Classifications

• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D31/00—Bags or like containers made of paper and having structural provision for thickness of contents
  • B65D31/04—Bags or like containers made of paper and having structural provision for thickness of contents with multiple walls
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes or webs of flexible sheet material, e.g. in folded wrappers
  • B65D75/52—Details
  • B65D75/58—Opening or contents-removing devices added or incorporated during package manufacture
  • B65D75/5861—Spouts
  • B65D75/5866—Integral spouts

Definitions

• the invention relates to a flexible, practical disposable container for sterile applications, adapted to be used in particular for transfers of products or small equipment such as piston seals or bottle caps and a method of manufacture of such a flexible container.
• these single-use enclosures also called single-use containers, generally consist of the combination of a rigid door (or cover) and a flexible plastic bag (or bag), most often transparent.
• Such single-use containers can be used to transfer all kinds of products, liquid, solid or powder, to more massive speakers (or even from them).
• these single-use containers When these single-use containers are intended for the transfer of products or small equipment, they may also comprise a second door, of the same type as the first, so as to allow the entry of products or equipment by one of the doors, and the exit of the products or materials by the other of these doors.
• such containers allow the application of a treatment products or materials contained therein, for example a sterilization treatment.
• This sterilization can be performed by steam, by gamma or beta radiation.
• Such sterilization can be especially provided when the containers are used for the transfer of small equipment, such as piston seals, plugs, needle shields, etc. which are intended to be in direct contact with injectables.
• the films constitute not only barriers to microorganisms but also barriers to water vapor (especially in the case of lyophilizates) and so on. It should be noted that, by way of example, these controls are not satisfied when the films are made of a thin-fiber material made of high-density polyethylene known under the trademark "TYVEK” ® from DUPONT, allowing for sterilization with steam.
• TYVEK high-density polyethylene
• the controls on the manufacturing steps are more severe.
• the welds are no longer simply visually inspected, but also undergo sealing tests, methylene blue for example, pressure resistance tests, elongation tests, etc.
• any intervention is necessarily a source of contamination, reducing the quality of the sheath in question. It follows that the mounting of one or more doors in a sheath initially having a high level of cleanliness in principle implies a deterioration of this level of cleanliness.
• the object of the invention is to obtain, with a high level of cleanliness, a flexible single-use container provided with two access doors which are in principle only used, intended respectively for an inlet and an outlet of products or materials, while allowing the application of treatments such as sterilization treatment.
• the invention proposes for this purpose a flexible transfer container comprising an inner bag formed of a flat sleeve closed at one end and whose other end is folded towards the first end, this inner bag being included in an outer bag formed a sheath provided with a first access door passing through the wall of the two bags, near the closed end of the inner bag and a second access door passing through only the wall of the outer bag, opposite a portion of the folded end of the inner bag.
• the container of the invention comprises an inner bag which houses the products (or materials), and an outer bag in which the inner bag is included.
• the folded end of the inner bag is shaped trompe, narrower than the rest of the inner bag, which facilitates the release of products or materials contained in the inner bag, the inner bag has a width at most equal to that of the outer bag, which allows the inner bag to be completely filled (if necessary) inside the outer bag,
• the two bags are connected near the first closed end of the inner bag, thus close to the first door, which contributes to relieving the load borne by the connection ensured between the door and the walls of the two bags,
• the two bags are connected by welding, which corresponds to a well known connection mode, respecting the cleanliness and sealing criteria, in particular,
• the two bags are connected near the folded end of the inner bag, which favors holding the second end in a folded configuration when filling the inner bag,
• the access doors are single-use doors, which helps to ensure that the container can not be used a second time, inadvertently,
• the inner and outer bags are made of different materials, one of which has a particulate holding capacity and the other has mechanical protection properties, which makes it possible to distribute between the two bags the various functions required of the container.
• the invention furthermore proposes a method of manufacturing such a container, namely a method of manufacturing a container of the aforementioned type, according to which a first flat duct is produced, leaving there, near a first end. , a hole passing through a single wall of this sheath and by folding the other end, a ring is slid inside this sheath from the first end so as to pass through this hole, a second sheath is also made in which two holes are made, is engaged in one of the holes a first access door and another door is engaged in the other hole, the first door being, after introduction of the inner bag into the outer bag, connected by snapping to the ring while the second door is facing the folded end of the first sheath.
• This method has preferred features, possibly combined, analogous to those set forth above with respect to the container; in particular :
• the two sheaths are connected near at least one end of the first sheath
• the two sheaths are made of two materials, one of which has a particulate holding capacity and the other has mechanical protection properties.
• FIG. 1 is a perspective view of a sheath adapted to form the inner bag of a container according to the invention
• Figure 2 is a partial view showing a portion receiving a ring to be assembled to an access door
• Figure 3 is a view of the sheath forming the outer bag 4 is a partial sectional view of the container when assembling a door to the ring
• FIG. 5 is a top view of the complete container.
• Figures 1 to 5 show steps for manufacturing a container according to the invention: this container, noted 1 as a whole, comprises an inner bag 10, completely included in an outer bag 20.
• the inner bag 10 is made from a flexible sheath 11 of completely flattened shape (its wall thus forms two superposed layers and in contact with one another so as to minimize the internal volume of this sheath), which is sectioned so as to have first and second ends.
• One of the ends, noted 12, is left intact while the other end is here modified, by shrinking, for example by welding since the outside, so as to form a horn, noted 13, of smaller section than the other end.
• a hole 14 is formed in the upper layer of the wall of the inner bag, near the first end, for example using a punch (see Figure 1).
• a rigid ring 15 is then (see FIG. 2) slid into the sheath from the first end 12, until it is fitted into the hole 14.
• This ring is for example made of a rigid plastic material, obtained by injection into conditions of cleanliness.
• this setting operation of the ring is the only one that is likely to allow to degrade the cleanliness of the interior of the inner bag since it involves opening the sheath between the end 12 and the hole 14 (this action to open the sheath is exaggerated in Figure 2, by analogy with Figure 1).
• this action to open the sheath is exaggerated in Figure 2, by analogy with Figure 1).
• such a degradation is insignificant since this preparation is carried out in clean room.
• the outer bag 20 is formed of a sheath, in practice slightly wider than the sheath 11, so as to allow easy introduction of the sheath 11.
• This outer bag 20 is here obtained by simply cutting a flexible tube, and its two ends 21 and 22 are here open (see Figure 3).
• This external bag has two holes, one of which, 23, is adapted to come opposite the hole 14 of the inner bag, and comprises an access door 25, cooperating with a hoop 24 cooperating with the access door so as to sandwich the periphery of the hole 23.
• This door 25 is adapted to cooperate, here by snapping, with the rigid ring 15 (see below with reference to Figure 4) and thus provide a connection between the two bags.
• the other hole 26, intended to come opposite the horn, is provided with an access door 27, in practice identical to the access door 25.
• access doors 25 and 27 are advantageously disposable, as for example described in the document EP-0 688 020 cited above. It will be understood that, by the concept of access door, here means the combination of a fixed flange with respect to at least one of the bags and a movable shutter adapted to seal, or not, the formed opening in the flange.
• the first access door 25 is for loading products or small equipment while the second access door 27 is intended for unloading these products or small equipment, via the horn.
• This outer bag can be prepared in less clean conditions than the inner bag.
• the container manufacturer can then introduce the inner bag, after folding the trunk, dragging the assembly and folded; the door 25 is then snapped onto the rigid ring 15 (see Figures 4 and 5).
• the mounting of the two doors is carried out after introduction of the inner bag into the outer bag, it will be noted that the fact of not having, after the sliding of the inner bag in the outer bag, to connect by snapping the first door to the rigid ring has the advantage of minimizing the risk of degradation of the inner bag due to its assembly to the outer bag.
• the material constituting the internal bag can be made of a material already validated for its qualities of compatibility with the products that are intended to be introduced while the material constituting the outer bag can be chosen for its ability to serve barrier, its resistance to vacuum, its impermeability to oxygen, steam, etc. ; it may especially be a multilayer material.
• the inner bag is made of a polyethylene film of high degree of cleanliness, with a thickness of the order of 80 to 120 microns while the outer bag can be made of a polyethylene-polyamide multilayer. polyethylene of thickness substantially equal to about 100 microns.
• the inner bag 10 is in practice longer than the outer bag 20, which makes it possible to fold the trunk while allowing the portion of maximum width of this inner bag to be only slightly shorter than the outer bag (it can be seen in the figure 5 that the portion of maximum width of the inner bag occupies about three quarters of the length of the outer bag and has a trapezoidal portion transition to the horn which is almost completely located after the fold of the inner bag.
• trunk that passes under this door and pulls it outward, to unfold and allow the exit of the products or materials to the outside, for example inside another enclosure to a port which the access door 27 has been fixed.
• the form of trunk allows a good flow of products when they are liquid or powdery or when the materials are very small parts.
• section of the horn is preferably slightly less than that of the access door so as to promote the output of products and materials.
• the two bags may be provided to secure the two bags by an external weld along the dotted line 30 near the left openings of the two bags, which prevents the inner bag is the only one to bear the burden of the products or materials to be transferred or processed. It can also be provided to secure the two bags by an external weld along the dotted line 31 near the folded end of the inner bag, which promotes the retention in the folded position of the inner bag during its filling by the door 25. It can of course be expected that there will be welds near each end of the outer bag, so as to avoid any significant entry of contamination between the two inner and outer bags.
• the trunk has a length representing about one quarter of the length of the set of two bags.

Landscapes

• Engineering & Computer Science (AREA)
• Mechanical Engineering (AREA)
• Bag Frames (AREA)
• Packages (AREA)
• Making Paper Articles (AREA)

Applications Claiming Priority (2)

Publications (2)

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Family Applications (1)

Country Status (7)

Families Citing this family (4)

Family Cites Families (18)

• 2007
  • 2007-05-11 FR FR0755036A patent/FR2915974B1/fr not_active Expired - Fee Related
• 2008
  • 2008-05-13 DE DE602008004564T patent/DE602008004564D1/de active Active
  • 2008-05-13 WO PCT/FR2008/000660 patent/WO2008155483A2/fr not_active Ceased
  • 2008-05-13 EP EP08805564A patent/EP2193086B1/de active Active
  • 2008-05-13 US US12/599,897 patent/US8523436B2/en active Active
  • 2008-05-13 AT AT08805564T patent/ATE495117T1/de not_active IP Right Cessation
  • 2008-05-13 JP JP2010507950A patent/JP5167346B2/ja active Active

Non-Patent Citations (1)

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