7, 2002FPAYFee paymentYear of fee payment: 8Apr 18, 2001ASAssignmentOwner name: CLEARANT, INC., CALIFORNIAFree format text: CHANGE OF NAME;ASSIGNOR:STERISURE, INC.;REEL/FRAME:011712/0232Effective date: 20000612Owner name: CLEARANT, INC. SUITE 500 11601 WILSHIRE BLVD. LOSOwner name: CLEARANT, INC. SUITE 500 11601 WILSHIRE BLVD.LOS AFree format text: CHANGE OF NAME;ASSIGNOR:STERISURE, INC. /AR;REEL/FRAME:011712/0232Apr 12, 2000ASAssignmentOwner name: STERISURE, INC., CALIFORNIAFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:STERWAYS PIONEER INC.;REEL/FRAME:010731/0688Effective date: 19990819Owner name: STERISURE, INC. SUITE 500 11601 WILSHIRE BLVD. LOSMay 8, 1998FPAYFee paymentYear of fee payment: 4Aug 26, 1993ASAssignmentOwner name: 2920913 CANADA INC., CANADAFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:KENT, RANDALL S.;REEL/FRAME:006649/0110Effective date: 19930712RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services©2012 Google