WO1995008317A1 - Containers for medical fluids - Google Patents
Containers for medical fluids Download PDFInfo
- Publication number
- WO1995008317A1 WO1995008317A1 PCT/SE1994/000876 SE9400876W WO9508317A1 WO 1995008317 A1 WO1995008317 A1 WO 1995008317A1 SE 9400876 W SE9400876 W SE 9400876W WO 9508317 A1 WO9508317 A1 WO 9508317A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- container
- cap
- containers
- sealing device
- container body
- Prior art date
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—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, 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)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Closures For Containers (AREA)
Abstract
Description
Claims
Priority Applications (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE69402825T DE69402825T2 (en) | 1993-09-24 | 1994-09-21 | MEDICAL LIQUID CONTAINERS |
EP94928539A EP0670709B1 (en) | 1993-09-24 | 1994-09-21 | Containers for medical fluids |
AU77934/94A AU7793494A (en) | 1993-09-24 | 1994-09-21 | Containers for medical fluids |
FI952505A FI107584B (en) | 1993-09-24 | 1995-05-23 | The containers for medicine liquid |
NO952050A NO306376B1 (en) | 1993-09-24 | 1995-05-23 | Container for medical fluids |
GR970401857T GR3024211T3 (en) | 1993-09-24 | 1997-07-23 | Containers for medical fluids. |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
SE9303123-5 | 1993-09-24 | ||
SE9303123A SE501925C2 (en) | 1993-09-24 | 1993-09-24 | Containers for medical fluids and procedures for their sealing |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1995008317A1 true WO1995008317A1 (en) | 1995-03-30 |
Family
ID=20391207
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/SE1994/000876 WO1995008317A1 (en) | 1993-09-24 | 1994-09-21 | Containers for medical fluids |
Country Status (11)
Country | Link |
---|---|
EP (1) | EP0670709B1 (en) |
AT (1) | ATE151979T1 (en) |
AU (1) | AU7793494A (en) |
DE (1) | DE69402825T2 (en) |
DK (1) | DK0670709T3 (en) |
ES (1) | ES2102254T3 (en) |
FI (1) | FI107584B (en) |
GR (1) | GR3024211T3 (en) |
NO (1) | NO306376B1 (en) |
SE (1) | SE501925C2 (en) |
WO (1) | WO1995008317A1 (en) |
Cited By (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1997039952A1 (en) * | 1996-04-23 | 1997-10-30 | Pharmacia & Upjohn Ab | Improved medical containers |
WO2000073156A1 (en) * | 1999-05-28 | 2000-12-07 | Novartis Ag | Package for a pharmaceutical product and method of sterilising the package |
US6308847B1 (en) | 1996-05-20 | 2001-10-30 | Fresenius Kabi Aktiebolag | Medical containers |
US6322739B1 (en) | 1997-02-20 | 2001-11-27 | Fresemus Kabi Ab | Method of manufacturing pharmaceutical articles |
WO2011026161A1 (en) * | 2009-09-03 | 2011-03-10 | Croma-Pharma Gmbh | Method for producing a container welded in a protective cover |
CN103458849A (en) * | 2011-04-06 | 2013-12-18 | 株式会社大塚制药工厂 | Plastic ampule |
GR20160100205A (en) * | 2016-04-25 | 2017-11-30 | Κωνσταντινος Ελευθεριου Σιδηροπουλος | Disposable natural-serum ampoule having a screwable nozzle made of sterilized plastic material - use as nasal wash in infants, children and adults |
WO2023000034A1 (en) * | 2021-07-20 | 2023-01-26 | Circulr Research Pty Ltd | Deformable plastic vessel and system for reducing plastic waste |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
PT1115362E (en) | 1998-09-22 | 2003-04-30 | Fresenius Kabi Ab | CONTAINER FOR INTRAVENOUS ADMINISTRATION |
Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE1532416A1 (en) * | 1965-09-15 | 1972-07-27 | Grace W R & Co | Process for the production of container closures with sealing inserts |
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 |
WO1989012584A1 (en) * | 1988-06-17 | 1989-12-28 | M.K. Plastics Pty. Limited | Linerless closure for carbonated beverage container |
GB2223008A (en) * | 1988-08-26 | 1990-03-28 | Reed Packaging Ltd | Container closures |
US4991731A (en) * | 1989-08-03 | 1991-02-12 | Abbott Laboratories/Ross Laboratories | Retortable composite closure for plastic containers |
US5033252A (en) * | 1987-12-23 | 1991-07-23 | Entravision, Inc. | Method of packaging and sterilizing a pharmaceutical product |
-
1993
- 1993-09-24 SE SE9303123A patent/SE501925C2/en not_active IP Right Cessation
-
1994
- 1994-09-21 AT AT94928539T patent/ATE151979T1/en active
- 1994-09-21 DE DE69402825T patent/DE69402825T2/en not_active Expired - Lifetime
- 1994-09-21 AU AU77934/94A patent/AU7793494A/en not_active Abandoned
- 1994-09-21 ES ES94928539T patent/ES2102254T3/en not_active Expired - Lifetime
- 1994-09-21 EP EP94928539A patent/EP0670709B1/en not_active Expired - Lifetime
- 1994-09-21 DK DK94928539.9T patent/DK0670709T3/en active
- 1994-09-21 WO PCT/SE1994/000876 patent/WO1995008317A1/en active IP Right Grant
-
1995
- 1995-05-23 FI FI952505A patent/FI107584B/en not_active IP Right Cessation
- 1995-05-23 NO NO952050A patent/NO306376B1/en not_active IP Right Cessation
-
1997
- 1997-07-23 GR GR970401857T patent/GR3024211T3/en unknown
Patent Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE1532416A1 (en) * | 1965-09-15 | 1972-07-27 | Grace W R & Co | Process for the production of container closures with sealing inserts |
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 |
WO1989012584A1 (en) * | 1988-06-17 | 1989-12-28 | M.K. Plastics Pty. Limited | Linerless closure for carbonated beverage container |
GB2223008A (en) * | 1988-08-26 | 1990-03-28 | Reed Packaging Ltd | Container closures |
US4991731A (en) * | 1989-08-03 | 1991-02-12 | Abbott Laboratories/Ross Laboratories | Retortable composite closure for plastic containers |
Non-Patent Citations (1)
Title |
---|
PATENT ABSTRACTS OF JAPAN, Vol. 13, No. 289, M-845; & JP,A,01 084 860 (SHOWA DENKO K.K.), 30 March 1989 (30.03.89). * |
Cited By (14)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU715663B2 (en) * | 1996-04-23 | 2000-02-10 | Fresenius Kabi Ab | Improved medical containers |
WO1997039952A1 (en) * | 1996-04-23 | 1997-10-30 | Pharmacia & Upjohn 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 |
US6322739B1 (en) | 1997-02-20 | 2001-11-27 | Fresemus Kabi Ab | Method of manufacturing pharmaceutical articles |
EP1352837A1 (en) * | 1999-05-28 | 2003-10-15 | Novartis AG | Process for manufacturing a sterilized squeezable package for a pharmaceutical product |
WO2000073156A1 (en) * | 1999-05-28 | 2000-12-07 | Novartis Ag | Package for a pharmaceutical product and method of sterilising the package |
US7051906B2 (en) | 1999-05-28 | 2006-05-30 | Novartis Ag | Package for a pharmaceutical product and method of sterilizing the package |
KR100775152B1 (en) * | 1999-05-28 | 2007-11-12 | 노파르티스 아게 | A process for manufacturing a sterilized squeezable package for a pharmaceutical product |
WO2011026161A1 (en) * | 2009-09-03 | 2011-03-10 | Croma-Pharma Gmbh | Method for producing a container welded in a protective cover |
EP2987736A1 (en) * | 2009-09-03 | 2016-02-24 | VALEANT sp. z o.o. sp. j. | Method for producing a container wrapped in a welded protective cover |
CN103458849A (en) * | 2011-04-06 | 2013-12-18 | 株式会社大塚制药工厂 | Plastic ampule |
GR20160100205A (en) * | 2016-04-25 | 2017-11-30 | Κωνσταντινος Ελευθεριου Σιδηροπουλος | Disposable natural-serum ampoule having a screwable nozzle made of sterilized plastic material - use as nasal wash in infants, children and adults |
WO2023000034A1 (en) * | 2021-07-20 | 2023-01-26 | Circulr Research Pty Ltd | Deformable plastic vessel and system for reducing plastic waste |
Also Published As
Publication number | Publication date |
---|---|
EP0670709A1 (en) | 1995-09-13 |
NO952050D0 (en) | 1995-05-23 |
SE9303123L (en) | 1995-03-25 |
DE69402825D1 (en) | 1997-05-28 |
NO952050L (en) | 1995-05-23 |
FI952505A0 (en) | 1995-05-23 |
GR3024211T3 (en) | 1997-10-31 |
FI952505A (en) | 1995-05-23 |
SE9303123D0 (en) | 1993-09-24 |
FI107584B (en) | 2001-09-14 |
DK0670709T3 (en) | 1997-09-29 |
SE501925C2 (en) | 1995-06-19 |
EP0670709B1 (en) | 1997-04-23 |
DE69402825T2 (en) | 1997-10-02 |
ES2102254T3 (en) | 1997-07-16 |
AU7793494A (en) | 1995-04-10 |
ATE151979T1 (en) | 1997-05-15 |
NO306376B1 (en) | 1999-11-01 |
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