EP3365250A1 - Contenant jetable pour petits éléments dans l'industrie pharmaceutique - Google Patents

Contenant jetable pour petits éléments dans l'industrie pharmaceutique

Info

Publication number
EP3365250A1
EP3365250A1 EP16779129.2A EP16779129A EP3365250A1 EP 3365250 A1 EP3365250 A1 EP 3365250A1 EP 16779129 A EP16779129 A EP 16779129A EP 3365250 A1 EP3365250 A1 EP 3365250A1
Authority
EP
European Patent Office
Prior art keywords
container
container according
transfer system
small parts
filling
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Withdrawn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
EP16779129.2A
Other languages
German (de)
English (en)
Inventor
Eric Netzhammer
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.)
Castus Sterile Systems GmbH and Co KG
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of EP3365250A1 publication Critical patent/EP3365250A1/fr
Withdrawn legal-status Critical Current

Links

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
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/18—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient
    • B65D81/20—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas
    • B65D81/2046—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas under superatmospheric pressure
    • B65D81/2061—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas under superatmospheric pressure in a flexible container
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/08—Radiation
    • A61L2/081—Gamma radiation
    • 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
    • B65D88/00—Large containers
    • B65D88/16—Large containers flexible
    • B65D88/22—Large containers flexible specially adapted for transport
    • 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
    • B65D90/00—Component parts, details or accessories for large containers
    • B65D90/0033—Lifting means forming part of the container
    • 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
    • B65D90/00—Component parts, details or accessories for large containers
    • B65D90/12—Supports
    • 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
    • B65D90/00—Component parts, details or accessories for large containers
    • B65D90/48—Arrangements of indicating or measuring devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/18—Aseptic storing means
    • A61L2202/181—Flexible packaging means, e.g. permeable membranes, paper
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/23—Containers, e.g. vials, bottles, syringes, mail

Definitions

  • Disposable container for small parts in the pharmaceutical industry is Disposable container for small parts in the pharmaceutical industry
  • the invention relates to disposable containers for the treatment (sterilization, washing, drying, etc.), transport, storage, filling into the containers and transfer into a filling machine of small parts in the pharmaceutical industry and a method for handling flexible containers.
  • a “filling machine” is a plant that fills pharmaceutical agents or other substances into small units, such as vials, ampoules or pre-filled syringes, etc.
  • small parts are components of primary packaging of the substances used by a filling machine, e.g., as sealing plugs of vials, etc.
  • integrality is used similarly as in the pharmaceutical industry understands “integrity” when a container of any type is first internally sterilized and then pressurized without interruption.As long as the container is under overpressure, the contents of the container are considered to be sterile.If necessary, this integrity is limited in time.
  • preformed flexible container refers to a container which, in contrast to a foil pouch or bag, on the one hand has a predetermined spatial form, and whose shape, on the other hand, is changed by greater pressures, in contrast to a pressure vessel, because of its flexibility
  • the small parts are either filled, handled, stored, transported and transferred either in pressure-stable containers, in which case a treatment device in the pharmaceutical industry is mostly in the immediate vicinity of a filling machine. Another possibility is to buy and use the small parts as "ready to use" parts on the market.
  • These packaging units are usually small, so that they can still be lifted by hand and coupled to the filling machine.
  • These packaging units are usually simple foil bags, which can hardly or hardly absorb pressure.
  • the invention has for its object to provide a container that can absorb large amounts of small parts, can be used as a disposable container and can be acted upon with a small overpressure to ensure integrity, and to propose a method for handling flexible containers ,
  • Fig. 1 shows an exemplary preformed flexible
  • FIG. 2 shows the packaging, transport and handling of a preformed flexible container within material locks and in a clean room
  • Fig. 3 shows an example of a lifting device in a clean room on a filling machine.
  • FIG. 1a shows a preformed flexible container 1 with an opening with closure / transfer system 2, a small bulge 3, which can serve for centering a possibly used riser during the treatment.
  • the preformed flexible container can be slightly stabilized by small grooves on the circumference 4.
  • the container opening can still be provided with a flap so that when the transfer system is open (the opening of the preformed flexible container then normally points downwards) the small parts do not fall out of the container. The flap is not drawn.
  • Fig. Lb shows the container of Fig. La, but with obliquely attached opening.
  • Fig. Lc shows a container which is equipped with lugs or eyelets 20 in order to lift the container with a hoist can.
  • Fig. 2a shows a preformed flexible container which lies on a transport holder 30.
  • This transport holder 30 consists for example of deep-drawn plastic and is made such that the transport bracket can carry a preformed flexible container together with content.
  • the transport bracket has two or more lateral recesses gene 31, so that the container with a hoist from the
  • Transport bracket can be lifted. Such a hoist may e.g. be used on a filling machine.
  • Fig. 2b shows a preformed flexible container 1 together with a transport bracket 30 from the rear.
  • the transport bracket has two pairs of entry openings 41 and 42, in which can be retracted with a pallet truck. When retracted into the lower opening 42, the transport holder with container is raised. If it is moved into the upper opening 41, the container is lifted out of the transport holder and lies in the fork of the lift truck. The container is held with one or more straps 40 during transport in the transport holder.
  • the preformed flexible container is filled at one location, but emptied at a completely different location.
  • the locations can be distributed worldwide.
  • the preformed flexible container with its transport holder is packed in a second packaging at the filling location, this is also called secondary packaging.
  • secondary packaging there are high demands on purity.
  • the secondary packaging may be, for example, an aluminum composite bag which is welded. In order to compensate for pressure differences, it may be necessary to integrate a small disposable sterile filter in this secondary packaging (not shown in the figure).
  • This secondary pack is usually still packed in another packaging, eg cardboard box, plastic box or wooden box.
  • another packaging eg cardboard box, plastic box or wooden box.
  • the third packaging outer packaging
  • the packaging is transported on a standard wooden pallet.
  • the secondary packaging together with its contents is lifted out of the outer packaging and thus also from the wooden pallet and repacked onto a clean pallet (eg aluminum or plastic).
  • a clean pallet eg aluminum or plastic.
  • tabs 52 may be attached to the secondary packaging.
  • disposable straps can be put around the secondary packaging. Usually one more is done
  • Fig. 2d / 2e To bring the secondary packaging with contents on a clean pallet into a clean room, the goods must pass through a material lock. In the material lock you can cut the secondary packaging 51 with a pair of scissors or a knife. The fork 61 of a lift truck 60 is moved either into the openings 41 or the openings 42 of a clean pallet 53, and the container (and possibly also the transport holder) is raised. The container (and possibly the transport holder) can then be removed from the clean pallet 53 and the secondary packaging 51 can be removed. Depending on the consumer, the goods must pass through one or two material locks.
  • Fig. 2f If two material locks are required, for example, in the first lock, as described in Fig. 2d / 2e, the preformed flexible container with transport bracket taken out of the secondary packaging, and in the second material lock the straps 40 are removed and removed the container from the transport bracket , The exact procedure is the responsibility of the consumer.
  • Fig. 3a / 3b show a holding device 100 for a preformed flexible container.
  • the holding device is designed so that the preformed flexible container fits into it.
  • the holding device stabilizes the shape of the preformed flexible container.
  • the holding device is provided with an opening 101 through which the opening of the preformed flexible container can be pushed with the transfer system.
  • the holding device is designed so that the preformed flexible container does not fall down when the holding device is rotated with the opening 101 down to be able to connect to the filling machine can.
  • the openings 102 allow, as shown in Figure 3c, to move with a hand pallet truck in the holding device, lower the fork and so store the preformed flexible container in the holding device.
  • the holding device is fastened, for example, with a holder 110 to a lift III with which the holding device 100 (and thus also the preformed flexible container) can be raised, tilted and coupled to the filling machine.
  • the lift In order to be able to place the preformed flexible container transfer system accurately enough to the transfer system of the filling machine, either the lift must perform the positioning position dependent on the transfer system of the preformed flexible container, or the transfer system of the preformed flexible container must be accurately positioned in the holder 100 and be fixed, or the opening of the preformed flexible container is movable enough to compensate for occurring tolerances can.
  • a fixing device is not visible in the figure.
  • the container with, for example, a groove and to position the opening or the transfer system on the container exactly in the holding device 100 with the aid of a clamping device. If the opening or transfer system of the container is positioned accurately enough, the lift can be designed so that preformed flexible containers with sufficient repeatability can be coupled to the transfer system of the insulator.
  • the transport and the unpacking of the flexible container are shown. The packing of the container is done in virtually the same way but in the opposite way.
  • a lift with a holding device as described in FIG. 3. This holding device then requires an additional device so that the container does not fall out of the holding device, since the filling of the flexible container, the opening of the flexible container facing upward. When emptying, the opening points downwards.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Basic Packing Technique (AREA)

Abstract

La présente invention concerne un contenant destiné à contenir, traiter, transporter, stocker, transférer etc. de petits éléments pour l'industrie pharmaceutique, le contenant étant un récipient souple préformé (1) qui a une forme géométrique prédéterminée et dont la forme est modifiée, en raison de sa flexibilité, par des pressions d'intensité supérieure de sorte qu'il peut supporter suffisamment l'effet de la pression (par ex. 50-500 mbar) pendant une période prolongée (par ex. 1 an), afin de garantir l'intégrité du contenu.
EP16779129.2A 2015-10-20 2016-10-12 Contenant jetable pour petits éléments dans l'industrie pharmaceutique Withdrawn EP3365250A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CH01528/15A CH711666A1 (de) 2015-10-20 2015-10-20 Behältnis für kleine Teile in der pharmazeutischen Industrie.
PCT/EP2016/074394 WO2017067826A1 (fr) 2015-10-20 2016-10-12 Contenant jetable pour petits éléments dans l'industrie pharmaceutique

Publications (1)

Publication Number Publication Date
EP3365250A1 true EP3365250A1 (fr) 2018-08-29

Family

ID=55345613

Family Applications (1)

Application Number Title Priority Date Filing Date
EP16779129.2A Withdrawn EP3365250A1 (fr) 2015-10-20 2016-10-12 Contenant jetable pour petits éléments dans l'industrie pharmaceutique

Country Status (4)

Country Link
US (1) US20190016520A1 (fr)
EP (1) EP3365250A1 (fr)
CH (1) CH711666A1 (fr)
WO (1) WO2017067826A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11753245B1 (en) 2020-11-10 2023-09-12 Express Scripts Strategic Development, Inc. Pharmaceutical container holder

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2656062B1 (fr) * 1989-12-15 1992-06-05 Lafon Prod Sa Limiteur de remplissage pour cuve de stockage d'un liquide.
US5344275A (en) * 1993-03-23 1994-09-06 Helmut Habicht Method and apparatus for lifting turning and tilting of containers
EP0666222A1 (fr) * 1994-02-03 1995-08-09 The Procter & Gamble Company Récipients étanches pouvant être révensiblement et graduellement pressurisés, et paquet de tels récipients
US5901718A (en) * 1995-01-31 1999-05-11 Kuraray Engineering Co., Ltd. Wash tank for small molded parts
DE69602251T2 (de) * 1995-01-13 1999-12-16 Duras Trading Ltd Kupplungsanordnung zur sterilen übergabe von sterilen materialien zwischen einem transportablen behälter und einem sterilen gehäuse
US5863500A (en) * 1996-05-30 1999-01-26 International Manufacturing & Licensing, Inc. Method and apparatus for preserving products
DE19916720B4 (de) * 1999-04-13 2005-05-04 Smeja Gmbh & Co Kg Reinigungs- und Sterilisiermaschine
SE521881C2 (sv) * 1999-06-09 2003-12-16 Getinge Sterilization Aktiebol Kopplingsenhet, steriliseringssystem och förfarande för överföring av steriliserat gods
US20030230356A1 (en) * 2003-02-20 2003-12-18 Lindsay Leveen Beverage bottle and method for maintaining carbonation
EP1510227B1 (fr) * 2003-09-01 2011-10-05 Atec Pharmatechnik Gmbh Conteneur de traitement et de transport
FR2942778B1 (fr) * 2009-03-06 2016-02-05 Sartorius Stedim Biotech Sa Montage a enceinte torique de maintien pour l'obturation de, ou le raccord sur, une collerette annulaire, a mise en place et enlevement rapides, destine au domaine biopharmaceutique
DE102010033738A1 (de) * 2010-02-05 2011-08-11 Busch, Rainer, 76889 Ermüdungsfeste Verbindung von Blechen und Profilen mit und ohne Hilfsfügeteil an einer Transportverpackung.
DE102011015044A1 (de) * 2011-03-24 2012-09-27 Atec Pharmatechnik Gmbh Geteilter Behälter und Verfahren zum Behandeln von kleineren Gegenständen
BE1021612B1 (nl) * 2013-01-15 2015-12-18 CARDIFF GROUP,naamloze vennootschap Houder voor een vloeibaar product en werkwijze voor het vervaardigen van een dergelijke houder.

Also Published As

Publication number Publication date
CH711666A1 (de) 2017-04-28
WO2017067826A1 (fr) 2017-04-27
US20190016520A1 (en) 2019-01-17

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