US20150107195A1 - Container and Method of Manufacture of Container - Google Patents

Container and Method of Manufacture of Container Download PDF

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Publication number
US20150107195A1
US20150107195A1 US14/119,280 US201114119280A US2015107195A1 US 20150107195 A1 US20150107195 A1 US 20150107195A1 US 201114119280 A US201114119280 A US 201114119280A US 2015107195 A1 US2015107195 A1 US 2015107195A1
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US
United States
Prior art keywords
closure
container
piston
active agents
recess
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.)
Abandoned
Application number
US14/119,280
Other languages
English (en)
Inventor
Spyridon Edouard Tsakas
Spyridon Christos Tsakas
Original Assignee
Eulysis Uk Limited
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 Eulysis Uk Limited filed Critical Eulysis Uk Limited
Publication of US20150107195A1 publication Critical patent/US20150107195A1/en
Abandoned legal-status Critical Current

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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
    • A61J1/14—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
    • A61J1/2027—Separating means having frangible parts
    • 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
    • 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
    • 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
    • A61J1/1412—Containers with closing means, e.g. caps
    • 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
    • A61J1/2068—Venting means
    • A61J1/2072—Venting means for internal venting
    • 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
    • B65B29/00—Packaging of materials presenting special problems
    • B65B29/10—Packaging two or more different substances isolated from one another in the package but capable of being mixed without opening the package, e.g. forming packages containing a resin and hardener isolated by a frangible partition
    • 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
    • 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
    • B65B63/00—Auxiliary devices, not otherwise provided for, for operating on articles or materials to be packaged
    • B65B63/08—Auxiliary devices, not otherwise provided for, for operating on articles or materials to be packaged for heating or cooling articles or materials to facilitate packaging
    • 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
    • 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
    • B65D51/00—Closures not otherwise provided for
    • B65D51/24—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes
    • B65D51/241—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes provided with freeze-drying means
    • 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
    • B65D51/00—Closures not otherwise provided for
    • B65D51/24—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes
    • B65D51/28—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials
    • B65D51/2807—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container
    • B65D51/2814—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container the additional article or materials being released by piercing, cutting or tearing an element enclosing it

Definitions

  • Methods of manufacturing sterile liquid containers and sterile liquid containers more specifically methods of manufacturing vials and vials.
  • the one or more active agents is an unstable species in solution
  • the one or more active agents and the diluent are often stored separately in two sterile storage units before administration.
  • the one or more active agents and the diluent are stored separately and combined immediately prior to administration, there is a risk of contamination of the medicament. To ensure that contamination does not occur, the combination of the one or more active agents and diluent is carried out using a lengthy and time consuming procedure.
  • a method of manufacturing a pre-loaded container for use in dispensing one or more active agents comprising the steps of;
  • the step of sealing the closure comprises sealedly mounting a sealing element comprising a piston.
  • the piston may comprise a hollow column retained within a cylinder in the closure.
  • the piston may comprise apertures suitable for ventilating the recess of the closure during the step of lyophilisation.
  • the step of sealing the closure may seal the apertures of the piston.
  • the piston may comprise a deformable feature extending from the outer surface of the closure such that deformation of the piston by the application of pressure to the said outer surface releases the lyophilised one or more active agents from the closure into the diluent of the container.
  • lyophilised active agent and diluent are stored in separate sterile containers. Therefore, for any one active agent to be available for use, two components must be sourced and stored.
  • the active agent is to be used, the diluent is extracted from its packaging using a syringe and the syringe is then inserted into the packaging of the active agent. The diluent is then added to solubilise the active agent.
  • the active agent packaging must then be agitated to ensure that the active agent is fully dissolved to reconstitute the active agent into its solubilised form. Finally, the solution is then drawn into the syringe ready for use.
  • container made according to the above method allows the active agent and diluent to be stored as a single entity, conserving space.
  • the process of reconstituting the active agent is greatly reduced to a two step process of breaking the closure to allow the lyophilised active agent to fall into the diluent and then agitating the vial to ensure the lyophilised one or more active agents are fully reconstituted, thereby ensuring that there is no risk of contamination and that the solubilised one or more active agents can be rendered ready for use much faster than convention methods.
  • the provision of a container storing both the lyophilised active agent and the diluent required to reconstitute the active agent results in less packaging being required to be manufactured and produces less waste when the container is to be disgarded.
  • the steps of adding the diluent to the container and sealing the container with the closure may be carried out before or after the steps of adding a portion of the solution into the recess of the closure, lyophilising the solution in the recess of the closure and sealing the closure.
  • the container may be a vial.
  • the closure may be a vial cap.
  • the closure is sterilised before the step of adding the solution to it.
  • the interior of the container and the interior of the closure are sterile after the container is sealed to the closure.
  • a sterilised closure ensures that the one or more active agents are not contaminated before the lyophilisation process and therefore that the lyophilised one or more active agents will be contaminant free. Ensuring that the interior of the container and the interior of the closure are sterile after the container is sealed to the closure allows the user to be confident that the diluent and the lyophilised one or more active agents are contaminant free and the resultant solubilised one or more active agents are safe to use, especially important in embodiments where the one or more active agents are a vaccine, for example.
  • the one or more active agents may be a biologically active species, such as artificially expressed or reconstituted proteins, nucleic acid sequences or their mixtures.
  • the one or more active agents may be medically active agents, such as a vaccine, for example.
  • the diluent is typically an aqueous solution.
  • the diluent may be saline solution, for example.
  • the method of the present aspect of the invention may be used to store proteins expressed in a laboratory or to store the one or more active agents of a medicament for transportation from the manufacturer to the site where it will be administered, for example.
  • the closure immediately preceding the step of lyophilising the solution in the closure, the closure is covered.
  • the closure may be covered by the sealing element comprising a piston and the piston may define at least one aperture to allow the recess of the closure to be ventilated during the step of lyophilisation.
  • the step of sealedly mounting the sealing element to the closure may seal the at least one aperture, thereby sealing the recess of the closure.
  • the closure may be covered by a cover comprising a material that is permeable to the solvent of the active agent solution, such that during lyophilisation the solvent may sublime into the applied vacuum.
  • the closure may comprise a frangible member.
  • the solution lyophilised within the recess of the closure may be in contact with the frangible member such that the lyophilised one or more active agents is in contact with the frangible member.
  • the piston of the sealing element may be moved from a first position to a second position so that in the second position the piston breaks and extends beyond the frangible member such that the lyophilised one or more active agents is combined with the diluent.
  • the piston of the sealing element is manually operable between the first position and the second position.
  • a pre-loaded container comprising a container body and a closure; the closure having a recess, a frangible member and a piston arranged adjacent to the frangible member; the container body retaining a diluent and the closure recess retaining one or more active agents lyophilised within the closure by the method of the first aspect of the invention; wherein the piston of the closure may be moved from a first position to a second position so that in the second position the piston breaks and extends beyond the frangible member such that the lyophilised one or more active agent is combined with the diluent.
  • the piston may be part of a sealing element sealedly mounted to the closure.
  • a pre-loaded container allows the one or more active agents that have been lyophilised within the cap of the vial and the diluent to be stored in the same sterile environment within which mixing and solubilisation of the one or more active agents will occur.
  • the piston of the closure is manually operable between the first position and the second position.
  • the portion of the piston forming an outer surface of the closure may comprise an air tight permeable or semi-permeable material such that a needle may penetrate the outer surface to extract the reconstituted active agent, but ensure that the lyophilised one or more active agents remain sterile and sealed within the closure.
  • the piston may move from a first position to a second position such that the piston displaces a floor element of the frangible member of the closure, thereby allowing the lyophilised one or more active agents resting on the said floor element to fall into the diluent in the vial.
  • the floor element may be pivotally mounted to the vial cap such that the movement of the piston results in the floor element being moved from a horizontal orientation to a vertical orientation and the lyophilised one or more active agents falls into the diluent.
  • the lyophilised one or more active agents are compressed into a cake or tablet for efficient storage.
  • the closure recess may retain a cake or tablet of lyophilised active agent such that when the piston is moved from the first position to the second position the cake or tablet of lyophilised active agent is combined with the diluent.
  • the cake or tablet of lyophilised active agent may comprise a single active agent.
  • the cake or tablet of lyophilised active agent may comprise more than one active agent.
  • the cake or tablet of lyophilised active agent may comprise a different active agent to the active agent lyophilised within the closure.
  • FIG. 1 is a side view of a pre-loaded vial (a) as stored and (b) after the one or more active agents have been applied to the diluent;
  • FIG. 2 is a scheme of the method of manufacture of a pre-loaded vial.
  • a pre-loaded vial 1 comprises a vial (acting as a container) 2 and a vial cap 4 (acting as a closure).
  • the vial cap comprises a piston 6 , a base 8 (acting as a frangible member) and a recess 10 retaining a lyophilised vaccine 12 (acting as an active agent).
  • the vial retains a diluent 14 (for example, saline solution) suitable for solubilising the lyophilised vaccine.
  • the piston of the vial cap defines apertures, which are sealed after manufacture.
  • the pre-loaded vial is manufactured by the following method, shown in FIG. 2 .
  • the vial and vial cap are sterilised.
  • a solution of the vaccine is prepared and one dose of the vaccine is placed into the recess of the vial cap.
  • the recess of the vial cap is then covered by the piston.
  • the apertures defined by the piston allow the recess of the vial cap to be ventilated.
  • the vaccine solution within the vial cap is then lyophilised. That is, the vaccine solution is frozen and then warmed in vacuum to allow solvent in the vial cap to sublime into the vacuum through the apertures defined by the piston, leaving the vaccine protein behind in the vial cap.
  • the advantage of lyophilisation is that the vaccine protein left behind in the vial cap is not structurally altered and is much more stable than the solubilised vaccine.
  • the vial cap is then sealed such that the apertures of the piston are sealed and the recess of the vial cap is sealed to ensure that the lyophilised vaccine retained within the recess remains sterile.
  • the diluent is added to the vial.
  • the vial cap is then sealed to the vial such that the diluent within the vial is sealed from the outside and that the lyophilised vaccine is sealed from the diluent in the vial and the outside, thereby ensuring that the diluent and vaccine are retained in sterile conditions.
  • a pre-loaded vial prepared by the above method may then be stored within a refrigerator or according to its recommended storage conditions to await use.
  • the piston of the vial cap is pressed by the user (a) such that the piston moves through and extends beyond the base of the vial cap, thereby breaking the said base and allowing the lyophilised vaccine to fall into the diluent within the vial (b).
  • the vial is then agitated to ensure that the vaccine is fully solubilised.
  • the vaccine is then ready for use, and may be extracted by piercing the seal of the piston of the vial cap with a syringe and drawing the newly solubilised vaccine into the syringe after sterilisation of the outer surface of the vial cap.
  • a lyophilised biologic may be stored in the pre-loaded vial using the method of the present invention for storage within a refrigerator or according to its recommended storage conditions.
  • the piston may move from a first position to a second position such that the piston displaces the base of the vial, thereby allowing the lyophilised active agent resting on the said base to fall into the diluent in the vial.
  • the base may be hinged such that the base is moved from a horizontal orientation to a vertical orientation such that the lyophilised active agent falls into the diluent.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Hematology (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Closures For Containers (AREA)
US14/119,280 2011-08-22 2011-12-09 Container and Method of Manufacture of Container Abandoned US20150107195A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB1114432.6 2011-08-22
GB201114432A GB2485254C (en) 2011-08-22 2011-08-22 A container having a recessed closure for drying and storing one or more active agents
PCT/GB2011/052453 WO2013026995A1 (fr) 2011-08-22 2011-12-09 Récipient et procédé de fabrication de récipient

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2011/052453 A-371-Of-International WO2013026995A1 (fr) 2011-08-22 2011-12-09 Récipient et procédé de fabrication de récipient

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US15/439,722 Continuation US20170224586A1 (en) 2011-08-22 2017-02-22 Container and method of manufacture of container

Publications (1)

Publication Number Publication Date
US20150107195A1 true US20150107195A1 (en) 2015-04-23

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US14/119,280 Abandoned US20150107195A1 (en) 2011-08-22 2011-12-09 Container and Method of Manufacture of Container
US15/439,722 Abandoned US20170224586A1 (en) 2011-08-22 2017-02-22 Container and method of manufacture of container

Family Applications After (1)

Application Number Title Priority Date Filing Date
US15/439,722 Abandoned US20170224586A1 (en) 2011-08-22 2017-02-22 Container and method of manufacture of container

Country Status (3)

Country Link
US (2) US20150107195A1 (fr)
GB (1) GB2485254C (fr)
WO (1) WO2013026995A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020109195A1 (fr) * 2018-11-26 2020-06-04 F. Hoffmann-La Roche Ag Fabrication d'un contenant souple
WO2020109194A1 (fr) * 2018-11-26 2020-06-04 F. Hoffmann-La Roche Ag Récipient de lyophilisat et kit de perfusion
CN111885990A (zh) * 2018-01-05 2020-11-03 太平洋有限公司 方法和装置

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB201415869D0 (en) * 2014-09-08 2014-10-22 Eulysis Uk Ltd Container And Closure
EP3695823A4 (fr) * 2017-10-10 2021-10-13 Seikagaku Corporation Récipient de stockage de médicament, élément de fermeture, procédé de fabrication d'un récipient de stockage de médicament, procédé d'inspection de micro-organismes et de contaminants, et préparation solide pour préparation de solution tampon

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US20170224586A1 (en) 2017-08-10
GB2485254A (en) 2012-05-09
GB2485254C (en) 2013-12-25

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