EP1007425A1 - Procede de fabrication et de remplissage d'un recipient - Google Patents

Procede de fabrication et de remplissage d'un recipient

Info

Publication number
EP1007425A1
EP1007425A1 EP98933779A EP98933779A EP1007425A1 EP 1007425 A1 EP1007425 A1 EP 1007425A1 EP 98933779 A EP98933779 A EP 98933779A EP 98933779 A EP98933779 A EP 98933779A EP 1007425 A1 EP1007425 A1 EP 1007425A1
Authority
EP
European Patent Office
Prior art keywords
plug
container
recess
seal
needle
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.)
Withdrawn
Application number
EP98933779A
Other languages
German (de)
English (en)
Inventor
Neil Arthur Gordon Stuart
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.)
INTRAMED (PROPRIETARY) LIMITED
Original Assignee
Pharmacare Ltd
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 Pharmacare Ltd filed Critical Pharmacare Ltd
Publication of EP1007425A1 publication Critical patent/EP1007425A1/fr
Withdrawn legal-status Critical Current

Links

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
    • A61J1/1406—Septums, pierceable membranes
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production

Definitions

  • This invention relates to a method of forming and filling a container with a liquid pharmaceutical product.
  • BFS Blow, fill and seal
  • a polyethylene/polypropylene cap with a rubberised polyethylene (PER) insert is welded onto the top of the bottle.
  • PER rubberised polyethylene
  • a method of forming and filling a container with a liquid pharmaceutical product which method includes the steps of:
  • liquid pharmaceutical product there is meant not only a pharmaceutical product for administration to humans, but also veterinary products for administration to animals.
  • the product will generally be an intravenous solution.
  • the container which is generally a bottle, may be formed by blow moulding.
  • step (b) the container is filled with the liquid pharmaceutical product by conventional means.
  • step (c) the open mouth is sealed with a seal to form a sealed container by conventional means.
  • the recess may be provided or formed in the seal for the open mouth of the container.
  • the recess may be provided in the container and may be formed during step (a).
  • the plug for location in the recess must have a shape and size, e.g the same shape and size, as the recess, so that it is a tight or close fit in the recess.
  • the plug may be secured in the recess by gluing or by being fused to the material of the container.
  • the plug may be made from a material which melts below 121 °C.
  • the plug material melts and fuses to the material of the container to secure the plug in the recess.
  • the plug may be glued or bonded into the recess using a suitable bonding agent such as for example ethyl vinyl acetate (EVA), either applied to the underside of the plug, for example by co-injection or coating, or utilised in the form of a wafer placed in the recess before the insertion of the plug.
  • EVA ethyl vinyl acetate
  • the EVA has a melting point of about 80 °C and thus melts during the autoclaving procedure to bond the plug to the bottle.
  • the plug must be made from a suitable natural or synthetic rubber or plastics material which is adapted to permit the passage therethrough of a needle and to seal again after withdrawal of the needle.
  • the material is preferably a thermoplastic elastomer, for example a rubberised polyethylene.
  • a thermoplastic elastomer for example a rubberised polyethylene.
  • other materials are suitable for use. These materials should preferably possess the following properties:
  • the container may also be provided with a dust cap, placed over the plug in the recess, and suitably secured to the container.
  • the plug may be held in place, prior to autoclaving or bonding, with a dust cap, for example a laminated polyethylene/nylon heat welded dust cap.
  • a dust cap for example a laminated polyethylene/nylon heat welded dust cap. This dust cap is removed at time of use to present a sterile surface for the administration of the pharmaceutical product in the container or for the addition of medicament via a needle to the pharmaceutical product in the container.
  • a combination of a container and a liquid pharmaceutical product in the container the container being completely sealed, the sealed container including a recess, and a plug of a suitable natural or synthetic rubber or plastics material located in the recess and secured thereto, the plug material being adapted to permit the passage therethrough of a needle and to seal again after withdrawal of the needle.
  • a seal for use in sealing an open mouth of a container made from a suitable plastics material and adapted to be filled with a liquid pharmaceutical product through the open mouth, the seal including a recess adapted to receive a plug of a suitable natural or synthetic rubber or plastics material, which material is adapted to permit the passage therethrough of a needle or the like and to seal again after the withdrawal of the needle or the like.
  • Figure 1 is a schematic side view of a container of the invention having a first top
  • Figure 2 is a top view of the first top of the container of Figure 1
  • Figure 3 is a perspective view of a second top for the container of Figure
  • Figure 4 is a schematic side view of the container of Figure 1 with the second top of Figure 3. DESCRIPTION OF EMBODIMENTS
  • FIG. 1 and 2 there is shown a container 10 which comprises a bottle 12 having a top or seal 14.
  • the top 14 includes a recess 16 in which is located a plug 18.
  • the plug 18 is covered with a dust cap 20.
  • the container 10 is manufactured as follows.
  • the bottle 12 is blown, by conventional means, with an open mouth in the vicinity of the recess 16.
  • the container is filled with a liquid pharmaceutical product such as a sterile IV solution.
  • the open mouth of the bottle 12 is sealed with a top or seal 14 which includes the recess 16, to form a completely sealed container 10.
  • the plug 18 is located in the recess 16.
  • the dust cap 20 generally comprising a laminated polyethylene/nylon material, is heat welded over the plug 18 to hold it in position prior to secural in the recess 16.
  • the container 10 is autoclaved, firstly to sterilise the container and contents, and secondly to melt the material from which the plug 18 is made, so that the plug fuses to the recess 16. This fusion is necessary in order to secure the plug 18 in the recess 16, and to eliminate any air space between the plug 18 and the recess 16 which might harbour bacteria that could in turn be released when piercing the plug 18.
  • a layer or a thin wafer of a suitable bonding material for example ethyl vinyl acetate, may be located in the recess 16, whereafter the plug 18 is inserted. Then, again on autoclaving, the bonding material will melt to bond the plug 18 in the recess 16.
  • a suitable bonding material for example ethyl vinyl acetate
  • the plug should be made from a material which is food grade and preferably FDA approved, which is soft, non-porous and easily pierceable by a hypodermic needle without coring, which has a good memory so that it seals after removal of the needle, and ideally which has a melting point below 121 °C.
  • a suitable material is for example rubberised polyethylene.
  • the dust cap 20 When it is desired to use the contents of the container 10, the dust cap 20 is removed, and a hypodermic needle or the like is pierced through the plug 18 and the material of the recess 16 and into the bottle 12. Thereafter the contents of the container 10 may be utilised or an additional medication may be added to the contents of the container 10.
  • FIG. 3 and 4 there is shown an alternative embodiment of the invention being a top or seal 30, for use on a bottle 12 of a container 10 as illustrated in Figure 1.
  • the container 10 is manufactured as set out above and is filled with a liquid pharmaceutical product.
  • the open mouth of the bottle 12 is sealed with the top or seal 30 which includes an elongate recess 32, to form a completely sealed container 10.
  • the recess 32 includes a humped section 34 separating two flat sections 36, 38.
  • a plug 40 which is of a shape and size to be a tight fit in the recess 32 is then located in the recess 32.
  • the plug 40 may be secured in the recess 32 in any of the manners described above, for example by glueing the plug 40 into the recess 32.
  • a dust cap 42 generally comprising a laminated polyethylene/nylon material, is heat welded over the plug 40, to form a peripheral seal around the top 30.
  • an indentation or other marking may be created in each portion of the plug 40 which is designed to fit on the flat sections 36, 38 of the recess 32, to indicate positions in which a needle may be inserted through the plug 40 into the bottle 12.
  • the dust cap 42 may include a tab (not shown) to assist in peeling the dust cap 42 off the top 30, when it is desired to use the contents of the container 10.
  • the container 10 is autoclaved as described above.
  • the plug 40 may be made from any of the materials discussed above.
  • the dust cap 42 When it is desired to use the contents of the container 10, the dust cap 42 is peeled off, and a hypodermic needle or the like is pierced through the plug 40 in either of the regions of the plug 40 above the flat sections 36, 38, and thus through the material of the flat sections 36, 38 of the recess 32, and into the bottle 12. Thereafter the contents of the container 10 may be utilised or any additional medication may be added to the contents of the container 10.
  • the dust cap 20, 42 is printed with instructions indicating the method of use of the container 10.
  • This novel system for providing a container for a liquid pharmaceutical product has the advantage that it is cheaper to manufacture than conventional systems and yet is effective in use.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (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)
  • Closures For Containers (AREA)

Abstract

La présente invention concerne un procédé de fabrication et de remplissage d'un récipient (10) avec un produit pharmaceutique liquide. Ce procédé consiste à fabriquer un récipient (10) à partir d'une matière plastique appropriée, le récipient possédant un orifice d'entrée ouvert; à remplir le récipient (10) avec le produit pharmaceutique liquide par l'intermédiaire de l'orifice d'entrée ouvert; à fermer hermétiquement l'orifice d'entrée ouvert avec un joint (14) étanche de façon à obtenir un récipient étanche; à ménager un évidement (16) dans le sommet (14); et à fixer dans l'évidement, un bouchon (18) en matériau approprié tel que du caoutchouc naturel ou synthétique ou de la matière plastique, ledit matériau étant conçu de façon à permettre le passage d'une aiguille ou analogue et à restaurer l'étanchéité après le retrait de l'aiguille ou analogue.
EP98933779A 1997-08-26 1998-07-10 Procede de fabrication et de remplissage d'un recipient Withdrawn EP1007425A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
ZA9707661 1997-08-26
ZA977661 1997-08-26
PCT/GB1998/002035 WO1999010248A1 (fr) 1997-08-26 1998-07-10 Procede de fabrication et de remplissage d'un recipient

Publications (1)

Publication Number Publication Date
EP1007425A1 true EP1007425A1 (fr) 2000-06-14

Family

ID=25586564

Family Applications (1)

Application Number Title Priority Date Filing Date
EP98933779A Withdrawn EP1007425A1 (fr) 1997-08-26 1998-07-10 Procede de fabrication et de remplissage d'un recipient

Country Status (3)

Country Link
EP (1) EP1007425A1 (fr)
AU (1) AU8347898A (fr)
WO (1) WO1999010248A1 (fr)

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4307059A (en) * 1978-03-16 1981-12-22 Respiratory Care, Inc. Method of making blow molded thermoplastic container having sterile needle puncture site
DE7832028U1 (de) * 1978-10-27 1979-04-19 Biotest-Serum-Institut Gmbh, 6000 Frankfurt Verschluss fuer einen plastikinfusionsloesungsbeutel
US4724028A (en) * 1983-04-15 1988-02-09 Baxter Travenol Laboratories Method of manufacturing disc-shaped rubber articles, such as injection sites
US4816221A (en) * 1986-12-08 1989-03-28 Baxter Travenol Laboratories, Inc. Method of simultaneously assembling and sterilizing a unitary container and a fluid transfer set
FR2613707B1 (fr) * 1987-04-07 1991-05-03 Fuso Pharmaceutical Ind Procede et dispositif d'obturation du goulot d'un recipient de transfusion en resine synthetique
CA2007620A1 (fr) * 1990-02-11 1991-07-11 Charles Terrence Macartney Tube pour la collecte d'echantillons biologiques

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO9910248A1 *

Also Published As

Publication number Publication date
AU8347898A (en) 1999-03-16
WO1999010248A1 (fr) 1999-03-04

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