Gusseted bag for medicinal or medical purposes formed of a...

Flexible bags – Lifting or suspending element – Unitary with bag

Reexamination Certificate

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Details

C383S104000, C383S109000, C383S120000

Reexamination Certificate

active

06332711

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a gusseted bag for medicinal or medical purposes that can be applied to a disposable sterilized container, which is subjected to no rinsing or sterilizing treatment for reiteration use, thus permitting use without validation.
2. Description of the Related Art
There has conventionally been used a drum can or box-shaped container made of stainless steel as a container for receiving intermediate products for pharmaceuticals. The drum can or box-shaped container, which has already been used for the intended use, must be subjected to a rinsing treatment for reiteration use to clean the inside of the drum can or box-shaped container. The drum can has for example the diameter of 50 cm and the height of 2 m and the box-shaped container has for example the dimensions of 1 m×1 m×1 m. The rinsing treatment of the inside of the drum can or box-shaped container however requires a great deal of labor and much time. In addition, there may occur problems of cross contamination and validation requires a long period of time and much cost in view of such problems of the cross contamination. As a result, there may be nothing for it but to dispose of the used drum can or box-shaped container.
There is, on the other hand, a demand that waste of resources should be avoided through reiteration use of the drum can or box-shaped container made of stainless steel. In reply to such a demand, there has been proposed a technical measures of placing an inner bag formed of polyethylene film in the drum can or box-shaped container made of stainless steel so that intermediate products for pharmaceuticals can be received in the inner bag and the used inner bag can be disposed after the completion of the intended use, thus permitting reiteration use of the drum can or box-shaped container made of stainless steel.
In general, a polyethylene film contains additives such as slipping agent, stabilizer, filler and the like. However, these additives should not be contained in a film for medicinal or medical purposes in view of medicinal or medical regulation. Therefore, such a film has a relatively small strength. In addition, the inner bag formed of the above-mentioned polyethylene film, which is to be placed in the drum can or box-shaped container is manufactured by heat-sealing the bottom portion of a tubular body formed of the polyethylene film under a collapsed condition, or by heat-sealing three portions, i.e., the both side portions and the bottom portion of a pair of polyethylene films placed on each other. The thus manufactured inner bag has no gusset, and the heat-sealed bottom portion thereof cannot accordingly be brought into close contact with the inner surface and the bottom surface of the drum can or box-shaped container, thus leading to a possible occurrence of breakage of the inner bag placed in the drum can or box-shaped container due to influences with respect to medicinal processes and vibration caused by transportation.
The other inner bag formed of polypropylene has also conventionally been proposed. The other inner bag mentioned above contains the same additives as described above, and is relatively brittle and has a poor impact resistance at a low temperature.
SUMMARY OF THE INVENTION
An object of the present invention, which was made in order to solve the above-described problems is therefore to provide a gusseted bag for medicinal or medical purposes, which permits prevention of breakage due to medicinal processes and vibration caused by transportation, and can be used as a disposable sterilized container without validation. In the present invention, when a film excellent in a gas-barrier property is used as an intermediate layer, both surfaces of which are to be laminated with other layers, respectively, it is possible to ensure a safely and stably stored condition of contents received in the gusseted bag.
In order to attain the aforementioned object, a gusseted bag for medicinal or medical purposes of the present invention comprises:
a gusseted bag body formed of a plastic film into a hollow shape; and
a scaled portion formed at a bottom of said gusseted bag body;
wherein:
said plastic film is a laminate composed of a plurality of layers; and
an innermost layer of said plurality of layers essentially consists of polyethylene.
The above-mentioned structure permits achievement of a sufficient close contact condition of the bottom of the gusseted bag with the inner surface of the bottom of the drum can or box-shaped container and prevention of occurrence of breakage of the gusseted bag even under the influence of medicinal processes and vibration caused by transportation. In the present invention, when a film excellent in a gas-barrier property is used as an intermediate layer, both surfaces of which are to be laminated with other layers, respectively, a safely and stably stored condition of contents received in the gusseted bag can be ensured.
The above-mentioned polyethylene may have a density within a range of from 0.910 to 0.919.
The above-mentioned sealed portion may be formed by heat-sealing the bottom of the gusseted bag body in a K-shaped form in a plan of the gusseted bag body under a collapsed condition thereof so as to form two flap portions corresponding to corner portions of the gusseted bag body, and cutting the two flap portions.
The above-mentioned gusseted bag body may have on an upper portion thereof at least one hole for hanging the gusseted bag.


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