EP3457062A1 - Poche et procédé de lyophilisation sans contamination d'une substance - Google Patents

Poche et procédé de lyophilisation sans contamination d'une substance Download PDF

Info

Publication number
EP3457062A1
EP3457062A1 EP18194693.0A EP18194693A EP3457062A1 EP 3457062 A1 EP3457062 A1 EP 3457062A1 EP 18194693 A EP18194693 A EP 18194693A EP 3457062 A1 EP3457062 A1 EP 3457062A1
Authority
EP
European Patent Office
Prior art keywords
bag
storage compartment
freeze
substance
drying
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.)
Granted
Application number
EP18194693.0A
Other languages
German (de)
English (en)
Other versions
EP3457062B1 (fr
Inventor
Rolf LENHARDT
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.)
Individual
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 EP3457062A1 publication Critical patent/EP3457062A1/fr
Application granted granted Critical
Publication of EP3457062B1 publication Critical patent/EP3457062B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26—DRYING
    • F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00—Drying solid materials or objects by processes not involving the application of heat
    • F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
    • F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
    • 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
    • A61J1/10—Bag-type containers
    • 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
    • B65D31/00—Bags or like containers made of paper and having structural provision for thickness of contents
    • B65D31/12—Bags or like containers made of paper and having structural provision for thickness of contents with two or more compartments
    • 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
    • B65D33/00—Details of, or accessories for, sacks or bags
    • B65D33/01—Ventilation or drainage of bags

Definitions

  • the invention relates to a bag and a method for the contamination-free freeze-drying of a substance in a bag, wherein the bag has at least one vapor-permeable layer.
  • Freeze-drying or lyophilisation enables the preservation of numerous products, mainly from the pharmaceutical, food and biology industries.
  • the process as such is well known in the art.
  • freeze-drying is used more and more frequently, since this method can extend their shelf-life while at the same time preserving the bioactivity of the pharmaceuticals.
  • measures must be taken to prevent contamination both before and during freeze-drying in the freeze-drying cabinet and after freeze-drying.
  • freeze drying took place in open containers in a vacuum apparatus (freeze drier).
  • a contamination-free freeze-drying the interior of the freeze-dryer has first been sterilized, for example with the aid of steam or suitable chemicals.
  • this process was time consuming and incurring additional costs.
  • a further development of the germ-free freeze-drying has led to the use of bags which have closed the substance to be freeze-dried safely and thus protected it from contamination.
  • the environment was thus protected from contamination with the substance sealed in the bag so that, advantageously, the interior of the freeze dryer did not have to be cleaned after processing a substance.
  • containers of the aforementioned type allows a contamination-free freeze-drying, but is associated with numerous disadvantages.
  • a prefabricated container sealed with a membrane has an already defined dimension (length x width x height) and therefore proves to be unsuitable in terms of the maximum surface yield when used on shelves in freezers of different manufacturers, which are usually have different dimensions.
  • the utilization of existing in a respective freeze dryer footprint is very rarely optimal for a given container size and if, then usually by accident.
  • the container dimensions could always be adapted individually to the shelves in a freeze drier or it would be necessary to provide containers of the aforementioned type which are variable in their dimensions.
  • a bag in which the substance to be freeze-dried is present.
  • a bag which has at least in its partial area a laminate which is a sterile Having barrier layer, which is permeable to water vapor, is for example from the document WO 96/31748 known.
  • the formulation is added directly into the bag and freeze-dried therein.
  • the layer thickness of the substance to be dried is subject to variations due to the flexible nature of the bag. In particular, the layer thickness decreases toward the edge, since the bag has a natural curvature towards the seam towards its edges, ie away from the placement surface on which it is deposited (see FIGS.
  • a bag for contamination-free freeze-drying of a substance which has a top and a bottom, wherein the top has a vapor-permeable film. Further, the bag has at least three side surfaces, which are arranged between the top and the bottom, wherein between two laterally adjacent side surfaces in each case a joint is arranged, which extends from the bottom to the top.
  • the bag according to the invention further comprises a storage compartment having a top and a bottom both having a vapor-impermeable film, which storage compartment may be externally attached to a side surface of the bag and having its interior communicating with the interior of the bag.
  • the storage compartment may correspond to a flat bag which is preferred a side surface of the bag is arranged.
  • the width of the storage bag may correspond to the width of a side surface, but it may be smaller.
  • the top of the storage compartment may be assembled with an upper film portion of the corresponding side surface, while the underside of the storage compartment may be assembled with a lower film portion of the same side surface, which assembly may be by welding.
  • the storage compartment can be used to store the freeze-dried substance after freeze-drying.
  • the storage compartment may be attached to the underside of the bag instead of on a side surface.
  • the top of the bag of the invention comprises a water vapor permeable sheet or membrane which is at the same time germ-tight (i.e., bacterial retentive).
  • the top of the bag can be made entirely of the vapor-permeable film, so that the vapor-permeable film is joined together at the edge of the bag with the side surfaces, for example by means of a weld.
  • only a portion of the upper surface may comprise the vapor permeable film, for example, a central portion of the upper surface, and the peripheral portion of the upper surface of the bag may comprise another, not necessarily water vapor or gas permeable (but germ proof) material, such as a water vapor or water vapor. gas impermeable film.
  • the underside and at least part of the side surfaces of the bag according to the invention may comprise or consist of a water vapor or gas impermeable film or membrane, for example a polypropylene film.
  • the vapor-permeable film may, for example, be a membrane of expanded polytetrafluoroethylene (PTFE) with a laminated polypropylene non-woven fabric (PP).
  • a vapor-impermeable film a PP film may be used, which may for example have a thickness of about 70 microns. Since the welding of the membrane does not lead to optimal joints, the PP film can be welded to the nonwoven fabric of the membrane for assembly purposes (by turning the nonwoven side of the membrane of the PP film). As a result, dense welds can be formed with high holding forces.
  • the substance can be any formulation, for example a pharmaceutical solution or another liquid mixture, which is to be processed by freeze-drying.
  • the substance can be introduced under sterile conditions into the bag and sealed.
  • the bag may be arranged to form a three-dimensional body and the joints may represent edges of the three-dimensional body.
  • these joints can be referred to as vertical (vertical) joints.
  • the bag may be configured to take the shape of a triangular prism.
  • the bottom and top may have the same basic shape.
  • the bag may have four side surfaces and be adapted to take the shape of a cuboid or cube.
  • the bag may correspond to a three-dimensional body of any shape.
  • the bag may take its "native" three-dimensional shape, for example, by inflation and, depending on the size of the bag and the rigidity of the joints, the bag may substantially retain this shape, even if pressure can be equalized between its interior and its surroundings.
  • the bag By forming joints, which run substantially perpendicular to the underside and, if necessary, also to the top of the bag, the bag can be stamped into a three-dimensional angular shape. When empty, the rigidity of the joints may be sufficient to give the bag its inherent three-dimensional shape. As a result of the three-dimensional basic shape of the bag according to the invention, it can be achieved that the substance to be freeze-dried has essentially the same fill level over its entire volume.
  • the joints act as shaping structures that imprint the bag's three-dimensional shape.
  • a joint may therefore correspond to one edge of the three-dimensional bag.
  • the joints may all be the same length and thus define the height of the bag. However, it is by no means necessary that all joints or edges of the bag are the same length, even if it is an expedient embodiment of a possible production method of the bag.
  • the joints may have welds.
  • the bag according to the invention can be produced, for example, from a flat bag by corresponding folding of the flat bag and welding of its corner regions. The projecting triangular corner sections of the folded flat bag can then be separated from this. The locations along which the overhanging corner portions of the folded flat bag are separated therefrom then correspond to the joints of the side surfaces of the bag, which are at the same time (side) edges of the bag.
  • the vapor-permeable film may extend over the entire top of the bag, so that the joints extend from the bottom of the bag to the vapor-permeable film.
  • the joints eg weld seams
  • the vapor-permeable membrane and the side surfaces then simultaneously form upper edges of the bag.
  • Such an embodiment of the bag can be made from a flat bag with a top and bottom, wherein the vapor-permeable membrane is arranged as a window in the top of the flat bag.
  • the vapor-permeable membrane may be joined to the surrounding material of the upper side, which may for example be vapor-impermeable, for example welded.
  • the nonwoven backing may be, for example, a mesh or web of polypropylene or other plastic such as polyethylene or polyesther.
  • the vapor-impermeable film surrounding the membrane may comprise, for example, polyethylene, polyester or coextruded films having two or more layers or may be made of one of these materials.
  • both surfaces, which are joined together by welding consist of the same material, for example polypropylene.
  • At least one of the side surfaces may comprise two film parts which are joined together by means of a further joint, which preferably extends from one vertical edge to the other vertical edge of the corresponding side surface.
  • This further joint which runs between two film parts of a side surface (and not between directly adjacent side surfaces) can be referred to as horizontal (horizontal) joints.
  • This embodiment can naturally result from the production of the bag according to the invention from a flat bag, wherein the further joint (eg weld) corresponds to the joint between the top and bottom of the flat bag and runs parallel to the bottom and / or top of the bag.
  • These "native" joints may be arranged in particular on three side surfaces in a bag designed as a cuboid or cube, if a flat bag open to one side Starting product is accepted. With the two Film parts can thus be part of the top or bottom of a flat bag. During the manufacture of the bag according to the invention, the then still one open side of the flat bag is closed by forming a further joint. It should be emphasized that the manufacturing process outlined above starting from a flat bag represents only one of many possible production methods of the bag according to the invention.
  • the bag may also be selectively formed by joining together (eg, welding) corresponding pieces (bottom, top, and side surfaces) to each other.
  • the upper side and a surface-adjacent part of at least one of the side surfaces may comprise the vapor-permeable film.
  • the vapor-permeable film can extend seamlessly over an upper edge between the top and side surface.
  • the vapor-permeable film can extend up to the further joint of the corresponding side surface.
  • This embodiment may in particular arise when the bag according to the invention is produced from a flat bag whose top or bottom completely consists of the vapor-permeable film and the joints between its top and bottom correspond to the other joints of the bag according to the invention.
  • the upper part of the bag which is separated from the lower part of the bag by the further joints, may comprise or consist of the vapor-permeable film.
  • the upper part of the bag may, for example, correspond to the upper half of the bag. That is, the other joints may be centered through the side surfaces of the bag.
  • the bag may further comprise an access opening through which the substance can be filled into the bag, wherein the access opening may preferably be arranged on a side face of the bag.
  • the access opening can be formed, for example, by a non-fully or not completely carried out sealing / joining along a further joint. In other words, the access opening can be formed between two film parts of a side surfaces.
  • a filler neck (filling / removal hopper) may be attached, for example by welding. The filler neck can serve for example for introducing and removing the substance into or out of the bag by means of a suction lance.
  • the filler neck can be made, for example, from a flat bag with 5 cm flat dimension, so that it has a diameter of about 1.6 cm.
  • the filler neck and the side surface of the bag to which it is attached may comprise or consist of the same material, for example polypropylene.
  • the pouch may have a support structure configured to support a lower portion of the pouch.
  • the holding structure can be used in particular for large dimensions of the bag. For large bags (for example, from 0.5m side surface length), it may happen that the side surfaces of the substance filled in the bag bulge outward very much.
  • the support structure may be made of a plastic suitable for vacuum applications and comprise a lower part of the bag according to the invention, for example, a part of the bag up to the height to which it is filled with the substance, and thus prevent the buckling of the side surfaces. Thus, a rounding of the shape, which takes the bag in a plan view, can be prevented, which may possibly lead to a poorer slot exploitation in the freeze dryer.
  • the holding structure may, for example, have a base area which substantially corresponds to the underside of the bag. Furthermore, the holding structure may have lateral holding elements which, for example, protrude perpendicularly from its base plate.
  • the support structure may have a shell shape or frame shape (without bottom), wherein both the bottom of the shell shape as well as the lateral holding elements for the shell and frame shape may be structured and may have approximately a grid or mesh structure.
  • a method for freeze-drying a substance in the pouch according to the invention which in particular allows freeze-drying and contamination-free transfer of the freeze-dried substance into the storage compartment.
  • the method comprises: providing the substance in the bag, sealing the bag; Freeze-drying the substance present in the bag in a freeze-drier and transferring the freeze-dried substance from the bag to the storage compartment having a top and a bottom both having a vapor-impermeable film and being attached to a side surface of the bag from the outside Interior of the storage compartment communicates with the interior of the bag.
  • the freeze-dried substance which is then in powder form, can be transferred from the bag into the storage compartment without contamination, ie in particular without having to open the outer casing of the bag and / or the storage compartment.
  • the method may further comprise clamping the storage compartment from the bag by means of a clamp closure.
  • the method may further comprise collapsing the clamped storage compartment so as to reduce the overall footprint of the bag along with the storage compartment attached thereto.
  • collapsing the clamped storage compartment may include curling, with the rolled-up storage compartment also being fixed to the clamp closure.
  • the clamp closure may, for example, comprise two straight arms which are coupled together on a hinge and between which the top and bottom of the storage compartment can be clamped.
  • the clamp closure can have holding parts which are set up to receive the rolled-up storage compartment. As a result, the storage compartment can be compressed to save space, so that the bag occupies a minimum footprint in the freeze dryer.
  • the latter may further comprise removal of the clamp closure after freeze-drying to transfer the freeze-dried substance from the pouch to the storage compartment.
  • the decanting of the dried substance takes place without tearing / opening of the bag, ie in the sealed / closed state of the bag and thus contamination-free.
  • the transfer operation can be done by changing the position of the bag so that the freeze-dried substance (which is then in powder form) is transferred by gravity and by shaking the bag from this into the storage compartment.
  • the method may further comprise hermetically sealing the storage compartment containing the freeze-dried substance to the bag and then separating the storage compartment from the bag.
  • the clamp closure already used in advance for the separation of the storage compartment from the bag can be used. After transferring the freeze-dried substance from the bag to the storage compartment and pinching off the transition between bag and storage compartment, the freeze-dried substance is sealed airtight and airtight in the storage compartment so that the bag can be safely separated therefrom.
  • a second clamp closure can be attached to the storage compartment, wherein the second clamp closure is attached to a location between the first clamp closure and the transition of the storage compartment to the pouch, for example as close as possible to the first clamp closure.
  • a freeze drying process of the substance is followed by sealing the freeze dried substance in a water vapor impermeable and optionally opaque storage compartment attached to the bag, wherein no opening of the bag and / or between the freeze drying process and the sealing process of the storage compartment is required and thus the process reliability is significantly increased.
  • the term "joined together" used in the context of this description in relation to parts of materials, in particular foils, may mean that the corresponding material parts are permanently connected to one another, for example by means of welding or gluing. As a result, the respective joints may have adhesive or weld seams.
  • the top side refers to the side of the bag (without a storage compartment), which at least partly consists of the vapor-permeable membrane, which is a gas and in particular Water vapor exchange with the environment allows.
  • the bottom of the bag means the side opposite the top and in contact with the volume of substance filled in the bag.
  • FIG. 1 An embodiment of the bag 1 according to the invention for contamination-free freeze-drying is illustrated.
  • the exemplary bag 1 has the shape of a cuboid and is shown in an empty state.
  • the bag 1 has a top 2 and a bottom 3, between which four side surfaces (a first side surface 4, a second side surface 5, a third side surface 6 and a fourth side surface 7) are arranged.
  • the side surfaces 4, 5, 6, 7 are each joined together in pairs by means of a joint.
  • first side surface 4 is joined to the second side surface 5 by means of a first joint 8
  • second side surface 5 is joined to the third side surface 6 by means of a second joint 9
  • third side surface 6 is connected to the fourth side surface 7 by means of a third joint 10 joined together
  • fourth side surface 7 is finally joined together by means of a fourth joint 11 with the first side surface 4.
  • each of the joints 8, 9, 10, 11 extends vertically at a substantially right angle from the bottom 3 of the bag to its top 2, wherein the angle between the top 2 and the joints 8, 9, 10, 11 is substantially 90 °.
  • the joints 8, 9, 10, 11 thus correspond to side edges of the three-dimensional bag 1 and are formed as welds.
  • Each joint 8, 9, 10, 11 and each side part 4, 5, 6, 7 has an equal height, which also corresponds to the height H of the bag.
  • the bag 1 has, in addition to the vertically extending joints 8, 9, 10, 11 additional joints.
  • the upper side 2 which in the embodiment shown is made entirely of the water vapor permeable membrane material, is fastened to the side surfaces 4, 5, 6 along its edges by means of upper joints 17.
  • the membrane material ie the top 2 of the bag 1
  • the upper joints 17 then correspond to joints, by means of which the membrane material with the side surface 4, 5,6 7 of the bag 1 is assembled.
  • each side surface 4, 5, 6, 7 has a further joint 16, which runs centrally and horizontally between two adjacent joints relative to the associated side surface.
  • Two opposing further joints 16 and additionally a further (then left or right) joint may correspond to joints, by means of which an upper side of a flat bag is joined to its underside assuming a flat bag, which is open only to one side. That is, these three further joints 16 may already be present in the starting product, from which the three-dimensional bag 1 can be produced. The remaining fourth of the four further joints 16 can be formed during the production of the three-dimensional bag 1.
  • each side surface 4, 5, 6, 7 is divided into two parts or partial films.
  • first double arrow 13 hereinafter the first, upper part of the fourth side face 6 is designated by the reference 13
  • first double arrow 12 hereinafter, the second, lower part of the fourth side surface 6 is associated with the reference numeral 12.
  • additional parts of the side surfaces 4, 5, 6 can also have a vapor-permeable membrane, for example the first, upper parts 13 of the side surfaces 4, 5, 6.
  • a vapor-permeable membrane for example the first, upper parts 13 of the side surfaces 4, 5, 6.
  • the top for example consists entirely of the vapor-permeable membrane.
  • the further joints 16 of the second and fourth side surfaces 5, 7 then represent borderlines between the vapor-impermeable film and the vapor-permeable film.
  • the access opening is arranged at the end of a filler neck 15 which is attached to the bag 1.
  • the filler neck 15 for example in the form of a suitably shaped flat bag in the region of the further joint 16 of one of the side surfaces 4, 5, 6, 7 are attached to the bag 1.
  • the top of the filler neck 15 may be joined to the first, upper portion 13 of the first side surface 4, and the bottom of the filler neck 15 may be joined to the second, lower portion 12 of the first side surface 4.
  • the filler neck 15 is in Fig. 1 shown in a tapered from the side surface of the bag 1 to its input port 15, which is an optional feature. In the transition from the side surface of the bag 1 to the filler neck 15, this can also be wider or narrower than shown.
  • FIG. 2 Another embodiment of the bag 1 is shown in FIG. 2 shown. Since the bag 1 except for the additionally attached to this storage compartment 20 to the in FIG. 1 the bag shown, are already based FIG. 1 explained features of the bag in FIG. 2 do not describe again. Compared to the representation in FIG. 1 the top 2 is shown only in part to better illustrate the interface between bag 1 and storage compartment 20.
  • the storage compartment 20 may correspond, for example, to a flat bag having a top 21 and a bottom 22. Both sides of the bag may have a vapor-impermeable film.
  • the storage compartment 20 is attached to the third side surface 6 in the embodiment shown. Alternatively, it can be attached to any further side surface 4, 5, 7 or even to a correspondingly provided in the bottom 3 of the bag 1 opening.
  • the storage compartment 20 is attached in a similar manner to the Beuel 1 as the filler neck 15, ie in the region of the further joint 16 of the third side surface 6.
  • the storage compartment 20 may be added in other embodiments, at other locations of the side surfaces 4, 5, 6, 7 be, wherein at these locations corresponding openings in the side surfaces 4, 5, 6, 7 may be provided.
  • the receiving compartment 20 can be used to keep the substance airtight and germ-free after freeze-drying.
  • the receiving compartment 20 After decanting the freeze-dried substance from the bag 1 in the receiving compartment 20 latter clamped by the terminal closure from the bag 1 and at the same time be hermetically sealed, for example, at the marked with the arrows 23 position of the receiving compartment 20.
  • the receiving compartment 20, which then the airtight and germ-free lyophilized substance can then be separated from the bag 1.
  • a second clamp closure can be attached to the storage compartment 20 between the location of the first clamp closure (indicated by arrows 23) and the transition of the storage compartment 20 to the pouch 1.
  • the bag 1 can then be separated from the storage compartment 20 at a location between the first and second clamp closures.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Molecular Biology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Hematology (AREA)
  • General Engineering & Computer Science (AREA)
  • Packages (AREA)
  • Bag Frames (AREA)
EP18194693.0A 2017-09-18 2018-09-17 Poche et procédé de lyophilisation sans contamination d'une substance Active EP3457062B1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE102017121537.9A DE102017121537A1 (de) 2017-09-18 2017-09-18 Beutel und Verfahren zur kontaminationsfreien Gefriertrocknung einer Substanz

Publications (2)

Publication Number Publication Date
EP3457062A1 true EP3457062A1 (fr) 2019-03-20
EP3457062B1 EP3457062B1 (fr) 2020-04-22

Family

ID=63637671

Family Applications (1)

Application Number Title Priority Date Filing Date
EP18194693.0A Active EP3457062B1 (fr) 2017-09-18 2018-09-17 Poche et procédé de lyophilisation sans contamination d'une substance

Country Status (4)

Country Link
EP (1) EP3457062B1 (fr)
DE (1) DE102017121537A1 (fr)
ES (1) ES2807076T3 (fr)
PT (1) PT3457062T (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4973327A (en) * 1989-11-01 1990-11-27 Cryopharm Blood bag for lyophilization
US5257983A (en) * 1991-04-12 1993-11-02 Cryopharm Corporation Blood bag for lyophilization
US6620436B1 (en) * 1991-10-09 2003-09-16 Lectec Corporation Mixing and dispensing package for a wound dressing
US20050268573A1 (en) * 2004-01-20 2005-12-08 Avantec Vascular Corporation Package of sensitive articles
DE102014105787A1 (de) * 2014-04-24 2015-10-29 Schott Ag Verpackungseinheit für ein pharmazeutisches, medizinisches oder kosmetisches Objekt und Verfahren zum Sterilisieren eines in der Verpackungseinheit anordenbaren pharmazeutischen, medizinischen oder kosmetischen Objekts

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5309649A (en) 1988-05-26 1994-05-10 Boehringer Mannheim Gmbh Process and container for freeze drying under sterile conditions
DE9407863U1 (de) * 1993-05-19 1994-07-14 Helvoet Pharma Belgium N.V., Alken Beutel zur Aufnahme und Sterilisation von medizinischen Geräten
WO1996031748A1 (fr) 1995-04-07 1996-10-10 W.L. Gore & Associates, Inc. Sac de lyophilisation et procede destine a minimiser la contamination des produits lyophilises
DE29802833U1 (de) * 1998-02-19 1998-05-07 Imer, Rodney Haydn, Barcelona, Vallvidrera Verbundfolie, insbesondere zur Herstellung von Verpackungsbeuteln, sowie aus einer derartigen Verbundfolie hergestellter Verpackungsbeuteln
USD430939S (en) 1999-02-11 2000-09-12 Gore Enterprise Holdings, Inc. Lyophilization container
US20050092636A1 (en) * 2003-10-31 2005-05-05 Wu Su-Syin Sterilization packaging
DE202010001261U1 (de) * 2010-01-22 2010-05-06 Mondi Ag Kunststofffolienbeutel mit Relief
DE202010010331U1 (de) * 2010-07-17 2011-11-24 Bischof + Klein Gmbh & Co. Kg Sterilisierbarer Polyolefinbeutel
DE102011001816B4 (de) * 2011-04-05 2016-11-17 Nordenia Technologies Gmbh Flachgelegter Beutel aus einem flexiblen, siegelfähigen Material zur Verwendung als Verpackung

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4973327A (en) * 1989-11-01 1990-11-27 Cryopharm Blood bag for lyophilization
US5257983A (en) * 1991-04-12 1993-11-02 Cryopharm Corporation Blood bag for lyophilization
US6620436B1 (en) * 1991-10-09 2003-09-16 Lectec Corporation Mixing and dispensing package for a wound dressing
US20050268573A1 (en) * 2004-01-20 2005-12-08 Avantec Vascular Corporation Package of sensitive articles
DE102014105787A1 (de) * 2014-04-24 2015-10-29 Schott Ag Verpackungseinheit für ein pharmazeutisches, medizinisches oder kosmetisches Objekt und Verfahren zum Sterilisieren eines in der Verpackungseinheit anordenbaren pharmazeutischen, medizinischen oder kosmetischen Objekts

Also Published As

Publication number Publication date
EP3457062B1 (fr) 2020-04-22
DE102017121537A1 (de) 2019-03-21
PT3457062T (pt) 2020-07-23
ES2807076T3 (es) 2021-02-19

Similar Documents

Publication Publication Date Title
DE60004345T2 (de) Stapelbarer, selbsttragender behälter mit ausrichtvorrichtung für den verschluss
EP0580989B1 (fr) Poche pour des matériaux liquides, pâteux ou granulaires et procédé de sa fabrication
EP3210669B1 (fr) Procédé de transfert d'une pluralité de récipients et/ou d'éléments de fermeture dans une salle blanche et récipient de transport et d'emballage
DE69206903T2 (de) Behälter aus flexiblem Material sowie Verfahren zu dessen Herstellung
DE69712509T2 (de) Verfahren zum herstellen einer luftdichten, wiederverschliessbaren verpackung aus flexiblem material
DE69309868T2 (de) Versiegelter flexibler beutel und verfahren zu dessen herstellen
DE69813315T2 (de) Satz von Zuschnitten, Verfahren und Vorrichtung zum Verpacken eines Produktes oder einer Menge Artikeln nichtspezifischer Form
DE1529970B2 (de) Verfahren zur herstellung eines boden und seitenwaende auf weisenden behaelters
DE2100833A1 (de) Halbsteifer Verpackungsbehälter
EP0796800A1 (fr) Poche pour des matériaux liquides, pâteux, granulaires ou pulvérulents ou pour des petits objets
DE2202001C3 (de) Mehrkammerbehälter
DE1166453B (de) Verfahren zum Herstellen eines verschlossenen Behaelters, z. B. eines Beutels oder einer Dose oder eines Bechers, mit einer leicht zu oeffnenden Schwaechungslinie
WO2019068384A1 (fr) Enveloppe d'emballage, emballage et procédé de fabrication d'un emballage
EP1506925A1 (fr) Dispositif de fabrication des récipients à plusieurs compartiments en utilisant une feuille soluble dans l'eau
DE2155441B2 (de) Verpackungsmaschine
EP1922255A1 (fr) Sachet tubulaire pourvu d'un corps pouvant etre dechire
EP3457062B1 (fr) Poche et procédé de lyophilisation sans contamination d'une substance
DE102015104214B3 (de) Behälter zur Aufnahme einer Flüssigkeit
DE3643030A1 (de) Verfahren zum herstellen eines folienbehaelters, nach dem verfahren hergestellter folienbehaelter und tiefziehform fuer die durchfuehrung des verfahrens
EP1627729A1 (fr) Procédé de fabrication d'un sachet fermé
DE102013103743B4 (de) Tiefzieh-Verpackung sowie Verfahren zu ihrer Herstellung
DE102009037667B4 (de) Verfahren zum Verpacken von Produkten
DE102017123011A1 (de) Packungsmantel, Verpackung und Verfahren zur Herstellung einer Verpackung
EP1484263B1 (fr) Procédé de conditionnement d'une lampe
DE944057C (de) Verpackung fuer kissenfoermige, aus einem Schlauch hergestellte Beutel

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION HAS BEEN PUBLISHED

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

AX Request for extension of the european patent

Extension state: BA ME

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: REQUEST FOR EXAMINATION WAS MADE

17P Request for examination filed

Effective date: 20190916

RBV Designated contracting states (corrected)

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

GRAP Despatch of communication of intention to grant a patent

Free format text: ORIGINAL CODE: EPIDOSNIGR1

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: GRANT OF PATENT IS INTENDED

INTG Intention to grant announced

Effective date: 20200123

GRAS Grant fee paid

Free format text: ORIGINAL CODE: EPIDOSNIGR3

GRAA (expected) grant

Free format text: ORIGINAL CODE: 0009210

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE PATENT HAS BEEN GRANTED

AK Designated contracting states

Kind code of ref document: B1

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

REG Reference to a national code

Ref country code: CH

Ref legal event code: EP

REG Reference to a national code

Ref country code: DE

Ref legal event code: R096

Ref document number: 502018001260

Country of ref document: DE

REG Reference to a national code

Ref country code: IE

Ref legal event code: FG4D

Free format text: LANGUAGE OF EP DOCUMENT: GERMAN

REG Reference to a national code

Ref country code: AT

Ref legal event code: REF

Ref document number: 1260674

Country of ref document: AT

Kind code of ref document: T

Effective date: 20200515

REG Reference to a national code

Ref country code: PT

Ref legal event code: SC4A

Ref document number: 3457062

Country of ref document: PT

Date of ref document: 20200723

Kind code of ref document: T

Free format text: AVAILABILITY OF NATIONAL TRANSLATION

Effective date: 20200720

REG Reference to a national code

Ref country code: LT

Ref legal event code: MG4D

REG Reference to a national code

Ref country code: NL

Ref legal event code: MP

Effective date: 20200422

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: NO

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20200722

Ref country code: GR

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20200723

Ref country code: IS

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20200822

Ref country code: FI

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20200422

Ref country code: SE

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20200422

Ref country code: LT

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20200422

Ref country code: NL

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20200422

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: BG

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20200722

Ref country code: HR

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20200422

Ref country code: RS

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20200422

Ref country code: LV

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20200422

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: AL

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20200422

REG Reference to a national code

Ref country code: DE

Ref legal event code: R097

Ref document number: 502018001260

Country of ref document: DE

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: EE

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20200422

Ref country code: SM

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20200422

Ref country code: DK

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20200422

Ref country code: RO

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20200422

Ref country code: CZ

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20200422

REG Reference to a national code

Ref country code: ES

Ref legal event code: FG2A

Ref document number: 2807076

Country of ref document: ES

Kind code of ref document: T3

Effective date: 20210219

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: PL

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20200422

Ref country code: SK

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20200422

PLBE No opposition filed within time limit

Free format text: ORIGINAL CODE: 0009261

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: NO OPPOSITION FILED WITHIN TIME LIMIT

26N No opposition filed

Effective date: 20210125

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: SI

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20200422

REG Reference to a national code

Ref country code: BE

Ref legal event code: MM

Effective date: 20200930

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: LU

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20200917

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: BE

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20200930

Ref country code: IE

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20200917

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: TR

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20200422

Ref country code: MT

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20200422

Ref country code: CY

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20200422

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: MK

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20200422

Ref country code: MC

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20200422

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: ES

Payment date: 20231124

Year of fee payment: 6

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: CH

Payment date: 20231001

Year of fee payment: 6

Ref country code: IT

Payment date: 20230927

Year of fee payment: 6

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: DE

Payment date: 20240918

Year of fee payment: 7

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: GB

Payment date: 20240920

Year of fee payment: 7

Ref country code: PT

Payment date: 20240905

Year of fee payment: 7

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: FR

Payment date: 20240925

Year of fee payment: 7