EP4389630A1 - Procédé de fourniture d'un bac de transport pour récipients de médicaments médicaux et procédé de remplissage d'une pluralité de récipients de médicaments médicaux - Google Patents
Procédé de fourniture d'un bac de transport pour récipients de médicaments médicaux et procédé de remplissage d'une pluralité de récipients de médicaments médicaux Download PDFInfo
- Publication number
- EP4389630A1 EP4389630A1 EP22214680.5A EP22214680A EP4389630A1 EP 4389630 A1 EP4389630 A1 EP 4389630A1 EP 22214680 A EP22214680 A EP 22214680A EP 4389630 A1 EP4389630 A1 EP 4389630A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- transport container
- storage pallet
- containers
- active substance
- closure devices
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 238000000034 method Methods 0.000 title claims description 10
- 239000004480 active ingredient Substances 0.000 claims abstract description 69
- 238000003860 storage Methods 0.000 claims abstract description 68
- 238000007789 sealing Methods 0.000 claims abstract description 47
- 210000003739 neck Anatomy 0.000 claims abstract description 42
- 230000001681 protective effect Effects 0.000 claims abstract description 41
- 238000003825 pressing Methods 0.000 claims abstract description 13
- 239000013543 active substance Substances 0.000 claims description 30
- 229910052751 metal Inorganic materials 0.000 claims description 23
- 239000002184 metal Substances 0.000 claims description 23
- 229920001169 thermoplastic Polymers 0.000 claims description 16
- 239000004416 thermosoftening plastic Substances 0.000 claims description 16
- 229960005486 vaccine Drugs 0.000 claims description 14
- 239000000126 substance Substances 0.000 claims description 7
- 239000011521 glass Substances 0.000 claims description 6
- 239000000945 filler Substances 0.000 claims description 2
- 239000011324 bead Substances 0.000 description 18
- 239000003814 drug Substances 0.000 description 12
- 229920001971 elastomer Polymers 0.000 description 12
- 229940079593 drug Drugs 0.000 description 11
- 239000004033 plastic Substances 0.000 description 7
- 229920003023 plastic Polymers 0.000 description 7
- 239000000463 material Substances 0.000 description 5
- 229920001707 polybutylene terephthalate Polymers 0.000 description 5
- 230000036512 infertility Effects 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- XECAHXYUAAWDEL-UHFFFAOYSA-N acrylonitrile butadiene styrene Chemical compound C=CC=C.C=CC#N.C=CC1=CC=CC=C1 XECAHXYUAAWDEL-UHFFFAOYSA-N 0.000 description 2
- 229920000122 acrylonitrile butadiene styrene Polymers 0.000 description 2
- 239000004676 acrylonitrile butadiene styrene Substances 0.000 description 2
- 229910052782 aluminium Inorganic materials 0.000 description 2
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 2
- 239000000806 elastomer Substances 0.000 description 2
- 238000005429 filling process Methods 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- -1 polybutylene terephthalate Polymers 0.000 description 2
- 229920002725 thermoplastic elastomer Polymers 0.000 description 2
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 239000003708 ampul Substances 0.000 description 1
- 238000005452 bending Methods 0.000 description 1
- 239000012141 concentrate Substances 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 229920001903 high density polyethylene Polymers 0.000 description 1
- 239000004700 high-density polyethylene Substances 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000001746 injection moulding Methods 0.000 description 1
- 238000010999 medical injection Methods 0.000 description 1
- 229940127554 medical product Drugs 0.000 description 1
- 238000002844 melting Methods 0.000 description 1
- 230000008018 melting Effects 0.000 description 1
- 239000004745 nonwoven fabric Substances 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 239000004417 polycarbonate Substances 0.000 description 1
- 229920000515 polycarbonate Polymers 0.000 description 1
- 230000000284 resting effect Effects 0.000 description 1
- 239000012815 thermoplastic material Substances 0.000 description 1
- 238000002255 vaccination Methods 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
- 238000003466 welding Methods 0.000 description 1
Images
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
- B65D25/00—Details of other kinds or types of rigid or semi-rigid containers
- B65D25/02—Internal fittings
- B65D25/10—Devices to locate articles in containers
- B65D25/108—Devices, e.g. plates, presenting apertures through which the articles project
-
- 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
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/06—Ampoules or carpules
- A61J1/065—Rigid ampoules, e.g. glass ampoules
-
- 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
- A61J1/1406—Septums, pierceable membranes
-
- 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
- A61J1/1425—Snap-fit type
-
- 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
- A61J1/16—Holders for containers
-
- 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
- B65D51/00—Closures not otherwise provided for
- B65D51/002—Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
-
- 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
- B65D51/00—Closures not otherwise provided for
- B65D51/18—Arrangements of closures with protective outer cap-like covers or of two or more co-operating closures
-
- 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
- B65D2251/00—Details relating to container closures
- B65D2251/0003—Two or more closures
- B65D2251/0006—Upper closure
- B65D2251/0015—Upper closure of the 41-type
-
- 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
- B65D2251/00—Details relating to container closures
- B65D2251/0003—Two or more closures
- B65D2251/0068—Lower closure
- B65D2251/009—Lower closure of the 51-type
Definitions
- the present invention relates to a transport container tray with a first storage pallet and a second storage pallet with medical active ingredient containers for filling medical active ingredients.
- the invention further relates to a filling method for a plurality of medical active ingredient containers and closure with associated closure devices.
- medical substance containers in the form of medical injection bottles, also known as "vials", where liquid medical substances are taken from such medical substance containers using drawing and/or application needles.
- vials A specific example of the medical substance containers or vials in question are vaccine containers, vaccine vials or vaccine ampoules.
- the well-known vials or medical drug containers made of glass or plastic today have different shapes and multi-part closure devices.
- the EP2948122 a medical drug container with a bottle neck and collar, whereby a rubber stopper is partially inserted into the bottle neck and is permanently fixed there by means of a locking ring.
- the rubber stopper has a sealing lip which is sealingly connected to the inner surface of the bottle neck.
- the locking ring encloses an edge of the rubber stopper and a collar end bead and is formed from a metal sheet.
- Additional means are provided to form a stopper securing device which additionally encloses the rubber stopper and the locking ring and a movable lid is attached.
- vaccine can be removed from the inside of the medical drug container by piercing a drawing and/or vaccination syringe or a drawing and/or application needle through the thinner center of the rubber stopper.
- additional means are required that go far beyond simply securing the rubber stopper with a sheet metal ring. This construction is technically complex and not really suitable for mass production.
- the present invention has set itself the task of providing a transport container which makes it possible to make large quantities of the medical active ingredient containers available to the filling plant in an effective manner, as well as corresponding closure devices by means of which the medical After being filled with active ingredients, active ingredient containers can be easily closed on site without the need for additional tools. In particular, a high level of sterility and hygiene should be guaranteed, even when transporting the medical active ingredient containers.
- a medical active ingredient container 1 with a multi-part compact closure device 2 is shown.
- Such medical active ingredient containers 1 or vials 1 can be referred to as injection vials, vaccine vials, vaccine ampoule, vaccine vials, multi-dose containers, medical vials for the aseptic storage and removal of liquid active ingredients or vaccines and vaccine concentrates as medical active ingredients.
- These medical active ingredient containers 1 are made of glass or plastic and are commercially available in standardized sizes.
- the multi-part closure device 2 is placed on a bottle neck 10.
- the multi-part closure device 2 is stored on the bottle neck 10 in a non-detachable manner and cannot be removed without being destroyed, so that no vaccine can escape from the medical active ingredient container 1 and no unwanted access is possible.
- the contents of the medical drug container 1 are not shown here. Contamination of the interior of the medical drug container must be avoided. 1 should be avoided during transport and storage. After opening or first use of the contents of the medical drug container 1, there are often only a few hours left before the contents - for example a vaccine - become unusable.
- the multi-part closure device 2 comprises at least one sealing plug 20 and a multi-part plug securing device 21, with which the sealing plug 20 can be detachably fastened to a collar 101 of the bottle neck 10. Due to the design of the plug securing device 21 presented here, the multi-part closure device 2 can be pressed onto the collar 101 in the direction of a longitudinal axis L of the medical active ingredient container 1 , and means of the plug securing device 21 engage the collar 101.
- the multi-part closure device 2 can thus be stored on the bottle neck 10 in a non-detachable manner and cannot be removed without destruction, can be pressed onto the collar 101 by simply pressing it in the direction of the longitudinal axis L of the medical active ingredient container 1 , and means of the plug securing device 21 engage the collar 101 , so that no active ingredient can escape from the medical active ingredient container 1 and no unwanted access is possible.
- the closure device 2 is not intended for multiple use, opening and closing of the closure device 2 , but remains, after fastening to the collar 101, sealing the interior of the medical active ingredient container 1 and remains immovable and undetachable.
- a protective cover 22 is intended as an optional part of the multi-part closure device 2 , which additionally provides mechanical protection.
- the bottle neck 10 of the medicinal active substance container 1 has a collar 101 , which has a collar end bead 102, an outer collar surface 103 and an inner contact surface 104.
- the multi-part closure device 2 interacts with the collar end bead 102 , with a part engaging behind the collar end bead 102 and a part resting on the outer collar surface 103 , so that the closure device 2 cannot slip relative to the collar 101 .
- the sealing plug 20 is formed in one piece from an elastomer, preferably from rubber or from a thermoplastic elastomer (TPE) and is designed to taper downwards from above, i.e. from the side facing away from the medical active substance container 1 , and is thus essentially conically shaped.
- TPE thermoplastic elastomer
- the sealing plug 20 is profiled and at least one sealing lip 201 and one edge 202 are arranged on the outer circumferential side surface of the sealing plug 20.
- the sealing plug 20 can thus be pressed onto the bottle neck 10 in the longitudinal direction L and arranged and secured so that it partially protrudes into it.
- three sealing lips 201 along the outer side surface of the sealing plug 20 have proven to be effective, which in the assembled state come to lie along the inner contact surface 104 of the bottle neck 10.
- the edge 202 protrudes radially over the tapered part of the sealing plug 20 and remains outside the bottle neck 10 in the assembled state.
- the tapered part of the sealing plug 20 is countersunk into the bottle neck 10 during assembly, with the edge 202 of the sealing plug 20 remaining outside the collar 101 and the bottle neck 10.
- a cage support surface 2021 and a circumferential cage edge recess 2022 in the form of an annular groove are arranged along the circumferential edge 202.
- the cage edge recess 2022 preferably has a circumferential bead 2023 which is formed by an undercut in a lower section of the cage edge recess 2022 on a radially inner surface of the cage edge recess 2022 .
- a central stopper taper 203 is provided in the sealing stopper 20 , also dashed in Figure 1a indicated. This stopper taper 203 makes it easier to push through a drawing-on and/or application needle.
- the multi-part compact closure device 2 has a plug securing device 21 which consists of two parts, a securing cage 210 and an outer cage shell 211.
- the safety cage 210 which in the assembled state is located on the inside, closer to the longitudinal axis L, is made in one piece, preferably from a thermoplastic material and comprises a central ring 2101 and a circumferential side wall 2102 with several undercut webs 2103.
- the central ring 2101 leaves a central opening in the safety cage 210 open so that the drawing and/or application needle can be pushed through.
- the size of the central opening is preferably as large as the diameter of the stopper taper 203 in the sealing stopper 20 or even larger.
- the safety cage 210 is particularly preferably made from polybutylene terephthalate (PBT).
- the undercut webs 2103 are arranged in the side wall 2102 in such a way that they can be brought into engagement below the collar end bead 102 on the collar 101 in the assembled state.
- an inclination from bottom to top in the direction of the longitudinal axis L is visible. Due to the inclination of the undercut webs 2103 in the direction of the longitudinal axis L, an engagement of the undercut webs 2103 behind the collar 101 is possible.
- a cage edge bead 2104 is arranged at least partially circumferentially in the side wall 2102.
- the cage edge bead 2104 is enclosed by the outer cage shell 211 in the assembled state of the multi-part closure device 2 .
- a plug engagement edge 2105 is arranged in a bent manner. With the plug engagement edge 2105, the safety cage 210 engages in the cage edge recess 2022 of the sealing plug 20 in the assembled state, whereby the safety cage 210 is fixed to the sealing plug 20 , while the centric ring 2101 rests directly on the cage support surface 2021 , which in Figure 1b can be seen.
- the safety cage 210 can be attached to the sealing plug 20 by the sealing plug 20 being firmly connected to the safety cage 210 , e.g. glued, welded or by means of a positive connection, such as a snap engagement.
- the outer cage cover 211 is thrown over the safety cage 210 and is provided as part of the stopper securing device 21.
- This cage cover 211 is preferably made from a metal sheet, although a correspondingly shaped plastic cover would also be possible.
- the cage cover 211 runs essentially parallel to the safety cage 210 and rests against it.
- the cage cover 211 is designed as an open sleeve with a central opening 2111 and an at least partially circumferential cage cover bead 2112. Once put together in the direction of the longitudinal axis L , the cage cover 211 can no longer be easily removed from the safety cage 210.
- the stopper securing device 21 can be pressed over the sealing plug 20 and the collar 101 , so that the sealing plug 20 is finally permanently attached to the bottle neck 10 .
- the plug securing device 21 can first be placed over the sealing plug 20 and connected to it, with the assembly of the securing cage 210, cage cover 211, protective cover 22 and sealing plug 20 then being placed as a unit over the collar 101 in order to fix the plug securing device 21 to the medical active ingredient container 1.
- the cage cover 211 completely encloses the securing cage 210 , while only the centric surfaces at the top and bottom of the securing cage 210 and the cage cover 211 remain accessible in the assembled state and a drawing and/or application needle can be pierced through the centric opening 2111 and the centric ring 2101 with centric opening.
- the multi-part closure device shown can be equipped without the cage cover 211 .
- Additional means are provided to releasably attach the additional protective cover 22 directly to the outer cage shell 211 or indirectly to the safety cage 210. These additional means are arranged either directly on the safety cage 210 or, as shown in the embodiment here, directly on the outer cage shell 211.
- a cover recess 2113 is formed on the edge of the central opening 2111 as part of the outer cage shell 211. The cover recess 2113 is inclined towards the longitudinal axis L , namely upwards, in the direction of the protective cover 22.
- the protective cover 22 is preferably made of polycarbonate (PC) or acrylonitrile-butadiene-styrene copolymers (ABS), is generally rotationally symmetrical and has a concentric area with an engagement edge 221.
- the engagement edge 221 runs around an area of the inner surface of the cover, the surface that faces the outer cage shell 211.
- the cover engagement 2113 engages in the engagement edge 221 , whereby the protective cover 22 is detachably held on the outer cage shell 211 and forms part of the multi-part closure device 2.
- the protective cover 22 can be shaped as a profile and have a central taper 222 or optional recesses 222 , which lead to increased stability or are selected to save material.
- the protective cover 22 is optional and not absolutely necessary. However, in order to provide better protection against external influences, the protective cover 22 should be detachably connected to the outer cage shell 211 or the safety cage 210 of the plug securing device 21 , so that the protective cover 22 can be removed from the plug securing device 21 before use.
- the protective cover 22 can also be attached to the closure device 2 by means of a material bond, e.g. by means of laser welding. outer cage shell 211 or the safety cage 210. An adhesive connection or a form-fitting connection is also possible, as explained above.
- the protective cover 22 is manufactured together with the safety cage 210, or, if present, with the outer cage shell 211 in one piece, for example as a plastic injection molding, with predetermined breaking points being formed for releasing the protective cover 22.
- the protective cover 22 and the safety cage 210 are made of plastic.
- FIG 1b the assembled state of the multi-part closure device 2 is shown.
- the undercut webs 2103 in the side wall 2102 behind the collar 101 engage concentrically at several points and the position of the sealing plug 20 on the inner contact surface 104 is secured, while the at least one sealing lip 201 seals.
- the side wall 2102 of the safety cage 210 and the outer cage shell 211 rest on the outer collar surface 103. Even when pulled in the direction of the longitudinal axis L, away from the medical active ingredient container 1, the safety cage 210 and thus the sealing plug 20 remain unmoved.
- the effect of the plug securing device 21 is maximum, with little material expenditure, few components and low weight of the entire plug securing device 21.
- sealing lips 201 which protrude radially outward from the sealing plug 20 , preferably three stepped sealing lips 201 are provided, i.e. arranged at different heights parallel to the longitudinal axis L , which in Figure 1c when the bottle neck 10 is omitted.
- the plug engagement edge 2105 engages in the concentrically encircling cage edge recesses 2022.
- the cage edge recesses 2022 are recessed from the sealing plug 20 at an angle to the longitudinal axis.
- the circularly encircling cage edge bead 2104 in the safety cage 210 and the cage shell bead 2112 running parallel to it in the outer cage shell 211 are well visible and engaged.
- the safety cage 210 is operatively connected to the outer cage shell 211 , encloses the sealing plug 20 and is covered by the cover 22 .
- the multi-part closure device 2 can be optionally adapted. Since such medical drug containers 1 made of glass often have more simply shaped bottle necks 10 without protruding or projecting collar end beads 102 , sufficient fastening is often more difficult to produce.
- an inner thermoplastic ring 23 and an outer metal ring 24 are preferably used, as in Figure 2a shown.
- the inner thermoplastic ring 23 is preferably made of polybutylene terephthalate (PBT), while the outer metal ring 24 is made of aluminum or another metal.
- the thermoplastic ring 23 has a profile matched to the profile of the metal ring 24.
- thermoplastic ring 23 Due to the thermoplastic design of the thermoplastic ring 23 , it can be glued to the metal ring 24.
- the metal ring 24 has an upper collar 240, a middle section with through holes 241 and a lower metal ring flange 242. Parts of the thermoplastic ring 23 melt through the through holes 241 during production, so that both rings 23, 24 are permanently connected to one another. This melting of the thermoplastic ring 23 onto the metal ring 24 can take place directly mounted on the collar 101 or can have been carried out beforehand.
- FIG. 2b Metal ring 24 and thermoplastic ring 23 are mounted on the bottle neck 10 before pressing on the multi-part compact closure device 2 shown.
- Figure 2c shows how such a multi-part closure device 2 combined with metal ring 24 and thermoplastic ring 23 can be attached to a simplified bottle neck 10 after pressing on in the direction of arrow L.
- the safety cage 210 engages with a part of the side wall 2102 under the thermoplastic ring 23 or the metal ring 24.
- the advantage of the multi-part closure device 2, which can be attached to the bottle neck by pressing and hooking, is that several unsealed medical active ingredient containers 1 with suitable multi-part closure devices 2 and possibly with the ring combination 23, 24 can be transported unfilled and unsealed to an active ingredient filling plant, filled there and also easily sealed there. Without special tools at the filling location by the active ingredient or vaccine filler themselves.
- a transport container 3 which can also be referred to as a delivery cassette 3 , comprising a transport container trough 33, in which a first storage pallet 31 with multi-part closure devices 2 and a second storage pallet 32 with medical active ingredient containers 1, delivered closed with a box lid 30 and/or a protective film 30.
- the medical active ingredient containers 1 are unlocked, i.e. the openings of the medical active ingredient containers 1 on the bottle neck 10 are free.
- One advantage of providing the medical active ingredient containers 1 and their multi-part closure devices 2 in a common transport container of an active ingredient filling system is, among other things, ensuring that the closures suitable for the medical active ingredient containers 1 are also provided. This makes the filling process more efficient and safer, especially with large production quantities. At the same time, a high level of hygiene is guaranteed.
- the multi-part closure devices 2 shown comprise, as explained above, a sealing plug 20, a plug securing device 21 with a securing cage 210, a cage cover 211 and a protective cover 22.
- the multi-part closure devices 2 are designed to be pressed on and snapped into place. to the collar 101 of the bottle necks 10 of the medical active substance containers 1.
- the transport container tray can also be used in combination with alternative embodiments of the multi-part closure devices, for example in combination with multi-part closure devices that do not have a cage cover or a protective lid.
- the plug securing device 21 comprises the already explained securing cage 210 with the central ring 2101, the central opening and the side wall 2102 , wherein a circumferential cage edge bead 2104 is formed into the outer surface of the side wall 2102 and the plurality of molded undercut webs 2103 protrude from the inner surface of the side wall 2102 in the direction of the longitudinal axis L , wherein a plug engagement edge 2105 formed on the securing cage 210 engages in a cage edge recess 2022 on the sealing plug 20 and the outer cage shell 211 made of metal with the cage shell bead 2112, the central opening 2111 and a cover engagement 2113 is at least partially slipped over the securing cage 210 and the protective cover 22 thus extends over the cover engagement 2113 is detachably attached to the plug securing device 21 , the multi-part closure device 2 can be locked into place particularly easily.
- the second storage pallet 32 with empty medical active ingredient containers 1 is arranged in the transport container tray above the first storage pallet 31 with the multi-part closure devices 2.
- the second storage pallet 32 even rests on the first storage pallet 31 with the multi-part closure devices 2.
- the multi-part closure devices 2 are arranged on the side of the medical active ingredient containers 1 facing away from the bottle necks 10. In other words, the multi-part closure devices 2 are placed under the bottom of the medical active ingredient containers 1. Such an arrangement ensures a high degree of hygiene and sterility when transporting the transport container 3.
- the multi-part closure devices 2 are arranged under the medical active substance containers 1, for example particles that could become detached from the multi-part closure devices 2 during transport as a result of vibrations or the like cannot penetrate into the medical active substance containers 1. It is therefore also not necessary to close the medical active substance containers 1 individually for transport.
- the closure by means of the box lid 30 and/or the protective film 30 is sufficient.
- the multi-part closure devices 2 in the first storage pallet 31 are oriented such that the sealing plug 20 is arranged on the side of the protective cover 22 or the safety cage 210 facing away from the bottle necks 10 , i.e. the pointed end of the conical sealing plug 20, which is first inserted into the bottle neck 10 when closing the medical active ingredient containers 1 , is oriented in the same direction as the lower end or the bottom of the medical active ingredient containers 1.
- the first storage pallet 31 with the multi-part closure devices 2 can be positioned above the second storage pallet 32 with the filled medical active ingredient containers 1 for the purpose of closing, without the multi-part closure devices 2 having to be additionally reoriented, e.g. rotated, because the sealing plug 20 with its front end is already oriented in the direction of the opening of the bottle neck 10. is.
- the arrangement of the multi-part closure devices 2 in the first storage plate 31 and the arrangement of the medical active ingredient containers 1 in the second storage pallet 32 are coordinated with one another in such a way that by placing and pressing the first storage pallet 31 onto the second storage pallet 32, the multi-part closure devices 2 snap into place on the bottle necks 10 of corresponding medical active ingredient containers 1 and close the respective medical active ingredient container 1. This enables the medical active ingredient containers 1 to be closed quickly and easily.
- a possible filling process for the medical active ingredient containers 1 is as follows. First, the transport container 3 or the transport container tray 33 is delivered to a filling plant for medical active ingredients and made available to it. There, the box lid 30 and/or the protective film 30 is removed. The second storage pallet 32 with the medical active ingredient containers 1 is then removed from the transport container tray 33 and brought into the filling station, where the open medical active ingredient containers 1 arranged locally in the second storage pallet 32 are filled.
- the complete first storage pallet 31 which is also taken from the transport container tray 33 , is placed over the second storage pallet 32 so that the sealing plugs 20 come to rest on the bottle necks of the filled medical active ingredient containers 1.
- the first storage pallet 31 By pressing the first storage pallet 31 in the direction of the transport container tray bottom or in the direction of the bottom of the medical active ingredient container 1, i.e. in the direction of the longitudinal axis L of the medical active ingredient container 1, each medical active ingredient container 1 is tightly closed with an associated closure device 31 .
- the multi-part closure devices 2 with their sealing plugs 20 and the plug lock 21 are pressed onto the openings of the bottle necks 10.
- the previously explained undercut webs 2103 in the side wall 2102 of the safety cage 210 reach behind the collar end bead 102 and secure the medical active ingredient container 1 against unwanted opening. This means that it locks into place and the multi-part closure devices 2 can no longer be easily removed.
- the second storage pallet 32 with the filled and closed medical active substance containers 1 can be positioned again in the transport container tray 33 and the transport container is closed with the box lid 30 and/or a protective film 30 .
- first and second storage pallets 31 and 32 from the transport container tray 33 and then place the second storage pallet 32 with the empty medical active ingredient containers 1 back into the transport container tray 33 , whereby the transport container tray 33 is then moved to the filling station together with the empty medical active ingredient containers 1 arranged therein for filling.
- the filled medical active ingredient containers 1 After the filled medical active ingredient containers 1 have been closed, they are closed as described above by pressing the first storage pallet 31 onto the multi-part closure devices 2.
- the further transport can then also take place here in the transport container tray 33 .
- thermoplastic ring 23 and a metal ring 24 are additionally mounted on the bottle neck 10 before the transport container trough 33 is closed and transported to a filling plant.
- the multi-part closure devices 2 are pressed on after filling as usual, then over the bottle neck 10 with ring combination 23, 24.
- thermoplastics in particular thermoplastics, can be used as material for the box lid 30, the storage pallets 31, 32 and the transport container tray 33.
- a nonwoven fabric made of high-density polyethylene has proven to be particularly suitable as material for the protective film 30 .
- the filling and closing can be simplified and greatly accelerated.
- This filling and closing process does not have to be carried out by a special company and special equipment. Since several components are packed in one package, here the Transport containers 3, which are delivered for filling, can prevent a large amount of waste and large transport volumes. Above all, the closure can be greatly simplified and the time for closing can be minimized. In addition, compliance with the necessary sterility during transport is guaranteed.
Landscapes
- 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)
- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Hematology (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP22214680.5A EP4389630A1 (fr) | 2022-12-19 | 2022-12-19 | Procédé de fourniture d'un bac de transport pour récipients de médicaments médicaux et procédé de remplissage d'une pluralité de récipients de médicaments médicaux |
PCT/EP2023/069785 WO2024132235A1 (fr) | 2022-12-19 | 2023-07-17 | Procédé de fourniture d'un plateau de transport pour conteneurs de principes actifs médicaux et procédé de remplissage d'une pluralité de conteneurs de principes actifs médicaux |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP22214680.5A EP4389630A1 (fr) | 2022-12-19 | 2022-12-19 | Procédé de fourniture d'un bac de transport pour récipients de médicaments médicaux et procédé de remplissage d'une pluralité de récipients de médicaments médicaux |
Publications (1)
Publication Number | Publication Date |
---|---|
EP4389630A1 true EP4389630A1 (fr) | 2024-06-26 |
Family
ID=84541630
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP22214680.5A Pending EP4389630A1 (fr) | 2022-12-19 | 2022-12-19 | Procédé de fourniture d'un bac de transport pour récipients de médicaments médicaux et procédé de remplissage d'une pluralité de récipients de médicaments médicaux |
Country Status (2)
Country | Link |
---|---|
EP (1) | EP4389630A1 (fr) |
WO (1) | WO2024132235A1 (fr) |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2893922A1 (fr) * | 2005-11-30 | 2007-06-01 | Biocorp Rech Et Dev Sa | Dispositif de bouchage pour un recipient et recipient equipe d'un tel dispositif |
US20120187072A1 (en) * | 2009-10-01 | 2012-07-26 | A. Raymond Et Cie | Locking cover for a vessel having a neck, including a cap having attachment tabs |
US20120248057A1 (en) * | 2011-04-04 | 2012-10-04 | Genesis Packaging Technologies | Cap systems and methods for sealing pharmaceutical vials |
EP2948122A1 (fr) | 2013-01-28 | 2015-12-02 | Becton Dickinson France | Adaptateur destiné à être accouplé à un récipient médical |
-
2022
- 2022-12-19 EP EP22214680.5A patent/EP4389630A1/fr active Pending
-
2023
- 2023-07-17 WO PCT/EP2023/069785 patent/WO2024132235A1/fr unknown
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2893922A1 (fr) * | 2005-11-30 | 2007-06-01 | Biocorp Rech Et Dev Sa | Dispositif de bouchage pour un recipient et recipient equipe d'un tel dispositif |
US20120187072A1 (en) * | 2009-10-01 | 2012-07-26 | A. Raymond Et Cie | Locking cover for a vessel having a neck, including a cap having attachment tabs |
US20120248057A1 (en) * | 2011-04-04 | 2012-10-04 | Genesis Packaging Technologies | Cap systems and methods for sealing pharmaceutical vials |
EP2948122A1 (fr) | 2013-01-28 | 2015-12-02 | Becton Dickinson France | Adaptateur destiné à être accouplé à un récipient médical |
Also Published As
Publication number | Publication date |
---|---|
WO2024132235A1 (fr) | 2024-06-27 |
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