Chemical apparatus and process disinfecting – deodorizing – preser – Process disinfecting – preserving – deodorizing – or sterilizing
Patent
1994-05-16
1996-07-16
Warden, Robert
Chemical apparatus and process disinfecting, deodorizing, preser
Process disinfecting, preserving, deodorizing, or sterilizing
206568, 206570, 206828, 422 25, 422 40, 422 41, 422256, 604408, 604410, A61L 200, B01J 1900
Patent
active
055364691
DESCRIPTION:
BRIEF SUMMARY
TECHNICAL FIELD
The present invention relates to a system employing a sterile medical solution comprising glucose or glucose-like compounds, for example nutritional solutions or solutions for peritoneal dialysis, whereby the majority of the solution is packed in a package whilst the glucose or the glucose-like compounds are packed separately in a second package, whereafter the two packages are heat sterilized. By the expression glucose-like compounds is meant for example glucose polymers.
BACKGROUND OF THE INVENTION
It is known to pack a CAPD-solution in a two chamber package from, for example, the article "In Vitro Testing of a Potentially Biocompatible Continuous Ambulatory Peritoneal Dialysis Fluid" by N Topey et al, in Nephrol Dial Transplant (1991) 6:574-581.
The same, or at least a similar, two chamber package having essentially the same inventors is described in international patent application no. WO 91/08008. From e.g. Example 1 of this document it is apparent that the two parts of the package are intended to contain essentially the same quantity of solution. Thus, when the article refers to a larger and smaller package respectively, this is assumed to mean that even in this case the two packages will contain the same quantity of solution, though with the one package being made larger so as to be able to serve as a mixing chamber.
It is known from, for example, the article "Toxity of peritoneal dialysis fluids on cultured fibroblasts L-929" by Anders Wieslander et al, in Kidney International, Vol 40 (1991) pp 77-79, that heat sterilized CAPD-solutions can contain harmful components which can depend on the decomposition of certain compounds, for example glucose, during the sterilization,
It is known from, for example, U.S. Pat. Nos. 4,369,779; and 4,753,697 to achieve a sterile coupling between two tubes in various ways, which can be joined to two separate packages.
DESCRIPTION OF THE INVENTION
The present invention can be said to be a development of the above mentioned teachings and relates to a system making use of a sterile medical solution comprising glucose or glucose-like compounds, for example nutritional solutions or solutions for peritoneal dialysis, whereby the majority of the solution is packed in a package whilst the glucose or the glucose-like compounds are separately packed in a second package, whereafter the two packages are heat sterilized.
The system according to the invention is characterized in that the content of the glucose or glucose-like compounds in the second package is maintained above 10% by weight, suitably above 20% by weight, and preferably in the order of 40% by weight. In this manner the breakdown of the packaged product is reduced. At the same time the risk of breakdown is reduced since the product which is sensitive to breakdown need not be in contact with all the compounds in the final solution during heat sterilization.
A further advantage with the invention is the possibility to achieve a final neutral solution with a pH between 6.5 and 7.5. Preferably, a pH of 7.0 is hereby achieved. Here it should be stressed that as far as we are aware no such neutral solutions for PD-dialysis are presently commercially available on the market.
In practice, it has been shown to be possible to make use of a sterilizing temperature between 110.degree. C. and 150.degree. C. and sterilizing times between 180 minutes and 10 minutes from the commencement of heating to cooling to room temperature. At the same time the time interval for the maximum heating should hereby be kept as short as possible, though sufficiently long, of course, to meet the requirements imposed by the authorities so that sufficient death rate of bacteria and spores is obtained.
One possibility is that the two packages are manufactured separately and each one provided with a connection piece or connection tube. Preferably, both packages are completely sealed and each one provided with a connection piece or connection tube made from a heat sealable material and sealed at its extremity with a welded seal,
REFERENCES:
patent: 3874384 (1975-04-01), Deindoerfer et al.
patent: 4368729 (1983-01-01), Dossin
patent: 4369779 (1983-01-01), Spencer
patent: 4657540 (1987-04-01), Iwamoto et al.
patent: 4994057 (1991-02-01), Carmen et al.
patent: 4997083 (1991-03-01), Loretti et al.
patent: 5114004 (1992-05-01), Isono et al.
patent: 5344392 (1994-09-01), Senninger et al.
"In Vitro Testing of Potentially Biocompatible Continuous Ambulatory Peritoneal Dialysis Fluid" Topley et al., Nephrol Dial. Transplant (1991) 6:574-581.
"Toxicity of Peritoneal Dialysis Fluids on Cultured Fibroblasts L-929", Anders Wieslander et al., Kidney International, vol. 40 (1991) pp. 77-79.
Feriani et al., "Will Bicarbonate--CAPD Strengthen the Natural Defence by Having a Physiological pH and a Natural Buffer?" Contr. Nephrol., vol. 57, pp. 101-109 (Karger, Basel 1987).
Andren Anders
Jonsson Sven
Kjellstrand Per
Martinson Evi
Svensson Eva
Gambro AB
Thornton Krisanne M.
Warden Robert
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