EP4124329A1 - Flaschenverschliessvorrichtung - Google Patents

Flaschenverschliessvorrichtung Download PDF

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Publication number
EP4124329A1
EP4124329A1 EP21398011.3A EP21398011A EP4124329A1 EP 4124329 A1 EP4124329 A1 EP 4124329A1 EP 21398011 A EP21398011 A EP 21398011A EP 4124329 A1 EP4124329 A1 EP 4124329A1
Authority
EP
European Patent Office
Prior art keywords
outer part
previous
injection
coating parts
inner part
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
Application number
EP21398011.3A
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English (en)
French (fr)
Inventor
designation of the inventor has not yet been filed The
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Guida & Nuno Dionisio Lda
Laboratorios Basi Industria Farmaceutica SA
Original Assignee
Guida & Nuno Dionisio Lda
Laboratorios Basi Industria Farmaceutica SA
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Guida & Nuno Dionisio Lda, Laboratorios Basi Industria Farmaceutica SA filed Critical Guida & Nuno Dionisio Lda
Priority to EP21398011.3A priority Critical patent/EP4124329A1/de
Publication of EP4124329A1 publication Critical patent/EP4124329A1/de
Pending legal-status Critical Current

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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
    • A61J1/1412—Containers with closing means, e.g. caps
    • 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
    • A61J1/1475—Inlet or outlet ports
    • A61J1/1487—Inlet or outlet ports with friction fit, e.g. connecting tubes directly to a protruding port
    • 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
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • 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
    • B65D55/00—Accessories for container closures not otherwise provided for
    • B65D55/02—Locking devices; Means for discouraging or indicating unauthorised opening or removal of closure
    • B65D55/024—Closures in which a part has to be ruptured to gain access to the contents

Definitions

  • a device for medical use particularly relating to a device intended to seal containers / vials for medical use, more particularly plastic vials, even more particularly to seal plastic vials used for the packaging of parenteral solutions, in a more particular way relating to a device for sealing plastic vials used for the packaging of small volume parenteral solutions (SVPS) and large volume parenteral solutions (LVPS), i.e. sterile and apyrogenic solutions intended for single-dose parenteral administration, where plastic is the primary packaging material used, such as for instance in saline drip bags.
  • SVPS small volume parenteral solutions
  • LVPS large volume parenteral solutions
  • plastic is the primary packaging material used, such as for instance in saline drip bags.
  • the present invention relates to a device for sealing containers / vials intended for medical use, as those used in the packaging of Parenteral Solutions, in a preferred embodiment being small or large volume parenteral solutions. It is usually favourable for these devices to have an inlet for some administration system and to have another inlet, independent of the first one, for the administration of additives/drugs to patients. Most relevant are the documents US2016038373A1 , US2014135711 , DE202004003267 , DE102005015504D1 and EP16825584A , which disclose solutions for sealing medical containers with means for injecting and/or withdrawing solutions.
  • EP16825584A is particularly relevant and discloses a needleless syringe connector cap for applying to a container having an aperture at its top, said cap comprising an elastically deformable plastic valve body to be coupled to said aperture at the top of the container, said valve body having an upper surface and a lower surface and two orifices, each orifice extending through the valve body from the upper surface to the lower surface thereof, wherein said first orifice comprises a first cross-slit valve at the lower end of said orifice, said first cross-slit valve being incorporated as an aeration valve, and wherein said second orifice comprises a second slit valve at the lower end of said orifice, said second cross-slit valve being incorporated as an aeration valve, and the first orifice is adapted to receive a first syringe tip and the second orifice is adapted to receive a second syringe tip, such that when fluid is withdrawn from a container to which the cap is coupled
  • the present invention differs, for the most part, from document EP16825584A in that the latter does not provide for the device to be unfolded into various parts, i.e. it is a single piece, and there is not the fitting of various elements as in the present invention. Another difference has to do with the fact that it does not present the possibility of multiple inlets, which is provided with the present invention, as it has two injection inlets, wherein one inlet may be for the purposes of saline drip and the other for additional medication that the patient needs.
  • the present invention has individual protection from the outside, allowing its independent use with guaranteed protection against contamination.
  • this invention presents, besides the injection independent inlets, a protection of the same, hereafter detailed as tabs and these injection inlets are coated by two rubber elements, hereafter referred to as coating parts, thus allowing the present invention to achieve a tight and uniform seal of the vial of parenteral solutions, enabling the sterile characteristics of the product to be maintained, without contamination and free of particles (as evidenced in the studies of tightness, sterility and particle testing carried out on the products after production).
  • These protections that are breakable by the health professional are not reusable, ensuring that the sterility of the injection inlet is preserved immediately before use.
  • the invention disclosed in document EP16825584A also does not achieve this effect.
  • This device thus guarantees the sealing of plastic containers / vials, in particular if these vials are also made of polypropylene, since in a preferred embodiment the invention is made of polypropylene, therefore the most suitable material of the vial should also be polypropylene because there is an excellent compatibility and it ensures sealing after the hot welding process.
  • This device also ensures the sealing of plastic vials used for packaging of Parenteral Solutions, avoiding the contact of the products with the rubber, which covers the injection inlets, since the same have in their surface a polypropylene plastic membrane, important for safety purposes so as to avoid the risk of rubber particles being released during puncture, and also for the final stability of the packaged product, as the product is in contact with one type of material only - the polypropylene, thus avoiding occurrence of leachable and extractable phenomena due to contact with the rubber.
  • extractable substances are chemical compounds that migrate from the packaging to the final product (through the action of solutions or solvents) under controlled and/or exaggerated conditions of temperature, pH, polarity and time, at levels that are not found in the normal production process and storage, and leachable substances are chemical compounds that are present in the packaging or production process and have potential to migrate to the drug or cosmetic during manufacturing or storage time.
  • the injection inlets (3) (4) have individual protections (8)(9), which may be referred to as tabs, which are removable and managed with only one hand, makes it much easier for healthcare professionals to use this device. It should be added that the protections must be removed to gain access to the pierceable area - the injection inlets (3) (4), so these have a "warning" function, revealing whether the product has been or has not been used, because if these protections no longer exist in the product, the user can automatically check whether the product has been or has not been used by means of visual inspection.
  • this type of product should be used only once, whether the product is fully or partially used, for example a saline drip bottle cannot be reused if it has not been finished, in as much as puncturing the same access twice may imply contamination of the product, and therefore is undesirable and inadvisable.
  • the present invention has a lower weight - in terms of the assembled product - compared to other solutions on the market. In a preferred embodiment, it weighs 4.80 ⁇ 0.5 grams. This was carefully studied at the development stage of the invention in order to reduce the "ecological footprint" as much as possible by reducing the amount of material used. Environmentally, it can be recyclable so that it can be reused for other products, since polypropylene is 100% recyclable, and it has a reduced number of components, therefore using less material.
  • the present invention due to the materials which it is comprised of, provides the possibility for sterilisation being achieved by the preferred and safest method recommended by the pharmacopoeias, so important in these health matters so that the safety of patients is ensured.
  • a reduced number of materials are used, i.e. it is a bi-material product (preferably polypropylene + polyisoprene), thus providing for the use of only two manufacturing processes to obtain the final product.
  • a bi-material product preferably polypropylene + polyisoprene
  • this device has snap-on assembly, which ultimately forms a cap-like product that allows it to fit onto a container, namely a bottle containing liquids such as solutions for medical use.
  • the present invention relates to a device for sealing containers / vials intended for medical use, which are used for packaging of Parenteral Solutions, particularly of large or small volume parenteral solutions.
  • this device comprises an outer part (1) and an inner part (2), the two of which fit together, in detail the inner part (2) fits into the outer part (1).
  • Both parts, the outer (1) one and the inner (2) one, are made of plastic or, in a preferred embodiment, of polypropylene.
  • the outer part (1) is a cap.
  • the outer part (1) in its external surface, comprises:
  • the outer protective tabs (8) (9) are never in contact with the liquid to be injected, having the only purpose of protecting the coating parts (10)(11) from the external environment.
  • this sealing device features two coating parts (10) (11), which are made of polyisoprene rubber.
  • the inner part (2) comprises:
  • the membranes (6)(7) are made of polypropylene so as to ensure that the liquid does not come into contact with the coating parts (10) (11), which are preferably made of polyisoprene rubber.
  • the device thus provides a tight and uniform sealing of the parenteral solution bottle, allowing the product to keep its sterility characteristics, without contamination and free of particles, as proven by the tightness, sterility and particle tests and trials performed on the products after production (table 1, 2).
  • the present invention given its composition, is resistant to sterilization by moist heat, as demonstrated by tests carried out on the products before and after production (table 1, 2).
  • the materials from which the device object of the present invention is made allow the sterilization which is considered the process of choice in the pharmaceutical industry to be performed, due to a greater effectiveness being guaranteed: sterilization by moist heat at a temperature of 121° C for a minimum of 15 minutes.
  • the first phase is a thermoplastic injection process, in this case for the polypropylene material; as such, the injection of the polypropylene components is carried out in fully electric injection machines in order to avoid contamination of the product through lubrication oils.
  • the two polypropylene parts i.e. the inner (2) and outer (1) parts, are injected in a clean room with positive pressure in order to eliminate contamination through air particles and these materials are processed in electric injection machines which are free of lubricants so as to avoid contact contamination.
  • the second phase concerns the assembly, in which the polyisoprene components (the two coating parts (10) (11)) are placed on the outer part (1), the latter being, in a preferred embodiment and as mentioned above, a multi-inlet cap, and the inner part (2) is assembled (said inner part being simply the inside of the outer part (1) with the coating parts (10) (11) fitted between them) in order to avoid the risk of rubber particles being released during puncture and, at the same time, of the liquid coming into contact with the coating parts (10) (11), since this inner part (2) has the two membranes (6)(7) detailed above.
  • the rubber must be a rubber complying with the pharmacopoeia requirements (monograph 3.2.9), preferably a polyisoprene for the unique characteristics they confer to the product. There are still no industrial rubbers on the market for injection process that can replace polyisoprene and guarantee the functionality required for this specific type of product.
  • LDPE low density polyethylene
  • Packing is also carried out in an ISO class 8 clean room, to avoid contact between the product and the outside environment and thus prevent possible contamination.
  • the double bag provides a greater guarantee of product integrity, e.g. prevention of tearing/perforation.
  • the LDPE Bag complies with the provisions contained in Regulations (EC) No. 1935/2004; No. 2023/2006 and No. 10/2011, ensuring compatibility with the product and guaranteeing that they are 100% recyclable.
EP21398011.3A 2021-07-29 2021-07-29 Flaschenverschliessvorrichtung Pending EP4124329A1 (de)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP21398011.3A EP4124329A1 (de) 2021-07-29 2021-07-29 Flaschenverschliessvorrichtung

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP21398011.3A EP4124329A1 (de) 2021-07-29 2021-07-29 Flaschenverschliessvorrichtung

Publications (1)

Publication Number Publication Date
EP4124329A1 true EP4124329A1 (de) 2023-02-01

Family

ID=77726427

Family Applications (1)

Application Number Title Priority Date Filing Date
EP21398011.3A Pending EP4124329A1 (de) 2021-07-29 2021-07-29 Flaschenverschliessvorrichtung

Country Status (1)

Country Link
EP (1) EP4124329A1 (de)

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE202004003267U1 (de) 2004-03-03 2004-05-13 Herbert, Reinhold, Dipl.-Ing. Verschlusskappe
DE102005015504A1 (de) 2005-04-05 2006-10-12 Beller, Klaus-Dieter, Dipl.-Ing. Dr. med. Infusionssystem bestehend aus Infusionsbesteck und speziellen Kappen für Flüssigkeitsbehältnis ohne zwingende Verwendung von Gummidichtungen
CN200951194Y (zh) * 2006-07-07 2007-09-26 湖南千山制药机械股份有限公司 采用双胶塞组合盖的大输液塑料瓶包装
EP1457429B1 (de) * 2003-03-14 2008-05-21 Helvoet Pharma Belgium N.V. Für pharmazeutische Verwendung dienende Überkappe mit Verschlussstopfen
US8211081B2 (en) * 2004-10-20 2012-07-03 Fresenius Kabi Deutschland Gmbh Closing cap for containers filled with medical liquids
US20140135711A1 (en) 2005-11-17 2014-05-15 Becton, Dickinson And Company Patient fluid line access valve antimicrobial cap/cleaner
EP2759284A1 (de) * 2013-01-28 2014-07-30 B. Braun Melsungen AG Überziehkappe für einen pharmazeutischen Behälter
US20160038373A1 (en) 2012-05-21 2016-02-11 Carmel Pharma Ab Protective Cap

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1457429B1 (de) * 2003-03-14 2008-05-21 Helvoet Pharma Belgium N.V. Für pharmazeutische Verwendung dienende Überkappe mit Verschlussstopfen
DE202004003267U1 (de) 2004-03-03 2004-05-13 Herbert, Reinhold, Dipl.-Ing. Verschlusskappe
US8211081B2 (en) * 2004-10-20 2012-07-03 Fresenius Kabi Deutschland Gmbh Closing cap for containers filled with medical liquids
DE102005015504A1 (de) 2005-04-05 2006-10-12 Beller, Klaus-Dieter, Dipl.-Ing. Dr. med. Infusionssystem bestehend aus Infusionsbesteck und speziellen Kappen für Flüssigkeitsbehältnis ohne zwingende Verwendung von Gummidichtungen
US20140135711A1 (en) 2005-11-17 2014-05-15 Becton, Dickinson And Company Patient fluid line access valve antimicrobial cap/cleaner
CN200951194Y (zh) * 2006-07-07 2007-09-26 湖南千山制药机械股份有限公司 采用双胶塞组合盖的大输液塑料瓶包装
US20160038373A1 (en) 2012-05-21 2016-02-11 Carmel Pharma Ab Protective Cap
EP2759284A1 (de) * 2013-01-28 2014-07-30 B. Braun Melsungen AG Überziehkappe für einen pharmazeutischen Behälter

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Inventor name: GONCALVES SIMOES, LUIS PEDRO

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Inventor name: SOUSA DIONISIO, MARCO NUNO DE

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