EP0270717B1 - Method of manufacturing a flexible disposable container for sterile products, and container so realised - Google Patents

Description

The present invention relates to a process for obtaining a disposable flexible container after use for the packaging of sterile products requiring high purity, in particular semi-worked pharmaceutical products and the container resulting therefrom.

Pharmaceutical products are currently stored, between the different manufacturing and packaging phases, in stainless steel containers. These containers, several hundred in number per factory, represent a considerable investment. In addition, their mandatory cleaning after each use, requires expensive and heavy washing facilities.

• - un cadre métallique léger, éventuellement démontable, sur lequel est suspendu
• - un conteneur souple en toile polypropylène, jetable après usage.

The object of the present invention is to replace these metal containers with an assembly comprising:

• - a light metal frame, possibly removable, on which is suspended
• - a flexible container in polypropylene fabric, disposable after use.

The packaging proposed by the present invention eliminates the storage of heavy stainless steel containers, their cleaning and various necessary controls. It constitutes a considerable reduction in production costs.

In addition, such packaging is obtained in a simple manner which ensures absolute sterility of the packaged product.

• - propreté avant remplissage, et absence de risque de pollution du pollution du produit contenu pendant les opérations de remplissage, vidange et stockage;
• - étanchéite : plusieurs niveaux possibles selon le matériau utilisé pour la poche intérieure;
• - facilité de mise en place sur le cadre métallique et précision de positionnement sur ce cadre;
• - contrôle de débit à la vidange et vidange complète à chaque utilisation.

The container according to the present invention must meet four main requirements which are:

• - cleanliness before filling, and absence of risk of pollution from pollution of the product contained during filling, emptying and storage operations;
• - sealing: several possible levels depending on the material used for the inner pocket;
• - ease of installation on the metal frame and positioning accuracy on this frame;
• - flow control on emptying and complete emptying at each use.

DE-A- 3 223 539 describes and illustrates a large-capacity bag comprising side seams and closure straps both at the top and at the bottom. This bag does not include lower and upper sleeves of oblong shape used to hang it on a metal frame as in the present invention. In this bag, there are provided four stop straps fixed on reinforcing elements integral with the walls of the bag.

• a) à découper deux bandes de toile identiques en forme de bouteille;
• b) à coudre sur chaque bande de toile deux fourreaux de forme oblongue afin que l'espace délimité entre les deux fourreaux supérieurs et les deux fourreaux inférieurs constitue après assemblage desdites deux bandes de toile un corps de forme cubique;
• c) à confectionner une poche de forme analogue à celle des deux bandes de toile à coller ladite poche;
• d) qui comporte une soudure étanche à chaque extrémité sur la surface de chacune desdites deux bandes de toile;
• e) à assembler les deux bandes de toile par deux coutures verticales symétriquement opposées, la partie sous les deux fourreaux inférieurs constituant une trémie en forme de tronc de cône terminé par un orifice fermé par une première sangle tandis que la partie au-dessus des deux fourreaux supérieurs qui est définie à partir des coutures desdits fourreaux supérieurs constitue une jupe pourvue en bout d'un orifice et munie d'une deuxième sangle pour la fermeture après remplissage;
• f) à plier à plat ledit conteneur de façon telle que les deux orifices soient à l'intérieur du pliage.

The present invention therefore provides a method for obtaining a flexible disposable container after use for the packaging of sterile products, in particular semi-worked pharmaceutical products, which is characterized in that it consists of a combination:

• a) cutting two identical strips of canvas in the shape of a bottle;
• b) sewing on each strip of canvas two oblong sheaths so that the space delimited between the two upper sheaths and the two lower sheaths constitutes after assembly of said two strips of canvas a body of cubic shape;
• c) making a pocket similar in shape to that of the two strips of canvas to glue said pocket;
• d) which has a sealed weld at each end on the surface of each of said two strips of fabric;
• e) assembling the two strips of canvas by two symmetrically opposite vertical seams, the part under the two lower sleeves constituting a hopper in the form of a truncated cone terminated by an orifice closed by a first strap while the part above the two upper sleeves which is defined from the seams of said upper sleeves constitutes a skirt provided at the end of an orifice and provided with a second strap for closing after filling;
• f) folding said container flat so that the two orifices are inside the fold.

• - le cadre métallique léger est démontable;
• - la section de l'orifice de vidange varie en fonction du débit désiré;
• - tant les deux coutures verticales que les coutures des fourreaux, sont réalisées en fil polyester et sont coupées à chaud;
• - les bandes de toile sont en polypropylène;
• - la poche interne est en polyéthylene.

The container is suspended both before filling and during emptying on a light metal frame by means of bars inserted in the sleeves, which bars are secured by any appropriate means to vertical uprights of said frame;

• - the light metal frame is removable;
• - the section of the drain orifice varies according to the desired flow;
• - both the vertical seams and the sheath seams are made of polyester thread and are hot cut;
• - the canvas bands are made of polypropylene;
• - the internal pocket is made of polyethylene.

• - la figure 1 est une représentation schématique des divers éléments constitutifs du conteneur avant assemblage;
• - la figure 2 est une vue en perspective du conteneur suspendu sur un cadre métallique pendant la vidange;
• - la figure 3 est une vue en perspective du conteneur à l'état rempli.

Various advantages and characteristics of the present invention will emerge from the detailed description below made with reference to the appended drawings in which:

• - Figure 1 is a schematic representation of the various components of the container before assembly;
• - Figure 2 is a perspective view of the container suspended on a metal frame during emptying;
• - Figure 3 is a perspective view of the container in the filled state.

In the accompanying drawings in which the same reference symbols designate similar parts, the flexible container according to the present invention is generally designated by 1. The container 1 is composed of an external envelope made from two strips of fabric 2, 3 and an internal envelope 4 in the form of a pocket, the material of which is chosen as a function of the desired degree of tightness. The two strips of fabric 2, 3 are cut as shown in Figure 1 in a bottle shape. These canvas strips 2, 3 each have two sleeves 7, 8, 9,10 added by sewing which will be used to suspend the container 1 on a metal frame 22 provided with vertical uprights 24 by means of metal bars 23. Thanks to such a arrangement, the placement of the container is performed very quickly. In addition, due to the provision of the two lower sleeves 9, 10, the container 1 does not deform during filling and therefore retains a cubic shape in its upper part. The seams of the two upper sleeves 7, 8 are made so as to materialize the top of the container 1 and delimit the parts 20 which provided with a strap 22 will serve as a skirt for closing the container 1 after filling. The pocket 4 is, for example, a polyethylene pocket. It seals the container 1 and is cut into a bottle. Its width is somewhat greater than that of the fabric strips 2, 3 and it includes a sealed weld 5, 6 at each end. When the container 1 is used, the bag 4 is glued to each of the fabric strips 2, 3. The internal part of the bag 4 thus remains protected from any contact with the dust until it is opening for filling.

The two strips of fabric 2, 3 are assembled by two vertical seams 12, 13, the lower part 14 constituting a hopper 15 in the form of a truncated cone terminated by a cylindrical emptying orifice 16 closed by a first strap 17. The section of the hopper 15 is calculated at will as a function of the desired flow rate. All the seams 19 are made of polyester thread and are cut hot, so as to avoid any risk of pollution of the product contained by fibrils which could detach from the threads.

The finished container is folded flat so that its two orifices 16, 21 are inside the fold, which thus avoids any risk of dust entering between the external envelope constituted by the strips of fabric 2, 3 and the internal pocket 4. Since the internal pocket 4 is welded at its two ends, it cannot be deployed due to the absence of air inside. In addition, since the pocket is glued to the sides of the container 1, it also cannot be deployed.

• - une construction aisée et simple à partir de deux seuls panneaux de toile de tout le conteneur comprenant le corps, la jupe de fermeture supérieure, la trémie et l'orifice de vidange;
• - une diminution sensible du nombre de coutures qui est un gage de propreté;
• - une géométrie parfaite due à la présence dwes deux fourreaux inférieurs;
• - une étanchéité totale du fait de la réalisation de la poche interne totalement fermée jusqu'à son ouverture pour le remplissage;
• - un procédé de stockage intermédiaire beaucoup plus économique que les procédés selon l'art antérieur.

The container opening operation can only be executed in the user's manufacturing workshop, protected from any dust when the container 1 is placed on its frame 22. The opening does not will be possible only after having cut the welded upper part of the pocket 4. It will be the same for the lower part at the time of emptying. The container according to the present invention provides numerous advantages:

• - easy and simple construction from two single canvas panels of the entire container comprising the body, the upper closing skirt, the hopper and the drain opening;
• - a significant reduction in the number of seams which is a guarantee of cleanliness;
• - perfect geometry due to the presence of two lower sleeves;
• - a total seal due to the realization of the internal pocket completely closed until its opening for filling;
• - an intermediate storage process much more economical than the processes according to the prior art.

Claims (8)

1. Process for obtaining a flexible container (1) which is disposable after use, for the packaging of sterile products, especially of semi-finished pharmaceutical products, characterized in that it consists, in combination, of:

a) cutting out two identical strips of web (2, 3) in the shape of a bottle;

b) sewing onto each strip of web (2, 3) two sleeves of oblong shape (7, 8, 9, 10) in order that the space defined between the two upper sleeves (7, 8) and the two lower sleeves (9, 10) should form, after assembly of the said two strips of web (2, 3), a body of cubic shape (11);

c) constructing a pocket (4) of a shape similar to that of the two strips of web (2, 3), which includes a sealed weld (5, 6) at each end, onto the surface of each one of the said two strips of web (2, 3);

d) cementing the said pocket (4)

e) assembling the two strips of web (2, 3) by two vertical sewings (12, 13) which are symmetrically opposite, the part (14) beneath the two lower sleeves (9, 10) forming a funnel (15) in the shape of a truncated cone terminated by an orifice (16) closed by a first strap (17) while the part (18) above the two upper sleeves (7, 8) which is defined from the sewings (19) of the said upper sleeves (7, 8) forms a skirt (20) provided, at the end, with an orifice (21) and equipped with a second strap (22') for closing after filling;

f) folding flat the said container (1) in such a manner that the two orifices (16, 21) are within the folding.

2. Process according to Claim 1, characterized in that the container (1) is suspended, both prior to filling and during emptying, on a light metal frame (22) by means of bars (23) inserted into the sleeves (7, 8, 9, 10), which bars (23) are fixed by any appropriate means to vertical uprights (24) of the said frame (22).

3. Process according to one of Claims 1 or 2, characterized in that the light metal frame (22) is demountable.

4. Process according to any one of Claims 1 to 3, characterized in that the cross-section of the emptying orifice (16) varies as a function of the desired flow rate.

5. Process according to any one of Claims 1 to 4, characterized in that both the vertical sewings (12,

13) and the sewings (19) of the sleeves are provided in polyester thread and are cut in the hot condition.

6. Process according to any one of Claims 1 to 5, characterized in that the strips of web (2, 3) are of polypropylene.

7. Process according to any one of Claims 1 to 6, characterized in that the internal pocket (4) is of _Dolvethvlene.

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