EP1004287A1 - Rubber plug for medical service - Google Patents

Rubber plug for medical service Download PDF

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Publication number
EP1004287A1
EP1004287A1 EP98932566A EP98932566A EP1004287A1 EP 1004287 A1 EP1004287 A1 EP 1004287A1 EP 98932566 A EP98932566 A EP 98932566A EP 98932566 A EP98932566 A EP 98932566A EP 1004287 A1 EP1004287 A1 EP 1004287A1
Authority
EP
European Patent Office
Prior art keywords
rubber plug
vial
top surface
mouth
projections
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Withdrawn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
EP98932566A
Other languages
German (de)
English (en)
French (fr)
Inventor
Kazuo Nishikawa
Tetsuya Okamoto
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.)
Eli Lilly Japan KK
Original Assignee
Eli Lilly Japan KK
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 Eli Lilly Japan KK filed Critical Eli Lilly Japan KK
Publication of EP1004287A1 publication Critical patent/EP1004287A1/en
Withdrawn legal-status Critical Current

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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
    • 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
    • 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
    • B65D51/24—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes
    • B65D51/241—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes provided with freeze-drying means
    • 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

Definitions

  • the present invention relates to a medical rubber plug for sealing or stopping a mouth of a container (or receptacle) for medical use, particularly for sealing or stopping the mouth of a vial which stores freeze-drying preparation.
  • a conventional medical rubber plug for sealing or stopping a mouth of a vial which stores preparation such as antibiotics has a leg 22 that is fitted into the mouth of the vial 21 and a flange 24 that contacts with a top edge surface 23 of the mouth of the vial 21, as shown in Fig. 2.
  • projections 26 are provided on the top surface 25 of the mushroom-cap-like part of the medical rubber plug in order to prevent rubber plugs from adhering (or sticking) each other during its cleaning, disinfection and drying, and/or in order to prevent the rubber plug from adhering to an aluminum cap to be fitted around the rubber plug.
  • the shape and position of the projection 26 on the top surface 25 of the mushroom-cap-like part of the rubber plug are not limited, for example, as shown in Fig. 3 illustrating T-shaped projections 27, and as shown in Figs. 4 and 5 illustrating semicylindrical (or semicircular) projections 28 and 29.
  • preparation such as antibiotics
  • preparation is frozen, evacuated (or made vacuous) and dried, by filling up a specified quantity of medicament (or medication liquid) in a vial, by half-inserting into the opening (or mouth) of the vial a rubber plug the leg of which has an opening to facilitate a passage of aqueous vapor from the medicament, by placing the vial in a shelf (or rack) inside a freeze dryer, and by maintaining a specified temperature and a specified degree of vacuum inside the freeze dryer.
  • the freeze vacuum drying of the preparation in the freeze dryer includes a primary drying step and a secondary drying step.
  • the medicament is frozen at temperature of -30 to -45°C, and then it is kept at the degree of vacuum of 1 to 0.03 Torr and at temperature of -20 to +30°C for 12 to 36 hours.
  • the freeze vacuum drying of the medicament is completed after the medicament is kept at temperature of +20 to +40°C for 1 to 6 hours in the secondary drying step.
  • the freeze dryer nitrogen is supplied to the freeze dryer to raise the inside pressure to the normal level (-300 mmH 2 O to 0), and a stainless steel press panel of the shelf inside the freeze dryer is employed to press (or bias) the rubber plug and to fit it completely in the vial mouth.
  • the general condition for plugging it therein is: the pressing force (or biasing force) per vial is 1 to 5 kg; the pressing duration is 1 to 10 minutes; and the frequency of pressing it is once or twice.
  • butyl rubber such as isobutylene-isoprene copolymer is generally employed as material of the rubber plug, in order to prevent water, air and the like from stealing in from outside while the preparation is hermetically kept therein, or in order to maintain air-tightness inside the vial.
  • Butyl rubber shows a high degree of unsaturation, and shows a low degree of bridge density; namely, the butyl rubber is inferior in elasticity, and the viscosity of the rubber surface is greater.
  • the top surface of the rubber plug may stick to the press panel due to the stickiness, and the vial may be hung upwards together with the rubber plug sticking to the press panel when the press panel is lifted. If the vial is dropped down in a few seconds, it may cause the surrounding vials to overturn, which hinders a removal of the vials from inside the freeze dryer and which blocks a transfer thereof to the following step (or process).
  • a technique for laminating the resin film onto the top surface of the rubber plug has an advantage that the top surface of the rubber plug is prevented from sticking to the press panel of the shelf inside the freeze dryer.
  • the top surface of the rubber plug has a double-layer construction in which the soft rubber thereof is laminated with a resin film. Therefore, not only the method for molding the rubber plug is complicated, but also it is difficult to prevent a generation of film fragments or coring, thus making difficult its quality assurance as a rubber plug for medical use.
  • the rubber plug in which the resin film is coated on the top surface thereof has a disadvantage that it is not possible to provide the rubber plug at low cost, because the resin film is relatively expensive, and because not a few manufacturing processes (or steps) are required.
  • An object of the present invention is to provide a rubber plug for medical use that solves the problems of the aforementioned prior art, in which it satisfies various characteristics including a low gas permeability, a low water permeability (or low moisture permeability), an air tightness (or hermetic property), an easiness of needling (or pricking) it, a nature (or property) of heat resistance, a nature (or property) of resistance against aging, a nature (or property) of low coring, and the like, which complies with the Japan Pharmacopoeia, which satisfies the Rubber Plug Testing Standard for Infusion, and which prevents the top surface of the rubber plug from sticking (or adhering) to the press panel when the rubber plug, being kept half-inserted inside an opening of a vial that is placed inside the freeze dryer, is completely plugged into the opening of the vial by the press panel of the shelf inside the freeze dryer after the preparation is frozen, evacuated and dried inside the vial.
  • various characteristics including a
  • the inventor et al. repeated various tests and discussed on shape, number and quantity, and mounting position, of projections on the top surface of the mushroom-cap-like part of the rubber plug, in order to achieve the aforementioned object.
  • the inventor et al. found that the adhesion of the top surface of the rubber plug to the press panel of the shelf inside the freeze dryer can be prevented, by positioning the projection for preventing the adhesion thereto of the rubber plug which is to be plugged in the mouth of the vial for medical use, on an upper part of an edge surface which locates outside the internal diameter of the mouth of the vial, and found that the rubber plug is easier in manufacturing and less expensive than the conventional rubber plug having the double-construction which is formed by laminating with the resin film.
  • the medical rubber plug in accordance with claim 1 of the present invention comprises: a leg part which is inserted into a mouth of a vial; and a flange part which contacts an upper edge surface of the mouth of the vial, in which a projection which is provided on a top surface of a mushroom-cap-shaped part of the medical rubber plug and which prevents an adhesion of the top surface thereof, is arc-shaped, and in which the projection is provided on an upper part of an edge surface locating outside an inner diameter of the mouth of the vial.
  • the projection which is provided on the top surface of the mushroom-cap-shaped part of the medical rubber plug and which prevents the adhesion of the top surface thereof is arc-shaped, and with the construction that the projection is provided on the upper part of the edge surface locating outside the inner diameter of the mouth of the vial, the lower part of the arc-shaped projection on the top surface of the mushroom-cap-shaped part of the rubber plug comes to contact the edge surface locating outside the mouth of the vial, and the compressive deformation of the arc-shaped projection is suppressed by the edge surface functioning as a base. Namely, the whole top surface of the rubber plug does not contact the press surface closely, and a space is formed between the press surface and the top surface of the rubber plug. Therefore, the adhesion therebetween is prevented.
  • the medical rubber plug in accordance with claim 2 of the present invention there are provided six to twelve projections each of which is the projection that is provided on the top surface of the mushroom-cap-shaped part of the medical rubber plug and that prevents the adhesion of the top surface thereof.
  • a medical rubber plug in accordance with the present invention has a leg to be fitted into a mouth of a vial, and a flange to come to contact with an upper edge surface of the mouth of the vial, which is similar to the conventional rubber plug, and the medical rubber plug has a size and a shape, each of which does not change especially.
  • the medical rubber plug is different from the conventional one in that each of projections provided on a top surface of a mushroom-cap-shaped part (or mushroom-pileus-shaped part or lamp-shade-like part) of the rubber plug of the present invention is arc-shaped (or arcuate in shape), and in that the projections are arranged on an upper part of an edge surface locating outside an internal diameter of the mouth of the vial.
  • the arc-shaped projections according to the present invention are added to the conventional rubber plug so that the arc-shaped projections are positioned on the upper part of the edge surface outside the internal diameter of the mouth of the vial, there is no particular difference in function and effect.
  • the material which the rubber plug of the present invention is made of, is butyl rubber with a low gas permeability and a low vapor (or moisture) permeability, which has been conventionally utilized.
  • the size of the projection provided on the top surface of the mushroom-cap-shaped part of the medical rubber plug in accordance with the present invention is determined by the size of the medical rubber plug, and is not specifically determined.
  • the desirable size thereof is 1.0 to 2.0 mm in its base and 0.4 to 0.8 mm in its height. It is preferable to provide six to twelve arc-shaped projections, and it is preferable that the arc-shaped projections are provided on the same circumference (or circle) at an equal interval. If the number of the arc-shaped projections is less than six, the adhesion between the top surface of the rubber plug and the aluminum cap can be prevented, but the adhesion between the pressing surface of the shelf inside the freeze dryer and the top surface of the rubber plug can not be prevented completely.
  • the number of the arc-shaped projections exceeds twelve, the adhesion between the pressing surface of the shelf inside the freeze dryer and the top surface of the rubber plug can be prevented completely, but the tightness between the flange of the rubber plug and the aluminum cap becomes deteriorated, thus easily allowing the rubber plug to drop in the vial at time of piercing a needle therethrough.
  • the usage of the medical rubber plug in accordance with the present invention is the same as that in accordance with the conventional medical rubber plug. Namely, a specified quantity of medicament liquid is filled up in the vial; the rubber plug is half-inserted (or half-engaged) into the mouth of the vial; plural vials are arranged inside each of the shelves inside the freeze dryer in alignment; they are frozen, evacuated and dried under a predetermined condition (in respect of temperature, degree of vacuum, and time); they are dried at a specified temperature for a specified duration of time; they are pressed down by the press panels of the shelves in the freeze dryer; and then the rubber plugs are completely fitted and inserted in the mouths of the vials.
  • Fig. 1a is a plan view of the medical rubber plug of the present invention
  • Fig. 1b is a vertical cross-sectional view showing a state in which the rubber plug is completely inserted inside the mouth of the vial.
  • a reference number 1 points to a vial; and 2 to a rubber plug which has a leg 4 having an opening 3 and being inserted into the mouth of the vial 1 and which has a flange 6 contacting the upper edge part 5 of the mouth of the vial 1.
  • the distance "D" between centers of the arc-shaped projections 8 is greater than the internal (or inner) diameter "d" of the mouth of the vial 1.
  • the rubber plug 2 when the rubber plug 2 is half-inserted into the mouth of the vial 1 for the purpose of the freeze vacuum drying of the medicament liquid therein, and then when the top surface 7 of the rubber plug 2 is pressed by the press panel of the shelf inside the freeze dryer, not shown in the figure, in order to completely put the rubber plug 2 inside the mouth of the vial 1, a lower surface of the flange 6 of the rubber plug 2 comes to contact with the upper edge part 5 of the mouth of the vial 1. Namely, the arc-shaped projection 8 on the top surface is securely supported on the upper edge surface 5 which functions as a base.
  • the vial made of glass has a capacity of 10 ml, an internal (or inner) diameter being 12.5 mm of the mouth, an external (or outer) diameter being 20mm of the edge surface of the mouth, and a height of 50 mm.
  • the rubber plug in accordance with the present invention has an construction in which 4 to 14 arc-shaped projections are symmetrically provided on the top surface on the upper part of the edge surface that locates outside the inner diameter of the mouth of the vial where the arc-shaped projection has a base of 1.5mm, a height of 0.6mm and where the distance "D" between the centers of the projections is 15.5mm, and has the construction in which silicone coat of 30 to 50 mg/piece is applied to the top surface thereof.
  • a rubber plug that has a construction in which 8 or 12 arc-shaped projections are symmetrically provided on the top surface on the upper part thereof that locates inside the inner diameter of the mouth of the vial, or symmetrically provided on the top surface on the upper part thereof that locates on a boundary with the edge surface, where the arc-shaped projection has a base of 1.5mm, a height of 0.6mm and where the distance "D" between the centers of the projections is 10.5mm or 12.5mm, and has the construction in which silicone coat of 30 to 50 mg/piece is applied to the top surface thereof.
  • Both of the rubber plugs were half-inserted into the mouths of the vials, and then each of the rubber plugs was pressed with a pressure of 5 kg for 10 minutes by a stainless steel press panel. Under the condition, the degrees of adhesion between the press surfaces and the top surfaces of the rubber plugs, were measured while video-recording the situation at time of raising the pressure plate. Using 50 specimens of both of the rubber plugs respectively, measurements were made in order to seek for the time during which they sticked to the pressure panels. Together with the measurements, the tightness with which the aluminum caps were wound around the flanges of the rubber plugs was also tested. Table 1 shows the results.
  • Adhesion Duration 1.0 sec. 1 - - - - 2 6 3 Adhesion Duration ⁇ 2.0 sec. - - - - 6 8 7 Adhesion Duration ⁇ 3.0 sec. - - - - 33 29 19 Adhesion Duration ⁇ 4.0 sec. - - - - 9 7 14 Adhesion Duration ⁇ 4.0 sec. - - - - - - 7 Tightness with Aluminum Cap 0/50 0/50 0/50 0/50 15/50 0/50 0/50 0/50 0/50 0/50
  • each projection has a width of 1.2mm, a length of 4.0mm, a height of 0.6mm and where the distance between the centers of the projections is 13.0mm, and has the construction in which silicone coat of 30 to 50 mg/piece is applied to the top surface thereof, the degrees of adhesion between the press panels and the top surfaces of the rubber plugs, were measured while video-recording the situation at time of raising the pressure plate, under the same condition as the condition of "EMBODIMENT 2.” Using 50 specimens of both of the rubber plugs respectively, measurements were made in order to seek for the time during which they sticked to the pressure panels.
  • Adhesion Duration 3.0 sec. - - 6 14 13 Adhesion Duration ⁇ 4.0 sec. - - 24 13 8 Adhesion Duration ⁇ 4.0 sec. - - 17 6 - Tightness with Aluminum Cap 0/50 0/50 0/50 0/50 0/50
  • the medical rubber plug according to claim 1 has a construction in which the projection for preventing the adherence of the top surface of the flange of the rubber plug is formed arc-shaped (or in arc) and in which the projection is arranged on the upper part of the edge surface outside the internal diameter of the mouth of the vial.
  • the lower part of the arc-shaped projection on the top surface of the flange of the rubber plug comes to contact with the edge surface outside of the mouth of the vial, and the compressive deformation of the arc-shaped projection is suppressed by the edge surface serving as a base. Namely, the whole top surface of the flange of the rubber plug does not adhere to the press surface, and a space is formed between the press surface and the top surface of the flange, thus preventing the adhesion therebetween.
  • the medical rubber plug according to claim 2 has six to twelve pieces of the arc-shaped projections for preventing the adherence of the top surface of the flange of the rubber plug.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Closures For Containers (AREA)
EP98932566A 1997-07-29 1998-07-17 Rubber plug for medical service Withdrawn EP1004287A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP21910097 1997-07-29
JP9219100A JPH1147234A (ja) 1997-07-29 1997-07-29 医療用ゴム栓
PCT/JP1998/003218 WO1999006006A1 (fr) 1997-07-29 1998-07-17 Bouchon en caoutchouc pour equipement medical

Publications (1)

Publication Number Publication Date
EP1004287A1 true EP1004287A1 (en) 2000-05-31

Family

ID=16730265

Family Applications (1)

Application Number Title Priority Date Filing Date
EP98932566A Withdrawn EP1004287A1 (en) 1997-07-29 1998-07-17 Rubber plug for medical service

Country Status (5)

Country Link
EP (1) EP1004287A1 (ja)
JP (1) JPH1147234A (ja)
AU (1) AU8243898A (ja)
CA (1) CA2298741A1 (ja)
WO (1) WO1999006006A1 (ja)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000059797A1 (en) * 1999-04-01 2000-10-12 Pentapharm Ag Stopper
EP2383199A1 (en) * 2010-04-30 2011-11-02 Sumitomo Rubber Industries, Ltd. Closure device for a container, and seal member for the device
WO2018103906A1 (de) * 2016-12-06 2018-06-14 Kisico Kirchner, Simon & Co. Gmbh Stopfen für einen behälter zur verwendung bei gefriertrocknung und anordnung eines stopfens und eines behälters

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001245956A (ja) * 2000-03-03 2001-09-11 Ohtsu Tire & Rubber Co Ltd :The 医療用ゴム栓
JP4601127B2 (ja) * 2000-06-06 2010-12-22 住友ゴム工業株式会社 医療用ゴム栓
JP4698056B2 (ja) * 2001-04-12 2011-06-08 住友ゴム工業株式会社 医療用ゴム栓
JP3530832B2 (ja) * 2001-05-11 2004-05-24 住友ゴム工業株式会社 医療用ゴム栓
JP2004123121A (ja) * 2002-09-30 2004-04-22 Sumitomo Rubber Ind Ltd 凍結乾燥用ゴム栓
GB0609113D0 (en) 2006-05-09 2006-06-21 Boc Group Plc Freeze Dryer Shelf
JP4980042B2 (ja) 2006-12-21 2012-07-18 カルソニックカンセイ株式会社 車両用収納ボックスの蓋体ロック構造
CN108186345B (zh) * 2017-12-20 2023-10-24 安徽华能医用橡胶制品股份有限公司 一种医用隔氧橡胶塞

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5710676Y2 (ja) * 1976-09-10 1982-03-02

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO9906006A1 *

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000059797A1 (en) * 1999-04-01 2000-10-12 Pentapharm Ag Stopper
EP2383199A1 (en) * 2010-04-30 2011-11-02 Sumitomo Rubber Industries, Ltd. Closure device for a container, and seal member for the device
US20110266249A1 (en) * 2010-04-30 2011-11-03 Sumitomo Rubber Industries, Ltd. Closure device for a container, and seal member for the device
CN102259723A (zh) * 2010-04-30 2011-11-30 住友橡胶工业株式会社 用于容器的封闭装置以及用于该装置的密封部件
US8978909B2 (en) 2010-04-30 2015-03-17 Sumitomo Rubber Industries, Ltd. Closure device for a container, and seal member for the device
CN102259723B (zh) * 2010-04-30 2015-08-26 住友橡胶工业株式会社 用于容器的封闭装置以及用于该装置的密封部件
WO2018103906A1 (de) * 2016-12-06 2018-06-14 Kisico Kirchner, Simon & Co. Gmbh Stopfen für einen behälter zur verwendung bei gefriertrocknung und anordnung eines stopfens und eines behälters
US11434050B2 (en) 2016-12-06 2022-09-06 Kisico Kirchner, Simon & Co. Gmbh Stopper for a container for use in freeze-drying processes, and assembly of a stopper and a container

Also Published As

Publication number Publication date
AU8243898A (en) 1999-02-22
CA2298741A1 (en) 1999-02-11
JPH1147234A (ja) 1999-02-23
WO1999006006A1 (fr) 1999-02-11

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