EP0670709B1 - Containers for medical fluids - Google Patents
Containers for medical fluids Download PDFInfo
- Publication number
- EP0670709B1 EP0670709B1 EP94928539A EP94928539A EP0670709B1 EP 0670709 B1 EP0670709 B1 EP 0670709B1 EP 94928539 A EP94928539 A EP 94928539A EP 94928539 A EP94928539 A EP 94928539A EP 0670709 B1 EP0670709 B1 EP 0670709B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- container
- cap
- containers
- sealing device
- 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.)
- Expired - Lifetime
Links
- 239000012530 fluid Substances 0.000 title claims abstract description 34
- 238000000034 method Methods 0.000 claims abstract description 22
- 238000007789 sealing Methods 0.000 claims description 38
- -1 polypropylene Polymers 0.000 claims description 13
- 239000004743 Polypropylene Substances 0.000 claims description 12
- 229920001155 polypropylene Polymers 0.000 claims description 11
- 238000003860 storage Methods 0.000 claims description 10
- 229920000098 polyolefin Polymers 0.000 claims description 7
- 229920001971 elastomer Polymers 0.000 claims description 6
- 239000000806 elastomer Substances 0.000 claims description 5
- 239000004698 Polyethylene Substances 0.000 claims description 2
- 229920000573 polyethylene Polymers 0.000 claims description 2
- 230000001954 sterilising effect Effects 0.000 abstract description 5
- 238000004064 recycling Methods 0.000 abstract description 4
- 238000003466 welding Methods 0.000 abstract description 4
- 239000002861 polymer material Substances 0.000 abstract description 2
- 239000000463 material Substances 0.000 description 14
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 4
- 239000004033 plastic Substances 0.000 description 4
- 229920003023 plastic Polymers 0.000 description 4
- 230000007774 longterm Effects 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 238000002844 melting Methods 0.000 description 3
- 230000008018 melting Effects 0.000 description 3
- 229920002943 EPDM rubber Polymers 0.000 description 2
- XUIMIQQOPSSXEZ-UHFFFAOYSA-N Silicon Chemical compound [Si] XUIMIQQOPSSXEZ-UHFFFAOYSA-N 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 230000004927 fusion Effects 0.000 description 2
- 238000001746 injection moulding Methods 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 238000007911 parenteral administration Methods 0.000 description 2
- 229920005989 resin Polymers 0.000 description 2
- 239000011347 resin Substances 0.000 description 2
- 229920003031 santoprene Polymers 0.000 description 2
- 229910052710 silicon Inorganic materials 0.000 description 2
- 239000010703 silicon Substances 0.000 description 2
- 239000011780 sodium chloride Substances 0.000 description 2
- 238000004659 sterilization and disinfection Methods 0.000 description 2
- 229920001169 thermoplastic Polymers 0.000 description 2
- 239000004416 thermosoftening plastic Substances 0.000 description 2
- 229920001328 Polyvinylidene chloride Polymers 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 238000000071 blow moulding Methods 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 230000002939 deleterious effect Effects 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 230000006866 deterioration Effects 0.000 description 1
- 238000009792 diffusion process Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 150000008282 halocarbons Chemical class 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 239000012567 medical material Substances 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 239000003921 oil Substances 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 239000004014 plasticizer Substances 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 239000005033 polyvinylidene chloride Substances 0.000 description 1
- 230000002633 protecting effect Effects 0.000 description 1
- 229920005604 random copolymer Polymers 0.000 description 1
- 230000000630 rising effect Effects 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- HLWRUJAIJJEZDL-UHFFFAOYSA-M sodium;2-[2-[bis(carboxymethyl)amino]ethyl-(carboxymethyl)amino]acetate Chemical compound [Na+].OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC([O-])=O HLWRUJAIJJEZDL-UHFFFAOYSA-M 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 229920002725 thermoplastic elastomer Polymers 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Images
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- 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 sterilization. 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.
- Rubber devices i.e. linings, have traditionally been used to provide flexible sealings, which are capable to maintain sealing properties after autoclaving.
- 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 reclosing 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.
- 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 dosed with a closure device consisting of a cap and a flexible sealing device, wherein all parts of the 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 the container consist of essentially the same polyolefin, in order to make it recyclable in the same process.
- the said sealing device besides the polyolefin, also contains an elastomer such that a weak sealing weld 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 sealing weld 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 such that a weak sealing weld 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.
- 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 MN.
- 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. Alter 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)
- External Artificial Organs (AREA)
- Materials For Medical Uses (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Closures For Containers (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SE9303123A SE501925C2 (sv) | 1993-09-24 | 1993-09-24 | Behållare för medicinska vätskor samt förfarande för dess försegling |
| SE9303123 | 1993-09-24 | ||
| PCT/SE1994/000876 WO1995008317A1 (en) | 1993-09-24 | 1994-09-21 | Containers for medical fluids |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| EP0670709A1 EP0670709A1 (en) | 1995-09-13 |
| EP0670709B1 true EP0670709B1 (en) | 1997-04-23 |
Family
ID=20391207
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP94928539A Expired - Lifetime EP0670709B1 (en) | 1993-09-24 | 1994-09-21 | Containers for medical fluids |
Country Status (11)
| Country | Link |
|---|---|
| EP (1) | EP0670709B1 (es) |
| AT (1) | ATE151979T1 (es) |
| AU (1) | AU7793494A (es) |
| DE (1) | DE69402825T2 (es) |
| DK (1) | DK0670709T3 (es) |
| ES (1) | ES2102254T3 (es) |
| FI (1) | FI107584B (es) |
| GR (1) | GR3024211T3 (es) |
| NO (1) | NO306376B1 (es) |
| SE (1) | SE501925C2 (es) |
| WO (1) | WO1995008317A1 (es) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6308847B1 (en) | 1996-05-20 | 2001-10-30 | Fresenius Kabi Aktiebolag | Medical containers |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SE9601540D0 (sv) * | 1996-04-23 | 1996-04-23 | Pharmacia Ab | Improved medical containers |
| US6720044B2 (en) | 1997-02-20 | 2004-04-13 | Pharmacia Ab | Polyolefinic closures comprising penetrable plugs and annular channels |
| CN1184948C (zh) | 1998-09-22 | 2005-01-19 | 弗雷泽纽斯卡比股份公司 | 用于静脉注射给药的容器 |
| 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 |
| ES2566178T3 (es) * | 2011-04-06 | 2016-04-11 | Otsuka Pharmaceutical Factory, Inc. | Ampolla de plástico |
| 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)
| 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 |
| WO1989012584A1 (en) * | 1988-06-17 | 1989-12-28 | M.K. Plastics Pty. Limited | Linerless closure for carbonated beverage container |
| 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 |
-
1993
- 1993-09-24 SE SE9303123A patent/SE501925C2/sv not_active IP Right Cessation
-
1994
- 1994-09-21 AU AU77934/94A patent/AU7793494A/en not_active Abandoned
- 1994-09-21 DE DE69402825T patent/DE69402825T2/de not_active Expired - Lifetime
- 1994-09-21 ES ES94928539T patent/ES2102254T3/es not_active Expired - Lifetime
- 1994-09-21 DK DK94928539.9T patent/DK0670709T3/da active
- 1994-09-21 AT AT94928539T patent/ATE151979T1/de active
- 1994-09-21 WO PCT/SE1994/000876 patent/WO1995008317A1/en active IP Right Grant
- 1994-09-21 EP EP94928539A patent/EP0670709B1/en not_active Expired - Lifetime
-
1995
- 1995-05-23 NO NO952050A patent/NO306376B1/no not_active IP Right Cessation
- 1995-05-23 FI FI952505A patent/FI107584B/fi not_active IP Right Cessation
-
1997
- 1997-07-23 GR GR970401857T patent/GR3024211T3/el unknown
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6308847B1 (en) | 1996-05-20 | 2001-10-30 | Fresenius Kabi Aktiebolag | Medical containers |
Also Published As
| Publication number | Publication date |
|---|---|
| FI952505A (fi) | 1995-05-23 |
| GR3024211T3 (en) | 1997-10-31 |
| DE69402825D1 (de) | 1997-05-28 |
| FI952505A0 (fi) | 1995-05-23 |
| AU7793494A (en) | 1995-04-10 |
| NO952050L (no) | 1995-05-23 |
| SE9303123L (sv) | 1995-03-25 |
| SE501925C2 (sv) | 1995-06-19 |
| NO306376B1 (no) | 1999-11-01 |
| DE69402825T2 (de) | 1997-10-02 |
| WO1995008317A1 (en) | 1995-03-30 |
| DK0670709T3 (da) | 1997-09-29 |
| ATE151979T1 (de) | 1997-05-15 |
| SE9303123D0 (sv) | 1993-09-24 |
| EP0670709A1 (en) | 1995-09-13 |
| FI107584B (fi) | 2001-09-14 |
| NO952050D0 (no) | 1995-05-23 |
| ES2102254T3 (es) | 1997-07-16 |
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