EP3691598A1 - Emballage primaire - Google Patents

Emballage primaire

Info

Publication number
EP3691598A1
EP3691598A1 EP18782944.5A EP18782944A EP3691598A1 EP 3691598 A1 EP3691598 A1 EP 3691598A1 EP 18782944 A EP18782944 A EP 18782944A EP 3691598 A1 EP3691598 A1 EP 3691598A1
Authority
EP
European Patent Office
Prior art keywords
primary packaging
container
layer
septum
channel
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.)
Pending
Application number
EP18782944.5A
Other languages
German (de)
English (en)
Inventor
Samuel Wyler
Ludwig Daniel Weibel
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.)
SHL Medical AG
Original Assignee
Weibel CDS AG
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 Weibel CDS AG filed Critical Weibel CDS AG
Publication of EP3691598A1 publication Critical patent/EP3691598A1/fr
Pending legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • A61J1/1406—Septums, pierceable membranes
    • 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
    • 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
    • A61J1/2048—Connecting means
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B1/00—Layered products having a non-planar shape
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B27/08—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/30—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers
    • B32B27/304—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers comprising vinyl halide (co)polymers, e.g. PVC, PVDC, PVF, PVDF
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
    • B32B27/322—Layered products comprising a layer of synthetic resin comprising polyolefins comprising halogenated polyolefins, e.g. PTFE
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
    • B32B27/325—Layered products comprising a layer of synthetic resin comprising polyolefins comprising polycycloolefins
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B3/00—Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar shape; Layered products comprising a layer having particular features of form
    • B32B3/02—Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar shape; Layered products comprising a layer having particular features of form characterised by features of form at particular places, e.g. in edge regions
    • B32B3/08—Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar shape; Layered products comprising a layer having particular features of form characterised by features of form at particular places, e.g. in edge regions characterised by added members at particular parts
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B7/00—Layered products characterised by the relation between layers; Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties; Layered products characterised by the interconnection of layers
    • B32B7/04—Interconnection of layers
    • B32B7/12—Interconnection of layers using interposed adhesives or interposed materials with bonding properties
    • 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
    • A61J1/1475—Inlet or outlet ports
    • 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
    • A61J1/2034—Separating means having separation clips
    • 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
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2250/00—Layers arrangement
    • B32B2250/02—2 layers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2250/00—Layers arrangement
    • B32B2250/24—All layers being polymeric
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/70—Other properties
    • B32B2307/724—Permeability to gases, adsorption
    • B32B2307/7242—Non-permeable
    • B32B2307/7244—Oxygen barrier
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/70—Other properties
    • B32B2307/724—Permeability to gases, adsorption
    • B32B2307/7242—Non-permeable
    • B32B2307/7246—Water vapor barrier
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/70—Other properties
    • B32B2307/732—Dimensional properties
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2439/00—Containers; Receptacles
    • B32B2439/40—Closed containers
    • B32B2439/46—Bags
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2439/00—Containers; Receptacles
    • B32B2439/80—Medical packaging

Definitions

  • the present invention relates to a primary packaging means for a liquid according to the preamble of claim 1.
  • Primary packaging means packaging such as vials, ampoules, cartridges, bottles, jars or cans that come into direct contact with food or medicine.
  • Such packaging can be made of different materials, for example of plastic materials, metals, glasses or ceramics.
  • Overpacks that are not in direct contact with food or pharmaceuticals are called secondary packaging and are therefore not among the primary packaging materials.
  • Primary packaging for the pharmaceutical industry increased Anfor ⁇ changes are made. They must thus be able to store a pharmaceutical over a longer period of time without it escaping from the packaging.
  • the active substance contained therein must be protected from external influences such as oxygen, moisture or UV radiation. Not least, it must not result in contamination of the specimen, for example by introducing Additi ⁇ ven of plastic materials through the primary packaging.
  • the related requirements are particularly high.
  • US 5,364,384 discloses a primary packaging means for a liquid comprising a collapsible container and a connection element for connecting the primary packaging means to a removal device.
  • Such containers have many advantages over other liquid containers. So they are characterized by a high level of robustness, low weight and a small footprint.
  • These containers are often made of polyvinyl chloride or ethylene vinyl acetate copolymer. They are usually gebil ⁇ det of two film parts, which are welded together on its four sides. Between the foils, a connection element is welded to one side, which allows a withdrawal of liquid from the container via a connection channel.
  • the object of the present invention to overcome the above-mentioned disadvantages in the prior art.
  • the primary packaging should also be manufacturable and sterilizable in a conventional manner and show high mechanical strength.
  • the packaging should meet all regulatory requirements.
  • the primary packaging for a liquid comprises an in particular at least partially collapsible container and a connection element for connecting the primary packaging means to a removal device.
  • the connection element has at least one connection channel which is in fluid communication with an interior of the container.
  • the container consists at least partially of a film which is constructed from a first layer which comes into direct contact with the liquid when the primary packaging material is used as intended. Both the first layer and the connection element consist of a plastic material containing a cycloolefin polymer.
  • Cycloolefin polymers are a class of polymers that can be prepared from at least one monomer that is a cyclic olefin. The said class will continue in
  • Cycloolefin polymers are characterized by excellent barrier properties with respect to ⁇ steam. In addition, they can be technically used in a high degree of purity, whereby a minimal use of additives is possible. This substantially prevents an entry of foreign substances into a pharmaceutical composition contained in a primary packaging material according to the invention. Cycloolefin polymers are moreover free of halogens and bisphenol A. it signalises sen a high mechanical strength and excellent opti ⁇ cal properties, especially transparency on. Furthermore, cycloolefin polymers can be sterilized well, be it by
  • An advantage of a primary packaging means according to the invention is, in particular, that when the product is used according to its intended purpose, a liquid contained therein is only mixed with cycloolefin. Polymer comes into contact. This makes it much easier to ensure with such a packaging that all regula ⁇ torischen requirements are met.
  • the proportion of the cycloolefin polymer in the plastic material of the ERS ⁇ th layer and / or the connection element can comprise at least 60 wt .-%, preferably at least 80 wt .-%, preferably 90 wt .- iquess we ⁇ %, respectively. It has been found that the advantageous properties described above can be achieved to a greater extent with a higher proportion of cycloolefin polymer.
  • the first layer and the connecting member may consist of two un ⁇ ter Kunststoff plastic materials, each containing a cycloolefin polymer exist.
  • a cycloolefin polymer composition can be used which extrudes particularly well into films.
  • the connection element it is possible to choose a composition which is particularly suitable for processing by means of injection molding.
  • the at least one cycloolefin polymer may be selected from a cycloolefin homopolymer and a cycloolefin copolymer. While cycloolefin homopolymers are positioned ⁇ builds only from monomers comprising cyclic olefins, cycloolefin copolymers consist on the one hand from monomers comprising cyclic olefins are, on the other hand also from other monomers insbesonde- re acyclic olefins. In particular, ethene has proved to be an acyclic olefinic monomer. However, other monomers, such as propene are used kom ⁇ men can.
  • Cycloolefin copolymers offer the advantage that their Properties can be influenced by the monomer composition. This allows a wide margin to achieve the desired material properties.
  • the at least one cycloolefin polymer can be prepared from a monomer selected from a list consisting of cyclopentene, cyclohexyls, norbornene, dicyclopentadiene, tetracyclodecene and methyltetracyclodecene. These are monomers which are particularly suitable for the preparation of cycloolefin polymers.
  • the first layer usually has a thickness of from 5 ⁇ m to 200 ⁇ m, preferably from 10 ⁇ m to 100 ⁇ m, preferably from 20 ⁇ m to 60 ⁇ m.
  • the film can be composed of at least one further ⁇ second layer.
  • the film can be equipped with other technical features or functions that may be required.
  • the at least one further layer may consist of a plastic material containing a fluoropolymer.
  • a film has in addition to the already mentioned barrier property with respect to water vapor also an extremely low permeability to oxygen and other gases.
  • the fluoropolymer may be selected from a list consisting of polyvinyl fluoride, polyvinylidene fluoride, polytetrafluoroethylene, polychlorotrifluoroethylene, ethylene-tetrafluoroethylene and perfluoro (ethylene propylene). Especially these fluoropolymers show a particularly good barrier effect towards oxygen.
  • the at least one further second layer advantageously has a thickness of from 10 ⁇ m to 500 ⁇ m, preferably from 25 ⁇ m to 250 ⁇ m, more preferably from 50 ⁇ m to 150 ⁇ m.
  • At least one adhesion promoter layer can be arranged between the first and the second layer. This helps to ensure that the first and second layers adhere better to each other.
  • the adhesive layer usually has a thickness of 1 ym to 100 ym, preferably 5 ym to 50 ym, Favor ⁇ ingly of 7 to 25 ym ym.
  • connection channel can be closed with a septum.
  • the septum may be formed integrally with the connection element.
  • the connection channel can be tightly sealed in an efficient manner.
  • no septum must be used in the form of a separate part in the connection channel in the preparation of the primary pact agent.
  • injection molding can be manufacturer-len a connecting element with integrally fancy ⁇ tem septum in a very efficient and cost effective manner.
  • the connecting element may have at least one additional filling channel, which is in fluid communication with an interior of the container. If such a filling channel is present, the packaging material can be filled with a liquid in the mounted state. Since the connection channel is not required for this purpose, this can already be closed with a septum, which does not have to be pierced for this purpose.
  • the filling channel can be closed with a stopper.
  • the primary packaging means has only a single connection channel , it can also be closed with a stopper at this connection channel. If the primary packaging means having a Ranka ⁇ nal and a filling channel, it may be closed at the connection channel and / or at the filling channel with a stopper.
  • this plug is also made of a cycloolephine polymer as described above.
  • the plug can also be made so that a septum is formed as a layer on the surface of the plug.
  • the stopper is formed so that the septum formed as a layer is turned in the intended insertion plug against the interior of the container.
  • the septum may be the sole part of the plug of cycoolefin polymer.
  • the remainder of the plug can be made from a low cost, easily processable or more resistant material. Nevertheless, it can be ensured that a liquid contained in the container comes into contact only with cycloolefin polymers.
  • An inventive plug can be produced for example by a multi-component injection molding process.
  • the primary packaging means can also be closed or closable with at least one stopper, which is formed from a septum and a sealing element.
  • the septum can be configured becherför ⁇ mig.
  • Cup-shaped in this context means that the septum is present as a hollow cylinder which is closed at a longitudinal end.
  • the septum has the shape of a hollow cylinder including a base.
  • a septum in this way forms a receptacle for a sealing element in the interior of the hollow cylinder.
  • Such a sealing element can be added in two-component injection molding process in the recording or pressed into the receptacle who ⁇ .
  • other production methods are also conceivable.
  • the septum be ⁇ is preferably made of cycloolefin polymers, which material has many advantages, but are not necessarily suitable as Dichtma ⁇ TERIAL.
  • the intended use septum on the side facing away from the In ⁇ nenraum of the container side an undercut, preferably a collar-shaped undercut, into which a introduced into the hollow cylinder interior sealing element is a ⁇ snapped. By such a latched sealing element, the closure is additionally improved.
  • the septum be made of a plastic material containing a cycloolefin polymer.
  • the cycloolefin polymer consists of a mixture of cycloolefin copolymer and a cycloolefin copolymer elastomer.
  • the COC-based inner layer of the film is made of a first plastic comprising loolefin copolymer and a cycloolefin elastomer.
  • the connecting element is preferably formed of a second plastic around ⁇ collectively cycloolefin copolymer, and a cycloolefin elastomer.
  • the optional septum may be formed of a third plastic comprising cycloolefin copolymer and a cycloolefin elastomer.
  • the proportion of cycloolefin copolymer in the first plastic is preferably lower and the elastomer content is preferably higher than in the second plastic.
  • the proportion of cycloolefin polymer in the third plastic may be higher with simultaneously lower elastomer content than in the second plastic.
  • cycloolefin elastomer is understood as meaning a partially crystalline elastomer which comprises cycloolefin repeat units and which has a glass transition temperature at room temperature (20 ° C.) or below.
  • the elastomer may be an ethylene / norborene copolymer elastomer having a norbornene content of 8 to 9 mol%, which has a rubbery transitional state between 10 ° to 20 ° C and 80 ° to 90 ° C.
  • Such elastomers have ty ⁇ pisch enough, 10 to 30% crystallinity.
  • cycloolefin polymers or cycloolefin copolymers are amorphous at room temperature.
  • ver Topas Advanced Polymers ⁇ turns can be used as cyclic olefin elastomer Topas Elastomer E-140th
  • Another aspect of the invention relates to a primary packaging means as described above, wherein the at least one formed on at closing element filling channel and / or connecting channel towards the mouth attachment out as a tapered tube is formed is / are that / e against the interior of the container a sealing lip forms.
  • a sealing lip ensures that in case of a possible overpressure in the container, the tightness does not diminish, but the pressure is transferred to the sealing lip and thus the secure closure after filling ge ⁇ guaranteed.
  • a further aspect of the invention relates to a primary packaging means as described above, wherein a cover-side and a back-side film of the container are welded in the part adjacent to the filling channel (12) ⁇ part of the container so that from ⁇ section, a shaft between the top side and the back foil surfaces is recessed.
  • Such Starting ⁇ staltung proves especially for the novel Ver ⁇ drive (below) as appropriate.
  • the section-wise ⁇ saving shaft has a diameter which is smaller than the diameter of the interior.
  • the shaft preferably has ei ⁇ NEN diameter ⁇ 15 mm, preferably a diameter of ⁇ 10 mm, more preferably a diameter of ⁇ 5 mm., While the interior of the container preferably has a diameter of several centimeters has.
  • Another aspect of the invention relates to a Primärpackmitel, in particular as described above, wherein the at least partially collapsible container is formed from a top-side and ei ⁇ ner rear-side film, these films are laterally welded together, and the connecting element at least from section ⁇ between the top side and the back photo lie welded. It is preferred that the Anschlus ⁇ selement converges to the directed towards the interior of the container area. In a side view, the on ⁇ closing element therefore has a converging towards the interior of the container side elevation.
  • the connecting element may be formed to schiffchenförmig ⁇ additionally or alternatively in a top view of the removal region, ie have two away from one another extending, sharp or blunt tapered end faces.
  • a sealing bead is understood to mean a protuberance on the connection element, which is preferably semi-cylindrical, with the half-cylinder particularly preferably having a radius of 0.1 to 0.5 mm.
  • the sealing bead extends over a first longitudinal side of the An ⁇ closing element, where the connecting element is welded to the cover side foil sheet and / or via a second longitudinal side of the connecting element where the connecting element is welded to the back ⁇ side foil sheet to the respective Mün ⁇ around the connection duct.
  • a primary packaging material according to the invention may contain a liquid pharmaceutical or diagnostic agent, in particular selected from a list consisting of the following agents:
  • the pharmaceutical is a monoclonal antibody.
  • the invention then relates to a method for filling a primary packaging means as described above, comprising the fol ⁇ constricting steps of:
  • a clamping can be done via a clamping device to a housing in which the primary packaging is located.
  • the primary packaging can be used in a Ge ⁇ housing made of polycarbonate.
  • the housing may be flexible as part ⁇ configured or flexible elements, such as having Fo ⁇ lien hinges.
  • the side surfaces of the housing can be moved against each other by mechanical pressure. If are formed on the housing inner sides Abklemmvoriquesen, for example Abklemmrippen, they can be pressed against each other when from ⁇ sectionally shaped slot between the top side and the rear side film surface in the mouth region of the filling channel so that after completion of Be Shel- len a-clamping of the shaft is brought about, which so long is maintained until the container is closed by a plug.
  • FIG. 1 shows a perspective view of a primary packaging means according to the invention
  • FIG. 2 Perspective sectional view of the primary packaging means according to FIG. 1;
  • FIG. 3 shows a perspective sectional view of the connection element of the primary packaging means according to FIG. 1;
  • Figure 4 is perspective view of an alternatively embodiment of a ⁇ ven erfindungsge- MAESSEN primary packaging means
  • FIG. 6 shows a perspective sectional view of the connection element of the primary packaging means according to FIG. 4;
  • FIGS. 7 and 8 are cross-sectional views of films of primary packaging according to the invention.
  • Figure 9 View of a longitudinal side of a Anschlußele ⁇ ment, wherein the connection element is welded ⁇ region between a cover-side and a back-side film.
  • Figures 10 and 11 Perspective views of a longitudinal section through the removal area of the primary packaging means (without and with Bephol ⁇ ter / closure elements / housing).
  • Figure 12 Perspective view on the Ent Spotifybe ⁇ area of the primary packaging material.
  • Figure 13 longitudinal section through a connecting element with
  • FIG. 14 detailed view of a cross section through a
  • FIGS. 1 and 2 show a first exemplary embodiment of a primary packaging means 1 according to the invention.
  • the primary packaging means 1 comprises a collapsible container 2, which is formed from two films 6 superimposed on one another and welded together at their edges. Due to the choice of the cutting plane in Figure 2, only one of the two films 6 is visible there.
  • the connecting element 3 is welded between the films 6. This makes it possible to establish fluid communication between a removal device and the interior 5 of the container 2.
  • Figure 3 closer details to the connection element 3 can be seen. It can be seen that this ver ⁇ adds a connection channel 4 and a filling channel 12.
  • connection channel 4 is closed by a septum 10, which is formed integrally with the connection element 3.
  • a seal 11 mounted on the outside of the septum is a seal 11 which, upon cannulation of the septum 10, prevents leaks at the junction of the septum 10 and the cannula.
  • the seal 11 is elastically deformable.
  • the filling channel 12, however, is closed with a stopper 13, which in the present example is the same as the connecting element 3 consists of a cycloolefin polymer.
  • FIGS. 4 and 5 show an alternative embodiment of a primary packaging means 1 according to the invention.
  • the container 2 here has the same film structure as described in the introduction.
  • the connection element 3 is equipped with a single connection channel 4. From Figure 6 are more single ⁇ units to the connecting element 3 can be seen. It can be seen that the connection channel 4 is closed by a plug 13. With the plug 13, a septum 10 is integrally formed, which can be pierced by a cannula for establishing a fluid connection between the interior 5 of the container 2 and a removal device. On the outside of the septum 10, in turn, a seal 11 is arranged.
  • Figures 7 and 8 show two possible variants of a layer structure of the film 6 of an inventive primary packaging means 1.
  • first layer 7 is a Cyc ⁇ loolefin polymer.
  • second layer 8 is before ⁇ hands, which is a Polychlotrifluorenthylen (PCTFE).
  • PCTFE Polychlotrifluorenthylen
  • Figure 7 9 is mounted between the first layer 7 and the second layer 8, a single Haftvermitt ⁇ lung layer.
  • two are between the first layer 7 and the second layer 8
  • Adhesive layers 9, 9 ⁇ attached.
  • the first adhesion-promoting layer 9 is selected such that it forms a good bond with the first layer 7 and the second adhesion promoter layer 9 ⁇ .
  • the second adhesive layer 9 ⁇ is selected so that it is 9, a ⁇ a good connection with the second layer 8 and the first adhesive layer.
  • the second layer of PCTFE fulfilled in the present case ⁇ play the function of providing a barrier layer for oxygen and at ⁇ particular gases.
  • connection element 3 together with the cover-side and back ⁇ gen film 2 form the primary packaging.
  • the connection element 3 has a filling channel 12 and a withdrawal channel 19.
  • the deck side and the rear side film are welded together, that they partially avoiding endon between the top side and the back foil-a chute 15 in the area adjacent to the fill ⁇ channel 12 of the container. 2
  • the shaft has a diameter which is smaller than the diameter of the interior 5.
  • the shaft 15 has a diameter of ⁇ 10 mm, particularly preferably a diameter of ⁇ 5 mm.
  • Figure 10 shows a perspective view of a longitudinal section through the connecting element 3.
  • the plugs are mounted on the connecting element 10 in the figure 13 and 13 ⁇ .
  • Figure 11 shows a perspective view of a longitudinal section through the removal area of the primary packaging means 1, that is, by connecting element 3 and container 2 are introduced reasonable Am terminal plugs 13,13 ⁇ and a protective cap 16.
  • the primary ⁇ pack medium is inserted into a housing 23rd
  • a septum facing the interior of the container side may be formed of at least one plug 13,13 ⁇ a septum 10,10 ⁇ as a layer on the surface, so that the septum is in its intended purpose inserted plug against the interior of the container. 2
  • Figure 12 shows a perspective view of the Ent Spotifybe ⁇ area of the primary packaging means.
  • the connection element 3 converges towards the container interior 5.
  • the connection element 3 can be designed ship-shaped in the plan view, so that even when looking at the connection element from the filling direction, the longitudinal ends converge bluntly.
  • FIG. 12 how the cover-side film is welded to the backsheet in the welding region 22, thus enclosing the interior 5. In the area of dark hatching 22, the films are welded together. In the field of medium ⁇ dark hatching 24, the deck-side sheet with the Anschlus ⁇ selement 3 is welded.
  • the deck-side film is un- welded.
  • the sealing bead is formed here as a comb-shaped protuberance along the connecting element, with the prongs of the comb shape extending around the mouth regions of the filling and removal channel, towards the container interior 5.
  • FIG. 13 shows a longitudinal section through a connecting element.
  • Siegelwulstabitese 17 are again visible, which protrude at the end of the connecting element, which faces against the bag interior, the body of the connecting element and therefore are visible in longitudinal section through the connecting element as a semicircular Ausstül ⁇ pungen.
  • FIG. 14 shows a detailed view of a cross section through a filling channel 12 on the connecting element 3.
  • the filling channel 12 is closed by a plug 13.
  • the primary packaging is inserted in a housing 23. It can be seen how the deckseiti ⁇ ge and a backside film of the container 2 are welded in the adjacent to the filling channel 12 part of the container 2 so that a slot 15 is recessed between the top side and the back side film surfaces.
  • the shaft has one Diameter of a few millimeters, while the container interior 5 forms a space with several centimeters in diameter. The thus formed shaft 15 can be clamped by trained on the housing Abklemmrippen 20, 20, 21 ⁇ .
  • two Abklemmrippen 20,20 ⁇ are formed on the back of the housing and a Abklemmrippe 21 is ⁇ forms on the front of the housing.
  • the Abklemmrippen are arranged spatially offset.
  • the housing is here slightly flexible, so that pressure can be exerted by pressure on the front and back respectively at the level of Abklemm ⁇ ribs after filling of the primary packaging means, for example by machine. As a result, the fluid is trapped in the primary packaging.
  • the result is a Zeitfens ⁇ ter, in which a filling cannula removed and the plug 13 can be used without this fluid would escape from the container, even if a slight overpressure should prevail in the bag interior. At the same time prevents air from entering the container. This simplifies the filling process, making it more efficient and safer.

Landscapes

  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Packages (AREA)
  • Bag Frames (AREA)

Abstract

L'invention concerne un emballage primaire (1) pour un liquide, comprenant un contenant (2) pouvant en particulier être partiellement replié et un élément de raccordement (3) pour raccorder l'emballage primaire (1) à un dispositif de prélèvement. L'élément de raccordement (3) présente au moins un canal de raccordement (4) qui est en communication fluidique avec un espace interne (5) du contenant (2). Le contenant (2) est au moins partiellement constitué par une feuille (6), qui est formée par une première couche, qui, lors d'une utilisation conformément à l'utilisation de l'emballage primaire (1), entre directement en contact avec le liquide. Tant la première couche (7) que l'élément de raccordement (3) sont constitués par un matériau synthétique contenant un polymère cyclooléfinique.
EP18782944.5A 2017-10-02 2018-10-02 Emballage primaire Pending EP3691598A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP17194377.2A EP3461469A1 (fr) 2017-10-02 2017-10-02 Emballage primaire
PCT/EP2018/076710 WO2019068667A1 (fr) 2017-10-02 2018-10-02 Emballage primaire

Publications (1)

Publication Number Publication Date
EP3691598A1 true EP3691598A1 (fr) 2020-08-12

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EP17194377.2A Withdrawn EP3461469A1 (fr) 2017-10-02 2017-10-02 Emballage primaire
EP18782944.5A Pending EP3691598A1 (fr) 2017-10-02 2018-10-02 Emballage primaire

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EP17194377.2A Withdrawn EP3461469A1 (fr) 2017-10-02 2017-10-02 Emballage primaire

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US (2) US11992456B2 (fr)
EP (2) EP3461469A1 (fr)
CN (1) CN111163741B (fr)
WO (1) WO2019068667A1 (fr)

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US11932714B2 (en) 2021-07-22 2024-03-19 Industrial Technology Research Institute Copolymer, film composition and composite material employing the same

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US20240269038A1 (en) 2024-08-15
CN111163741A (zh) 2020-05-15
WO2019068667A1 (fr) 2019-04-11
US20200230024A1 (en) 2020-07-23
EP3461469A1 (fr) 2019-04-03
US11992456B2 (en) 2024-05-28
CN111163741B (zh) 2024-04-30

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