EP3554449B1 - Dispositifs formant réceptacles à flacons et systèmes - Google Patents

Dispositifs formant réceptacles à flacons et systèmes Download PDF

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Publication number
EP3554449B1
EP3554449B1 EP17880792.1A EP17880792A EP3554449B1 EP 3554449 B1 EP3554449 B1 EP 3554449B1 EP 17880792 A EP17880792 A EP 17880792A EP 3554449 B1 EP3554449 B1 EP 3554449B1
Authority
EP
European Patent Office
Prior art keywords
packaging holder
holder
secondary packaging
primary
primary packaging
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP17880792.1A
Other languages
German (de)
English (en)
Other versions
EP3554449A1 (fr
EP3554449A4 (fr
Inventor
Chaley LARSON
Kostadinka LILOVA
Mike Cannamela
William CAGNEY
Gordon KOSOVAN
Elaine Hughes
Maria FICCHI
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.)
Gyroscope Therapeutics Ltd
Original Assignee
Gyroscope Therapeutics Ltd
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
Priority claimed from US15/380,718 external-priority patent/US10206852B2/en
Application filed by Gyroscope Therapeutics Ltd filed Critical Gyroscope Therapeutics Ltd
Publication of EP3554449A1 publication Critical patent/EP3554449A1/fr
Publication of EP3554449A4 publication Critical patent/EP3554449A4/fr
Application granted granted Critical
Publication of EP3554449B1 publication Critical patent/EP3554449B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61J1/16—Holders for 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
    • B65D11/00—Containers having bodies formed by interconnecting or uniting two or more rigid, or substantially rigid, components made wholly or mainly of plastics material
    • B65D11/10—Containers having bodies formed by interconnecting or uniting two or more rigid, or substantially rigid, components made wholly or mainly of plastics material of polygonal cross-section and all parts being permanently connected to each other
    • 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
    • B65D25/00—Details of other kinds or types of rigid or semi-rigid containers
    • B65D25/20—External fittings
    • 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
    • B65D61/00—External frames or supports adapted to be assembled around, or applied to, articles
    • 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
    • B65D73/00—Packages comprising articles attached to cards, sheets or webs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A61J1/065—Rigid ampoules, e.g. glass ampoules
    • 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
    • A61J1/1475—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
    • A61J2205/00—General identification or selection means
    • A61J2205/30—Printed labels

Definitions

  • the present invention relates to devices and systems for use with vials and storage of a sterile product.
  • Vials containing agents, medicine, products or biological and/or chemical agents are fragile and require careful handling. Further, because common shapes of vials are cylindrical, it can be difficult to label the vials, for example, when vials are labeled in bulk. Specialized equipment or manual labor has been employed to label vials. However, current labelling of vials remains cumbersome and expensive. Further, the storage of bulk vials can require bulky equipment to make sure that the vials do not tip over and spill.
  • JP 2016 036415 A discloses a hanging case for a drip bag which facilitates sanitary, UV and electromagnetic control, covers the drip bag wholly, facilitates confirmation of a kind of liquid drug in the drip bag, and allows an outer face to function as a visual advertisement.
  • the case is composed of a shallow box-shaped body and lid allowing the drip bag to be hung and stored between lateral facing areas.
  • a secondary packaging holder for holding a primary packaging holder such as a sterile product, as recited in the claims.
  • the primary packaging holder can have a portion exposed outside of the secondary packaging holder based on a height relationship between the secondary packaging holder and the primary packaging holder.
  • the secondary packaging holder can be configured to snap fit to a neck of the primary packaging holder to securely and irreversibly hold the primary packaging holder.
  • the primary packaging holder can be a vial.
  • the plurality of apertures can be configured to allow air to flow into the secondary packaging holder.
  • a primary packaging holder can be “securely” held by a secondary packaging holder when the secondary packaging holder is sized to hold the primary packaging holder without allowing movement of the primary unit relative to the secondary packaging holder.
  • a secondary packaging holder can be “securely” held by a tertiary packaging holder when the tertiary packaging holder is sized to hold the secondary packaging holder without allowing movement of the secondary packaging holder relative to the tertiary packaging holder.
  • primary packaging holder is intended to have a broad meaning as, for example, a packaging unit or device configured to hold a sterile product and maintain sterility of the sterile product during handling, storage, and transportation.
  • second packaging holder is intended to have a broad meaning as, for example, a packaging unit or device configured to hold a primary packaging holder, in particular to securely and irreversibly hold the primary packaging holder.
  • secondary packaging holder is intended to have a broad meaning as, for example, a packaging unit or device configured to hold a secondary packaging holder, in particular to securely and irreversibly hold the secondary packaging holder.
  • non-enclosing is intended to have a broad meaning as, for example, a secondary and/or tertiary packaging holder is non-enclosing if at least a portion of the exterior of the primary packaging holder is accessible without disrupting the secondary and/or tertiary packaging holder.
  • direct access is intended to have a broad meaning as, for example, access to an interior space of a primary packaging holder without the need to open, disrupt or tamper with a secondary or tertiary packaging holder.
  • Fig. 1 shows an embodiment not according to the present invention.
  • Fig. 1 shows a perspective view of a packaging apparatus 100 for holding a sterile product.
  • the packaging apparatus 100 can include a secondary packaging holder 102 having a base 108 at a first end 104 and a receiving portion 110 at an opposing second end 106.
  • the secondary packaging holder 102 can be configured to receive and securely and irreversibly hold a primary packaging holder 120.
  • the packaging apparatus 100 can be configured to provide an area adapted for labeling and/or providing identification information, preferably, directed to primary packaging holder 120.
  • packaging apparatus 100 can include at least one substantially planar wall 114 that can extend from the first end 104 to the second end 106.
  • the at least one substantially planar wall 114 can be configured to affix an identifying label thereto.
  • An interior of the secondary packaging holder 102 can be configured to receive the primary packaging holder 120 and to snap fit to a neck 122 of the primary packaging holder 120 to securely and irreversibly hold the primary packaging holder 120.
  • the primary packaging holder 120 can be permanently secured in the secondary packaging holder 102.
  • the primary packaging holder 120 can have a portion 124 exposed outside of the secondary packaging holder 102. As shown, the exposed portion 124 can be based on a height relationship between the secondary packaging holder 102 and the primary packaging holder 120. This can allow for the secondary packaging holder 102 not to interfere with the integrity of a cap 128 of the primary packaging holder 120.
  • the height relationship between the secondary packaging holder 102 and the primary packaging holder 120 can also allow for the secondary packaging holder 102 not to interfere with removal of the cap 128.
  • the secondary packaging holder 120 when the primary packaging holder 120 is being securely and irreversibly held, an entirety of the cap 128 can be exposed outside the secondary packaging holder 102 allowing for removal of the cap 128. Further, product from the primary packaging holder 120 can also be removed without regard to interference from the secondary packaging holder 102.
  • the secondary packaging holder 102 can be made of plastic or other sturdy and resilient materials.
  • the secondary packaging holder 102 can be transparent or opaque.
  • at least one non-planar wall 112 can extend from a side of the base 108 different from the at least one substantially planar wall 114 of the secondary packaging holder 102.
  • the at least one non-planar wall 112 can extend from the first end 104 to the second end 106.
  • the secondary packaging holder 102 can allow for the primary packaging holder 120 to be thawed within the secondary packaging holder 102 in a variety of thaw mechanisms. For example, thawing can take place in a customized dry heater block to fit to the shape of the secondary packaging holder 102. Further, for example, thawing can take place in a saline bath or at room temperature.
  • Each of the non-planar walls 112 can outline an aperture 118 along a substantial portion of a longitudinal axis of the non-planar wall 112.
  • the aperture 118 can provide for direct access to the primary packaging holder 120.
  • the primary packaging holder 120 can include a sealable port 126 configured to enclose an interior space of the primary packaging holder 120 when sealed.
  • the sealable port can be sealed by the cap 128.
  • the secondary and tertiary packaging holders ( see Fig. 5 ) permit direct access to the interior space via the sealable port 126.
  • Fig. 1 shows an identifying label 113 affixed to the secondary packaging holder for illustration purposes. In some embodiments, however, the identifying label 113 is not part of the secondary packaging holder 102.
  • the identifying label 113 can be a primary label that can be used to identify the product of the primary packaging holder 120.
  • the identifying label can be permanently affixed to the secondary packaging holder 102.
  • the secondary packaging holder 102 can be a vial holder.
  • the secondary packaging holder 102 and the identifying label can be designed with tamper evident features.
  • the secondary packaging holder 102 can accept the primary packaging holder 120.
  • the primary packaging holder 120 can be a vial.
  • the vial can be a frozen, un-labeled product vial.
  • the vial can be without a label and the vial identification unique to that vial can be included on the label 113.
  • Various information about the vial and/or the vial contents can be included on the label, such as, lot number, serial number, etc.
  • Assembly of the primary packaging holder 120 into the secondary packaging holder 102 can be rapid and can be performed with gloved hands and/or tools. Based on the ability for the primary packaging holder 120 and the secondary packaging holder 102 to be assembled, the packaging apparatus 100 can allow for the allowable temperature exposure time for a drug product contained in the primary packaging holder 120 to not be exceeded.
  • the plurality of vials can be at a site of secondary packaging and distribution.
  • the assembly process can allow for advantages. With regard to supply chain, first, the packaging apparatus can move labelling operations outside a predetermined manufacturing time window. For example, a predetermined manufacturing time window can be three hours.
  • labeling can be co-located with the secondary packaging holder 102 and can be applied at the same time as the secondary packaging holder 102 receives the primary packaging holder 120.
  • inventive principles described herein investment of specialized labeler/robotics and serialization equipment and/or other machinery can be avoided or mitigated. Additionally, segregation of country-specific labeled product during long-term storage can be avoided or mitigated.
  • the packaging apparatus has additional commercial and regulatory advantages as well. For example, labeling for specific markets can occur closer to a customer. The labeling can be better aligned with forecast/orders and can allow for more flexibility for demand changes. Further, a label can be designed to meet country-specific regulatory and language requirements. Thus, the packaging apparatus can be multi-functional, can be user-friendly, and can include distinguished branding.
  • the packaging apparatus 100 allows for increased surface area for labeling. Further, the packaging apparatus 100 by having a substantially planar surface for which to affix the identifying label can provide for an improved label adhesion at room temperature.
  • the identifying label that the packaging apparatus is configured to affix can meet country-specific regulatory and language requirements for all markets. Information on the label can take on various forms including, for example, text and/or machine readable code, sensors, etc.
  • the identifying label can be adhesive. In another embodiment, the identifying label can be printed directly onto the substantially planar surface. In one embodiment, labeling of the secondary packaging holder can be performed either manually or in an automated way.
  • the packaging apparatus 100 allows for a customizable, injection mold design where many sizes and style options are possible.
  • the shape of the packaging apparatus can leverage cryo-cart or similar environment through an assembly operation for the handling of frozen drug product. Rapid, manual operation can be utilized to limit product exposure to ambient temperatures. Small, customized "batch operations" can be utilized using the packaging apparatus to fulfill regional orders as needed.
  • the vial can be permanently secured in the secondary packaging holder by means of a quick, "snap-fit" assembly.
  • the snap-fit assembly consists of the secondary packaging holder having shoulders that irreversibly snap fit at a neck 122 of a primary packaging holder 120.
  • the base of the secondary packaging holder 102 can provide for a stable presentation of the packaging apparatus 100.
  • the stable presentation can result from a lower center of gravity, for example, by a weight of the base.
  • Fig. 2 shows an exploded representation of a primary packaging holder 120 outside of a secondary packaging holder 102.
  • Fig. 3 shows a side view of the packaging apparatus 100.
  • Fig. 3 shows that the primary packaging holder 120 is in a received position of the secondary packaging holder 102.
  • the at least one substantially planar walls 114 can be in a rectangular shape that extends from a side of the base of the first end 104 to the second end 106.
  • Fig. 4 shows a cross section of Fig. 3 .
  • primary packaging holder 120 can make contact with a substantial portion of its exterior surface with an interior surface of the secondary packaging holder 102.
  • the secondary packaging holder 102 can include two substantially planar walls 114.
  • Fig. 5 shows another embodiment not according to the invention.
  • Fig. 5 shows a packaging system 200 for housing a sterile product that can include a secondary packaging holder 240 having a primary packaging holder-receiving portion 250 at a first end 246.
  • the secondary packaging holder 240 can be configured to securely and irreversibly hold a portion of a primary packaging holder 220 that is configured to hold a sterile product.
  • the packaging system 200 can also include a tertiary packaging holder 260 having a base 268 and having a secondary packaging holder receiving portion 270 at an opposing end 266 to the base 268.
  • the tertiary packaging holder can be configured to receive and securely and irreversibly hold the secondary packaging holder.
  • the tertiary packaging holder 260 can include at least one substantially planar wall 274 extending from the base 268 to the opposing end 266 of the tertiary packaging holder 260.
  • the at least one substantially planar wall 274 can have an exterior surface 213 configured to affix an identifying label thereto.
  • the tertiary packaging holder 260 can have two substantially planar walls 274.
  • the height relationship between the secondary packaging holder 240 and the primary packaging holder 220 can allow for the secondary packaging holder 240 to not interfere with removal of the cap 228 of the primary packaging holder 220.
  • the primary packaging holder 220 can have a portion exposed outside of the secondary packaging holder 240 to allow the secondary packaging holder 240 to not interfere with the integrity of the cap 228 of the primary packaging holder 220.
  • Cap 228 attaches to the top end 226 of primary packaging holder 220.
  • the height relationship between the secondary packaging holder 240 and the primary packaging holder 220 can allow for the secondary packaging holder 240 to interfere with removal of the cap 228.
  • the height of the secondary packaging holder 240 can be approximately the same as the height of the tertiary packaging holder 260.
  • the primary packaging holder receiving portion 250 can have a region 242 with at least a portion of an interior surface having an arc-shape.
  • the region 242 can be configured to receive and hold a primary packaging holder having a cylindrical shape.
  • the primary packaging holder can be a vial that houses a sterile product.
  • the secondary packaging holder 240 can be made of plastic or other sturdy and resilient materials.
  • the secondary packaging holder 240 can be transparent or opaque.
  • the secondary packaging holder 240 can have a base 248 at a second end 244 opposite to the first end 246, and at least one substantially planar wall 252 that extends from the first end 246 to the second end 244 of the secondary packaging holder 240.
  • the tertiary packaging holder 260 can be made of plastic or other sturdy and resilient materials.
  • the tertiary packaging holder 260 can be transparent or opaque.
  • the base 268 of the tertiary packaging holder 260 can be rectangular and the at least one substantially planar wall 274 of the tertiary packaging holder 260 can extend from at least one side of the base 268.
  • the at least one substantially planar wall of the tertiary packaging holder 260 can extend from the base 268 to the opposing end 266 of the tertiary packaging holder 260.
  • An interior surface of the at least one planar wall 274 of the tertiary packaging holder 260 can contact an exterior surface of the at least one surface of the secondary packaging holder 240.
  • two substantially planar walls 274 of the tertiary packaging holder 260 can extend from respective sides of the rectangular base 268 to the secondary packaging holder receiving portion 270. Further, two substantially planar walls 252 of the secondary packaging holder 240 can extend from the respective sides such that interior surfaces of the two substantially planar walls 274 of the tertiary packaging holder 260 can contact exterior surfaces of the two substantially planar walls 252 of the secondary packaging holder 240 in a received position.
  • two non-planar walls 272 of the tertiary packaging holder 260 can extend from other respective sides of the rectangular base 268 to the secondary packaging holder receiving portion 270.
  • Each of the non-planar walls 272 of the tertiary packaging holder 260 can outline an aperture 278 located in a middle section of each of the non-planar walls 272. Spacings 256 in between the two planar walls 252 of the secondary packaging holder 240 can overlap with the apertures 278 of the tertiary packaging holder 260 when the secondary packaging holder 240 is securely and irreversibly held.
  • the overlapped apertures and spacings allowing for direct access through the walls on the side to the primary packaging holder when the primary packaging holder 220 is securely and irreversibly held in the secondary packaging holder 240 and the tertiary packaging holder 260.
  • the apertures can allow for direct access to at least a portion of a side of the primary packaging holder 220 when the primary packaging holder 220 is securely and irreversibly held in the secondary packaging holder 240 and tertiary packaging holder 260.
  • the spacings 256 of the secondary packaging holder 240 can extend from the primary packaging holder receiving portion 250 to a lip 258 on the base.
  • the base 248 of the secondary packaging holder 240 along each of the spacings 256 can include a lip 258 that borders the base 248 and that extends along the longitudinal axis in between the planar surfaces.
  • the lip 258 of the secondary packaging holder 240 can be configured to contact an interior surface 251 of substantially arc-shaped walls of the tertiary packaging holder 260.
  • the secondary packaging holder 240 can be configured to snap fit into the tertiary packaging holder 260.
  • the primary packaging holder can be a necked cylinder, and the secondary packaging holder can have shoulders configured to irreversibly snap fit at a neck 222 of the primary packaging holder 220.
  • Other portions of the secondary packaging holder 240 and primary packaging holder 220 interacting are possible as well, including, for example, the base of the secondary packaging holder 240 snapping into the bottom portion of the primary packaging holder 220.
  • the packaging unit can include a sealable port 126 configured to enclose an interior space of the primary packaging holder when sealed.
  • the secondary and tertiary packaging holders permit direct access to the interior space via the sealable port 126.
  • the tertiary packaging holder can have an external profile configured to permit close packing of a plurality of tertiary packaging holders in at least two dimensions.
  • a packaging apparatus 300 for housing a sterile product can include a secondary packaging holder comprises a substantially cylindrical vial holder 312 having a receiving portion 310 at a first end 314 and a base 316 at a second opposing end.
  • the packaging apparatus 300 can include a label stand 318 that is adjacent to the substantially cylindrical vial holder 312.
  • the label stand 318 can have a cross-section shape that is different than a cross-section shape of the substantially cylindrical vial holder.
  • the label stand 318 can be a substantially non-uniform cross-section shape.
  • a portion of the label stand 318 cross-section shape can share an edge with the substantially cylindrical vial holder portion.
  • the label stand 318 cross section can be concave.
  • the height relationship between the secondary packaging holder 312 and the primary packaging holder 320 can allow for the secondary packaging holder 312 to not interfere with removal of the cap 328 of the primary packaging holder 320.
  • the primary packaging holder 320 can have a portion 324 exposed outside of the secondary packaging holder 312 to allow the secondary packaging holder 312 not to interfere with the integrity of cap 328 of the primary packaging holder 320.
  • the height relationship between the secondary packaging holder 312 and the primary packaging holder 320 can allow for the secondary packaging holder 312 to interfere with removal of the cap 328.
  • the packaging apparatus 300 can include lock-in units 317 that are disposed on an interior surface of the receiving portion 310.
  • the lock-in units 317 can be configured to lock in a vial 320 (see Fig. 7 ) once the vial 320 has been inserted into the cylindrical vial holder 312 a predetermined amount. For example, a predetermined amount can be until the vial has been inserted up until a neck 322 of the vial.
  • a predetermined amount can be until the vial has been inserted up until a neck 322 of the vial.
  • the substantially cylindrical vial holder 312 can have a height h that allows for a user to remove a vial holder lid after the vial has been locked-in.
  • the secondary packaging holder/vial holder 312 can include at least one region 315 of the base 316 that is configured to encircle a bottom portion of the primary packaging holder 320. For example, as shown in Fig. 6 , this region 315 of the base 316 borders an aperture of the secondary packaging holder 312.
  • the label stand 318 can be formed by a first wall 304 that is integral with the cylindrical vial holder 312 and that extends in a tangential plane from a longitudinal line at a first point along the cylindrical vial holder and a second wall 306 that is integral with the cylindrical vial holder and that extends in a tangential plane from a longitudinal line at a substantially opposing point than the first point along the cylindrical vial holder 312.
  • exterior surfaces of the first and second walls 304, 306 can include at least one substantially planar labelling surface 308 configured to affix an identifying label 313 thereto.
  • the first and second walls 304, 306 can join in a substantially rounded manner forming an arc-shaped curve.
  • the arc-shaped curve can have a circular portion that has a smaller arc-length than an arc-length of the cylindrical vial holder.
  • Fig. 7 shows an exploded view of the secondary packaging holder
  • Fig. 8 shows an alternative perspective of the exploded view of Fig. 7
  • Figs. 6-8 show label 313, it is to be understood that this is for illustrative purposes only and that label 313 is not part of the secondary packaging holder.
  • Fig. 9 shows a method of packaging a sterile product.
  • the method can include in step S110 providing a primary packaging holder.
  • the primary packaging holder can have a sterile interior space and a sealable port.
  • the method can include step S120 depositing a sterile product.
  • the step S120 can include depositing into the interior space through the port.
  • the method can include S130 sealing the port.
  • the port can be sealed by securing a cap on the primary packaging holder.
  • the method can further include S140 receiving the primary packaging holder through a receiving portion of a secondary packaging holder.
  • the method can further include S150 snapping fit the primary packaging holder to the secondary packaging holder.
  • the steps S140 and S150 can be such that the secondary packaging holder securely and irreversibly holds the primary packaging holder.
  • the method can further include S160 receiving the secondary packaging holder through a receiving portion of a tertiary packaging holder.
  • the step S160 can be such that the tertiary unit securely and irreversibly holds the secondary unit.
  • the tertiary packaging holder can include a substantially planar exterior surface that is configured to affix an identifying label thereto.
  • the method can include S170 snapping fit the secondary packaging holder to the tertiary packaging holder.
  • the method can further include step S180 affixing a label to the tertiary packaging holder.
  • the method can further include affixing an identifying label to the substantially planar exterior surface of the tertiary packaging holder.
  • the exterior surface can be substantially planar.
  • the identifying label can be an adhesive label.
  • the depositing a sterile product in the interior space can take place after securing the primary packaging holder to the secondary packaging holder.
  • the depositing a sterile product in the interior space can also occur after securing the secondary packaging holder to the tertiary packaging holder.
  • the packaging apparatus 1000 can include a secondary packaging holder 1002 that is configured to hold a primary packaging holder 1020.
  • the secondary packaging holder 1002 can have a substantially cuboid exterior shape.
  • the secondary packaging holder 1002 can be made of two halves 119A and 119B that can connect by means of a hinge pin 1088 near a base 1008 of the secondary packaging holder 1002.
  • the base 1008 can be square-shaped.
  • the hinge pin 1088 can be used to lock the two halves together.
  • Embodiments contemplate various configurations for locking the two halves together using the hinge pin such as, for example, pressing the two halves together or by pressing the hinge pin, for example, by a user.
  • the secondary packaging holder 1002 can have a circularly-shaped opening near a top portion to snap fit to a neck 1022 of the body and cap 1028 of the primary packaging holder 1020.
  • the secondary packaging holder 1002 can include one surface 1014 that may be substantially planar.
  • the surface 1014 can be configured such that a label 1013 can adhere thereto.
  • the secondary packaging holder 1002 can outline an aperture 1018 on one or more sides from the base 1008 to the receiving portion 1010.
  • the packaging apparatus 1100 can include a secondary packaging holder 1102 that has a circular base 1108 and a circular receiving portion 1110.
  • the base 1108 can have an outer diameter that substantially conforms to the outer diameter of a primary packaging holder 1120.
  • the receiving portion 1110 can have an inner diameter that substantially conforms to the outer diameter of the primary packing holder 1120.
  • the circular base 1108 can have a lower rim 1121 and an upper rim 1123.
  • the secondary packaging holder 1102 can connect the base 1108 to a receiving portion 1110 by means of a connecting portion 1117.
  • the connecting portion 1117 can extend from the base and have a generally planar portion or surface 1114 configured to receive a label 1113 thereto.
  • a gap 1118 between the primary packaging holder 1120 and the connecting portion 1117 of the secondary packaging holder 1102 can be more pronounced than the distance between the regions near the receiving portion 1110 and the base 1108.
  • the primary packaging holder 1120 has a cap 1128.
  • the secondary packaging holder 1102 can outline an aperture 1118 around a majority of the secondary packaging holder 1102 from the base 1108 to the receiving portion 1110.
  • the secondary packaging holder 1102 can secure the primary packaging holder 1120 by means of a ratchet pin 1190.
  • a ratchet pin 1190 can work by snapping the pin to lock, for example, by a user.
  • the ratchet pin 1190 can be located at the receiving portion 1110.
  • the packaging apparatus 1200 can include a secondary packaging holder 1202 that has a circular base 1208 and a circular receiving portion 1210.
  • the circular base 1208 has a diameter that is substantially larger than a diameter of a primary packaging holder 1220 that is configured to be received therein.
  • the receiving portion 1210 can have a diameter that is substantially larger than the outer diameter of the primary packaging holder 1220.
  • the secondary packaging holder 1202 can connect the base 1208 to the receiving portion 1210 by means of at least one side panel 1225.
  • the secondary packaging holder 1220 can be configured such that at least one aperture 1218 is formed between the base 1208 and the receiving portion 1210.
  • the primary packaging holder 1220 has a cap 1228.
  • the receiving portion can include a substantially planar region 1214 that is configured to receive at least one label 1213.
  • the base 1208 can include crush ribs 1296 that can allow for the secondary packaging holder 1202 to securely and tightly fit the primary packaging holder 1220.
  • Embodiments contemplate various configurations for locking the secondary packaging holder 1202. For example, the primary packaging holder 1220 can be pushed to interact with the crush ribs and thus lock the primary packaging holder 1220 inside the secondary packaging holder 1202.
  • the packaging apparatus 1300 can include a secondary packaging holder 1302 that has a circular base 1308 and a circular receiving portion 1310.
  • the base 1308 can have an inner diameter that substantially conforms to the outer diameter of a primary packaging holder 1320.
  • the receiving portion 1310 can have an inner diameter that substantially conforms to the outer diameter of the primary packing holder 1320.
  • the secondary packaging holder 1302 can connect the base 1308 to the receiving portion 1310 by means of at least one side panel 1325.
  • the secondary packaging holder 1302 can be configured such that at least one aperture 1318 is formed between the base 1308 and the receiving portion 1310.
  • the primary packaging holder 1320 has a cap 1328.
  • a region 1314 that spans at least a portion of a surface of the secondary packaging holder 1302 can be configured to adhere at least one label 1313 thereto.
  • the secondary packaging holder 1302 can have flex arms that slide and snap to lock the secondary packaging holder 1302.
  • Embodiments contemplates various configurations of using the flex arms to slide and snap to lock, thus securely and tightly fitting the primary packaging holder 1320 inside the secondary packaging holder 1302.
  • the packaging apparatus 1400 can include a secondary packaging holder 1402 that has at least a partially circular base 1408 and at least a partially circular receiving portion 1410.
  • the secondary packaging holder 1402 includes a stand 1494 that projects outwardly from a side of the secondary packaging holder 1402.
  • the stand 1494 can include at least one buttons or locking mechanisms 1492 that are configured to be snapped to lock the primary packaging holder 1420 inside the secondary packaging holder 1402.
  • the stand 1494 can include at least one substantially planar surface 1414 that is configured to receive at least one label 1413.
  • the primary packaging holder 1420 has a cap 1428.
  • Fig. 15 shows an alternative embodiment.
  • Fig. 15 shows a packaging system 1500 for having a sterile product that can include a secondary packaging holder 1501 configured to receive, permanently secure and irreversibly hold a primary packaging holder 1502.
  • the packaging system 1500 may also include an identifying label 1503 affixed to at least a portion of the secondary packaging holder 1501.
  • Fig. 16 shows an exploded view of the packaging system 1500.
  • the primary packaging holder 1502 can have a portion 1504 exposed outside of the secondary package holder 1501. This can allow for the secondary packaging holder 1501 to not interfere with the integrity of a cap 1505 of the primary packaging holder 1502 and allow for the removal of the cap 1505 from the primary packaging holder 1502.
  • the entire cap 1505 can be exposed outside of the secondary packaging holder 1501, thereby not interfering with the integrity of a cap 1505 and allowing for its removal.
  • the secondary packaging holder 150 1 can be made of plastic or other sturdy and resilient material, and it can be transparent or opaque.
  • the secondary packaging holder 1501 can comprise a body 1506 having an opening 1507 therethrough, a first plate 1508 configured to be securely inserted into a first end of the opening 1507 and a second plate 1509 configured to be placed into a second opposing end of the opening 1507.
  • the first and second plates 1508, 1509 can be capable of being assembled in cryogenic temperatures.
  • the body 1506 can comprise a top 1510, a bottom 1511, a first and second planar side wall 1512, 1513 extending from opposing ends of the bottom 1511 in parallel to opposing ends of the top 1510.
  • the body can also comprise four curved portions 1514, 1515, 1516, 1517 each configured to fixedly connect an end of the first planar side wall 1512 or the second planar side wall 1513 to an end of the top 1510 or bottom 1511.
  • the top 1510 can have a receiving portion 1533 for insertion of the primary packaging holder 1502 into the body 1506.
  • the receiving portion 1533 can be located in the middle of the top 1510.
  • the receiving portion 1533 can also be capable of at least partially securing the primary packaging holder 1502.
  • the receiving portion 1533 can have a size and/or shape equivalent to the primary packaging holder 1502.
  • the receiving portion 1533 can be in the shape of a circle to match the cylindrical shape of the primary packaging holder 1502.
  • an interior 1534 of the receiving portion 1533 can comprise a material, such as rubber, capable of assisting in partially securing the primary packaging holder 1502. The material can provide an airtight seal between the receiving portion 1533 and the primary packaging holder 1502.
  • the label 1503 can provide identifying information relating to at least one of a patient and a formulation contained in the primary packaging holder 1502.
  • the label 1503 can be adhered to at least one of the top 1510, curved portions 1514, 1515, first planar side wall 1512 and second planar side wall 1513 of the body 1506.
  • the label 1503 can have the same shape and/or size as the portion of the body that is being adhered to.
  • the label 1503 can also have a receiving portion matching the receiving portion 1533 of the body 1506.
  • the bottom 1511 of the body 1506 can comprise a plurality of openings 1521 configured to allow air to flow into the secondary packaging holder 1501.
  • the cavity or aperture 1521 can be arranged in a sequence across the bottom 1511.
  • the sequence of cavity or aperture 1521 can be arranged to provide an even disbursement of air into the primary packaging holder 1502.
  • the sequence of cavity or aperture 1521 can be arranged to direct air into a particular portion of the secondary packaging holder 1501 and/or onto a particular portion of the primary packaging holder 1502.
  • a number of the cavity or aperture 1521 can be configured to divert air in one or more predetermined directions. To do so, the cavity or aperture 1521 can be formed at an angle in the secondary packaging holder 1501.
  • cavity or aperture 1521 located in the middle of the bottom 111 can be configured to permit air to be released upwards towards the primary packaging holder 1502
  • the cavity or aperture 1521 located at the ends of the bottom 1511 can be configured to divert air towards the middle of the secondary packaging holder 1501 and onto the primary packaging holder 1502.
  • Fig. 17 shows a cross-sectional view taken along lines A-A of the body 1506.
  • the body 1506 can comprise a first and second supporting member 1535, 1536 configured to guide and support the primary packaging holder 1502 into the body 1506.
  • the first and second supporting members 1535, 1536 can extend from opposing ends of a portion of an interior surface 1537 of the body 1506.
  • the first and second supporting members 1535, 1536 can be flexible.
  • the first and second supporting members 1535, 1536 can be capable of snapping into a groove 1540 of the primary packaging holder 1502.
  • the first and second supporting members 1535, 1536 can extend from the curved portion 1514, 1515, respectively, at an angle to the outer boundaries of the receiving portion 1533 to intersect with the groove 1540 of the primary packaging holder 1502.
  • the first and second plates 1508, 1509 are configured to be securely inserted into opposing sides of the opening 1507 of the body 1506.
  • the first plate 1508 can comprise an outer edge 1522, a cover 1523 and an opening 1524 in a portion of the cover 1523.
  • the opening 1524 can be aligned with the receiving portion 1533 of the body 1506.
  • the cover 1523 can be slanted towards the location of the opening 1524. This can provi de a closer view of the primary packaging holder 1502.
  • the opening 1524 can comprise a transparent material, such as glass, acrylic, butyrate, Lexan, and PETG.
  • Fig. 18 shows an exploded view of an interior of the first plate 1508.
  • the first plate 1508 can comprise a lip 1525 extending from an interior portion 1526.
  • the lip 1525 can be configured to provide an airtight seal between the body 1506 (illustrated in Fig. 16 ) and the first plate 1508.
  • the lip 1525 can comprise the same or different material than the first plate 1508.
  • the first plate 1508 can comprise a plastic, whereas the lip 1525 can comprise a rubber.
  • the first plate 1508 can comprise a first securing feature 1527 configured to secure a portion of the primary packaging holder 1502 in the body 1506 (illustrated in Fig. 16 ).
  • the first securing feature 1527 can comprise an upper section 1528, an opposing lower section 1529 and a first and second planar side wall 1531, 1532 extending in parallel from opposing ends of the upper section 1528 to opposing ends of the lower section 1529.
  • the upper section 1528 can be configured to at least partially secure an upper portion of the primary packaging holder 1502. As shown, the upper section 1528 can have of an arc-shaped interior surface 1547 to at least partially secure and wrap around a neck 1519 of the secondary packaging holder 1501. The upper section 1528 can be configured to extend past, and reside above, the first and second supporting members 1535, 1536 (illustrated in Fig. 17 ).
  • the lower section 1529 can have the same or different shape and/or configuration as the upper section 1528. In contrast to the upper section 1528, the lower section 1529 can be configured to expose a bottom 1539 of the secondary packaging holder 1501 to the plurality of cavity or aperture 1521 (illustrated in Fig. 16 ). As shown, the lower section 1529 can have an arc-shaped interior surface 1538. The arc-shaped interior surface 1538 of the lower section 1529 can be smaller than the arc-shaped interior surface 1547 of the upper section 1528.
  • the lower section 1529 can be aligned to be directly below, and in the center of, the upper section 1528. The lower section 1529 can also be aligned such that at least one of the cavity or aperture 1521 resides directly below the arc-shaped interior surface 1538.
  • the second plate 1509 can also comprise a second securing feature 1542 that is the same or different than the first securing feature 1527 of the first plate 1508 (illustrated in Fig. 18 ).
  • the first and second securing features 1527, 1542 can capable of jointly securing and irreversibly holding the primary packaging holder 1502 in the secondary packaging holder 1501.
  • the second securing feature 1542 can have an upper section 1543 configured to at least partially secure the secondary packaging holder 1501.
  • the upper section 1543 can have an arc-shaped interior surface 1544 configured to wrap around a portion of the neck 1519 of the primary packaging holder 1502.
  • the second securing feature 1542 have a lower section 1545 configured to expose a bottom 1539 of the secondary packaging holder 1501 to the plurality of cavity or aperture 1521.
  • the lower section 1545 can have an arc-shaped interior surface 1546 smaller than the arch-shaped interior surface 1544 of the upper section 1543.
  • the second securing feature 1542 can comprise planar side walls 1548, 1549 extending in parallel from opposing ends of the upper section 1543 to opposing ends of the lower section 1545.
  • the primary packaging holder 1502 can be first inserted into the receiving portion 1533 of the body 1506 and, thereafter, the first and second plates 1508, 1509 can be inserted into opposing sides of the opening 1507 of the body 1506 of the secondary packaging holder 1501.
  • the secondary packaging holder 1402 can outline at least one aperture 1418 from the base 1408 to the receiving portion 1410.
  • the secondary packaging holder 1402 can include a flexible mesh. While Figs. 10-14 show labels 1013, 1113, 1213, 1313, 1413, respectively, the identifying labels are for illustrative purposes only and are not part of the secondary packaging holders 1002, 1102, 1202, 1302, 1402.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Packages (AREA)
  • Details Of Rigid Or Semi-Rigid Containers (AREA)

Claims (12)

  1. Réceptacle d'emballage secondaire (1501) pour contenir un réceptacle d'emballage primaire (1502), le réceptacle d'emballage secondaire (1501) comprenant :
    une première plaque (1508) conçue pour sécuriser une première extrémité d'une ouverture (1507) ; et
    une seconde plaque (1509) conçue pour sécuriser une seconde extrémité opposée de l'ouverture (1507) ;
    et
    la première plaque (1508) comprenant un premier élément de fixation (1527) et la seconde plaque (1509) comprenant un second élément de fixation (1542), les premier et second éléments de fixation (1527, 1542) pouvant fixer conjointement et contenir de manière irréversible le réceptacle d'emballage primaire (1502) dans le réceptacle d'emballage secondaire (1501) ; et caractérisé en ce que le second réceptacle d'emballage (1501) comprend en outre :
    un corps (1506) ayant l'ouverture (1507) au travers ;
    le corps (1506) comprenant une base (1511), une partie supérieure (1510) et une première et une seconde paroi plane (1512, 1513) s'étendant depuis les extrémités opposées de la base (1511) parallèlement aux extrémités opposées de la partie supérieure (1510), la base (1511) comprenant une pluralité de cavités ou d'ouvertures (1521), et la partie supérieure (1510) comprenant une partie de réception (1533) conçue pour recevoir le réceptacle d'emballage primaire (1502).
  2. Réceptacle d'emballage secondaire (1501) selon la revendication 1, le corps (1506) comprenant en outre un premier et un second élément de support (1535, 1536) conçus pour guider et supporter le réceptacle d'emballage primaire (1502) dans le corps (1506).
  3. Réceptacle d'emballage secondaire (1501) selon la revendication 2, les premier et second éléments de support (1535, 1536) s'étendant à partir des extrémités opposées d'une surface intérieure (1537) du corps (1506) .
  4. Réceptacle d'emballage secondaire (1501) selon la revendication 2 ou 3, les premier et second éléments de support (1535, 1536) étant flexibles.
  5. Réceptacle d'emballage secondaire (1501) selon la revendication 2 ou 3, les premier et second éléments de support (1535, 1536) pouvant s'encliqueter dans une rainure (1540) du réceptacle d'emballage primaire (1502).
  6. Réceptacle d'emballage secondaire (1501) selon la revendication 1 ou 2, les cavités ou ouvertures (1521) étant disposées dans un ordre dans la base (1511) du corps (1506).
  7. Réceptacle d'emballage secondaire (1501) selon la revendication 1 ou 6, l'une des cavités ou ouvertures (1521) étant conçue pour dévier l'air dans une direction différente de celle d'une autre des cavités ou ouvertures (1521).
  8. Réceptacle d'emballage secondaire (1501) selon la revendication 1 ou 2, chacun des premier et second éléments de fixation (1527, 1542) comprenant une section supérieure (1528, 1543) conçue pour fixer au moins partiellement une partie supérieure du réceptacle d'emballage primaire (1502).
  9. Réceptacle d'emballage secondaire (1501) selon la revendication 8, au moins une partie des sections supérieures (1528, 1543) se croisant.
  10. Réceptacle d'emballage secondaire (1501) selon la revendication 1 ou 2, chacun des premier et second éléments de fixation (1527, 1542) comprenant une section inférieure (1529, 1545) conçue pour exposer une partie inférieure (1539) du réceptacle d'emballage secondaire (1501) à la pluralité d'ouvertures (1521).
  11. Système d'emballage comprenant :
    un réceptacle d'emballage primaire (1502) ; et
    le réceptacle d'emballage secondaire (1501) selon l'une quelconque des revendications 1 à 10.
  12. Système d'emballage selon la revendication 11, comprenant en outre une étiquette (1503) conçue pour être apposée sur au moins une partie extérieure du réceptacle d'emballage secondaire (1501).
EP17880792.1A 2016-12-15 2017-12-06 Dispositifs formant réceptacles à flacons et systèmes Active EP3554449B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US15/380,718 US10206852B2 (en) 2014-12-18 2016-12-15 Vial holder devices and systems
PCT/US2017/064807 WO2018111632A1 (fr) 2016-12-15 2017-12-06 Dispositifs formant réceptacles à flacons et systèmes

Publications (3)

Publication Number Publication Date
EP3554449A1 EP3554449A1 (fr) 2019-10-23
EP3554449A4 EP3554449A4 (fr) 2019-10-30
EP3554449B1 true EP3554449B1 (fr) 2021-03-03

Family

ID=62559631

Family Applications (1)

Application Number Title Priority Date Filing Date
EP17880792.1A Active EP3554449B1 (fr) 2016-12-15 2017-12-06 Dispositifs formant réceptacles à flacons et systèmes

Country Status (3)

Country Link
EP (1) EP3554449B1 (fr)
AR (1) AR110530A1 (fr)
WO (1) WO2018111632A1 (fr)

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL118232A (en) * 1995-05-15 2001-07-24 Smithkline Beecham Corp Bottle holder
US6601720B2 (en) * 2000-09-28 2003-08-05 Gerber Products Company Nursing bottle
US7311205B2 (en) * 2005-01-25 2007-12-25 Target Brands, Inc. Pharmacy bottle system including label
US8230997B1 (en) * 2007-11-02 2012-07-31 Mcwilliams Glenn P Bottle support for packaging and shipping
US9327886B2 (en) * 2013-03-13 2016-05-03 Bayer Healthcare Llc Vial container with collar cap
JP2016036415A (ja) 2014-08-06 2016-03-22 株式会社コージン 点滴バッグの吊ケース
US10206852B2 (en) * 2014-12-18 2019-02-19 Orbit Biomedical Limited Vial holder devices and systems

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
None *

Also Published As

Publication number Publication date
WO2018111632A1 (fr) 2018-06-21
EP3554449A1 (fr) 2019-10-23
AR110530A1 (es) 2019-04-10
EP3554449A4 (fr) 2019-10-30

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