EP1539583B1 - Procede et dispositif pour produire un conditionnement individuel primaire d'un cachet - Google Patents

Procede et dispositif pour produire un conditionnement individuel primaire d'un cachet Download PDF

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Publication number
EP1539583B1
EP1539583B1 EP03757797A EP03757797A EP1539583B1 EP 1539583 B1 EP1539583 B1 EP 1539583B1 EP 03757797 A EP03757797 A EP 03757797A EP 03757797 A EP03757797 A EP 03757797A EP 1539583 B1 EP1539583 B1 EP 1539583B1
Authority
EP
European Patent Office
Prior art keywords
packaging material
active substance
wafer
substance film
material webs
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.)
Expired - Lifetime
Application number
EP03757797A
Other languages
German (de)
English (en)
Other versions
EP1539583A1 (fr
Inventor
Wolfgang Schäfer
Ronald Hackbarth
Hans-Dieter Sahm
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.)
LTS Lohmann Therapie Systeme AG
Original Assignee
LTS Lohmann Therapie Systeme AG
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
Priority claimed from DE10249705A external-priority patent/DE10249705A1/de
Application filed by LTS Lohmann Therapie Systeme AG filed Critical LTS Lohmann Therapie Systeme AG
Priority to SI200330645T priority Critical patent/SI1539583T1/sl
Publication of EP1539583A1 publication Critical patent/EP1539583A1/fr
Application granted granted Critical
Publication of EP1539583B1 publication Critical patent/EP1539583B1/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
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B61/00—Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B9/00—Enclosing successive articles, or quantities of material, e.g. liquids or semiliquids, in flat, folded, or tubular webs of flexible sheet material; Subdividing filled flexible tubes to form packages
    • B65B9/02—Enclosing successive articles, or quantities of material between opposed webs

Definitions

  • the invention relates to a method and a device for producing a primary individual packaging of a wafer, in particular of a wafer taken from a drug film of one or more active substances for use as Dosiertechnik- and dosage form for drugs.
  • the dosage form of the "wafer” is a thin plate made of a drug film with a predetermined amount of active ingredient, which is tuned in its thickness and its dimensions to the amount of active ingredient to be dispensed.
  • a wafer is flexible, soft, lightweight and tear-resistant. Since the contact surface of the wafer is directly related to the dosage of the drug, its dimensions must be largely consistent with the calculated and within the tolerance range. Because of the dependency of the dosage on the area, the soft drug film material must not be stretched before cutting, otherwise the amount of active ingredient would be changed. Therefore, the production of the wafer and its individual packaging or the packaging of multiple wafers in a primary packaging unit are also expensive.
  • DE 198 00 682 A1 discloses a method for producing a primary packaging unit for film-like or wafer-like administration forms (wafers) for oral application, each having a section of a packaging material upper and lower layer.
  • the method which in principle also applies to individual packaging of wafers, has a different procedure for square or rectangular wafers versus producing wafers of a different shape.
  • a packaging material web and a sub-web are brought together without cold or hot deformation via a respective deflection shaft, wherein at the same time the film-like or wafer-like administration form is guided between the two packaging material webs with the aid of rollers or forceps advantages.
  • an active-substance film can also be supplied as a web product - with one or more webs parallel to one another at a distance from one another - with the desired width of the dosage units.
  • dosage units are separated from the sheet-like active substance film by a cross-cutting device, which is positioned immediately in front of the deflection shafts.
  • the two packaging material webs are sealed relative to one another with the aid of a heated sealing tool in such a way that the individual dosage units are sealed in compartments and are completely surrounded by sealing seams or sealing surfaces.
  • perforations between the compartments are stamped and primary packaging units are divided.
  • the process for producing the primary packaging unit according to DE 198 00 682 A1 is designed as follows: In a first process step, a laminate of the web-like active substance film and a carrier film is provided, from which in another Step with a punching device, the dosage units are punched out without the carrier film is punched through. The stamped laminate is then deflected by means of roller or pliers advantages over an edge or deflection shaft so that thereby solve the dosage units of the carrier film. If necessary, a scraper can also be used for this purpose.
  • a packaging material web and a sub-base without cold or Hot deformation over each other guided a guide shaft wherein at the same time the detaching from the carrier film dose units between the two packaging material webs are performed.
  • the two packaging material webs are sealed against each other using a heated sealing tool in such a way that the individual dosage units are sealed in compartments and are completely surrounded by sealing seams or sealing surfaces.
  • perforations between the compartments are stamped and primary packaging units are divided. It goes without saying that this method can also be used for the production and primary individual packaging of square or rectangular wafers.
  • DE 198 00 682 A1 has also disclosed devices for carrying out the respective method.
  • One of these devices has a storage device for a laminate of a drug film and a carrier film, a cutting or punching device for the active substance film for punching a wafer on the carrier film, a separating tool for detaching the active substance film from the carrier film, a preferred device for the carrier film and thus Also, the drug film with the wafer, a Packstoffzu wool- and -vorzugs adopted for two packaging material webs, which take over the respective wafer, a heated sealing tool for the packaging material and a cutting tool for separating the sealed bag.
  • the wafer material is elastic and can change its shape and dimensions due to the mechanical stress during the transport movement between the packaging material web and the sub-base, with the risk that the amount of active ingredient in the separated wafer changes, since the area of the wafer is decisive for the dosage of the active ingredient is. With the methods described above the required constancy of the amount of active ingredient can not be ensured because the wafer material is mechanically stressed before insertion between the packaging material webs.
  • the inventive method is that a laminate of a carrier film and a drug film is provided and withdrawn, wherein the carrier film is released from the drug film and wound separately. Due to the preferential movement of the carrier film and the drug film is moved forward. With its front end, this is guided without mechanical load between two stationary packaging material webs, fixed by these and cross-cut for the production of the wafer at the predetermined rearward distance from them. Subsequently, the wafer fixed between the packaging material webs is pulled forward jointly and in synchronism with the latter, wherein the preferential force acts on the packaging material webs, and fed to a sealing station. In this sealing station, the packaging material webs are sealed outside the arrangement region of the wafer into a bag, which is subsequently separated from the packaging material webs.
  • the laminate is produced by the coating process and then cut into strips which are wound up, the width of a coil corresponding to the width of the desired wafer or a multiple of this wafer width. If several wafers are cut out of the bobbin, the individual wafers are spread and brought to the width necessary to insert them into the packaging material webs.
  • the coil is provided as a supply spool.
  • the scattered wafer is then held during the preferential movement of the packaging material webs over its entire extension between them and thereby not mechanically stressed.
  • the procedure is easy to perform.
  • the active substance film dissolved by the carrier film is guided in a vertical alignment between the packaging material webs resting in this process step and spaced apart from one another. Subsequently, these are applied to the wafer and pulled forward at the same preferred speed and in the same preferred direction on both sides of the drug film, so that the active substance film is mechanically preferred between the packaging material webs with.
  • the packaging material webs are guided by a clamping device, which the packaging material webs at the end of the power stroke, in which the drug film was spent with its front end between the packaging material webs to presses and fixes the wafer. A relative movement between this and the packaging material webs is thereby excluded. In this position, the active substance film is cross-cut at the predetermined distance from the clamping station for the separation of a wafer and pulled in the next step completely and stress-free between the packaging material webs and preferred.
  • the device for carrying out the method comprises in a known manner a storage device for the laminate formed from a carrier film and a drug film, a separating tool for detaching the active substance film from the carrier film, a preferred device for this and thus also the drug film, a cutting tool for this, a packaging material supply - and -vorzugs adopted for two packaging material webs, which also come from a packaging material roll and can be separated and deflected by a separation process, a heated sealing tool for the packaging material and a cutting tool for separating the finished sealed edge bag on.
  • the packaging material supply and advancing device is provided with a receiving and clamping device for the front end of the drug film, which lies in the vertical direction under the separating film for separating the drug film, and between which the cutter for cutting the length of the wafer is arranged such that the active substance film dissolved by the carrier foil passes vertically downwards into the receiving and clamping device during a feed cycle.
  • the drug film is not mechanically stressed.
  • the receiving and clamping device is preferably formed from pinch rollers between which the packaging material webs are guided in a tensioned manner and which are guided in opposite directions between a receiving position for the active-substance film and thus transversely to the preferred direction of the active-substance film. are wegbar. To form an inlet funnel for the active substance film, two pairs of clamping rollers can be arranged one above the other.
  • the device shown in Fig. 1 has on the input side a supply reel 1 with vorzu endeavourdem, consisting of a carrier film 2 and a drug film 3 laminate 4, a guide roller 5 and a scraper 6 for detaching the active substance film 3 of the carrier film 2 and a coil 8 for winding the Carrier film 2 on.
  • a cross-cutting device 10 with a knife (not shown) and a Packstoffzu wool- and -vorzugs owned 11 for two packaging material webs 12 are arranged for the exact alignment of the carrier film 2 dissolved drug film, the cutter side a comprising receiving and clamping device formed from two pairs of superimposed pinch rollers 13 and 14.
  • the packaging material webs 12 are arranged on supply rolls 15 and guided over the pinch rollers 13 and 14 to preferential rolls 16, by which they are fixed in a clamping manner and are pulled forward, whereby they are also tensioned against the pinch rollers 13 and 14. Between these (13, 14) and the preferred rollers 16 are heated transverse sealing and longitudinal sealing tools 17 and 18 and in the preferred direction after the preferred rollers 16, a flat blade 19 is arranged as a cross-cutting tool.
  • laminate 4 having the predetermined width of the wafer in the predetermined length thereof is withdrawn from the supply reel 1 by operation of the reel 8.
  • the active substance film 3 is released from the carrier film 2 by the separating roller 7 and aligned vertically downwardly through the guideways or strips 9, these having no clamping function relative to the active substance film 3.
  • the front end of the active-substance film 3 passes between the clamping rollers 13 and 14 which are spaced apart in their receiving position, via which the packaging material webs 12 are guided on the active-material film side and in the receiving position are in tension against them.
  • the packaging material webs 12 are provided by the previous cycle with a transverse seam 20, which now represents the front or bottom seam of the sealed edge bag or the primary single packaging of the wafer to be produced. This process step is shown in FIG.
  • the packaging material webs 12 are pressed by the pinch rollers 13, 14 against the front region of the preformed active substance film 3 and this is fixed between the packaging material webs 12 by moving them towards one another. From the active substance film 3, a wafer 21 is now separated in the predetermined length by the cross-cutting device 10.
  • the dunnage webs 12 are advanced with the wafer clamped between them by a synchronous operation of the idler rolls 16 to the position of the back side seam seal ( Figure 4), moving the wafer 21 frictionless and at the same speed as the dunnage webs 12.
  • the packaging material webs 12 are heat-sealed together at the two longitudinal sides by the two longitudinal sealing tools 18 and at the rear transverse side by the transverse sealing tool 17.
  • the resulting transverse seam is chosen so wide that it can be divided transversely and both the back Sealing seam of just produced, but still to be separated primary individual packaging as well as the Fornt- or bottom seam of the subsequent individual packaging results.
  • the pinch rollers 13, 14 are brought into their receiving position and thus opened.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Containers And Plastic Fillers For Packaging (AREA)
  • Dicing (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Crystals, And After-Treatments Of Crystals (AREA)
  • Making Paper Articles (AREA)
  • Auxiliary Devices For And Details Of Packaging Control (AREA)

Claims (8)

  1. Procédé pour fabriquer un emballage individuel primaire d'une tranche (21), dans lequel un stratifié (4) à base d'un film support (2) et d'un film de substance active (3) est mis à disposition, le film de substance active (3) est coupé en travers avec une longueur prédéfinie et est détaché du film support (2), guidé entre deux bandes de matériau d'emballage (12) et est amené avec celles-ci à une station de scellement, les bandes de matériau d'emballage (12) sont scellées pour former un sachet et celui-ci est séparé des bandes de matériau d'emballage (12), caractérisé en ce que le film support (2) détaché du film de substance active (3) est avancé dans la longueur prédéfinie de la tranche (21) et dans le même temps le film de substance active (3) détaché du film support est guidé avec son extrémité avant de façon mécanique et sans charge entre les bandes de matériau d'emballage (12) au repos, est réceptionné et fixé par celles-ci et est coupé en travers à distance de ces bandes pour former une tranche (21) avec la longueur prédéfinie, et en ce qu'ensuite la tranche (21) est avancée de façon conjointe et synchrone avec les bandes de matériau d'emballage (12) et est amenée à la station de scellement (17/18), dans laquelle les bandes de matériau d'emballage (12) sont scellées en dehors de la zone de la tranche (21) fixée entre celles-ci.
  2. Procédé selon la revendication 1, caractérisé en ce que le film de substance active (3) détaché du film support (2) est guidé dans l'orientation verticale entre les bandes de matériau d'emballage (12) entrant des deux côtés de ce film.
  3. Procédé selon la revendication 1 ou 2, caractérisé en ce que le détachement du film de substance active (3) du film support (2) avancé s'effectue sur une arête ou sur un galet de renvoi (5).
  4. Procédé selon la revendication 3, caractérisé en ce que le détachement du film de substance active (3) du film support (2) s'effectue avec le soutien d'un racleur (6), qui est disposé entre le film de substance active (3) et le film support (2).
  5. Procédé selon la revendication 1, caractérisé en ce que les bandes de matériau d'emballage (12) sont guidées à l'entrée du film de substance active (3) dans le dispositif d'arrivée et d'avancement de matériau d'emballage (11) au moyen d'un dispositif de serrage (13/14), par lequel les bandes de matériau d'emballage (12) sont pressées pendant la séparation de la tranche (21) du film de substance active (3) et pendant leur avancement consécutif sur celles-ci de telle sorte qu'un déplacement relatif entre la tranche (21) et les bandes de matériau d'emballage (12) est exclu.
  6. Dispositif pour la mise en oeuvre du procédé selon l'une quelconque des revendications 1 à 5, pour fabriquer un emballage individuel (22) primaire d'une tranche (21), avec un dispositif de réserve pour un stratifié (4) à base d'un film de substance active (3) et d'un film support (2), un galet séparateur (7) pour le détachement du film de substance active (3) du film support (2), un dispositif d'avancement pour le film support (2) et donc également le film de substance active (3), un dispositif de coupe transversale (10) pour le film de substance active (3), un dispositif d'arrivée et d'avancement de matériau d'emballage (11) pour deux bandes de matériau d'emballage (12), un outil de scellement chauffé pour le matériau d'emballage et avec un outil de coupe pour la séparation du sachet scellé, caractérisé en ce qu'au-dessous du galet de séparateur (7) est disposé un dispositif de coupe transversale (10) avec un couteau et au-dessous un dispositif d'arrivée et d'avancement de matériau d'emballage (11) pour deux bandes de matériau d'emballage (12) avec un dispositif de réception et de serrage (13/14), afin de recevoir l'extrémité avant du film de substance active (3) entre les deux bandes de matériau d'emballage (12) au repos de façon mécanique et sans charge et de la coincer entre celles-ci.
  7. Dispositif selon la revendication 6, caractérisé en ce que le dispositif de réception et de serrage est formé par des poulies à serrage (13, 14), entre lesquelles les bandes de matériau d'emballage (12) sont guidées, les poulies à serrage (13, 14) étant mobiles entre une position de réception et une position de serrage pour le film de substance active (3) dans des directions opposées transversalement au film de substance active (3).
  8. Dispositif selon la revendication 7, caractérisé en ce que deux paires de poulies à serrage (13, 14) sont disposées l'une au-dessus de l'autre.
EP03757797A 2002-09-16 2003-09-06 Procede et dispositif pour produire un conditionnement individuel primaire d'un cachet Expired - Lifetime EP1539583B1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
SI200330645T SI1539583T1 (sl) 2002-09-16 2003-09-06 Postopek in naprava za izdelavo posamezne primarne embalaze vafra

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US41126902P 2002-09-16 2002-09-16
US411269P 2002-09-16
DE10249705A DE10249705A1 (de) 2002-09-16 2002-10-25 Verfahren und Vorrichtung zur Herstellung einer primären Einzelverpackung eines Wafers
DE10249705 2002-10-25
PCT/EP2003/009911 WO2004026692A1 (fr) 2002-09-16 2003-09-06 Procede et dispositif pour produire un conditionnement individuel primaire d'un cachet

Publications (2)

Publication Number Publication Date
EP1539583A1 EP1539583A1 (fr) 2005-06-15
EP1539583B1 true EP1539583B1 (fr) 2006-11-02

Family

ID=32031493

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03757797A Expired - Lifetime EP1539583B1 (fr) 2002-09-16 2003-09-06 Procede et dispositif pour produire un conditionnement individuel primaire d'un cachet

Country Status (16)

Country Link
EP (1) EP1539583B1 (fr)
JP (1) JP4180054B2 (fr)
KR (1) KR100958774B1 (fr)
CN (1) CN100482538C (fr)
AT (1) ATE344181T1 (fr)
AU (1) AU2003273833B2 (fr)
BR (1) BR0314407B1 (fr)
CA (1) CA2495122C (fr)
DE (1) DE50305600D1 (fr)
DK (1) DK1539583T3 (fr)
ES (1) ES2276107T3 (fr)
MX (1) MXPA05002595A (fr)
NO (1) NO331288B1 (fr)
PL (1) PL204113B1 (fr)
RU (1) RU2290355C2 (fr)
WO (1) WO2004026692A1 (fr)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4972729B2 (ja) * 2006-04-24 2012-07-11 パウダーテック株式会社 シュート、シート供給装置、およびシート包装機
CN102514765B (zh) * 2012-01-09 2014-02-26 山东碧海机械有限公司 一种无菌纸盒灌装机的密封条不间断送条装置
CN107651230A (zh) * 2016-07-25 2018-02-02 杨辰 医用采血管打包装置
DE102017006991B4 (de) 2017-07-26 2020-02-27 Lts Lohmann Therapie-Systeme Ag Vorrichtung und Verfahren zur Herstellung von Siegelrandbeuteln
CN108163244B (zh) * 2018-01-19 2023-07-25 珠海市安粤科技有限公司 一种工业胶片自动包装装置
CN114955028A (zh) * 2022-05-16 2022-08-30 厦门高容纳米新材料科技有限公司 一种粉体自动包装系统及方法

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE1876961U (de) * 1963-03-02 1963-08-01 Noack E Th Verpackungsmasch Verpackungsmaschine fuer heftpflaster.
DE1895537U (de) * 1963-08-27 1964-06-25 Noack E Th Verpackungsmasch Maschine zum verpacken von flachem, bandfoermigem material.
IT712838A (fr) * 1963-12-05
JPS5153964Y2 (fr) * 1972-08-21 1976-12-23
JPS50150590A (fr) * 1974-05-28 1975-12-03
JPS6145304U (ja) * 1984-08-29 1986-03-26 ナショナル住宅産業株式会社 シ−ト梱包機
US4841712A (en) * 1987-12-17 1989-06-27 Package Service Company, Inc. Method of producing sealed protective pouchs with premium object enclosed therein
US5182128A (en) * 1991-03-12 1993-01-26 Kraft General Foods Canada Inc. Method and apparatus for producing a wrapped food material in single slice form
US5643391A (en) * 1995-01-13 1997-07-01 Hunt Holdings, Inc. Method and apparatus for an improved roller system for calendar machines
US5740661A (en) * 1995-05-23 1998-04-21 Sumitomo Chemical Company, Limited Method and apparatus of producing sheet wrapping body
JPH0939930A (ja) * 1995-07-26 1997-02-10 Morita & Co:Kk マーキング方法
DE19800682B4 (de) * 1998-01-10 2004-07-08 Lts Lohmann Therapie-Systeme Ag Verfahren zur Herstellung einer Primärverpackung für film- oder oblatenförmige Darreichungsformen

Also Published As

Publication number Publication date
KR100958774B1 (ko) 2010-05-18
CN1681708A (zh) 2005-10-12
MXPA05002595A (es) 2005-05-27
WO2004026692A1 (fr) 2004-04-01
EP1539583A1 (fr) 2005-06-15
JP4180054B2 (ja) 2008-11-12
AU2003273833A1 (en) 2004-04-08
BR0314407A (pt) 2005-07-19
NO20051250L (no) 2005-03-10
KR20050065542A (ko) 2005-06-29
DE50305600D1 (de) 2006-12-14
ES2276107T3 (es) 2007-06-16
BR0314407B1 (pt) 2012-10-16
NO331288B1 (no) 2011-11-14
RU2005103607A (ru) 2005-07-20
CA2495122A1 (fr) 2004-04-01
DK1539583T3 (da) 2007-02-19
CA2495122C (fr) 2010-06-08
RU2290355C2 (ru) 2006-12-27
PL204113B1 (pl) 2009-12-31
CN100482538C (zh) 2009-04-29
ATE344181T1 (de) 2006-11-15
PL375880A1 (en) 2005-12-12
JP2005538906A (ja) 2005-12-22
AU2003273833B2 (en) 2009-11-12

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