EP2303700B1 - Verfahren zum befüllen von doppelkammersystemen in vorsterilisierbaren trägersystemen und vorsterilisierbares trägersystem - Google Patents
Verfahren zum befüllen von doppelkammersystemen in vorsterilisierbaren trägersystemen und vorsterilisierbares trägersystem Download PDFInfo
- Publication number
- EP2303700B1 EP2303700B1 EP20090765594 EP09765594A EP2303700B1 EP 2303700 B1 EP2303700 B1 EP 2303700B1 EP 20090765594 EP20090765594 EP 20090765594 EP 09765594 A EP09765594 A EP 09765594A EP 2303700 B1 EP2303700 B1 EP 2303700B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- chamber
- dual
- container
- magazine
- chamber system
- 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.)
- Active
Links
- 238000011049 filling Methods 0.000 title claims description 43
- 238000000034 method Methods 0.000 title claims description 43
- 238000004108 freeze drying Methods 0.000 claims description 28
- 230000009977 dual effect Effects 0.000 claims description 13
- 238000007599 discharging Methods 0.000 claims description 3
- 239000002671 adjuvant Substances 0.000 claims description 2
- 230000000717 retained effect Effects 0.000 claims 2
- 239000013543 active substance Substances 0.000 claims 1
- 230000001954 sterilising effect Effects 0.000 description 11
- 238000004659 sterilization and disinfection Methods 0.000 description 10
- 241000894006 Bacteria Species 0.000 description 7
- 241000700605 Viruses Species 0.000 description 7
- 244000052616 bacterial pathogen Species 0.000 description 7
- 239000007789 gas Substances 0.000 description 7
- 230000036512 infertility Effects 0.000 description 5
- 238000004806 packaging method and process Methods 0.000 description 5
- 239000002904 solvent Substances 0.000 description 5
- 238000004519 manufacturing process Methods 0.000 description 4
- 239000000463 material Substances 0.000 description 3
- 239000012528 membrane Substances 0.000 description 3
- 238000002360 preparation method Methods 0.000 description 3
- 238000007789 sealing Methods 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 230000004913 activation Effects 0.000 description 2
- 238000004140 cleaning Methods 0.000 description 2
- 230000000149 penetrating effect Effects 0.000 description 2
- 238000012371 Aseptic Filling Methods 0.000 description 1
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 241001233037 catfish Species 0.000 description 1
- 230000000249 desinfective effect Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000008030 elimination Effects 0.000 description 1
- 238000003379 elimination reaction Methods 0.000 description 1
- 238000005429 filling process Methods 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 238000003958 fumigation Methods 0.000 description 1
- 229910001385 heavy metal Inorganic materials 0.000 description 1
- 238000011068 loading method Methods 0.000 description 1
- 238000012857 repacking Methods 0.000 description 1
- 238000005475 siliconizing Methods 0.000 description 1
- 239000011877 solvent mixture Substances 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
Images
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
- B65D21/00—Nestable, stackable or joinable containers; Containers of variable capacity
- B65D21/02—Containers specially shaped, or provided with fittings or attachments, to facilitate nesting, stacking, or joining together
-
- 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
- B65B55/04—Sterilising wrappers or receptacles prior to, or during, packaging
- B65B55/10—Sterilising wrappers or receptacles prior to, or during, packaging by liquids or gases
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2093—Containers having several compartments for products to be mixed
-
- 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
-
- 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
-
- 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
-
- 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
- B65B7/00—Closing containers or receptacles after filling
- B65B7/16—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons
- B65B7/28—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers
- B65B7/2821—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers applying plugs or threadless stoppers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/06—Ampoules or carpules
- A61J1/062—Carpules
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/202—Separating means
- A61J1/2041—Separating means having removable plugs
Definitions
- the invention relates to a method for filling dual-chamber systems in pre-sterilized carrier systems according to claim 1, a method for filling dual-chamber systems in pre-sterilized carrier systems according to claim 2, a pre-sterilizable carrier system according to claim 12, and a pre-sterilizable carrier system according to claim 13.
- a known carrier system usually comprises washed, siliconized and sterilized syringes which are placed in a magazine after the washing and siliconizing step.
- the magazine - also called Nest - is then introduced into a container, which is then sealed with a closure element, preferably a gas-permeable membrane film, and sterilized by suitable sterilization processes.
- a closure element preferably a gas-permeable membrane film
- sterilization gas can penetrate into the interior of the container and also sterilize the contents of the container, so the washed and siliconized syringes and the magazine comprising them.
- the container does not have to be reopened after the sterilization step and can be delivered directly to a customer in the present form or fed to a filling line.
- the gas-permeable sealing element has a filtering effect such that it is permeable to a sterilizing gas, but closes the container in a sealed and sterile manner against germs, viruses and bacteria. As long as the container remains closed, is thus ensuring the sterility of its contents.
- the container is opened, the hollow bodies are filled and closed, whereupon the container can also be resealed and transported to the end customer.
- the filled and closed hollow body can also be removed from the container and passed on in other packaging units to the end customer. It is essential in the case of the above-mentioned pre-sterilized carrier systems and the method for their filling that a standardized packaging form is used which can be used in connection with standardized filling lines.
- the hollow body to be filled therefore need not be removed from the container before filling, whereby a complex step is eliminated.
- the hollow bodies can be sterilized together in already packaged form, after which a shipment or further processing can take place immediately, without elaborate intermediate steps such as repackaging in a pre-sterilized further packaging unit or repacking is necessary. On the part of a producing pharmaceutical company, which carries out the filling, a clean room or working step for the preparation of the hollow body can be omitted, since these are delivered ready for filling.
- the production and / or preparation of the hollow body can also be done as an in-line process with the filling, when a hot air tunnel between the sterilization device and the clean room in which the filling takes place, is provided.
- the known pre-sterilizable carrier systems and the methods for their filling are designed only for single-chamber systems, ie single-chamber syringes, single-chamber carpules or vials.
- single-chamber systems ie single-chamber syringes, single-chamber carpules or vials.
- double-chamber systems such as dual-chamber syringes or cartridges, more complex processes and carrier devices are still necessary.
- the object of the invention is therefore to provide a method for filling at least one dual-chamber system in a vorsterilisierbaren carrier system.
- At least one sterilized dual-chamber system which has a separating element separating the two chambers.
- a magazine accommodates the at least one dual chamber system, preferably a number of such systems, the magazine being disposed in a container sealed with a closure member.
- the container is introduced into a clean room. It is opened and the first chamber of the at least one dual-chamber system is filled.
- the container is closed with a gas-permeable closure element.
- This is followed by a process step in which the material contained in the first chamber of the at least one dual-chamber system is freeze-dried. In this case, the solvent vapor sublimes through the gas-permeable closure element of the container.
- freeze-drying the container is opened and the first chamber of the at least one dual-chamber system is closed.
- a second chamber of the at least one dual-chamber system is filled and closed.
- the at least one filled Doppelcrosystern is discharged from the clean room.
- At least one sterilized dual-chamber system each with a separating the two chambers separating element in a magazine, which accommodates the at least one dual-chamber system, preferably a number of such systems
- the magazine in one with a Closing element sealed container is arranged.
- the sealed container is introduced into a clean room. There it is opened, and it is filled a first chamber of the at least one dual-chamber system. This first chamber is closed.
- the magazine is inverted and a second chamber of the at least one dual chamber system is filled. It is also closed the second chamber, and the at least one filled dual-chamber system is discharged from the clean room.
- a method is also preferred, which is characterized in that the magazine, which accommodates the at least one dual-chamber system, comprises plastic, preferably made of plastic.
- the magazine which accommodates the at least one dual-chamber system, comprises plastic, preferably made of plastic.
- a new plastic magazine is supplied with each new delivery, which is assigned to exactly one dual-chamber system or, in particular, to a batch of dual-chamber systems and disposed of after use. In addition to the elimination of complex work steps, this leads in particular to the fact that it is possible to handle double-chamber systems that are highly reproducible with respect to their sterility.
- the container comprises plastic, preferably made of plastic.
- the container is used once and disposed of after use.
- Each batch of double-chamber systems is assigned a container so that the sterility of the batches with very good reproducibility is guaranteed.
- a method is preferred that is characterized in that the closure element for the container is gas-permeable.
- this responds to the closure element with which the container is delivered in the filling station.
- This closure element is preferably gas-permeable, so that the container can be pre-sterilized in the manufacturer's already closed state.
- the closure element should namely be designed to be permeable to sterilization gases, but no germs, viruses or bacteria
- the closure element is addressed, with which the container is closed, before possibly a freeze-drying step is stirred.
- This closure element is preferably gas-permeable so that the solvent vapor released during freeze-drying can sublimate through the closure element and thus leave the space enclosed by the container. It is preferred that both closure elements are designed as gas-permeable membrane films.
- the container is provided with a gas-permeable closure member which, while permitting the sublimated solvent vapor to pass outwardly from the interior of the container during the freeze-drying process, but deters germs, viruses and bacteria from entering the container.
- the interior of the container thus remains aseptic, even if the environment in the freeze dryer is not sterile. In this way, elaborate cleaning and disinfecting steps for the freeze dryer can be omitted, and this need not be located within the clean room.
- a method is preferred which is characterized in that the device for freeze-drying itself is not sterile and / or aseptic. As said, this is possible by closing the container with a gas-permeable but impermeable to viruses, bacteria and germs closure element.
- the object of the invention is also to provide a vorsterilisierbares carrier system for at least one dual-chamber system.
- a vorsterilisierbares carrier system having the features of claim 12. It comprises at least one sterilized dual-chamber system, which has a separating element which separates the two chambers from each other. Furthermore, the pre-sterilisable carrier system comprises a magazine which serves to receive the at least one dual-chamber system. It also includes a container. The magazine accommodating the at least one dual-chamber system is disposed in the container, which is sealed with a closure member so that an active and / or adjuvant present in the first chamber is freeze-dried in the sealed container. The result is a closed container in which a magazine is arranged, which comprises at least one sterilized dual-chamber system. Particularly preferred is when the entire container is sterilized in its interior.
- such pre-sterilisable carrier systems equipped with dual-chamber systems can be produced and stored in advance, the contents remaining sterile.
- the magazine comprises plastic, preferably made of plastic.
- the magazine is particularly lightweight and also disposable after the use of the pre-sterilizable carrier system, so that consuming cleaning or autoclaving omitted.
- each batch of dual-chamber systems is assigned to exactly one magazine, so that in terms of sterility very reproducible handling is possible.
- a vorsterilisierbares carrier system with the features of claim 13. It comprises at least one sterilized dual-chamber system which has a separating element which separates the two chambers from one another. Furthermore, the pre-sterilisable carrier system comprises a magazine which serves to receive the at least one dual-chamber system. It also includes a container.
- the magazine can be arranged in the container and comprises plastic, or preferably consists of plastic. It comprises the at least one dual-chamber system in such a way that it is held securely in the magazine regardless of the orientation of the magazine.
- the container is sealable with a closure element.
- the magazine comprises the at least one dual-chamber system in such a way that it is held securely in this regardless of the orientation of the magazine, it is ensured that the double-chamber system can not slip out of it even when the magazine is turned. Therefore, a filling of the second chamber of the dual-chamber system after filling and closing the first chamber to particularly easy catfish is possible by the magazine is turned.
- a vorsterilisierbares carrier system which is characterized in that the container comprises plastic, preferably made of plastic. Also in this case, the container is for single use so that each batch of dual chamber systems is associated with exactly one container. This also increases the reproducibility of the handling in terms of their sterility.
- a vorsterilisierbares carrier system is preferred in which the closure element for the container is gas-permeable.
- the container already equipped with the magazine and the at least one dual-chamber system can be closed at the manufacturer and then sterilized by the gas intended for sterilization penetrating through the gas-permeable closure element into the interior of the container. After sterilization, it is no longer necessary to open the container, and it can be transported immediately, for example to a filling line.
- the fact that the container is already closed during the sterilization can not penetrate by a subsequent opening or closing germ-containing material from the outside into the interior of the container.
- gas-permeable refers to the fact that the closure element allows gases and vapors to pass through but prevents germs, viruses or bacteria from penetrating into the interior of the container.
- FIG. 1 schematically shows an embodiment of a vorsterilisierbaren carrier system.
- the vorsterilisierbare carrier system 1 comprises at least one sterilized and preferably washed and preferably siliconized dual chamber system 3 with two chambers 5, 5 ', which are separated by a separating element 7 from each other.
- the dual-chamber systems 3 are received by a magazine 9, which in turn can be arranged in a container 11. This is sealed with a closure element 13.
- the container 11 may comprise plastic, preferably it consists of plastic.
- the magazine 9 may include plastic and is preferably made of plastic. Both elements are determinable for single use in this way, so that each batch of dual chamber systems 3 is assigned a magazine 9 and a container 11, respectively.
- the closure element 13 for the container 11 is preferably gas-permeable, so that the fully loaded and sealed container 11 can be sterilized in the closed state by placing it in an atmosphere comprising a sterilization-specific gas or steam intended for sterilization.
- the gas or steam can penetrate through the closure element 13 into the interior of the container 11, and thus in particular also sterilize the interior of the container 11 and the double-chamber systems 3 and the magazine 9 contained therein.
- the pre-sterilizable carrier system 1 is provided, and introduced into a clean room. Then, the closure element 13 is removed, so that the dual-chamber systems 3 are accessible.
- FIG. 2 shows the step of filling a first chamber 5 of the dual-chamber systems 3.
- a dispensing device 15 is provided, through which a first solution L1 of a heat and / or auxiliary substance can be introduced into a first chamber 5 of the dual chamber systems 3
- a first closing device 17 is provided, with which the first chamber 5 of the dual-chamber systems 3 can be closed, each with a closure 19.
- the closure 19 may be a crimp cap, tamper-evident closure, attachable needle closure, or needle-fitted closure. In principle, other types of closures can be used, it is only essential that the first chamber 5 of the dual-chamber systems 3 is sealed by a closure 19.
- the container 11 is closed after filling the first chamber 5 of the dual-chamber systems 3 with a gas-permeable closure element, preferably a gas-permeable membrane film.
- the container 11 sealed in this manner may be introduced into a freeze-drying apparatus where the solvent contained in the first chamber 5 is sublimated through the gas-permeable sealing member, so that the active and / or auxiliary substance present in the dual-chamber systems 3 is freeze-dried.
- the container 11 Since the container 11 is hygienically sealed by the gas-permeable closure member 13, it is possible to provide the apparatus for freeze-drying outside the clean room.
- the container 11 can thus be discharged from the clean room and introduced into an external freeze-drying device. This does not have to be sterile and / or aseptic itself, since no germs, viruses or bacteria can pass through the closure element 13 into the interior of the container 11. This is how the double-chamber systems in particular remain 3 sterile or aseptic, even if the freeze-drying is carried out in a non-sterile and / or aseptic environment. After freeze-drying, the container 11 can again be introduced into a clean room in which the further method steps take place.
- the apparatus for freeze-drying in the clean room itself, so that a discharging and re-slipping of the container 1 is eliminated. It is obvious that in this case also the apparatus for freeze drying itself has to be sterile and / or aseptic.
- the dual-chamber systems 3 are embedded in the container 11 and safely protected against interference or other interference.
- FIG. 4 schematically shows the filling of the second chamber 5 'of the at least one dual-chamber system 3.
- the same and functionally identical elements are provided with the same reference numerals, so that reference can be made to the preceding description.
- a dispensing device 15 is provided, through which a second medium L2 in the second chamber 5 'of the dual-chamber systems 3 can be introduced.
- the second medium L2 may be the solution of another active and / or auxiliary substance, but it may also be a - preferably pure - solvent or a solvent mixture.
- FIG. 5 shows schematically the step of closing the second chamber 5 'of the dual-chamber systems 3.
- the same and functionally identical elements are provided with the same reference numerals, so that reference is made to the preceding description.
- the second chamber 5 ' is closed with the aid of a second closing device 21 with a closure element, which here for example is designed as a stopper 23.
- a closure element which here for example is designed as a stopper 23.
- This is preferably displaceable in the dual-chamber system 3, so that pressure forces in the second chamber 5 'and ultimately in the separating element 7 can be introduced via it, which lead to an activation of the dual-chamber system 3.
- the plug 23 is formed as a threaded plug.
- He can act as a piston element, with a not shown Piston rod by means of an external thread with the internal thread of the threaded plug 23 can be brought into engagement.
- pressure forces in the second chamber 5 'and thus indirectly in the separating element 7 can be introduced in a very simple manner, which lead to an activation of the dual-chamber systems 3.
- the container 11 After closing the second chamber 5 ', the container 11 can be closed again and discharged from the clean room. It is also possible to omit the closing of the container 11, and optionally to eject the container 11 openly out of the clean room, or to eject only the magazine 9 or even the individual dual-chamber systems 3 from the clean room. Since both chambers 5, 5 'of the dual chamber systems 3 are sealed, it is not necessary to keep the dual chamber systems 3 in a sterile and / or aseptic environment.
- the production methods according to the invention and the presterilizable carrier system according to the invention are advantageous over known methods and devices for filling dual-chamber systems.
- a manufacturing pharmaceutical company it is possible for a manufacturing pharmaceutical company to use standardized packaging directly on standardized filling lines.
- products intended for freeze-drying can be filled on systems designed for pre-sterilisable systems.
- heavy and expensive metallic magazines are used which are reused and therefore autoclaved at high cost have to.
- a standardized packaging form is used instead of such magazines during the entire filling process, which is preferably fed to a single use and then disposed of.
- the carrier system according to the invention can be gas-permeable, but impermeable to germs, viruses or bacteria, it is possible to arrange the filling and the freeze-drying decentralized to each other, which also makes it possible to carry out the freeze-drying in a non-sterile environment.
- the content of the carrier system according to the invention therefore remains sterile at all times.
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- Mechanical Engineering (AREA)
- Engineering & Computer Science (AREA)
- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Filling Of Jars Or Cans And Processes For Cleaning And Sealing Jars (AREA)
- Basic Packing Technique (AREA)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE200810030267 DE102008030267B3 (de) | 2008-06-19 | 2008-06-19 | Verfahren zum Befüllen von Doppelkammersystemen in vorsterilisierbaren Trägersystemen und vorsterilisierbares Trägersystem |
PCT/EP2009/004308 WO2009153014A1 (de) | 2008-06-19 | 2009-06-16 | Verfahren zum befüllen von doppelkammersystemen in vorsterilisierbaren trägersystemen und vorsterilisierbares trägersystem |
Publications (2)
Publication Number | Publication Date |
---|---|
EP2303700A1 EP2303700A1 (de) | 2011-04-06 |
EP2303700B1 true EP2303700B1 (de) | 2013-03-27 |
Family
ID=40997438
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP20090765594 Active EP2303700B1 (de) | 2008-06-19 | 2009-06-16 | Verfahren zum befüllen von doppelkammersystemen in vorsterilisierbaren trägersystemen und vorsterilisierbares trägersystem |
Country Status (11)
Country | Link |
---|---|
US (3) | US8677723B2 (es) |
EP (1) | EP2303700B1 (es) |
JP (1) | JP5607037B2 (es) |
BR (1) | BRPI0914157B1 (es) |
CA (1) | CA2728115C (es) |
DE (1) | DE102008030267B3 (es) |
ES (1) | ES2405270T3 (es) |
MX (1) | MX2010012840A (es) |
PT (1) | PT2303700E (es) |
RU (1) | RU2512298C2 (es) |
WO (1) | WO2009153014A1 (es) |
Families Citing this family (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE102008030268B3 (de) * | 2008-06-19 | 2010-02-04 | Arzneimittel Gmbh Apotheker Vetter & Co. Ravensburg | Verfahren zum Befüllen von Doppelkammersystemen in vorsterilisierbaren Trägersystemen und vorsterilisierbares Trägersystem |
MY166078A (en) * | 2010-08-06 | 2018-05-23 | Hospira Australia Pty Ltd | Vial preparation method and system |
US9365306B2 (en) * | 2010-08-27 | 2016-06-14 | Sanofi-Aventis Deutschland Gmbh | Packaging system for multi-component medical products |
DE102011119657B4 (de) * | 2011-11-29 | 2015-03-12 | Gerhard Schubert Gmbh | Verpackungsmaschine für keimfreies Abpacken |
ITBO20110691A1 (it) | 2011-12-02 | 2013-06-03 | Ativa | Linea e procedimento di imbottigliamento in ciclo continuo di contenitori in materiale termoplastico. |
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RU2512298C2 (ru) | 2014-04-10 |
JP2011524314A (ja) | 2011-09-01 |
CA2728115C (en) | 2016-02-23 |
EP2303700A1 (de) | 2011-04-06 |
MX2010012840A (es) | 2011-04-04 |
US8677723B2 (en) | 2014-03-25 |
RU2011101687A (ru) | 2012-07-27 |
BRPI0914157B1 (pt) | 2019-04-02 |
US11027882B2 (en) | 2021-06-08 |
JP5607037B2 (ja) | 2014-10-15 |
WO2009153014A1 (de) | 2009-12-23 |
DE102008030267B3 (de) | 2010-01-28 |
BRPI0914157A2 (pt) | 2015-10-20 |
US20110094188A1 (en) | 2011-04-28 |
US20140103045A1 (en) | 2014-04-17 |
CA2728115A1 (en) | 2009-12-23 |
ES2405270T3 (es) | 2013-05-30 |
US20200262609A1 (en) | 2020-08-20 |
PT2303700E (pt) | 2013-05-08 |
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