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EP0670709A1 - Contenant pour liquides medicaux. - Google Patents

Contenant pour liquides medicaux.

Info

Publication number
EP0670709A1
EP0670709A1 EP94928539A EP94928539A EP0670709A1 EP 0670709 A1 EP0670709 A1 EP 0670709A1 EP 94928539 A EP94928539 A EP 94928539A EP 94928539 A EP94928539 A EP 94928539A EP 0670709 A1 EP0670709 A1 EP 0670709A1
Authority
EP
European Patent Office
Prior art keywords
container
cap
sealing device
containers
container body
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.)
Granted
Application number
EP94928539A
Other languages
German (de)
English (en)
Other versions
EP0670709B1 (fr
Inventor
Gunnar Andersson
Joens Hilborn
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.)
Fresenius Kabi AB
Pfizer Health AB
Original Assignee
Pharmacia AB
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 Pharmacia AB filed Critical Pharmacia AB
Publication of EP0670709A1 publication Critical patent/EP0670709A1/fr
Application granted granted Critical
Publication of EP0670709B1 publication Critical patent/EP0670709B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

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
    • B65D1/00—Rigid or semi-rigid containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material or by deep-drawing operations performed on sheet material
    • B65D1/09—Ampoules
    • B65D1/095—Ampoules made of flexible material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • 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
    • B65D41/00—Caps, e.g. crown caps or crown seals, i.e. members having parts arranged for engagement with the external periphery of a neck or wall defining a pouring opening or discharge aperture; Protective cap-like covers for closure members, e.g. decorative covers of metal foil or paper
    • B65D41/02—Caps or cap-like covers without lines of weakness, tearing strips, tags, or like opening or removal devices
    • B65D41/04—Threaded or like caps or cap-like covers secured by rotation
    • B65D41/0435—Threaded or like caps or cap-like covers secured by rotation with separate sealing elements

Definitions

  • the present invention relates to improved thermoplastic containers for medical fluids which are terminally sealed when autoclaving the filled containers.
  • Polymeric materials are cheap and convenient to use, but they often deteriorate in their capacity of providing an oxygen and a water barrier after autoclaving.
  • Another drawback with polymeric materials is that they can be incompatible with sensitive medical fluids intended for parenteral administration.
  • plasticizers and other components with deleterious effects have dissolved into medical fluids during storage.
  • Many medical materials are prepared from halogenated hydrocarbons like PVC and PVDC, which have excellent properties after heat sterlization. These materials will, however, today be avoided for the long term storage of fluids because of the mentioned dissolvement problems and also because of their negative influence on the environment.
  • Another problem with polymeric materials, especially those found in conventional bottle-type medical containers is related to the sealing of the filled containers and the subsequent sterilizing of the goods before storage.
  • the U.S. patent 4,606,470 discloses a container having the container body, the neck and the cap all made of the same plastic, material such as polyethylene or polypropene which is potentially possible to recycle.
  • This container is sealed by a spin fusion technique, whereby the closure is rotated relative the container and the resultant friction heat leads to sealing fusion by partial melting.
  • the U.S. patent 4,640,427 teaches how to seal a thermoplastic container by means of applying radiant energy from a laser to partially melt and fuse a tab with the container wall.
  • the U.S. patent 4,011,961 describes an autoclavable plastic bottle having a cap in two parts as a closure, wherein both the cap and the bottle can be made of polypropylene.
  • the cap is sealed to the bottle by ultrasonic welding of meltable material rings.
  • the cap is also constructed by three different elements, an inner and an outer cap and a elastic disc which has a redosing effect after being penetrated with a cannula.
  • the U.S. patent 5,033,252 is directed to autoclaving of filled polypropylene bottles with polypropylene caps.
  • a silicon gasket is positioned between the cap and the bottle having capacity of absorbing the pressures developed by the expansion of the cap and /or the bottle.
  • Most of the mentioned plastic containers will be dependent on sealing methods that employs external energy sources to partially melt container details, which is resource consuming and often result in weldings that may be weakened or wasted subsequent to their autoclavation.
  • Another drawback with the sealings obtained by melting of polymeric materials is that they normally do not have the capacity to reseal the container once the welding has been ruptured.
  • the autoclavable constructions cited above have closing devices comprised of several parts and will be unnecessarily complicated and thereby expensive to manufacture, as well as they introduce components such an elastic disc and a silicon gasket, that must be collected separately, if the containers shall be recycled after use.
  • Another important object of the present invention to provide containers which fulfil the requirements of being capable to withstand heat sterilizing procedures and yet be made from parts which can be recyclable together in a single process and thereby form a convenient, cheap and resource saving alternative to the conventional technology.
  • the present invention relates to an autoclavable container for storage of medical fluids, suitable for repeated collection fluid dosages, having a bottle formed container body with an opening for receiving and/or collecting the fluids, which is closed with a closure device consisting of a cap and a flexible sealing device, wherein all parts of container consist of essentially the same polyolefin, in order to make it recyclable in the same process.
  • a closure device consisting of a cap and a flexible sealing device
  • all parts of container consist of essentially the same polyolefin, in order to make it recyclable in the same process.
  • An important feature of the invention is that the said sealing device, besides the polyolefin, also contains an elastomer so a weak seal is formed between the container body and/or the cap and the sealing device when autoclaving the said container.
  • the invention is also related to a method for sealing the said containers after they have been filled and closed, by subjecting them to autoclavation, whereby a weak seal is formed between the container body and /or the cap and the sealing device.
  • the sealing will take place between the connecting parts of the container and /or the cap and the sealing device during the autoclaving procedure. Since both the container body and the sealing device are made from polymers compatible with each other, the molecules in their contact surfaces will mix by inter-diffusion under the influence of the heat so a weak seal welding is formed between the said container parts, which effectively separates the medical fluid from the environment. To successfully obtain the weak seals, it is important that the sealing device contains a certain amount of elastomer, such as dispersed EPDM-rubber, so the sealing device can exert a balancing pressure when the polyolefin container expands and contracts during the autoclaving process.
  • elastomer such as dispersed EPDM-rubber
  • the sealing device can be pre-formed separately from the cap and assembled with the cap and the container body after the filling procedure.
  • the sealing device can be formed by injection moulding directly in the cap or the sealing device can be coextruded with the cap in the same tool.
  • Another manufacturing alternative is to spray or blow mould the bottle formed container on a pre-formed cap.
  • the sealing device is preferably annular or disc-formed, but other forms can be possible to fit a desired form of the container and the cap.
  • the sealing device both can reseal the container properly once the weak seal has been broken and that it is so resilient that it will be resealed after being pierced by a conventional injection needle used to collect a dosage of the fluids.
  • Figure 1 shows a the bottle formed container body according to a first embodiment of the invention.
  • Figure 2 shows a closure device according to a first embodiment of the invention.
  • Figure 3A shows a container according to second embodiment of the invention.
  • Figure 3B is a top view of the container shown in Figure 3A.
  • the container body is formed as a conventional bottle (1) with a neck part (2) and a threaded top part (3) which is engaged with a corresponding closure device, see Figure 2, consisting of a threaded cap (4) and a flexible sealing device in the form of a resilient lining (5).
  • a suitable material for the container body (1) which is formed by blow moulding, is polypropylene of the grade PD-9122 random copolymer resin supplied by Exxon Chemical Company.
  • the resilient lining (5) is preferably made of a polypropylene containing a compatible thermoplastic elastomer.
  • a suitable material for the lining is Santoprene® 55 shore from Monsanto Company that besides polypropylene contains dispersed EPDM-rubber.
  • the lining is preferably formed by injection moulding.
  • the cap is preferably manufactured from the polypropylene Appryl 3050 M .
  • the closure device is a cap (11) sealingly secured around the annular flange (13) of a resilient, pierceable stopper (12).
  • the cap consists of a handle (14) attached to a knob (15). When opening the container, the handle will be turned so the knob is released from a preformed weakened or rupturable section to form an aperture in the cap (not shown), through which aperture the needle of a syringe can pierce the stopper and contact the liquid stored in the container.
  • the bottle formed container body (10) and the cap (11) are preferably made in a single piece of material, such as polypropylene of the type PP 23M2 (random copolymer-medical grade) from Rexene® Resins, and the resilient stopper is preferably made of the above mentioned Santoprene® 55 shore from Monsanto Company.
  • the container is manufactured by a conventional blow- fill-seal method, whereby a parison of polypropylene is formed in a suitable tool with an extruder. The parison is sealed in the bottom, and thereafter the medical fluid is filled in the formed bottle or container body, which is sealed with the resilient stopper, whereafter the cap is sealed around, and on the top of the stopper.
  • the cap and bottle are preferably parts of the same comparison and are processed with conventional tools. After autoclaving, these parts will form a weak seal together with the resilient stopper, in the same manner, as described with the first embodiment of the invention.
  • the inventive containers will be used to contain medical fluids, which are subjected to autoclaving when filled in the closed container.
  • the containers are also suitable to contain multiple dosages of the fluid for repeated use since the sealing device is capable of resealing the container after each fluid collection.
  • Typical medical fluids to be filled in the containers are rinsing liquids of dissolved sodium chloride, but any fluids for parenteral administration are conceivable to fill and store in the containers.
  • the containers according to the invention can withstand autoclaving procedures without any material deterioration effects and will be suitable for long term storage for sensitive medical fluids which must retain their integrity after repeated fluid collection.
  • the inventive containers can be collected for recycling after use without disassembling its parts and without any other separation processes.
  • the collected material can be chopped to pieces, washed and dried and thereafter melted and re-granulated for new applications or moulded into new containers.
  • the recycling scheme for the inventive containers will be advantageously simple and free from environmental influences, since the containers during their manufacture, assembly, storage and use not have been involved in any procedures such as treatment with ultra-violet light, heat or oils.
  • the containers will provide for a simple collection procedure at hospitals without any inconvenient sorting of materials or any other laborious procedures.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Ceramic Engineering (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Lining Or Joining Of Plastics Or The Like (AREA)
  • Materials For Medical Uses (AREA)
  • External Artificial Organs (AREA)
  • Closures For Containers (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

L'invention concerne des contenants en matières polymères pour liquides médicaux constitués d'un corps de contenant en forme de bouteille (1, 10) et d'un dispositif de fermeture (4, 11) capables de résister aux opérations de stérilisation à haute température bien qu'ils soient fabriqués à partir d'éléments pouvant être recyclés par un seul procédé. Les contenants selon l'invention sont également fermés de manière étanche pendant la stérilisation au moyen de soudures de fermeture à faible résistance.
EP94928539A 1993-09-24 1994-09-21 Contenant pour liquides medicaux Expired - Lifetime EP0670709B1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
SE9303123 1993-09-24
SE9303123A SE501925C2 (sv) 1993-09-24 1993-09-24 Behållare för medicinska vätskor samt förfarande för dess försegling
PCT/SE1994/000876 WO1995008317A1 (fr) 1993-09-24 1994-09-21 Contenant pour liquides medicaux

Publications (2)

Publication Number Publication Date
EP0670709A1 true EP0670709A1 (fr) 1995-09-13
EP0670709B1 EP0670709B1 (fr) 1997-04-23

Family

ID=20391207

Family Applications (1)

Application Number Title Priority Date Filing Date
EP94928539A Expired - Lifetime EP0670709B1 (fr) 1993-09-24 1994-09-21 Contenant pour liquides medicaux

Country Status (11)

Country Link
EP (1) EP0670709B1 (fr)
AT (1) ATE151979T1 (fr)
AU (1) AU7793494A (fr)
DE (1) DE69402825T2 (fr)
DK (1) DK0670709T3 (fr)
ES (1) ES2102254T3 (fr)
FI (1) FI107584B (fr)
GR (1) GR3024211T3 (fr)
NO (1) NO306376B1 (fr)
SE (1) SE501925C2 (fr)
WO (1) WO1995008317A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000016729A1 (fr) 1998-09-22 2000-03-30 Fresenius Kabi Ab Recipient pour administration par voie intraveineuse

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE9601540D0 (sv) * 1996-04-23 1996-04-23 Pharmacia Ab Improved medical containers
US6308847B1 (en) 1996-05-20 2001-10-30 Fresenius Kabi Aktiebolag Medical containers
US6720044B2 (en) 1997-02-20 2004-04-13 Pharmacia Ab Polyolefinic closures comprising penetrable plugs and annular channels
MXPA01012223A (es) * 1999-05-28 2002-07-02 Novartis Ag Paquete para un producto farmaceutico y metodo para esterilizar el paquete.
AT508683B1 (de) * 2009-09-03 2013-09-15 Croma Pharma Gmbh Verfahren zur herstellung eines in einer schutzhülle eingeschweissten behältnisses
WO2012137945A1 (fr) * 2011-04-06 2012-10-11 株式会社大塚製薬工場 Ampoule en plastique
GR20160100205A (el) * 2016-04-25 2017-11-30 Κωνσταντινος Ελευθεριου Σιδηροπουλος Αμπουλα φυσιολογικου ορου με βιδωτο ρυγχος απο πολλαπλα αποστειρωσιμο πλαστικο για ρινικες πλυσεις, σε νεογνα, βρεφη και παιδια
US20240237860A1 (en) * 2021-07-20 2024-07-18 Circulr Research Pty Ltd Deformable plastic vessel and system for reducing plastic waste

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE1532416A1 (de) * 1965-09-15 1972-07-27 Grace W R & Co Verfahren zur Herstellung von Behaelterverschluessen mit Dichtungseinlagen
GB2162158A (en) * 1984-04-13 1986-01-29 Donald Paul Pilla Closure
US4606470A (en) * 1984-11-09 1986-08-19 Superpac Vending (Curacao) N.V. Spin fusion method and container made therefrom
US5033252A (en) * 1987-12-23 1991-07-23 Entravision, Inc. Method of packaging and sterilizing a pharmaceutical product
EP0481981B2 (fr) * 1988-06-17 1999-11-17 Closures and Packaging Services Limited Couvercle sans revetement interieur pour recipients de boissons gazeuses
GB8820393D0 (en) * 1988-08-26 1988-09-28 Reed Packaging Ltd Plastic containers
US4991731A (en) * 1989-08-03 1991-02-12 Abbott Laboratories/Ross Laboratories Retortable composite closure for plastic containers

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO9508317A1 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000016729A1 (fr) 1998-09-22 2000-03-30 Fresenius Kabi Ab Recipient pour administration par voie intraveineuse

Also Published As

Publication number Publication date
NO952050D0 (no) 1995-05-23
DE69402825D1 (de) 1997-05-28
FI107584B (fi) 2001-09-14
AU7793494A (en) 1995-04-10
WO1995008317A1 (fr) 1995-03-30
SE9303123D0 (sv) 1993-09-24
EP0670709B1 (fr) 1997-04-23
SE9303123L (sv) 1995-03-25
FI952505A0 (fi) 1995-05-23
NO306376B1 (no) 1999-11-01
DK0670709T3 (da) 1997-09-29
ES2102254T3 (es) 1997-07-16
FI952505L (fi) 1995-05-23
NO952050L (no) 1995-05-23
SE501925C2 (sv) 1995-06-19
DE69402825T2 (de) 1997-10-02
ATE151979T1 (de) 1997-05-15
GR3024211T3 (en) 1997-10-31

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