EP1435893B1 - Sicherheitsverpackung für eine flasche für medizinische anwendungen - Google Patents
Sicherheitsverpackung für eine flasche für medizinische anwendungen Download PDFInfo
- Publication number
- EP1435893B1 EP1435893B1 EP20020796303 EP02796303A EP1435893B1 EP 1435893 B1 EP1435893 B1 EP 1435893B1 EP 20020796303 EP20020796303 EP 20020796303 EP 02796303 A EP02796303 A EP 02796303A EP 1435893 B1 EP1435893 B1 EP 1435893B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- bottle
- packaging device
- tube
- storage position
- partition
- 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.)
- Expired - Lifetime
Links
- 238000004806 packaging method and process Methods 0.000 title claims abstract description 18
- 238000001802 infusion Methods 0.000 claims abstract description 12
- 238000005192 partition Methods 0.000 claims abstract description 9
- 229920003023 plastic Polymers 0.000 claims abstract description 8
- 238000012546 transfer Methods 0.000 claims description 8
- 238000003860 storage Methods 0.000 claims description 7
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 claims description 3
- 239000011324 bead Substances 0.000 claims description 3
- 238000006073 displacement reaction Methods 0.000 claims description 3
- 210000002105 tongue Anatomy 0.000 claims description 3
- 230000005855 radiation Effects 0.000 claims description 2
- 238000005096 rolling process Methods 0.000 claims description 2
- 230000014759 maintenance of location Effects 0.000 claims 6
- 239000011521 glass Substances 0.000 abstract description 7
- 239000004033 plastic Substances 0.000 abstract description 7
- 230000003019 stabilising effect Effects 0.000 abstract 1
- 239000003814 drug Substances 0.000 description 14
- 229940079593 drug Drugs 0.000 description 12
- 239000007788 liquid Substances 0.000 description 6
- 238000002347 injection Methods 0.000 description 4
- 239000007924 injection Substances 0.000 description 4
- 239000000843 powder Substances 0.000 description 4
- 238000004891 communication Methods 0.000 description 3
- 238000005553 drilling Methods 0.000 description 3
- 210000003739 neck Anatomy 0.000 description 3
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 239000013543 active substance Substances 0.000 description 2
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 2
- 229910052782 aluminium Inorganic materials 0.000 description 2
- 239000002246 antineoplastic agent Substances 0.000 description 2
- 229940041181 antineoplastic drug Drugs 0.000 description 2
- 238000004090 dissolution Methods 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 210000003813 thumb Anatomy 0.000 description 2
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 241001639412 Verres Species 0.000 description 1
- 239000008186 active pharmaceutical agent Substances 0.000 description 1
- 238000004026 adhesive bonding Methods 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 230000000712 assembly Effects 0.000 description 1
- 238000000429 assembly Methods 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 238000002788 crimping Methods 0.000 description 1
- 238000005202 decontamination Methods 0.000 description 1
- 230000003588 decontaminative effect Effects 0.000 description 1
- 229940088679 drug related substance Drugs 0.000 description 1
- 229920001971 elastomer Polymers 0.000 description 1
- 239000000806 elastomer Substances 0.000 description 1
- 230000004578 fetal growth Effects 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 239000003978 infusion fluid Substances 0.000 description 1
- 229940102223 injectable solution Drugs 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000012907 medicinal substance Substances 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 230000010412 perfusion Effects 0.000 description 1
- 229920000515 polycarbonate Polymers 0.000 description 1
- 239000004417 polycarbonate Substances 0.000 description 1
- -1 polypropylene Polymers 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 239000011347 resin Substances 0.000 description 1
- 229920005989 resin Polymers 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 238000003466 welding Methods 0.000 description 1
Images
Classifications
-
- 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
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
-
- 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
- A61J1/10—Bag-type containers
-
- 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
- A61J1/1475—Inlet or outlet ports
-
- 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
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2006—Piercing means
- A61J1/201—Piercing means having one piercing end
-
- 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
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2006—Piercing means
- A61J1/2013—Piercing means having two piercing ends
-
- 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
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2048—Connecting means
- A61J1/2065—Connecting means having aligning and guiding means
Definitions
- the subject of the present invention is a safety packaging device for a bottle for medical use, in particular for a bottle containing substances that are potentially dangerous for users or the environment (anticancer drugs, antibiotics, etc.).
- These medicinal substances are generally packaged in glass vials capped by a pierceable elastomeric stopper, itself fixed inviolably on the vial by crimping an aluminum cap.
- These drugs can be in the form of a liquid, a powder or a lyophilisate. They are intended to be transferred to an infusion bag containing an infusion fluid (NaCl, glucose, etc.) and then injected to the patient. Drugs stored in the vial as a liquid can be directly transferred to the infusion bag, those in the form of a powder or lyophilizate must first be reconstituted by dissolution in a solvent.
- the object of the present invention is therefore to provide a device offering the best guarantees of safety with regard to both the risk of breakage of the bottle, the risk of accidental puncture and the risk of leakage.
- the patent FR1380706 describes a device for transferring a container into another consisting of a plate traversed by two hollow needles pointed at both ends.
- the patent FR1545963 discloses a transfer device constituted by a hollow cylinder provided with a stop diaphragm traversed by a perforated needle having two tips.
- the patent FR2302134 discloses a device for transferring the liquid contents of a container through the stopper or lid of motivation-ci into a second container comprising a tubular body covering the necks of the two containers, a hollow needle having two pointed ends of a length sufficient to cross the caps or lids of the containers and another hollow needle, one end of which passes through the plug or cap of one of the containers and the other end remains in communication with the atmosphere.
- Licences EP0192661 and EP0195018 describe devices for reconstituting drugs for connecting a powder vial and an infusion bag with a bi-tip needle and including means to prevent accidental separation of the elements.
- the FR2780878 discloses a transfer cap for the passage of a medicament between a vial and a solute bag comprising a tubular monoblock body and a needle, characterized by particular detent means.
- connection devices between a closed container and a container in particular form of ready-to-use assemblies.
- a device for the preparation of a liquid drug solution reconstituted from two components comprising at least one element carrying a cannula for communicating the two containers when they are arranged head to tail and a conduit arranged to open through a first port in the container containing the active substance and to terminate, through a second port, to a transfer tip of the reconstituted liquid drug substance.
- the present invention is defined in claim 1 and provides a cheap transfer device, easy to manufacture and meeting both the objectives of personnel safety and protection against breakage.
- the device may be a one-piece cylindrical plastic body consisting of two parts: a lower part intended to completely cover the glass bottle and possibly comprising at its base means of stabilization of the device in vertical position and a lower part of smaller diameter constituted by a cylindrical chamber containing means, for example a bi-tip needle, for transferring the contents of the vial into a container, such as an infusion bag.
- FIG. 1 represents a standard glass bottle (1) closed by an elastomer stopper (2) fixed on the bottle by an aluminum capsule (3).
- the vial contains a drug in the form of a powder or lyophilizate (4). But it can be a sterile liquid.
- Figure 2 shows a standard infusion bag (6) provided with an injection site (5) for transferring the drug.
- FIG. 3 represents a device constituted by a tubular monobloc body comprising a partition (12), perpendicular to the axis of the tubular body, which delimits two open chambers (A) and (B).
- the partition (12) which constitutes the base of the chamber (A) is provided with means for holding in place a two-point needle (10, 11).
- the height of the cylindrical chamber (A) is chosen so as to completely protect the tip (10) of the needle.
- the inside diameter of the chamber (A) is less than that of the chamber (B) but sufficient to accept the passage of the injection sites (5) equipping the infusion bags.
- the two-point needle (10, 11) can be held in the partition (12) by any appropriate means, such as gluing, welding, overmolding.
- the chamber (B) in which opens the other end (11) of the bi-tip needle is constituted by a tube (13).
- This chamber (B) is intended to cover the bottle (1).
- the diameter of the tube (13) is therefore chosen so as to insert the bottle (1) into the tube.
- the diameter of the tube (13) is slightly greater than the diameter of the body of the bottle (1).
- the tube (13) is narrowed at its upper end forming a tube (13a) of smaller diameter than that of the tube (13), the diameter of the tube (13a) being slightly greater than the diameter of the lid (3). ) of the bottle.
- the diameters are chosen so as to allow the insertion of bottles of slightly different dimensions.
- the height of the tube (13a) is chosen as a function of the height h plug (2) - operculum (3) of the bottle (1).
- This embodiment comprising a tube (13) and a tube (13a) makes it possible to match the shape of the bottle (1) by improving the connection between the bottle (1) and the tip (11).
- the wall of the tube (13) covering the bottle may be full or have recesses over part or all of the height.
- the bottle is held in the storage position by means of retaining means (8) intended to prevent the bottle from leaving the chamber (B) and retaining means (7) intended to prevent drilling. inadvertent plug.
- the retaining means (8) are sufficiently elastic to allow the force introduction of the bottle into the device.
- a continuous annular bead can be used.
- these retaining means are constituted by axial ribs formed inside the tube (13) which provide a frictional force on the body of the bottle.
- the device can be used for bottles having slightly different diameters.
- the retaining means (8) can be replaced by a perforable seal by the thumb (film or welded paper) or by a captive plug.
- the retaining means (7) may be formed by any means capable of providing an elastic stop function, for example a continuous annular bead or no.
- the tube (13) comprises at its base means for increasing the stability of the device in vertical position.
- This is for example a flange (9), optionally comprising additional means, for example flats, to prevent the device from rolling when in the horizontal position.
- the tubular monobloc body is made of a shockproof plastic material, to avoid the risk of breakage, and preferably transparent to allow reading of the information mentioned on the body of the bottle and the monitoring of its contents. Any plastic material having such properties as polypropylene, polycarbonate or K resin may be used.
- the contents of the bottle (1) are placed in communication with the contents of the infusion bag (6) after perforation of the stopper (2) by the tip (11) and the injection site (5) by the tip (10).
- the bottle (1) slides in the chamber (B) under the action of a thrust exerted on the bottom (14) of the bottle.
- the bottle moves until it abuts on the partition (12), which allows the tip (11) to pierce the stopper (2).
- it is pushed on the bottom (14) of the bottle with the thumb.
- the retaining means (7) make it possible to keep the bottle in the use position and to avoid the axial displacement of the bottle downwards.
- the injection site (5) of the infusion bag (6) is pierced in a conventional manner by force introduction of the site in the chamber (A).
- FIG. 5 represents a particular embodiment of the abutment means (7) preventing the inadvertent piercing of the plug.
- the elastic retaining means consist of tabs (15, 16) whose free ends are oriented towards the inside of the tube (13a).
- the thrust exerted on the bottom of the bottle separates the tabs (15, 16) which, after drilling the stopper (2), prevent the bottle from falling back to the bottom of the device.
- the elastic means (8) may also consist of tongues such as tongues (15, 16).
- FIG. 6 represents a particular embodiment of the base of the device.
- the base of the tube (13) has one or more openings (17) to facilitate the thrust on the bottom of the bottle. Systems with a single opening are preferred to avoid the risk of the bottle being pulled out.
- the figures illustrate an embodiment in which a vial (1) and an infusion bag (6) are placed in communication.
- the system can be used to port a vial to another type of container.
- the exemplified embodiments relate to a device with a two-point needle, but a device with a bottle-side needle and a pouch-side luer site can also be used.
- the device is a one-piece plastic body. It is therefore easy to produce using the conventional processes of the plastics industry.
- the device is sterilized with ethylene oxide, steam or radiation.
- the device is placed in advance on the bottle (1).
- the device / vial assembly is pre-assembled, placed in a blister and sterilized as above.
- the device may be provided with a removable cap sealingly sealing the chamber A, then after mounting the bottle in the chamber B the bottom of the chamber B may be sealed with a "heat sealable" paper, allowing sterilization from the assembly to ethylene oxide or steam.
- a "heat sealable” paper allowing sterilization from the assembly to ethylene oxide or steam.
- the device is placed on the bottle (1) at the time of its use. Just remove the cap (3) and forcefully insert the vial into the tube (13).
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)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Buffer Packaging (AREA)
- Closures For Containers (AREA)
Claims (11)
- Sicherheitsverpackungsvorrichtung für ein Fläschchen (1) mit medizinischer Nutzung, die ermöglicht, den Inhalt des Fläschchens (1) direkt in ein aufnehmendes Element wie etwa einen Perfusionsbeutel (6) zu übertragen, mit- einem zylindrischen, röhrenförmigen Körper, der die Seitenwände des Fläschchens (1) sowohl in der Aufbewahrungsposition als auch in der Verwendungsposition des Fläschchens auf dessen gesamter Höhe abdeckt, und- einer Trennwand (12), die zu der Achse des röhrenförmigen Körpers senkrecht ist,✔ wobei die Trennwand eine offene erste Kammer (A) und eine offene zweite Kammer (B) definiert, wobei die zweite Kammer (B) durch ein Rohr (13) gebildet ist, das erste Rückhaltemittel (7), die in der Aufbewahrungsposition über dem Fläschchen (1) angeordnet sind, und zweite Rückhaltemittel (8), die in der Aufbewahrungsposition unter dem Fläschchen (1) angeordnet sind, enthält,■ wobei die ersten Rückhaltemittel (7) dazu bestimmt sind, eine unerwünschte Durchlochung des Stopfens des Fläschchens (1) in der Aufbewahrungsposition und die axiale Verlagerung nach unten des Fläschchens in der Verwendungsposition zu verhindern, und ausreichend elastisch sind, um die axiale Verlagerung des Fläschchens zu den Übertragungsmitteln unter der Wirkung eines auf den Boden (14) des Fläschchens ausgeübten Schubs zuzulassen, und■ wobei die zweiten Rückhaltemittel (8) dazu bestimmt sind, ein Austreten des Fläschchens (1) aus der zweiten Kammer (B) in der Aufbewahrungsposition zu verhindern, und ausreichend elastisch sind, um die Einführung des Fläschchens in die Vorrichtung zuzulassen,✔ wobei die Trennwand mit Mitteln versehen ist, um die Mittel zum Übertragen des Inhalts des Fläschchens (1) in das aufnehmende Element festzuhalten.
- Verpackungsvorrichtung nach Anspruch 1, dadurch gekennzeichnet, dass die Übertragungsmittel durch eine Doppelspitzen-Nadel (10, 11) gebildet sind.
- Verpackungsvorrichtung nach Anspruch 1, dadurch gekennzeichnet, dass die Übertragungsmittel durch eine Nadel auf Seiten des Fläschchens (1) und durch einen Stecker- oder Buchsen-Luersitz auf Seiten des aufnehmenden Elements gebildet sind.
- Verpackungsvorrichtung nach einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, dass das Rohr (13) an seinem oberen Ende eingeschnürt ist, indem es ein Rohr (13a) mit einem Durchmesser bildet, der etwas kleiner als jener des Rohrs (13) ist.
- Verpackungsvorrichtung nach einem der Ansprüche 1 bis 4, dadurch gekennzeichnet, dass die elastischen Rückhaltemittel (7, 8) durch einen ununterbrochenen oder unterbrochenen ringförmigen Wulst gebildet sind.
- Verpackungsvorrichtung nach einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, dass die elastischen Rückhaltemittel (7, 8) durch Zungen (15, 16) gebildet sind, deren freie Enden in den Innenraum des Rohrs (13) orientiert sind.
- Verpackungsvorrichtung nach einem der Ansprüche 1 bis 6, dadurch gekennzeichnet, dass die Basis des Rohrs (13) mit einem Flansch (9) ausgerüstet ist, der eventuell mit Mitteln versehen ist, die dazu bestimmt sind, ein Rollen der Vorrichtung in horizontaler Position zu verhindern.
- Verpackungsvorrichtung nach einem der Ansprüche 1 bis 7, dadurch gekennzeichnet, dass die Basis des Rohrs eine oder mehrere Öffnungen (17) aufweist, die dazu bestimmt sind, die Ausübung des Schubs auf den Boden des Fläschchens zu erleichtern.
- Verpackungsvorrichtung nach einem der Ansprüche 1 bis 8, dadurch gekennzeichnet, dass der röhrenförmige Körper aus einem stoßfesten und lichtdurchlässigen Kunststoff besteht.
- Verpackungsvorrichtung nach einem der Ansprüche 1 bis 9, dadurch gekennzeichnet, dass die Vorrichtung in ihrer Verpackung mit Ethylenoxid, mit Dampf oder durch Bestrahlung sterilisiert wird.
- Verpackungsvorrichtung nach einem der Ansprüche 1 bis 10, dadurch gekennzeichnet, dass die Vorrichtung in Blister verpackt ist.
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR0110982A FR2828802A1 (fr) | 2001-08-22 | 2001-08-22 | Conditionnement de securite pour flacon a usage medical |
FR0110982 | 2001-08-22 | ||
FR0116379 | 2001-12-18 | ||
FR0116379A FR2828803B1 (fr) | 2001-08-22 | 2001-12-18 | Conditionnement de securite pour flacon a usage medical |
PCT/FR2002/002920 WO2003017916A1 (fr) | 2001-08-22 | 2002-08-22 | Conditionnement de securite pour flacon a usage medical |
Publications (2)
Publication Number | Publication Date |
---|---|
EP1435893A1 EP1435893A1 (de) | 2004-07-14 |
EP1435893B1 true EP1435893B1 (de) | 2008-02-06 |
Family
ID=26213151
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP20020796303 Expired - Lifetime EP1435893B1 (de) | 2001-08-22 | 2002-08-22 | Sicherheitsverpackung für eine flasche für medizinische anwendungen |
Country Status (8)
Country | Link |
---|---|
EP (1) | EP1435893B1 (de) |
AT (1) | ATE385418T1 (de) |
DE (1) | DE60224940T2 (de) |
DK (1) | DK1435893T3 (de) |
ES (1) | ES2300504T3 (de) |
FR (2) | FR2828802A1 (de) |
PT (1) | PT1435893E (de) |
WO (1) | WO2003017916A1 (de) |
Families Citing this family (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2863161B1 (fr) | 2003-12-05 | 2006-09-01 | Map France | Capuchon pour conditionnement de securite pour flacon a usage medical |
US7615041B2 (en) | 2004-07-29 | 2009-11-10 | Boston Scientific Scimed, Inc. | Vial adaptor |
FR2878737B1 (fr) | 2004-12-07 | 2007-03-16 | Maptech Soc Par Actions Simpli | Dispositif de securite pour flacon a usage medical |
AU2010294420B2 (en) * | 2009-09-14 | 2015-08-13 | Société des Produits Nestlé S.A. | Package with foil seals and penetrating means |
US20160039546A1 (en) * | 2014-08-07 | 2016-02-11 | Greg Gardner | Condiment transfer device and method |
ITUB20153260A1 (it) * | 2015-08-27 | 2017-02-27 | Paolo Gobbi Frattini S R L | Tappo di chiusura ermetica per flacone sterile sigillato di contenimento di sostanze attive medicinali o nutrizionali, idoneo per la connessione sterile con un contenitore di soluzione liquida diluente, e sistema di connessione sterile utilizzante detto tappo di chiusura. |
US20220087901A1 (en) * | 2019-02-12 | 2022-03-24 | Amgen Inc. | Systems and approaches for drug delivery device reconstitution |
CH716516A1 (fr) * | 2019-08-22 | 2021-02-26 | Mpi Int Sa | Procédé de préparation d'au moins une solution injectable en poche, unité pour la préparation de ladite solution injectable et poche contenant ladite solution injectable. |
CH716733A1 (fr) * | 2019-10-29 | 2021-04-30 | Mpi Int Sa | Procédé de préparation d'au moins une solution injectable en ampoule, unité pour la préparation de ladite solution injectable et ampoule contenant ladite solution injectable. |
Family Cites Families (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR1380706A (fr) | 1963-10-23 | 1964-12-04 | Dispositif pour le transvasement d'un fluide d'un récipient à un autre | |
FR1545963A (fr) | 1967-11-07 | 1968-11-15 | Abc Ist Biolog Chem Spa | Emballage de deux substances séparées et miscibles, dont une au moins liquide, avec dispositif de transvasement |
FR2302134A1 (fr) | 1975-02-28 | 1976-09-24 | Merieux Inst | Dispo |
US4607671A (en) | 1984-08-21 | 1986-08-26 | Baxter Travenol Laboratories, Inc. | Reconstitution device |
US4759756A (en) | 1984-09-14 | 1988-07-26 | Baxter Travenol Laboratories, Inc. | Reconstitution device |
WO1988007358A1 (en) * | 1987-04-02 | 1988-10-06 | Drg (Uk) Limited | Apparatus for contacting material such as a drug with a fluid |
DE19513666C1 (de) * | 1995-04-11 | 1996-11-28 | Behringwerke Ag | Vorrichtung zum Zusammenführen einer ersten flüssigen und einer zweiten festen oder flüssigen Komponente mittels Unterdruck unter sterilen Bedingungen |
FR2738550B1 (fr) | 1995-09-11 | 1997-11-07 | Biodome | Dispositif d'obturation d'un recipient lui-meme ferme, ensemble pour dispenser un produit comprenant un tel recipient et un tel dispositif d'obturation |
WO1997020536A1 (fr) * | 1995-12-06 | 1997-06-12 | Gabriel Meyer | Dispositif pour la preparation d'une solution medicamenteuse reconstituee a partir de deux composants |
FR2753624B1 (fr) | 1996-09-25 | 1999-04-16 | Biodome | Dispositif de connexion, en particulier entre un recipient avec bouchon perforable et une seringue |
FR2780878B1 (fr) | 1998-07-10 | 2000-09-29 | Frederic Senaux | Capuchon de transfert encliquetable |
FR2790749B1 (fr) * | 1999-03-10 | 2001-05-18 | Maco Pharma Sa | Dispositif de transfert d'une substance contenue dans un flacon dans une poche de solute |
-
2001
- 2001-08-22 FR FR0110982A patent/FR2828802A1/fr active Pending
- 2001-12-18 FR FR0116379A patent/FR2828803B1/fr not_active Expired - Fee Related
-
2002
- 2002-08-22 PT PT02796303T patent/PT1435893E/pt unknown
- 2002-08-22 WO PCT/FR2002/002920 patent/WO2003017916A1/fr active IP Right Grant
- 2002-08-22 AT AT02796303T patent/ATE385418T1/de active
- 2002-08-22 ES ES02796303T patent/ES2300504T3/es not_active Expired - Lifetime
- 2002-08-22 EP EP20020796303 patent/EP1435893B1/de not_active Expired - Lifetime
- 2002-08-22 DK DK02796303T patent/DK1435893T3/da active
- 2002-08-22 DE DE2002624940 patent/DE60224940T2/de not_active Expired - Lifetime
Also Published As
Publication number | Publication date |
---|---|
WO2003017916A1 (fr) | 2003-03-06 |
FR2828802A1 (fr) | 2003-02-28 |
FR2828803A1 (fr) | 2003-02-28 |
DE60224940D1 (de) | 2008-03-20 |
FR2828803B1 (fr) | 2004-10-22 |
ATE385418T1 (de) | 2008-02-15 |
DK1435893T3 (da) | 2008-06-09 |
ES2300504T3 (es) | 2008-06-16 |
PT1435893E (pt) | 2008-05-09 |
EP1435893A1 (de) | 2004-07-14 |
DE60224940T2 (de) | 2008-08-21 |
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