Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/008—Racks for supporting syringes or needles
• • 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
  • A61L2/26—Accessories or devices or components used for biocidal treatment
• • 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
  • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
  • B65B55/02—Sterilising, e.g. of complete packages
  • B65B55/027—Packaging in aseptic chambers
• • A61L2103/05—
• • 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
  • A61L2202/182—Rigid packaging means
• • 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
  • A61L2202/21—Pharmaceuticals, e.g. medicaments, artificial body parts
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2207/00—Methods of manufacture, assembly or production
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/001—Apparatus specially adapted for cleaning or sterilising syringes or needles
• • 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
  • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
  • B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
• • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
  • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10S220/00—Receptacles
  • Y10S220/20—Safety locking devices
• • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
  • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10S604/00—Surgery
  • Y10S604/905—Aseptic connectors or couplings, e.g. frangible, piercable
• • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
  • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
  • Y10T137/00—Fluid handling
  • Y10T137/6851—With casing, support, protector or static constructional installations
• • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
  • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
  • Y10T137/00—Fluid handling
  • Y10T137/8593—Systems
  • Y10T137/86292—System with plural openings, one a gas vent or access opening

Definitions

• DE 44 19 475 A1 discloses a device for removing the cover of magazine cups. which can be used, for example, as trays in tray filler technology.
• this may also provide at least substantial resistance to sterilization by radiation sources (for example electromagnetic radiation sources, in particular UV Light, and / or radioactive radiation sources, such as gamma radiation sources) or resistance to suitable chemicals for sterilization, for example by means of gases or other fluid media, for example ethylene oxide, water toffperoxid, formaldehyde or the like.
• radiation sources for example electromagnetic radiation sources, in particular UV Light, and / or radioactive radiation sources, such as gamma radiation sources
• suitable chemicals for sterilization for example by means of gases or other fluid media, for example ethylene oxide, water toffperoxid, formaldehyde or the like.
• this at least partial resistance is configured in such a way that a multiplicity of such sterilization cycles is possible without the container (ie the outer shell and / or components accommodated inside the container, for example an inner container) undergoing a change (for example surface, shape or shape) - or material changes) learns.
• the interior is microbially isolated against the environment of the container.
• the interior of the container preferably comprises several hundred or more pharmaceutical containers and thus usually replaces many trays.
• the sealed, sterilized in its interior contents including container can be spent, for example, from the manufacturer of the containers, to the drug manufacturer or to the filling for filling with the pharmaceutical medium.
• the container is moved to a sterile room where it is coupled to a lock (in the following "sterile lock") of the sterile room, after which the container is opened, for example automatically, semiautomatically or manually, and its interior including contents Sterile space exposed, so that the sterility of the interior of the container and its contents at least largely guaranteed.
• the contents of the container can be removed in different ways, for example by removing the pharmaceutical containers from the nests, the nests being wholly or partly remain in the interior of the container.
• the nests can also be removed together with the pharmaceutical containers from the container or an inner container thereof.
• the nests can be moved out of the container or an inner container together with the pharmaceutical containers, but not completely removed.
• the container contains an inner container, in the interior of which the holders are received for receiving the at least one nest.
• the nests contain no individual, for example, microbially dense, envelope.
• the container door should then be designed such that the inner container is reversibly removable from the interior of the container.
• the inner container together with the nests and the pharmaceutical containers contained therein can be removed from the container and spent, for example, in the sterile room.
• this radiation source may comprise, for example, an intense light source (for example an ultraviolet light source), a different shaped electromagnetic radiation source, a radioactive radiation source (for example an alpha, beta or gamma source or a combination of such radiation sources
• Container may be configured such that this source of radiation can be introduced only temporarily via the opening in this container, or the container may completely and integrally comprise such a radiation source for disinfecting and / or sterilizing the interior or the pharmaceutical containers
• the container may be configured with at least one tempering device for heating and / or cooling the interior, for example corresponding heating elements and / or differently configured heating devices ehen, wherein the heating can be carried out, for example, up to a thermal disinfection.
• the container may have an inner container.
• one or more horizontally or vertically arranged rails or comparable suitable devices for reversibly receiving nests may be provided.
• the pharmaceutical containers which can serve as primary packaging body, may be included.
• the interior of the container may further, as described above, have devices for reversibly receiving the removable inner container.
• the inner container can in principle be made of the same materials as, for example, the outer shell of the container, but also a use of different materials, according to different requirements, is possible.
• the nest is transferred through the container door into the sterile room. There, then, the at least one pharmaceutical medium can be introduced into the containers.
• a line-Filler-plant can be used, in which the pharmaceutical containers are filled one after the other.
• tray-filler system it is also possible to use a so-called tray-filler system in which all the pharmaceutical containers located in the nest or a plurality of these containers are filled at the same time or the containers individually.
• the container can be either empty or at least loaded with empty nests again decoupled from the sterile room and back, for example, to the place of manufacture of the pharmaceutical containers and / or a supplier, spent, for example, a tray Suppliers.
• the inner container 122 is thus received in the interior 118 of the container 110.
• the inner container 122 in turn has an inner space 124, in which holders 126 for receiving nests 128 are arranged.
• These stances 126 may include various types of brackets, such as rails for inserting the nests 128 through an opening 130 for loading the inner container 122.
• FIG. 2B shows a nest 128 in which the openings 134 are arranged in a row.
• the configuration of the nests 128 ensures a spatially and temporally ordered handling of the syringe bodies 114 such that the removal of nests 128 and / or syringe bodies 114 from nests 128 can be reversed under sterile conditions during the pharmaceutical filling process.
• already filled syringe bodies 114 can again be sorted back into the nests 128, wherein the nests 128 can be located outside or inside the container 110 and / or inner container 122.
• the pharmaceutical containers 112 or the syringe bodies 114 can be cleaned and disinfected or sterilized, for example, directly after the manufacturer or a further operation or operating part after production. Alternatively or additionally, the disinfection or sterilization can also be wholly or partly carried out in the interior 118 of the container. Tainers 110 take place, or a sterilized or disinfected state can be maintained in the interior 118 of the container 110. For this purpose, the container 110 has various facilities which may favor or effect such disinfection or sterilization. These devices, all of which are optional and can be combined as desired, may comprise different designs.
• the container door 170 is shown in highly schematic form in FIG. 1 and has a closure mechanism 174, for example simple rotary closures, hooks, etc.
• a closure mechanism 174 for example simple rotary closures, hooks, etc.
• a bulkhead can be used as a container door 170.
• a transfer system 178 is shown schematically, which comprises a container 110, for example according to the embodiment in Figure 1, and a walk-in sterile room 180.
• the container 110 is connected via its lock 176 to a sterile lock 184 coupled to a sterile room wall 182.
• This sterile lock 184 can surround a sterile-room opening 186, which in particular can be adapted to the dimensions of the container door 170.
• the container door 170 can be opened from the sterile room 180 when the container 110 is coupled, for example, without interrupting the sterile interior atmosphere in the interior 118 of the container 110.
• the coupling mechanism can be designed such that when coupling the first lock part 192 to the first sterile lock part 194 (for example, by a rotary movement), the second lock part 196 is simultaneously coupled to the second sterile lock part 198.
• the intermediate space between the two doors 170, 188 is preferably reduced to a minimum, and there is a mechanically strong, for example rotationally fixed, connection between the two doors 170, 188.
• the sterile room door 188 and the container door 170 for example out of the sterile room 180, opened and / or closed at the same time.
• the container door 170 may comprise, for example, a bayonet closure 200 which may be opened or closed by, for example, rotating the sterile room door 188 coupled to the container door 170. Accordingly, to see the coupling between the second lock portion 196 and the second sterile lock portion 198 only mechanical requirements, but not special requirements in terms of sterility, since no microbial shielding, but only a mechanical coupling must be done by this coupling.

Landscapes

• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Mechanical Engineering (AREA)
• Epidemiology (AREA)
• Vascular Medicine (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Hematology (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)
• Apparatus For Disinfection Or Sterilisation (AREA)
• Details Of Rigid Or Semi-Rigid Containers (AREA)
• Packages (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)

Priority Applications (6)

Applications Claiming Priority (2)

Related Child Applications (1)

Publications (1)

Family

ID=39563362

Family Applications (1)

Country Status (7)

Cited By (1)

Families Citing this family (25)

Citations (5)

Family Cites Families (12)

• 2008
  • 2008-02-14 EP EP20080151420 patent/EP2090324A1/de not_active Ceased
  • 2008-11-17 JP JP2010546227A patent/JP5382663B2/ja not_active Expired - Fee Related
  • 2008-11-17 EP EP20080872388 patent/EP2252331B1/de not_active Not-in-force
  • 2008-11-17 CN CN200880127103.7A patent/CN101945673B/zh not_active Expired - Fee Related
  • 2008-11-17 CA CA 2712263 patent/CA2712263C/en not_active Expired - Fee Related
  • 2008-11-17 ES ES08872388.7T patent/ES2478268T3/es active Active
  • 2008-11-17 WO PCT/EP2008/065690 patent/WO2009100787A1/de not_active Ceased
• 2010
  • 2010-08-12 US US12/855,491 patent/US8124010B2/en not_active Expired - Fee Related

Patent Citations (5)

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