WO2012168268A1 - Bouchon de piston pour une unité de lyophilisation - Google Patents

Bouchon de piston pour une unité de lyophilisation Download PDF

Info

Publication number
WO2012168268A1
WO2012168268A1 PCT/EP2012/060640 EP2012060640W WO2012168268A1 WO 2012168268 A1 WO2012168268 A1 WO 2012168268A1 EP 2012060640 W EP2012060640 W EP 2012060640W WO 2012168268 A1 WO2012168268 A1 WO 2012168268A1
Authority
WO
WIPO (PCT)
Prior art keywords
piston stopper
piston
recess
height
axial direction
Prior art date
Application number
PCT/EP2012/060640
Other languages
German (de)
English (en)
Inventor
Mark VAN ESSCHE
Ronny Prosper Elisabeth Vrijens
Original Assignee
Helvoet Pharma Belgium N. V.
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 Belgium N. V. filed Critical Helvoet Pharma Belgium N. V.
Publication of WO2012168268A1 publication Critical patent/WO2012168268A1/fr

Links

Classifications

    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26—DRYING
    • F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00—Drying solid materials or objects by processes not involving the application of heat
    • F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
    • F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing

Definitions

  • the invention relates to a piston stopper for a lyophilization unit.
  • Lyophilization or lyophilization is used in the pharmaceutical sector to dry drugs that are not stable in dissolved form for a long time and thus to be able to store them until application.
  • the solution of the drug is first placed in a container, e.g. a cartridge, and then freeze-dried, after which the container is sealed.
  • the typically cylindrical cartridge can be either closed by an end plug, or it is a piston plug - typically made of elastic material - used, which not only hermetically seals the cartridge, but is also displaceable within this.
  • a system comprising a container, such as a cartridge, within which a lyophilization is carried out, and at least one piston stopper, which is intended to close the container and be inserted into it after the lyophilization has been carried out, are used as lyophilization Unit designates.
  • the object of the present invention is to propose measures with which a lyophilization can be carried out simply and safely and a subsequent closure of the container is made possible.
  • the object is achieved by a piston stopper for a lyophilization unit according to claim 1.
  • the stopper has an upper side and a lower side opposite to the upper side in an axial direction.
  • the axial direction is in this case the direction in which the piston can be displaced within the container, this direction corresponds in many cases, for example when the container is a cylindrical cartridge, an axis of symmetry of Kolbenstop- fens.
  • the underside is in this case the one side which faces the lyophilizate when the solution to be dried is placed on the stopper or after the drying has ended. These are also used in the following terms such as “below” and "above”.
  • the piston stopper in the region of the underside at least one outwardly continuously open recess for gas exchange during lyophilization, which is open in the axial direction downwards and in the radial direction.
  • Such an outwardly continuously open recess may in particular represent a depression or depression.
  • the piston stopper on a plurality, preferably two to ten, more preferably four recesses for gas exchange.
  • Such a plurality of recesses may preferably be arranged symmetrically with respect to an axis extending in the axial direction.
  • the entire piston plug can be constructed rotationally symmetrical, whereby a corresponding symmetrical distribution of the recesses is predetermined.
  • the dimension of the at least one recess allows the rate of sublimation to be controlled during lyophilization. Qualitatively, the sublimation speed is greater, the larger the recesses are.
  • the proportion of the at least one recess on the cross-sectional area of the piston plug is altogether between 5% and 80%, preferably between 10% and 60%, particularly preferably between 15% and 30%.
  • the at least one recess extends by 5% to 80%, preferably 10% to 60%, particularly preferably 30% to 50% of a maximum radius of the piston plug in the radial direction inwards. In cases where the piston plug does not have a circular cross section, this statement refers to half of the largest transverse dimension of the piston stopper instead of a maximum radius.
  • the height of the at least one recess in the axial direction can be varied within a wide range.
  • the piston stopper on four recesses, wherein the tangential extent of each recess between 5 ° and 80 °, preferably between 30 ° and 70 °, more preferably between 50 ° and 60 °.
  • the piston stopper has a preferably concave groove which is arranged above the at least one recess and rotates in the tangential direction.
  • the lower edge of the groove is preferably between 20% and 60%, more preferably between 30% and 50%, particularly preferably between 40% and 50% of the total height of the piston stopper and its upper boundary is preferably between 50% and 90 ° %, more preferably between 70% and 90%, more preferably between 80% and 90% of the height of the piston stopper.
  • the piston stopper advantageously has a tangential in the circumferential direction taper, through the upper edge of a bearing for the edge of a container of a lyophilization -Systems is defined.
  • the upper edge preferably forms a shoulder here.
  • the taper extends starting from the bottom up to 5% to 95%, preferably 20% to 80%, particularly preferably 40% to 60% of the height of the at least one recess.
  • the effective size of the opening for the passage of gas is preferably defined by the part of the recess which lies above the upper edge of the taper.
  • the piston stopper is designed to receive a piston rod. For this purpose, it has an outgoing from the bottom, extending in the axial direction recess for a piston rod whose height is 20% to 90%, preferably 40% to 85%, particularly preferably 60% to 80% of the height of the piston stopper.
  • the ranges and ranges of values given above and below also include all intermediate values, in particular in 1/10 increments of the respective dimension, if appropriate also without dimension, that is to say, for example, 1/10 ⁇ , mm, kg or m 3 on the one hand to delineate the abovementioned area boundaries from below and / or above, alternatively or additionally, but also with regard to the disclosure of one or more singular values from a respectively specified area.
  • FIG. 1 is a perspective view of a first embodiment of a piston plug according to the invention obliquely from above.
  • FIG. 2 is a side view of the piston plug of FIG. 1;
  • FIG. Fig. 3 is a plan view of the piston stopper of Fig. 1;
  • Fig. 4 is a side sectional view taken along the line IV - IV in Fig. 3;
  • Fig. 5 is a side sectional view taken along the line V - V in Fig. 3;
  • Fig. 6 is a bottom view of the piston stopper of Figures 1 to 5.
  • FIG. 7 is a perspective view of a second embodiment of a piston plug according to the invention obliquely from above;
  • Fig. 8 is a plan view of the piston plug of Fig. 7;
  • FIGS. 7 to 9 are perspective views of the piston stopper of FIGS. 7 to 9 obliquely from below.
  • FIGS. 11-17 are photorealistic representations of the piston stopper from FIG. 1
  • FIGS. 1 to 6 show a first embodiment of a piston stopper 1 according to the invention.
  • this stopper is made of rubber or a thermoplastic elastomer, in particular halobutyl elastomers being suitable.
  • the piston plug 1 is intended for use with a cylindrical cartridge (not shown) and therefore has a roughly cylindrical shape. In this case, it is symmetrical with respect to an axis of symmetry Z extending along an axial direction along which the piston stopper 1 is displaceable within the cartridge.
  • this On an upper side 2 of the piston stopper 1, this has a substantially flat, circular end face 8, on which four elongated rib elements 9 are formed, which are each offset with respect to.
  • the symmetry axis Z offset by 90 °. While the diameter of the piston stopper 1 shown in the region of the end face 8 is 10 mm and its height from the top 2 to the opposite bottom 3 is 11 mm, the rib elements only have a length of 3 mm and a width of 0.5 mm and a height of 0.25 mm. Therefore, when the plunger stopper 1 is pressed onto the cartridge by means of a tool during the lyophilization process, the rib members 9 provide only a very small contact surface, thereby minimizing the risk of freezing.
  • the piston stopper 1 In the region of the underside 3, the piston stopper 1 four recesses 4, which, as is apparent in particular from the bottom view in Fig. 6, symmetrically with respect.
  • the symmetry axis Z are arranged.
  • the shape of the recesses 4 is substantially concave and their lower boundary is circular arc-like, as shown in FIG. 6 can be seen.
  • the recesses extend in the radial direction from the outside 2 mm inwards and their height is in axial Direction 2.5 mm.
  • the piston stopper 1 In the lower region of the recesses 4, the piston stopper 1 also has a taper 6. In this area, its wall is tapered by 0.2 mm.
  • the upper edge 7 of the taper 6 is when placing the piston stopper 1 on the cartridge at its upper edge, which is why a further slipping of the piston stopper 1 without further effort is not possible. In this way, the piston stopper 1 is held in a defined position.
  • the portion of the recesses 4 located below the edge 7 is shielded by the wall of the cartridge to the outside and only the part above it allows a passage of gas to the outside.
  • the number, shape and size of the recesses 4 and the position of the edge 7 are selected such that there is a specific passage for gases, which in turn results in a certain desired sublimation.
  • Above the recesses 4 closes, as can be seen, for example, from Fig. 2, an approximately cylindrical, slightly tapering down to the area. Above this in turn, the piston stopper 1 has a circumferential groove 5, at the narrowest region of which a diameter of 9.2 mm is present.
  • FIG. 7 to 10 another embodiment of a fiction, contemporary piston stopper is shown.
  • This piston plug 101 is substantially similar to the just described plug 1, but also has a recess 10 for a piston rod.
  • This recess 10 is arranged centrally and extends in the axial direction. It extends from an opening at the bottom 3 to a height of 8 mm, wherein it is approximately cylindrical, but tapers from bottom to top of 3.5 mm to 3 mm in diameter.

Landscapes

  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Molecular Biology (AREA)
  • Mechanical Engineering (AREA)
  • General Engineering & Computer Science (AREA)
  • Drying Of Solid Materials (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un bouchon de piston (1, 101) pour une unité de lyophilisation, comprenant un côté supérieur (2) et un côté inférieur (3) qui est opposé au côté supérieur (2) dans une direction axiale. L'invention vise à perfectionner un bouchon de piston de manière avantageuse. A cet effet, le bouchon de piston (1) présente dans la région du côté inférieur (3) au moins un évidement (4) qui est ouvert en continu vers l'extérieur pour l'échange de gaz pendant la lyophilisation et qui est ouvert vers le bas dans la direction axiale et ouvert dans la direction radiale.
PCT/EP2012/060640 2011-06-10 2012-06-06 Bouchon de piston pour une unité de lyophilisation WO2012168268A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE202011050413.1 2011-06-10
DE201120050413 DE202011050413U1 (de) 2011-06-10 2011-06-10 Kolbenstopfen für eine Lyophilisations-Einheit

Publications (1)

Publication Number Publication Date
WO2012168268A1 true WO2012168268A1 (fr) 2012-12-13

Family

ID=46395587

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2012/060640 WO2012168268A1 (fr) 2011-06-10 2012-06-06 Bouchon de piston pour une unité de lyophilisation

Country Status (2)

Country Link
DE (1) DE202011050413U1 (fr)
WO (1) WO2012168268A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019063772A1 (fr) * 2017-09-28 2019-04-04 F. Hoffmann-La Roche Ag Bouchon de flacon pour flacon de lyophilisation et procédé de fermeture d'un flacon de lyophilisation
EP3536362A1 (fr) 2018-03-05 2019-09-11 Weibel CDS AG Dispositif de maintien bouchon sur une ouverture d'un récipient

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3333523B1 (fr) 2016-12-06 2019-09-04 KISIKO Kirchner, Simon & Co. GmbH Bouchon de récipient destiné à être utilisé lors de la lyophilisation

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3338447A (en) * 1965-09-22 1967-08-29 Ct Lab Inc Quick closing stopper
US4230231A (en) * 1979-04-16 1980-10-28 Coulter Electronics, Inc. Closure cap
US5740654A (en) * 1996-03-04 1998-04-21 Semco Packaging assembly for freeze-dried preparations

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3338447A (en) * 1965-09-22 1967-08-29 Ct Lab Inc Quick closing stopper
US4230231A (en) * 1979-04-16 1980-10-28 Coulter Electronics, Inc. Closure cap
US5740654A (en) * 1996-03-04 1998-04-21 Semco Packaging assembly for freeze-dried preparations

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019063772A1 (fr) * 2017-09-28 2019-04-04 F. Hoffmann-La Roche Ag Bouchon de flacon pour flacon de lyophilisation et procédé de fermeture d'un flacon de lyophilisation
CN111148956A (zh) * 2017-09-28 2020-05-12 豪夫迈·罗氏有限公司 用于冻干小瓶的小瓶塞子和用于封闭冻干小瓶的封闭方法
JP2020535081A (ja) * 2017-09-28 2020-12-03 エフ．ホフマン−ラ ロシュ アーゲーＦ． Ｈｏｆｆｍａｎｎ−Ｌａ Ｒｏｃｈｅ Ａｋｔｉｅｎｇｅｓｅｌｌｓｃｈａｆｔ 凍結乾燥バイアルのバイアルストッパ、および凍結乾燥バイアルを閉じるための閉鎖方法
CN111148956B (zh) * 2017-09-28 2021-07-02 豪夫迈·罗氏有限公司 用于冻干小瓶的小瓶塞子和用于封闭冻干小瓶的封闭方法
US11577893B2 (en) 2017-09-28 2023-02-14 Hoffmann-La Roche Inc. Vial stopper for a lyophilization vial and closure method for closing a lyophilization vial
EP3536362A1 (fr) 2018-03-05 2019-09-11 Weibel CDS AG Dispositif de maintien bouchon sur une ouverture d'un récipient

Also Published As

Publication number Publication date
DE202011050413U1 (de) 2012-09-11

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