Sterile inflation system for a sealed bag with flexible wall

Package making – With contents treating – Vacuum or inert atmosphere

Reexamination Certificate

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Details

C053S432000, C053S510000, C414S412000

Reexamination Certificate

active

06244023

ABSTRACT:

SUMMARY OF THE INVENTION
This invention concerns a sterile inflation system for a sealed bag, and more specifically for a compacted bag with a flexible wall, in particular placed under vacuum.
The invention is intended particularly but not exclusively for the pharmaceutical industry and/or the medical field, and concerns the economical transfer of loose products or individual objects from a sterile and compacted bag, for example placed under vacuum, to a sterile enclosure.
A transfer technique of this type is the subject of International Application PCT/EP96/05 117, and the bag described in that patent application is particularly suited for use with the sterile inflation system which is the subject of this invention.
This type of bag is made of plastic, heat-sealed from a plastic sheath or sheets, for example from polyethylene with a low level of thickness, of the order of 120 micrometers; the bag presents, when flat, a transfer zone presenting a mouth constituted by a folded zone, able to be expanded to form a pocket adaptable to the transfer chamber of a sterile enclosure.
This invention is particularly suited to a bag of this type which is designed to contain sterile materials or objects, the sterilisation of the bag and its contents being carried out after the materials or objects have been introduced into the bag via an appropriate filling appendage and the bag has been re-sealed by heat-sealing or sealed.
More particularly, the invention is intended for a configuration in which the bag is compacted, that is to say, a bag in which the internal surfaces of the bag wall are more or less closely flattened one against the other, through the creation of a certain vacuum within the bag, this arrangement having the advantage of immobilising materials or objects therein and preventing or limiting their movement during transit; another advantage of compacting, naturally, is to reduce the space occupied by the bag.
When one wishes to transfer the contents of the bag into a sterile enclosure, in particular by means of a system in accordance with the above-mentioned patent application PCT/EP96/05 117, the bag must be inflated first. This enables the bag wall to expand to size, freeing the products it contains and the bag mouth to be adapted to the transfer chamber.
To do this, there is however one problem, associated with the fact that the bag wall is compacted and that its internal facing surfaces are in contact with each other, or at least very close to one another.
It is difficult, even impossible, to cut one wall only without piercing the opposite wall.
The purpose of the present invention is to solve this problem.
This objective is achieved due to the fact that the sterile inflation system for a sterile and compacted sealed bag with flexible wall, in particular placed under vacuum, which is the subject of the invention, comprises:
a) a bag which presents at least one appendage into which a spacer device has been inserted which forms a pocket between the interior surfaces of the bag, separating from each other two facing, flexible, partition sections of its wall, this pocket connecting with the interior space of the bag;
b) an inflation chamber comprising a fixed, exterior part and a mobile, interior part, which constitutes a cutting/inflation device;
in which:
c) the fixed and mobile parts are each fitted with a heatable blade with closed outline, one exterior, integral to the fixed part and the other interior, integral to the mobile part, these two blades being linked and joined at their apex in an airtight manner when the inflation chamber is in the closed state.
d) the inflation chamber and the outline of the spacer device are shaped in such a way that it is possible to adapt the pocket containing the spacer device to the exterior part so that one of the flexible partition sections is positioned in relation to the set of blades;
e) the inflation chamber is equipped with vacuum outlets capable of applying the flexible partition section of the bag by means of suction against the heated blades and to initiate the cutting by fusion of the zones which come into contact with the blades;
f) the said mobile part is fitted with an inflation channel, with a sterilising filter, through which air may pass into the space formed by the interior of the pocket when the inflation chamber is in the open state.
In a particularly advantageous embodiment of this system, the said spacer device is markedly cup-shaped, comprising a base and a raised rim or skirt, the latter presenting at least one opening which connects the space formed by the interior of the rim to the exterior of the rim.
The invention also comprises a bag with flexible wall intended for use in a system as described above.
This bag is remarkable in that it comprises at least one appendage containing an spacer device which forms a pocket between the interior surfaces of the bag, separating two facing flexible partition sections of its wall from each other, this pocket connecting with the interior space of the bag.
Other characteristics and advantages of the invention will appear from the description and the drawings in annex which show, by way of non-limitative example, a preferred method of embodiment of the invention.


REFERENCES:
patent: 2895270 (1959-07-01), Blaess
patent: 5496301 (1996-03-01), Hlavinka et al.
patent: 5910138 (1999-06-01), Sperko et al.
patent: 6070397 (2000-06-01), Bachhuber

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