EP0322547A1 - Bouchon pour lyophilisation - Google Patents

Bouchon pour lyophilisation Download PDF

Info

Publication number
EP0322547A1
EP0322547A1 EP88118842A EP88118842A EP0322547A1 EP 0322547 A1 EP0322547 A1 EP 0322547A1 EP 88118842 A EP88118842 A EP 88118842A EP 88118842 A EP88118842 A EP 88118842A EP 0322547 A1 EP0322547 A1 EP 0322547A1
Authority
EP
European Patent Office
Prior art keywords
pin
freeze
transverse plane
drying
cams
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.)
Granted
Application number
EP88118842A
Other languages
German (de)
English (en)
Other versions
EP0322547B1 (fr
Inventor
Rik Schrooten
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.)
Helvoet Pharma NV
Original Assignee
Helvoet Pharma NV
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 Helvoet Pharma NV filed Critical Helvoet Pharma NV
Priority to AT88118842T priority Critical patent/ATE78781T1/de
Publication of EP0322547A1 publication Critical patent/EP0322547A1/fr
Application granted granted Critical
Publication of EP0322547B1 publication Critical patent/EP0322547B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime 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
    • B65D51/24—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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/508—Rigid containers without fluid transport within
    • B01L3/5082—Test tubes per se
    • B01L3/50825—Closing or opening means, corks, bungs
    • 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
    • B65D39/00—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers
    • B65D39/0005—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers made in one piece
    • B65D39/0023—Plastic cap-shaped hollow plugs
    • 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
    • B65D2539/00—Details relating to closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers
    • B65D2539/001—Details of closures arranged within necks or pouring opening or in discharge apertures, e.g. stoppers
    • B65D2539/005—Details of closures arranged within necks or pouring opening or in discharge apertures, e.g. stoppers provided with slits or gaps for increasing the elasticity

Definitions

  • the invention relates to a freeze-drying stopper made of rubber-elastic material, consisting of a substantially cylindrical outer circumferential surface intended for insertion into the container neck to be sealed, with a pin having a slightly larger diameter with respect to the inner neck diameter and an integrally molded thereon with the lower boundary surface of its radially projecting edge defining a first transverse plane, essentially circular disk-shaped flange, the pin containing a cavity surrounding the pin longitudinal axis, open to the free pin face and extending essentially over the entire pin length, which extends to the peripheral surface of the pin via a is open in the direction of the longitudinal axis of the pin, which extends from the free face of the pin and extends to a perpendicular to the longitudinal axis of the pin, roughly approximating the free pin length of the second transverse plane and weaves i the pin has a plurality of cams projecting over the circumferential surface and arranged at a distance from one another, the axially outer limits of which lie on a
  • Freeze-drying plugs of this type are known and have a spigot, the outer circumferential surface of which is completely cylindrical over the entire axial length, apart from a conical surface serving for easier introduction into the container mouth at the transition to the free spigot end face, from which the circumferential surface interrupting slot and of four over the circumferential surface projecting, sawtooth-shaped cams in cross section, which are arranged close and symmetrically to a longitudinal plane containing the longitudinal axis of the pin and perpendicular to a longitudinal plane through the center of the slot, also containing the longitudinal axis of the pin stands.
  • the plug of the stopper is only partially pressed in to a first position, which is defined by the cams resting on the end face of the container neck. In this first position, the interior of the container is still connected to its surroundings via the slot, so that vapors and gases can escape during freeze-drying.
  • the plug is pushed in completely by means of a mechanical device, i. H. brought into a second position, in which the first section of the pin, which is not interrupted by the slot, brings about the complete sealing.
  • a first type of tube made of tubular glass in which the inside of the neck is completely cylindrical
  • a second, referred to as a glassworks container Type in which the neck is also cylindrical in shape for most of its length, but there is a blow back directly at the transition to the end face of the neck, which appears as a small, radially inward protruding ridge .
  • the ridge causes greater press-in forces.
  • the linear stability of the ridge reduces the stability of the stopper in the first position mentioned. This city strength could be improved by lengthening the pin section standing in the first position and thus lengthening the entire pin.
  • a large spigot length is undesirable because it makes it difficult to position the plugs with the flange facing downwards in sorting machines, requires more material and increases the flow resistance of the slot. Furthermore, the provision of different stoppers for different types of containers with the same nominal neck diameter is disadvantageous because of the additional shapes required for the production and the increased storage.
  • the object of the invention is to develop a freeze-drying stopper of the type mentioned at the outset such that the same stopper can be used for containers of tubular glass with the same nominal neck diameter and for glassworks containers and has advantageous properties in both applications, in particular with regard to material requirements, simpler machinability, tight fit in both Positions with low press-in force.
  • a groove extending in a fourth transverse plane perpendicular to the longitudinal axis of the pin is formed in the first position.
  • the groove takes up the burr of glassworks containers in a force-fitting and also form-fitting manner, so that the stopper has good stability with a relatively low press-in force.
  • the groove also facilitates the elastic displacement of the cams when the plug is transferred to its second position, which on the one hand enables a reduction in the press-in forces and also achieves an optimal design of the cam.
  • the axially inner side wall of the groove lies in the third transverse plane, i. H. represents a radially inner extension of the axially outer limits of the cams.
  • the axial width of the groove, as well as its depth, is advantageously at least 0.8 mm.
  • three cams are provided, one cam of which is diametrically opposite the slot, the center of which lies in a first longitudinal plane containing the longitudinal axis of the pin and running through the center of the slot, and that the centers of the other two cams each contain the longitudinal axis of the pin second and third longitudinal planes are arranged, which include the same longitudinal angle of more than 90 ° with the first longitudinal plane, the cams being designed as elongated beads, the length of which in the circumferential direction is at least 2.5 times their axial extension.
  • the freeze-drying stopper is shown in FIGS. 1 to 4 in a magnification of approximately 5 times. It consists of rubber and contains a pin 1 intended for insertion into the container neck to be closed and a flange 2 formed therewith in one piece.
  • the pin 1 has, in addition to its special design which will be explained in the following, in principle the shape of a hollow cylinder which delimits a cavity 4 which is open to the free pin end face 3.
  • the flange 2 has an edge 2a projecting laterally beyond the pin 1, on which a lower edge extends radially outward from the pin kende plane annular boundary surface 5 is formed.
  • This boundary surface lies in a first transverse plane Q 1 penetrated perpendicularly by the longitudinal axis A of the pin, is intended for bearing against the end face of the neck of the container and limits the insertion depth of the pin in its closed position.
  • the closed central wall part 2b of the flange 2 axially delimits the cavity 4 with an inner wall surface 6 which is flat in a surface area surrounding the pin longitudinal axis A and lies in a transverse plane P which runs at a short distance from the first transverse plane Q 1.
  • the outer surface 7 of the flange 2 facing away from the peg 1 has two projections 8 each running approximately semicircularly, the diameter of which is small with respect to the outer diameter of the flange and which mark a surface area surrounding the longitudinal axis A of the pin intended for the puncture of a withdrawal cannula. From the surface area of the outer surface 7 surrounding the projections 8, further projections 9 extend radially to the longitudinal axis A of the pin and at equal angular intervals, which prevent freeze-drying stoppers lying against one another with their outer surfaces from adhering to one another or to other objects and thereby hinder their processing.
  • the pin 1 In a first section Z1 of its axial length, which is located between the first transverse plane Q1 and a perpendicular to the longitudinal axis A, the pin length in a rough approximation centrally dividing second transverse plane Q2, the pin 1 is of full-walled design, ie it has a closed outer upper peripheral surface 10a on. This peripheral surface is adjacent to the first transverse plane Q 1 narrow and flat annular recess 10 'and an adjoining, axially longer cylindrical surface is formed, the latter having a diameter D which is slightly larger than the inside diameter of the neck of the container and, when the stopper is fully inserted, rests against the container neck under elastic prestress.
  • a second section Z2 of the axial length of the pin 1, which extends from the second transverse plane Q2 to the free pin end face 3, has an outer cylindrical envelope surface 10b, which has essentially the same diameter D as the upper peripheral surface 10a.
  • the passage 11 has the shape of a slot and contains two side surfaces 12a, 12b, which are substantially flat, run almost parallel to the longitudinal axis A of the pin, widen from the cavity 4 to the mouth 13 and have a mutual mean distance which is approximately the middle Corresponds to the diameter of the cavity.
  • a first inner part 12c of the bottom surface of the passage 11 lies in a plane parallel to the second transverse plane Q2 and in this respect offset by a small distance to the end face 3 of the pin.
  • the inner part 12c is followed by an outer part 12d of the bottom surface shaped in the form of a sector of a truncated cone, which passes into the peripheral surface 10b with an edge which forms part of the mouth 13 and is located in the second transverse plane Q2.
  • the axially outer (ie adjacent to the pin face) 15 all lie on a common third transverse plane Q3, which is perpendicular to the longitudinal axis of the pin A runs and is located approximately in the middle between the second transverse plane Q2 and the pin end face 3.
  • cams 14a-14c When the pin 1 is inserted into the container neck, these cams 14a-14c cause an inhibition by the abutment of their delimitations 15 on the end face of the container neck and define a first position of the stopper in which it is already non-positively connected by elastic deformation of the pin part adjacent to the end face of the pin is held in the container neck, but the interior of the container is still open to the environment via the passage 11. Vapors and gases can therefore escape from the material contained in the container during freeze drying to the surroundings of the container.
  • the cams 14a-14c are pushed back by increased application of force to the plug, the cams themselves and the material of the pin 1 surrounding them being deformed.
  • the pin can then be inserted into the container neck up to a second position (closed position), which is defined by contact of the boundary surface 5 of the flange 2 on the end face of the container neck and in which the first section Z 1 of the pin equipped with the closed upper peripheral surface 10 a a complete seal of the container neck causes.
  • the cams 14a-14c each have the shape of semi-circular elongated beads in cross-section, which extend in the circumferential direction of the pin 1, their length in this direction in each case being at least 2.5 times their axial extension.
  • a first cam 14a is arranged diametrically opposite the passage (slot) 11, such that its center lies in a first longitudinal plane L1, which contains the longitudinal axis A of the pin and passes through the middle between the side surfaces 12a, 12b of the passage 11.
  • the centers of the other two cams 14b, 14c are defined by a second longitudinal plane L2 or third longitudinal plane L3, which contain the pin longitudinal axis A containing on different sides of the first longitudinal plane L1 and with this each have the same angle ⁇ 2 or ⁇ 3 of Include approx. 110 ° (old degree).
  • a groove 16 is arranged such that its inner (ie adjacent to the flange 2) side wall lies in the third transverse plane Q3.
  • the groove 16 the depth T and the axial width W of which is equal to or greater than 0.8 mm, extends around the entire circumference and opens into the side surfaces 12a, 12b of the passage 11.
  • the groove 16 is followed by a peripheral surface 17 of the pin 1, the diameter of which is slightly larger than the diameter of the peripheral surface from which the cams 14a-14c project. The peripheral surface closes via one of the easier insertion of the pin 1 into the container neck conical surface 18 on the pin end face.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Closures For Containers (AREA)
EP88118842A 1987-12-24 1988-11-11 Bouchon pour lyophilisation Expired - Lifetime EP0322547B1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AT88118842T ATE78781T1 (de) 1987-12-24 1988-11-11 Gefriertrocknungs-stopfen.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19873744173 DE3744173A1 (de) 1987-12-24 1987-12-24 Gefriertrocknungs-stopfen
DE3744173 1987-12-24

Publications (2)

Publication Number Publication Date
EP0322547A1 true EP0322547A1 (fr) 1989-07-05
EP0322547B1 EP0322547B1 (fr) 1992-07-29

Family

ID=6343656

Family Applications (1)

Application Number Title Priority Date Filing Date
EP88118842A Expired - Lifetime EP0322547B1 (fr) 1987-12-24 1988-11-11 Bouchon pour lyophilisation

Country Status (3)

Country Link
EP (1) EP0322547B1 (fr)
AT (1) ATE78781T1 (fr)
DE (2) DE3744173A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0823383A1 (fr) * 1996-07-31 1998-02-11 Daikyo Seiko, Ltd. Bouchon de caoutchouc pour un récipient pour des médicaments

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB984149A (en) * 1963-06-25 1965-02-24 Becton Dickinson Co Self sealing pierceable stopper for sealed containers
FR2096680A1 (fr) * 1970-05-29 1972-02-25 Barville Jean
GB2014115A (en) * 1978-02-08 1979-08-22 Rumpler J J Bottle stopper
GB2026995A (en) * 1978-08-01 1980-02-13 Coulter Electronics Closure Caps

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB984149A (en) * 1963-06-25 1965-02-24 Becton Dickinson Co Self sealing pierceable stopper for sealed containers
FR2096680A1 (fr) * 1970-05-29 1972-02-25 Barville Jean
GB2014115A (en) * 1978-02-08 1979-08-22 Rumpler J J Bottle stopper
GB2026995A (en) * 1978-08-01 1980-02-13 Coulter Electronics Closure Caps

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0823383A1 (fr) * 1996-07-31 1998-02-11 Daikyo Seiko, Ltd. Bouchon de caoutchouc pour un récipient pour des médicaments

Also Published As

Publication number Publication date
EP0322547B1 (fr) 1992-07-29
DE3744173A1 (de) 1989-07-06
ATE78781T1 (de) 1992-08-15
DE3873297D1 (de) 1992-09-03

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