Special receptacle or package – For mixing
Reexamination Certificate
2001-08-09
2004-03-30
Foster, Jim (Department: 3728)
Special receptacle or package
For mixing
C053S452000, C604S410000, C604S416000
Reexamination Certificate
active
06712202
ABSTRACT:
The invention relates to a method for producing a two-chamber arrangement having a first chamber, which is filled with a first component, and a second chamber, which is filled with a second component. The invention moreover relates to such a two-chamber arrangement.
Two-chamber systems of this kind are used for example for storing substances for infusion therapy or for parenteral nutrition, which substances are intended to be mixed together shortly before administration. Multi-chamber bags are known for example from DE 32 38 649, DE 94 01 288 and EP 0,737,468.
A common feature of the known two-chamber bags is that they have two chambers which are separated by a peel seam. Upon use, the seam is opened so that the components contained in the chambers can be mixed together. To remove the content of the bag, a closable outlet opening is provided on one of the two chambers.
The known two-chamber bags have proven themselves in practice. However, if one of the two chambers is filled with a sensitive substance, the sterilization of the bag can prove problematic.
It is therefore an object of the invention to make available a method which permits simplified and cost-effective production of a two-chamber arrangement in large batch numbers. It is a further object of the invention to make available a two-chamber arrangement which can be produced easily and cost-effectively.
The method according to the invention is based on producing and filling not just one common bag with two chambers, but instead two separate bags each with only one chamber, said bags being connected to each other only at a later stage. Each bag can therefore be sterilized independently of the other and using different methods.
To produce the two-chamber arrangement, the first and second film bags are each sealed with an openable seam. The two bags are then joined together in such a way that, after the two seams have been opened, the two components can be mixed together. The two bags are preferably welded to each other after being filled. However, they can also be adhesively bonded to each other. Sealing each bag with an openable seam has the advantage that the content of the bag is securely enclosed before the bags are joined together.
The film bags can be made from superposed film webs connected to each other at their edges, or from a film tubing.
The first and second peel seams are preferably arranged in such a way that the salient bag films form pockets so that the bags can be easily connected to each other. The pockets are preferably sealed in order to keep the bags free from particles. The bag films are advantageously prevented from sticking together by means of an air cushion.
For the production of antibiotics or cytostatics, the first bag can be filled with a carrier solution and the second bag can be filled with an active powder substance independently of each other and at different locations. The first bag can be autoclaved at relatively high temperatures in a known manner and the second bag can be radiosterilized before filling. After the two bags are connected, the two-chamber arrangement again forms a user-friendly unit which allows the component contained in one chamber to be transferred into the other chamber.
It is advantageous if the first bag containing the carrier solution is made from a weldable polyolefin film, while the second bag receiving the moisture-sensitive active powder substance is made of a water-absorbing and oxygen-absorbing aluminum composite film. In order to be able to weld the aluminum film too, the latter is preferably provided with an appropriate coating.
The two-chamber arrangement can be incorporated as a primary bag into a secondary bag with appropriate barrier properties. Oxygen-absorbing bags can also be provided between primary packing and secondary packing.
In a second embodiment, the two bags are connected by means of a tubular connection piece which is sealed with a detachable part. One end of the connection piece is inserted into the first bag, and the part of the connection piece protruding beyond the bag is advantageously protected by a protective cap which is removed before the other end of the connection piece is inserted into the second bag.
In a further alternative, a first connector piece is inserted into the first bag, and a second connector piece is inserted into the second bag, and these connector pieces are connected to each other, for example screwed together or plugged one into the other, for the purpose of mixing the two components together.
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Eschenbach Bernd
Muller Hans-Jorg
Sommermeyer Klaus
Foster Jim
Fresenius Kabi Deutschland GmbH
Heslin Rothenberg Farley & & Mesiti P.C.
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