WO2016150581A1 - Élément adapteur destiné à un dispositif de transfert, et installation pharmaceutique - Google Patents

Élément adapteur destiné à un dispositif de transfert, et installation pharmaceutique Download PDF

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Publication number
WO2016150581A1
WO2016150581A1 PCT/EP2016/050851 EP2016050851W WO2016150581A1 WO 2016150581 A1 WO2016150581 A1 WO 2016150581A1 EP 2016050851 W EP2016050851 W EP 2016050851W WO 2016150581 A1 WO2016150581 A1 WO 2016150581A1
Authority
WO
WIPO (PCT)
Prior art keywords
adapter element
connection
transfer container
adapter
pharmaceutical
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.)
Ceased
Application number
PCT/EP2016/050851
Other languages
German (de)
English (en)
Inventor
Uli FLECHSLER
Florian Kauder
Bernd Lang
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.)
Robert Bosch GmbH
Original Assignee
Robert Bosch GmbH
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 Robert Bosch GmbH filed Critical Robert Bosch GmbH
Publication of WO2016150581A1 publication Critical patent/WO2016150581A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L1/00—Enclosures; Chambers
    • B01L1/02—Air-pressure chambers; Air-locks therefor
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/02—Adapting objects or devices to another
    • B01L2200/026—Fluid interfacing between devices or objects, e.g. connectors, inlet details
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/14—Process control and prevention of errors
    • B01L2200/141—Preventing contamination, tampering
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/04—Closures and closing means
    • B01L2300/041—Connecting closures to device or container
    • B01L2300/042—Caps; Plugs

Definitions

  • the invention relates to an adapter element for a transfer device between a sterile area and an unsterile area in a pharmaceutical
  • the invention relates to a pharmaceutical system with an adapter element according to the invention.
  • transfer systems are characterized in that in a dividing wall of the pharmaceutical plant, which separates the sterile area from the non-sterile area, a passage lock is formed, to which a transfer container can be coupled from the non-sterile side.
  • the transfer container which contains in its interior the objects or objects which are to be introduced into the sterile area of the pharmaceutical plant, can be closed to the outside by means of a lid closure.
  • Closure element and the closure lid existing cover assembly can be introduced into the sterile area of the pharmaceutical plant without the sterility of the pharmaceutical plant is impaired.
  • the objects or objects can be introduced into the sterile room of the pharmaceutical plant from the transfer container.
  • transfer devices are exemplary in EP 0 691 913 B1 or US
  • 2013/0167442 A1 discloses. It is essential that the transfer device have at the partition and the transfer container exactly matched connection areas or connection elements, which are designed manufacturer-specific. Will you now already in the planning or construction of the pharmaceutical plant or subsequently, conditionally, for example by a system change, use corresponding transfer devices, it is necessary to provide in the partition of the pharmaceutical plant each manufacturer-specific provided connection elements or connection areas, about a coupling with the transfer container is made possible. If, for example, systems from different manufacturers are used at the same time, then it is necessary to install them in the partition for each
  • the present invention seeks to provide an adapter element for a pharmaceutical plant, which is able to cooperate across manufacturers or systems with different transfer containers or connecting elements on the partition wall of the pharmaceutical plant.
  • Connection systems are based to be able to couple. This object is achieved with an adapter element for a
  • the adapter element has two connection areas, a first one
  • Connection area which is adapted to be coupled to a connection element in the region of a partition of the pharmaceutical plant, and a second connection area, which is adapted to a
  • Adapter element has a passage opening for transferring elements between the two terminal portions, and wherein the
  • Connection element is formed in the partition of the pharmaceutical plant.
  • the adapter element In a particularly preferred structural design of the adapter element, it is provided that this is a sleeve-shaped, and that the two connection areas are arranged on opposite end sides of the adapter element.
  • Such a configuration of the adapter element has the
  • Objects is facilitated by or in the transfer container, for example, as an immediate manual, straight access to the formed in the transfer container interior is made possible.
  • Adapter element and the transfer container or the adapter element with the partition wall is made possible if the connections between the connection areas of the adapter element and the connection area on the partition or on the transfer container are at least partially designed as threaded or bayonet connections.
  • Adapter element provides that the passage opening formed in the adapter element is at least substantially formed by a cylindrical, undercut-free inner wall of the adapter element.
  • Transfer container facilitates.
  • the invention comprises a pharmaceutical plant under
  • FIG. 3 in a simplified representation of a transfer device
  • Section of a pharmaceutical plant according to the prior art in which a transfer container is attached to a partition of the pharmaceutical plant, while different times the coupling of the
  • FIG. 5 is a schematic representation of the use of an adapter element according to the invention for bridging non-compatible connecting elements in the region of the dividing wall of the pharmaceutical plant and of the transfer container.
  • FIGS. 1 to 3 show a partial region of a pharmaceutical system 100 known per se in the region of a dividing wall 1.
  • the partition 1 separates a disposed within the pharmaceutical plant 100 or
  • sterile room 2 which is a sterile area, from an unsterile area 3 outside the pharmaceutical plant 100.
  • pharmaceutical containers not shown, such as vials, ampoules, vials or the like. with a
  • the pharmaceutical plant 100 has a transfer device 10.
  • Transfer device 10 has in the partition 1 on a through hole 5 in the form of a hole, for example in the form of a round hole.
  • the transfer device 10 comprises a fixed to the partition wall 1 first connection element 1 1, which is closable from the side of the sterile room 2 ago by means of a removable closure lid 12.
  • Connecting element 1 1 on the partition wall 1 forms on the unsterile region 3 facing outside a first connection region 13.
  • This first connection region 13 is manufacturer-specific. Under a production-specific training is the size and / or geometry and / or accurate structural design of the first
  • Connection area 13 understood, such that the first terminal portion 13 only with a second terminal portion 14 at a second
  • Connection element 15 can cooperate, which is designed specifically to cooperate with the first connection element 1 1 and the first connection region 13.
  • the second connection region 14 or the second connection element 15 are arranged on a transfer container 20 having an inner space 16 for receiving objects or objects.
  • the transfer container 20 is closed to the outside at the level of the second connection element 15 or at its end face opposite to a bottom 21 with a closure cover 22.
  • Pharmaceutical plant 100 is in accordance with the illustration of FIG. 1, the transfer container 20 with cap 22 placed thereon in a first step in the direction of the arrow 23 in the direction of the first
  • Connecting element 1 1 and the first terminal portion 13 to the partition wall 1 moves. After contacting the transfer container 20 with the
  • addressed elements of the transfer container 20 is for example rotated in the direction of arrow 24 about its longitudinal axis.
  • a threaded connection formed on the two connection elements 11, 15 is operatively connected such that a firm, sealed connection is formed between the two connection elements 13, 15.
  • Access to the interior 16 of the transfer container 20 is made possible, for example, to either transfer objects from the transfer container 20 into the sterile room 2 or to introduce objects from the sterile room 2 into the interior 16 of the transfer container 20. It is also essential that the two closure covers 12, 22 or the closure lid unit 25 are / is designed in such a way that, if appropriate, on the outside of the transfer container 20 Associated closure cover 22 adhering germs or contaminants that would cancel the sterility of the sterile room 2, within a formed by the two closure lid 12, 22 interior 26 of the
  • Closing lid unit 25 are isolated.
  • the transfer device 10 described so far is already known from the prior art and, as described above, requires matched, manufacturer-specific connecting elements 11, 15 or connecting regions 13, 14 on the dividing wall 1 or the transfer container 20.
  • the first connection element 1 1 arranged on the dividing wall 1 with its first connection region 13 can also be used to couple a transfer container 30 (FIG. 4), which has a third connection region 31 with a third connection region 31
  • Connection element 1 1 and the first connection region 13 are formed, it is provided to use an inventive adapter element 50.
  • the adapter element 50 has a connection region 14 or a connection element 15 on the side facing the first connection element 11 or the first connection region 13 in analogy to the transfer container 20, which are designed to be connected to the first connection element 11 or to cooperate with the first connection area 13.
  • the adapter element 50 has a connection region 51 or a connection element 52, which are designed to cooperate with the third connection region 31 or the third connection element 32 on the transfer container 30.
  • the adapter element 50 is preferably approximately sleeve-shaped, wherein the second connection region 14 and the connection region 51 are formed on opposite end sides of the adapter element 50.
  • a preferably cylindrical passage opening 54 is preferably formed concentrically to a longitudinal axis 53 of the adapter element 50 within the adapter element 50, which is formed by an inner wall 55 of the adapter element 50 and is preferably formed without undercuts.
  • the adapter element 50 has means 56, which are formed to the interior 57 of the adapter element 50, preferably by steam sterilization, to clean or sterilize. These means 56 are shown by way of example with reference to a connection arranged on the outer wall of the adapter element 50, but moreover comprise further elements for guiding and discharging the sterilizing agent.
  • Actuator 58 arranged in the form of a pivot lever.
  • the coupled to the connection element 52 actuating lever 58 is pivotable in the direction of arrow 59 to the connecting element 52 together with the
  • Transfer container 30 allow.
  • the adapter element 50 is either always coupled to the partition wall 1 or always with the transfer container 30.
  • the connection is formed either by coupling the transfer container 30 to the adapter element 50, or by coupling the adapter element 50 (with attached transfer container 30) to the first connection element 1 1 in the region of the partition wall 1.
  • the adapter element 50 depending on whether the
  • Adapter element 50 is attached either to the partition wall 1 or to the transfer container 30, on the respective opposite side of the adapter element 50 a merely exemplified closure element 60, which in analogy to the closure lid 12 and the closure cover 22nd
  • closure element 60 is arranged in the region of the second connection element or of the second connection region 14 of the adapter element 50.
  • the adapter element 50 described so far or the pharmaceutical device 100 described so far can be modified or modified in many different ways without departing from the inventive concept

Landscapes

  • Health & Medical Sciences (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

L'invention concerne un élément adaptateur (50) destiné à un dispositif de transfert (10) entre un compartiment stérile (2) d'une installation pharmaceutique (100) et une zone non stérile (3), l'élément adaptateur (50) présentant deux zones de raccordement (14, 51), une première zone de raccordement (14) conçue pour être couplée à un élément de raccordement (11) situé dans la zone d'une cloison (1) de l'installation pharmaceutique (100), et une deuxième zone de raccordement (51) conçue pour être couplée à un élément de raccordement (32) d'un contenant de transfert (30), l'élément adaptateur (50) présentant un orifice débouchant (54) destiné au transfert d'éléments entre les deux zones de raccordement (14, 51), et l'élément de raccordement (32) du contenant de transfert (30) étant conçu non compatible avec l'élément de raccordement (11) situé dans la cloison (1) de l'installation pharmaceutique (100).
PCT/EP2016/050851 2015-03-23 2016-01-18 Élément adapteur destiné à un dispositif de transfert, et installation pharmaceutique Ceased WO2016150581A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102015205168.4A DE102015205168A1 (de) 2015-03-23 2015-03-23 Adapterelement für eine Transfereinrichtung und pharmazeutische Anlage
DE102015205168.4 2015-03-23

Publications (1)

Publication Number Publication Date
WO2016150581A1 true WO2016150581A1 (fr) 2016-09-29

Family

ID=55174627

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2016/050851 Ceased WO2016150581A1 (fr) 2015-03-23 2016-01-18 Élément adapteur destiné à un dispositif de transfert, et installation pharmaceutique

Country Status (2)

Country Link
DE (1) DE102015205168A1 (fr)
WO (1) WO2016150581A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2026082742A1 (fr) * 2024-10-16 2026-04-23 Merck Patent Gmbh Outil et procédé d'ouverture manuelle de couvercle de récipient pour la fixation à un orifice d'un système de transfert stérile (d'environnement restreint)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4162196A (en) * 1976-11-24 1979-07-24 National Appliance Company Adaptor collar
GB2237816A (en) * 1989-11-09 1991-05-15 Cambridge Isolation Tech Isolator transfer containers
US5226781A (en) * 1991-03-20 1993-07-13 Euritech Process and installation for transferring products from a contaminated enclosure into a second enclosure without contaminating the latter

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5425400A (en) 1993-03-29 1995-06-20 Lee A. Francis Transfer port apparatus and method
US8950624B2 (en) 2011-12-29 2015-02-10 Giuseppe Sacca Externally operated alpha port system for use with a rapid transfer port

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4162196A (en) * 1976-11-24 1979-07-24 National Appliance Company Adaptor collar
GB2237816A (en) * 1989-11-09 1991-05-15 Cambridge Isolation Tech Isolator transfer containers
US5226781A (en) * 1991-03-20 1993-07-13 Euritech Process and installation for transferring products from a contaminated enclosure into a second enclosure without contaminating the latter

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2026082742A1 (fr) * 2024-10-16 2026-04-23 Merck Patent Gmbh Outil et procédé d'ouverture manuelle de couvercle de récipient pour la fixation à un orifice d'un système de transfert stérile (d'environnement restreint)

Also Published As

Publication number Publication date
DE102015205168A1 (de) 2016-09-29

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