Classifications

• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L1/00—Enclosures; Chambers
  • B01L1/02—Air-pressure chambers; Air-locks therefor
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
  • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
  • B01L3/505—Flexible containers without fluid transport within
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
  • B01L3/56—Labware specially adapted for transferring fluids
  • B01L3/563—Joints or fittings; Separable fluid transfer means to transfer fluids between at least two containers, e.g. connectors
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
  • A61L2202/10—Apparatus features
  • A61L2202/18—Aseptic storing means
  • A61L2202/181—Flexible packaging means, e.g. permeable membranes, paper
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
  • B01L2200/14—Process control and prevention of errors
  • B01L2200/141—Preventing contamination, tampering
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
  • B01L2200/18—Transport of container or devices
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2300/00—Additional constructional details
  • B01L2300/04—Closures and closing means
  • B01L2300/041—Connecting closures to device or container
  • B01L2300/043—Hinged closures
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2300/00—Additional constructional details
  • B01L2300/12—Specific details about materials
  • B01L2300/123—Flexible; Elastomeric

Definitions

• the present invention relates to a sealed transfer bag suitable for gas sterilization, having increased mechanical strength.
• Such a double-door device provided with a multiple-safety control is for example known from document FR 2 695 343.
• Each volume is closed by a door mounted in a flange.
• Each door is secured to its flange either by a bayonet connection or by a hinge and a locking system and the two flanges are intended to be secured to each other by a bayonet connection.
• one of the closed volumes is formed by an isolator and the other volume is formed by a flexible container, also referred to as a sealed transfer bag.
• connection part carried by the insulator is designated the alpha part and the connection part carried by the container is designated the beta part.
• Gaskets are provided on the alpha part and on the beta part to ensure sealing between the connected volumes.
• the connection between the transfer bag and the enclosure is made by mechanical cooperation of the beta flange and the alpha flange, for example by a bayonet-type connection. This mechanical cooperation seals the connection.
• Such bags are usually intended for the sterile transfer of small components such as stoppers, syringe plungers, plastic vials, etc. on filling lines in the pharmaceutical industry.
• Transfer bags suitable for sterilization by autoclave or EtO comprise a flexible container generally comprising a face formed by a non-woven textile sheet of high density polyethylene fibers, for example marketed under the brand name Tyvek® forming a microbial barrier, impermeable to water but permeable to vapor and gas.
• the flexible container comprises for example a face made of Tyvek® and a face made of extruded polyethylene.
• the beta part comprises a flange, a door, a seal sealing between the flange and the door, and a clamp.
• the beta part is made of polycarbonate or polysulfone (PSU), because these materials have good performance for their temperature resistance.
• PSU polysulfone
• Polycarbonate commonly withstands a temperature of 142°C and PSU a temperature of 149°C. Since the polycarbonate and the PSU do not weld to the polyethylene, a polyethylene connector loaded with fiberglass is welded to the extruded polyethylene film and is assembled in a tight manner to the flange by means of the clamping collar and a gasket. .
• the polyethylene connector can be loaded with glass beads. These transfer bags are satisfactory.
• a transfer bag comprising at least one part made of nonwoven fabric of high density polyethylene fibers and a beta connection part secured in leaktight manner to the part of nonwoven fabric of high density polyethylene fibers. density.
• connection part could be assembled by welding directly to the non-woven textile part of high density polyethylene fibers.
• the flexible container is entirely made of nonwoven fabric of high density polyethylene fibers and the connection part is welded to the end of the flexible container.
• the bag has a larger steam exchange surface for autoclaving cycles.
• the position of the beta part at the end of the container facilitates the transfer of objects to the insulator.
• An object of the present application is then a transfer bag intended to be connected to a sealed transfer device comprising a connection part and a flexible container, the flexible container comprising at least one part made of nonwoven fabric of high density polyethylene fibers, and the connection part comprising at least one element compatible with a weld with the part made of nonwoven fabric of high density polyethylene fibers , said compatible element, in which the compatible element is welded to the non-woven textile part of high density polyethylene fibers and bordering an opening of the bag.
• connection part comprises a flange intended to be fixed to the transfer device, a door mounted in the flange, a gasket sealing between the flange and the door, a polyethylene connector forming the compatible element, a clamp assembling the flange and the connector and a gasket disposed between the connector and the flange.
• the flange is made of a material comprising between 0.01% by mass of cyclic olefin polymer and 100% by mass of cyclic olefin polymer, the flange forming the compatible element.
• the flexible container comprises a first and a second wall assembled in a sealed manner by their edges, the first wall being made of a non-woven fabric of high density polyethylene fibers, the opening of the bag being formed in the first wall and the polyethylene connector is welded to the first wall.
• the second wall can be made of extruded polyethylene.
• the flexible container is made entirely of non-woven fabric of high density polyethylene fibers.
• the flexible container may extend along a longitudinal axis between a closed end and an open end, with the compatible member being welded to the edge of the open end.
• Another object of the present application is a method of manufacturing a transfer bag according to the present application, comprising:
• the method may also include assembly by means of the clamping collar of the connector and of the flange.
• FIG. 1A is a view in longitudinal section schematically illustrating the connection of a transfer bag to a cell by means of a sealed transfer device with a double door by means of the bayonet type.
• Figure IB is an exploded representation of the beta part alone.
• Figure 2 is a schematic representation of an example of a transfer bag according to the invention.
• Figure 3 is a schematic representation of another example of a transfer bag according to the invention.
• Figure 4 is a schematic representation of another example of a transfer bag according to the invention.
• Figure 5 is a schematic representation of another example of a transfer bag according to the invention.
• FIG. 1A one can see a schematic representation of a sealed double-door transfer system in which a flexible transfer bag according to the invention can be implemented.
• the double door transfer system has a symmetry of revolution around the X axis which is the axis of the isolator flange.
• the two closed volumes that one wishes to connect correspond respectively to an isolator 10 and a flexible container 12.
• the insulator 10 is delimited by a wall 14 of which only part is visible in FIG. It is equipped, in a conventional manner, for example with remote manipulation means such as telemanipulators and/or gloves (not shown) integral with the wall 14, thanks to which the centralized control mechanism can be maneuvered from inside the this cell 10.
• the container 12 is also delimited by a wall 16, as shown in particular in Figure IA.
• the wall 16 is formed by a flexible bag, for example obtained by welding at their edges two pieces of film, for example of rectangular shape. The bag has an opening sealed to a flange.
• the double door sealed transfer device mainly comprises an isolator flange 18, a container flange 20, an isolator door 22 normally closing a circular opening delimited by the isolator flange 18, and a container door 24 closing normally an opening delimited by the container flange 20.
• the insulator flange 18 and the container flange 20 are fixed respectively to the wall 14 of the cell 10 and to the wall 16 of the container 12.
• the door of the insulator 22 is hinged to the insulator flange 18 by a hinge 26.
• Means designated generally by the reference 28 make it possible to control the opening and closing of the doors 22 and 24.
• the fixing of the container door 24 on the container flange 20 is provided by a bayonet connection 30 as described in document FR 2 695 343.
• the double-door leaktight transfer system also comprises two other bayonet connections designated respectively by the references 32 and 34.
• the three bayonet connections 30, 32 and 34 are arranged such that after docking of the container flange 20 on the insulator flange 18, a rotation of the container 12 around its axis, for example in the direction of clockwise a watch, a the effect of joining the container flange 20 and the insulator flange 18, of joining the container door 24 and the insulator door 22, and of separating the container door 24 from the container flange 20.
• These last two operations are carried out consecutively, so that the opening of the container only occurs after the container door 24 has been secured to the insulator door 22 to form a double door.
• the assembly formed by the insulator flange and the insulator door is commonly referred to as the “alpha part”.
• the assembly formed by the container flange 20, the container door 24 and the seal 25 mounted on the flange and which provides both the seal between the flange and the door and between the flange and the sealed transfer device is commonly referred to as a "beta part".
• This set is shown in Figure IB.
• the beta part also comprises a connector 36 intended to be fixed to the flexible container, a clamp 38 to secure the connector and the flange and a seal 40 interposed between the flange 20 and the connector 36 to ensure sealing. of assembly.
• the transfer bag then comprises a beta connection part and a flexible container.
• the flexible container 42 comprises a wall 44 made of non-woven textile of high density polyethylene fibers, for example marketed under the Tyvek® brand, and a wall 46 made of extruded high density polyethylene.
• a wall 44 made of non-woven textile of high density polyethylene fibers for example marketed under the Tyvek® brand
• a wall 46 made of extruded high density polyethylene for the sake of simplicity, in the remainder of the description the nonwoven fabric of high density polyethylene fibers will be referred to as textile, and the extruded high density polyethylene will be referred to as extruded HDPE.
• the two walls 44, 46 are sheets, in the example shown rectangular, superimposed and welded to each other at their outer edges.
• the shape of the sheets can be different, for example sheets in the form of a disc does not depart from the scope of the present invention.
• the sheets are welded only by their side edges and the bottom left open for a filling by the bottom and a welding of the bottom after filling.
• the textile wall 44 includes an opening 48 to the contour of which is welded the connector 36 made of polyethylene loaded with glass fibers, for example at 20%.
• the textile being made of polyethylene and the connector comprising polyethylene, there is a chemical compatibility between the wall 44 and the connector 36 allowing welding between the two.
• the polyethylene connector forms a weld-compatible element with the non-woven fabric portion of high-density polyethylene fibers.
• the flange is assembled in a sealed manner on the connector 36 by means of the gasket and the clamping collar.
• connection by welding between the connector 36 and the textile offers a mechanical resistance that is particularly suited to the stresses to which a flexible transfer bag is subjected, in particular during gas sterilization.
• Temperature tensile strength measurements were carried out on a tensile bench in order to compare the maximum tensile strength of a weld between the textile and the connector, and a weld between the extruded HDPE film and the connector.
• the maximum tensile strength at a temperature of 123°C of the weld between the textile and the connector was of the order of 3 to 4 times greater than that of the weld between the extruded HDPE film and the connector.
• the assembly according to the invention therefore deforms substantially less than the connector assembly and extruded HDPE film.
• this increased tensile strength reduces the risk of rupture of the flexible container during handling of the flexible bag by the operators.
• the two walls 44, 46 are made of textile, offering a larger exchange surface for sterilization.
• the flexible container comprises a wall 44 made of textile and a wall 46 made of a material other than extruded HDPE or an HDPE/LDPE complex.
• the bag of Figure 2 can be manufactured according to the following manufacturing method.
• a flexible container 42 comprising a textile wall 44 and an extruded HDPE wall 46 is supplied or manufactured.
• the opening 48 is made in the textile wall 44.
• a connector 36 made of polyethylene loaded with glass fibers is provided.
• the connector is positioned in the opening 48.
• the connector 36 is welded to the edge of the opening 48 in the textile wall 44 by means of thermal welding.
• connection flange 20 is firmly secured to the connector 36 by means of the clamping collar 38 and the seal 40.
• the door 24 is mounted in the connection flange 20 equipped with a seal with lips 25.
• a gas sterilization step can then take place.
• the transfer bag has a beta connection part, a flexible container 50 comprising a closed end 52 and an open end 54, the edges of which are sealed to the connection part.
• the connection part is positioned in the axis of the bag. In this embodiment in the axis of the bag, the connection part is tube-shaped.
• the flexible container 50 is formed entirely of textile. For example, it comprises two textile sheets welded by their edges except at the open end or it comprises a textile sheet folded in half and welded along two of the three edges, leaving one end for welding to the connector of the beta part.
• the connector 36 of the connection part is welded directly to the flexible textile container 50 at the open end.
• the position of the beta part in the axis of the bag facilitates the transfer of objects from the bag to the isolator and vice versa.
• the flexible container is entirely made of textile and the connector is welded to one of the walls as in Figure 2.
• Bags with a container made entirely of textile can be Gamma irradiated and are also resistant to autoclaving.
• FIG. 4 another example of a transfer bag can be seen in which at least the flange 56 of the beta connection part is made of a material comprising cyclic olefin polymer or COC (Cyclic Olefin Copolymer in English terminology). Saxon).
• the gate of the beta connection part is also made of a material comprising cyclic olefin polymer, and even more preferably the flange and the gate are made of the same material comprising cyclic olefin polymer.
• the cyclic olefin polymer will be designated in the rest of the description by COC.
• the flange material has at least 0.01% COC by mass up to 100% COC.
• the cyclic olefin copolymer or COC is an amorphous polymer; it is for example marketed under the name TOPAS®, whose grades 6013, 6015, 6017 have been determined to be advantageously suited to the flange according to the invention.
• the choice of grade depends on temperature resistance, processability and mechanical resistance.
• the flange material may include a mixture of COC and high density polyethylene (HDPE).
• the flexible container 58 comprises at least one textile wall 60 and the flange 56 is welded directly to the textile wall.
• the flange of a material comprising COC forms an element compatible with a weld with the non-woven textile part of high density polyethylene fibers.
• the container can be identical to that of the bag of FIG. 3 and the flange is welded to the end of the container in the axis of the bag, directly on the textile.
• the manufacture of this transfer bag is simplified and faster, since the step of mechanical assembly of the flange and the connector is eliminated. In addition, the risks of defective assembly are reduced.
• the transfer bag comprises a flexible container 50 made entirely of textile and an internal sleeve 62.
• the internal sleeve 62 has one end welded to the opening of the flexible container and has a dimension between its two ends that is greater than the longitudinal dimension of the flange of the beta part allowing, when the bag is connected to the transfer device carried by the isolator, to deploy the sleeve inside the isolator through the connecting device, protecting the beta part seal and facilitating the spillage of bag components into the isolator.
• the sleeve 62 is deployed through the container flange.
• the flexible container and the sleeve comprise a textile wall and a wall, for example made of polyethylene, or are entirely made of textile, or the flexible container comprises at least one textile wall and the sleeve is entirely made of polyethylene.
• the textile part of the flexible container and the textile part of the sleeve are welded simultaneously to the connector.
• the sleeve is made by a second flexible container inside the first, welded to the first flexible container by their closed end and having a larger dimension between its two ends so as to deploy the second flexible container inside of the insulator and to cover the joint of the flange of the beta part.
• the transfer bag and the sleeve form a double bag.
• the sleeve also forms an additional protective layer; therefore, the double bag range has greater particle and microbiological cleanliness.
• transfer bags suitable for gas sterilization are produced, offering an even greater mechanical resistance.
• it can make it possible to produce transfer bags offering facilitated transfers.

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• Health & Medical Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Clinical Laboratory Science (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Analytical Chemistry (AREA)
• General Health & Medical Sciences (AREA)
• Hematology (AREA)
• Bag Frames (AREA)
• Packaging Of Annular Or Rod-Shaped Articles, Wearing Apparel, Cassettes, Or The Like (AREA)

Applications Claiming Priority (2)

Publications (1)

Family

ID=74758828

Family Applications (1)

Country Status (3)

Families Citing this family (2)

Family Cites Families (4)

• 2020
  • 2020-08-27 FR FR2008745A patent/FR3113653B1/fr active Active
• 2021
  • 2021-08-26 WO PCT/FR2021/051491 patent/WO2022043638A1/fr not_active Ceased
  • 2021-08-26 EP EP21777569.1A patent/EP4204149A1/de active Pending

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