WO1999010248A1 - Method of forming and filling a container - Google Patents
Method of forming and filling a container Download PDFInfo
- Publication number
- WO1999010248A1 WO1999010248A1 PCT/GB1998/002035 GB9802035W WO9910248A1 WO 1999010248 A1 WO1999010248 A1 WO 1999010248A1 GB 9802035 W GB9802035 W GB 9802035W WO 9910248 A1 WO9910248 A1 WO 9910248A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- plug
- container
- recess
- seal
- needle
- Prior art date
Links
- 0 C=C(CCC1)C=C1C1C*C1 Chemical compound C=C(CCC1)C=C1C1C*C1 0.000 description 1
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.
Abstract
Description
Claims
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU83478/98A AU8347898A (en) | 1997-08-26 | 1998-07-10 | Method of forming and filling a container |
EP98933779A EP1007425A1 (en) | 1997-08-26 | 1998-07-10 | Method of forming and filling a container |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
ZA97/7661 | 1997-08-26 | ||
ZA977661 | 1997-08-26 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1999010248A1 true WO1999010248A1 (en) | 1999-03-04 |
Family
ID=25586564
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/GB1998/002035 WO1999010248A1 (en) | 1997-08-26 | 1998-07-10 | Method of forming and filling a container |
Country Status (3)
Country | Link |
---|---|
EP (1) | EP1007425A1 (en) |
AU (1) | AU8347898A (en) |
WO (1) | WO1999010248A1 (en) |
Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0011144A1 (en) * | 1978-10-27 | 1980-05-28 | Biotest-Serum-Institut GmbH | Closure for a plastic bag containing an infusion solution |
US4307059A (en) * | 1978-03-16 | 1981-12-22 | Respiratory Care, Inc. | Method of making blow molded thermoplastic container having sterile needle puncture site |
US4724028A (en) * | 1983-04-15 | 1988-02-09 | Baxter Travenol Laboratories | Method of manufacturing disc-shaped rubber articles, such as injection sites |
WO1988004181A1 (en) * | 1986-12-08 | 1988-06-16 | Baxter Travenol Laboratories, Inc. | A unitary, sterile fluid dispensing assembly and a method of forming the assembly |
US4984415A (en) * | 1987-04-07 | 1991-01-15 | Fuso Pharmaceutical Industries, Ltd. | Method and apparatus for blockading an opening through a cylindrical mouthpiece of a synthetic resin container |
US5306270A (en) * | 1990-02-11 | 1994-04-26 | Starplex Scientific | Sealing closure cap and biological sample collection tube |
-
1998
- 1998-07-10 AU AU83478/98A patent/AU8347898A/en not_active Abandoned
- 1998-07-10 WO PCT/GB1998/002035 patent/WO1999010248A1/en not_active Application Discontinuation
- 1998-07-10 EP EP98933779A patent/EP1007425A1/en not_active Withdrawn
Patent Citations (6)
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 |
EP0011144A1 (en) * | 1978-10-27 | 1980-05-28 | Biotest-Serum-Institut GmbH | Closure for a plastic bag containing an infusion solution |
US4724028A (en) * | 1983-04-15 | 1988-02-09 | Baxter Travenol Laboratories | Method of manufacturing disc-shaped rubber articles, such as injection sites |
WO1988004181A1 (en) * | 1986-12-08 | 1988-06-16 | Baxter Travenol Laboratories, Inc. | A unitary, sterile fluid dispensing assembly and a method of forming the assembly |
US4984415A (en) * | 1987-04-07 | 1991-01-15 | Fuso Pharmaceutical Industries, Ltd. | Method and apparatus for blockading an opening through a cylindrical mouthpiece of a synthetic resin container |
US5306270A (en) * | 1990-02-11 | 1994-04-26 | Starplex Scientific | Sealing closure cap and biological sample collection tube |
Also Published As
Publication number | Publication date |
---|---|
EP1007425A1 (en) | 2000-06-14 |
AU8347898A (en) | 1999-03-16 |
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