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
  • B65D39/00—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers
  • B65D39/0005—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers made in one piece
• • 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
  • B65D39/00—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers
  • B65D39/0005—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers made in one piece
  • B65D39/0017—Injection-molded plastic closures for "Champagne"- or "Sekt"-type bottles
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/1412—Containers with closing means, e.g. caps
• • 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
  • B65D39/00—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers
  • B65D39/16—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers with handles or other special means facilitating manual actuation
• • 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
  • B65D47/00—Closures with filling and discharging, or with discharging, devices
  • B65D47/04—Closures with discharging devices other than pumps
  • B65D47/06—Closures with discharging devices other than pumps with pouring spouts or tubes; with discharge nozzles or passages
  • B65D47/12—Closures with discharging devices other than pumps with pouring spouts or tubes; with discharge nozzles or passages having removable closures
  • B65D47/121—Stoppers

Definitions

• the present invention relates to hermetic closure caps for mouthpiece, in particular in the field of containers for biopharmaceutical fluids
• a sub-assembly is delivered with a hermetically sealed end piece pending subsequent connection.
• This sealed end piece is formed by a plug taking the place of the missing end piece on which the screw-in cuff is installed, as illustrated in section in FIG. 8.
• the screw-in cuff may present a risk of damage by screw contact.
• a stopper configured to hermetically close a tip intended to contain a biopharmaceutical fluid, said tip having a cylindrical bore of diameter D1 and a collar with a groove, the stopper comprising:
• a stop disc extending a rear portion of the body at least radially outwards and generally extending in a plane transverse to the axis
• the stop disc comprising an annular bead, interposed radially between a first annular bearing surface and a second annular bearing surface, the bead extending WO 2020/161401 PCT / FR2020 / 000025
• two hermetic barriers are formed between an internal space of the end piece and the external environment, namely a first barrier at the level of the wall of the body of the received stopper in the internal bore and a second barrier at the level of the docking of the bead in the groove.
• the use of a handcuff of the triclamp connection type is avoided.
• the use of a gasket is also avoided, because the bead, at least in part, acts as a gasket.
• Such a stopper has a moderate or even very advantageous cost price and can therefore be a single-use part.
• the body and the stopper disc can be formed from a single piece made of elastomeric material.
• a silicone or a TPE thermoplastic elastomer
• other bases are not excluded, such as polyurethane, polyester, polyethylene, polypropylene, polyurethane, polyamide type copolymers.
• a sufficiently elastic material is chosen which gives flexibility such that the hardness of the body of the plug is less than Shore 70A.
• a sufficiently elastic material is chosen which gives flexibility such that the hardness of the body of the plug is between 50A and 80A Shore.
• the stopper can be formed as a bi-material part of silicone or TPE, with a first portion made of a first material and a second portion made of a second material, the first material being more flexible than the second subject.
• the first material can be a silicone or a TPE (thermoplastic elastomer;
• the second material can be a polypropylene, a polyamide or a polybutylene terephthalate.
• the cylindrical outer wall of the front part as well as the annular bead can be formed in the first portion. A good contact is thus obtained which forms a hermetic barrier.
• the body is flexible and the peripheral support means more rigid.
• peripheral retaining means extending the stop disk at least towards the front with a return towards the axis to come to bear on the rear of the collar.
• the peripheral retaining means are formed by an outer annular edge which is continuous circumferentially. This forms a completely symmetrical configuration of revolution around the A axis.
• the peripheral retaining means are formed by retaining claws arranged in a circumferentially discontinuous manner.
• such claws can deform more easily, the claws can come back towards the axis much more than the annular edge.
• the retaining claws may be made from one material or from another material, with a predefined number of claws, for example two, three or four. Depending on the configuration and customer requirements, the retaining force imparted by the retaining church can thus be adjusted.
• the bead extends annularly at a diameter D3 of between 18 mm and 40 mm. This covers the standard dimensions of 3 ⁇ 4 inch and 1.5 inch.
• the bearing interface between the stopper body and the bore extends over an axial length L1 of at least 3 mm, and preferably at least 6 mm, and preferably at most 10 mm. This forms an important bearing surface for sealing and mechanical retention.
• D1 ’ is between 1.05 D1 and 1.25 D1 or else D1’ is between D1 + 1 mm and D1 + 5 mm.
• the compression coefficient can be greater or lesser.
• D1 ’ 1, 20 D1. This forms a good compromise between the moderate insertion force and a good hold and a good seal.
• a non-use indicator collar with a front ring and a rear ring and one or more fusible zones joining the front ring. with the rear ring.
• a gripping element in the form of a tongue or a handle. This facilitates the removal of the cap for subsequent authorized use of the biopharmaceutical fluid. It may be provided to pinch the gripping element between two fingers and then perform an axial traction towards the rear of the stopper.
• the gripper protrudes rearwardly from the stopper disc of the plug.
• the gripping element may be integral with the body of the stopper, it may be in an axial central position.
• the present invention also relates to an assembly comprising on the one hand a tip (2) intended to contain a biopharmaceutical fluid, said tip having a cylindrical bore (21) of diameter D1 and a collar with a groove (23) , and on the other hand a stopper as described above.
• the set in question may contain a bag of high added value biopharmaceuticals, a filter, other tubing and tips, etc.
• Figure 1A is a general sectional view of a stopper according to a first embodiment of the invention
• Figure 1 B is a general front view of the cap of Figure 1,
• FIG. 2 illustrates in section another embodiment
• Figure 5 illustrates in section yet another embodiment
• FIG. 6 illustrates in section yet another embodiment
• FIG. 7 illustrates in section yet another embodiment
• FIG. 8 Figure 8 illustrates the prior art. Description of embodiments
• Figure 8 shows a conventional solution for which it is necessary to hermetically seal a nozzle 2.
• a flexible tube 3 is connected to said nozzle 2.
• the nozzle, the cap and the tubing are part of an assembly intended to contain a biopharmaceutical fluid.
• Such an assembly can include one or more bags, one or more filters, one or more tubes, one or more shut-off valves, etc.
• An O-ring 85 or alternatively a flat seal with bead 83 is placed on the face of the end piece and then in place over a cap marked 81. Then a handcuff closure 84 is installed and the screw 82 is screwed in to tighten the handcuff and, thanks to the bevelled shapes, apply axial pressure on the joint to ensure a good level of tightness.
• Figures 1A and 1B show a first embodiment of the invention.
• a nozzle 2 with conventional dimensions in the field of biopharmaceutical fluids.
• the inside diameter of the tip can range from 10mm to 30mm millimeters, and the length of the tip can range from 10mm to 50mm.
• a flexible tube 3 is inserted on the rear part of the nozzle as recognized in itself.
• the front part of the nozzle comprises a tubular body with a cylindrical bore 21 of diameter D1 and a flange 28 extending generally in a plane transverse to the axis A radially outward.
• the collar 28 comprises a groove 23, designed to receive an element forming a seal.
• the groove 23 extends annularly at a diameter D3 between 18 mm and 40 mm. Two particular values are considered for the diameter D3 namely three-quarters of an inch is one and a half inch (3/4 inch and 1.5 inch).
• the present invention provides a cap 1 which will form a single piece to hermetically seal the nozzle 2 and thus replace the solution shown in Figure 8.
• the stopper 1 can be considered as a single-use piece, namely that it is not recycled after shipment of the biopharmaceutical assembly to a customer.
• the cap can effectively be recycled, sterilized and used several times.
• front and rear are taken with respect to a direction of insertion of an element, here the insertion of the plug 1 in the nozzle 2
• the forward and reverse directions are noted in Figures 2, 5 and 6 and apply similarly to the other embodiments.
• the cap comprises a body 10 comprising a front part 10A and 10B rear part.
• the front part 10A comprises an outer wall 11, cylindrical about an axis
• the front part 10A has a diameter at rest D1 ’substantially greater than D1.
• D1 ’ can be between 1.05 D1 and 1.25 D1; according to another example D1 ’can be between D1 + 1 mm and D1 + 5 mm.
• D1 ’ can be close to 1, 2 D1.
• the front part 10A is intended to be received with stress in the cylindrical bore 21 of the nozzle 2.
• the stopper 1 comprises a stopper disc 12, extending a rear part 10B of the body at least radially outwardly and generally extending in a plane P transverse to the axis A.
• the outer diameter of the plug denoted D5 may be between 1, 6 x D1 and 2 x D1.
• the stop disc 12 comprises a first annular seat 15 which extends in a plane P transverse to the axis A and a second annular seat 16 located radially more outward, in the same transverse plane P.
• the stop disk 12 comprises an annular bead 13, interposed radially between the first annular surface 15 and the second annular surface 16.
• the annular bead 13 is intended to be received in the groove 23 of the collar
• first bearing surface 25 facing the first annular bearing surface 15 of the stopper and a second bearing surface 26 facing the second annular bearing surface 16 of the plug .
• the stop disc is extended by a return border denoted 14 which extends forward.
• peripheral retaining means are provided, to secure the position of the stopper once installed on the end piece 2.
• peripheral retaining means are here formed as retaining claws 18.
• the number of retaining claws can be different, they can be 2.3 in number, or any number greater than or equal to 5.
• the stopper is devoid of a retention flange, which can be envisaged when the maintenance of the stopper in the end piece is sufficiently ensured by the friction and the residual stress between the two parts once the assembly carried out.
• the length of engagement L1 of the body within the bore 21 as well as the residual radial stress after insertion may be such that the retention is sufficient for certain applications.
• the length of engagement L1 of the body inside the bore 21 may be equal to at least 3 mm, according to another example the length of engagement L1 may be equal to at least 5 mm, up to 10 mm.
• the tensile force to remove the plug can be calibrated to be greater than 30 Newtons. This value can be considered for all health embodiments.
• the front part 10A of the body of the stopper may include an entry chamfer 31 which facilitates the start of insertion of the stopper 1 into the end piece 2.
• the gripper 50 protrudes rearwardly from the stopper disc 12 of the stopper.
• the gripping element 50 may project, for example, by a dimension of at least 10 mm towards the rear.
• the gripping element 50 may be integral with the body of the stopper, it may be in the central axial position.
• Figure 3 there is shown a variant of the tip which comprises a small diameter bore D1 having a greater length, and an enlargement of diameter D2 just before the flange 28.
• the hermetic contact between the cap and the tip is made at the level of the small diameter D1.
• peripheral retaining means formed by an outer annular edge 19 continuous circumferentially.
• This outer annular rim has an outer chamfer which assists insertion on the tip, sufficient radial deformation is provided to allow the annular rim to pass the maximum outside diameter of the tip.
• FIG 5 there is shown another variant of a plug made of bi-material.
• the part above the centerline illustrates an example of material forming, while the part below the centerline illustrates another example.
• the stopper 1 is formed as a bi-material part with a first portion M1 made of a first material, for example silicone or thermoplastic elastomer, and a second portion M2 made of a second material, the first material being more flexible than the second subject.
• a first material for example silicone or thermoplastic elastomer
• a second portion M2 made of a second material
• the second material M2 it is possible to choose bases of copolymers of polyurethane, polyester, polyethylene, polypropylene, polyurethane, polyamide.
• the flexible material M1 forms the cylindrical outer wall 11 of the body of the stopper as well as the bead 13 and the bearing surfaces 15,16 which surround it. Note that once the cap is installed in the mouthpiece, the first M1 material is not accessible from the outside, only the elements formed by the second material are.
• the flexible material M1 forms the bead 13 and the bearing surfaces 15,16 which surround it, but the body 11 of the stopper 1 is formed in the second material M2.
• a non-use indicator collar 4 with a front ring 41 and a rear ring 42 and one or more fusible zones 44 joining the front ring with the rear ring .

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• Engineering & Computer Science (AREA)
• Mechanical Engineering (AREA)
• Health & Medical Sciences (AREA)
• Pharmacology & Pharmacy (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Closures For Containers (AREA)

Applications Claiming Priority (2)

Publications (1)

Family

ID=67383892

Family Applications (1)

Country Status (4)

Family Cites Families (12)

• 2019
  • 2019-02-08 FR FR1901276A patent/FR3092568B1/fr active Active
• 2020
  • 2020-02-07 EP EP20714265.4A patent/EP3921243A1/de active Pending
  • 2020-02-07 US US17/424,583 patent/US20220119161A1/en active Pending
  • 2020-02-07 WO PCT/FR2020/000025 patent/WO2020161401A1/fr unknown

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