WO2024086108A1 - Flacons et procédés de remplissage de flacons - Google Patents

Flacons et procédés de remplissage de flacons Download PDF

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Publication number
WO2024086108A1
WO2024086108A1 PCT/US2023/035225 US2023035225W WO2024086108A1 WO 2024086108 A1 WO2024086108 A1 WO 2024086108A1 US 2023035225 W US2023035225 W US 2023035225W WO 2024086108 A1 WO2024086108 A1 WO 2024086108A1
Authority
WO
WIPO (PCT)
Prior art keywords
vial
cap
septum
primary
primary cap
Prior art date
Application number
PCT/US2023/035225
Other languages
English (en)
Inventor
Matthew G. CASURA
Michael A. Francis
Andrew M. QUICK
Randall S. Williams
Original Assignee
Colder Products Company
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 Colder Products Company filed Critical Colder Products Company
Publication of WO2024086108A1 publication Critical patent/WO2024086108A1/fr

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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

Definitions

  • This document relates to vials, caps for vials, and methods for filing vials.
  • this document relates to sterile vials with caps that are designed to enhance the efficiencies and logistics of the vial filling process.
  • a vial (also known as a phial or flacon) is a small glass or plastic vessel or bottle, often used to store medication as liquids, powders or capsules.
  • This document describes vials, caps for vials, and methods for filing vials.
  • this document describes sterile pharmaceutical vials with caps that are designed to enhance the efficiencies and flexibility of the logistics of the vial filling process.
  • fluid means any substance that can be made to flow including, but is not limited to, liquids, gases, granular or powdered solids, mixtures or emulsions of two or more fluids, suspensions of solids within liquids or gases, vapors, steam, mists, gels, semi-solids, etc.
  • this disclosure is directed to a pharmaceutical vial system that includes a vial comprising a rim that defines an opening to an interior of the vial; a primary cap comprising a peripheral portion configured to engage with the rim of the vial, the primary cap defining a second opening within the peripheral portion; and a cover removably attached to the primary cap and covering the second opening. The cover is removable from the primary cap to expose the second opening.
  • a pharmaceutical vial system may optionally include one or more of the following features.
  • the pharmaceutical vial system may also include a septum cap configured to be engaged with the primary cap.
  • the septum cap may include: a septum portion configured to be pierced by a syringe needle; a cap portion surrounding the septum portion; and a neck portion extending from the cap portion.
  • the neck portion may be configured to engage with the second opening of the primary cap.
  • the septum cap may also include an elastomeric seal arranged to seal against the primary cap when the septum cap is engaged with the primary cap.
  • the neck portion of the septum cap includes male threads and the primary cap includes corresponding female threads that define the second opening.
  • the pharmaceutical vial system may also include an elastomeric seal arranged to seal between the primary cap and the vial when the primary cap is engaged with the vial.
  • the primary cap may be configured to snap into engagement with the rim of the vial.
  • the cover may be made of a film or foil that is adhered to the primary cap.
  • the cover may be configured to be peeled off the primary cap.
  • the cover may include a tab extending away from the vial and configured to be grasped.
  • the pharmaceutical vial system may be sterile.
  • this disclosure is directed to a method of filling a vial with a pharmaceutical substance.
  • the method includes providing a pharmaceutical vial system that includes: a vial comprising a rim that defines an opening to an interior of the vial; a primary cap comprising a peripheral portion engaged with the rim of the vial, the primary cap defining a second opening within the peripheral portion; and a cover removably attached to the primary cap and covering the second opening to seal the interior of the vial.
  • the interior of the vial is sterile.
  • the method also includes removing, in a cleanroom environment, the cover from the primary cap to expose the second opening and the interior of the vial to the cleanroom environment; filling, in the cleanroom environment and through the second opening, at least a portion of the interior of the vial with the pharmaceutical substance; and engaging, in the cleanroom environment, a septum cap with the primary cap to seal the pharmaceutical substance within the vial.
  • the septum cap includes: a septum portion configured to be pierced by a syringe needle; a cap portion surrounding the septum portion; and a neck portion extending from the cap portion and into the second opening of the primary cap.
  • Such a method may optionally include one or more of the following features.
  • the septum cap may be sterile during the engaging with the primary cap.
  • the step of removing the cover from the primary cap may include peeling the cover off the primary cap.
  • the step of engaging the septum cap with the primary cap may include threading the septum cap into engagement with the primary cap.
  • the step of engaging the septum cap with the primary cap may include snapping the septum cap into engagement with the primary cap.
  • the vial can be received to the filling process area or machine in a configuration such that the interior of the vial is sealed and sterile. Accordingly, in some cases no cleaning of the vial (prior to filling the vial with the pharmaceutical substance) is required.
  • the seal can be removed from the vial in a cleanroom environment just prior to the filling step. Then, after infilling the pharmaceutical substance into the vial, a septum cap can be engaged with the vial to seal the pharmaceutical substance therein.
  • the septum cap can be sterile and can be engaged with the vial in the cleanroom environment. Accordingly, the finished vial that is filled with the pharmaceutical substance can be made in an efficient manner.
  • components of the pharmaceutical vial systems described herein can be designed for ease-of-use.
  • a primary cap of the system can be designed to snap into engagement with a vial.
  • the seal can be readily peeled off the primary cap.
  • the primary cap and/or the septum cap can have seals so that the pharmaceutical vial systems described herein are liquid tight and prevent ingress of biological contamination.
  • the designs described herein allow the vial washing process to be separated from the filling process, adding flexibility to the manufacturing and logistics of the processes.
  • FIG. 1 is a perspective view of an example vial with an example snap-on cap that includes a removable cover in accordance with some embodiments.
  • FIG. 2 is a longitudinal cross-sectional view of the vial and cap of FIG. 1.
  • FIG. 3 is a perspective view of an example vial cap with a septum in accordance with some embodiments.
  • FIG. 4 is a longitudinal cross-section view of vial cap of FIG. 3.
  • FIG. 5 is perspective view of the vial cap of FIG. 3 engaged with the vial of FIG. 1.
  • FIG. 6 is a longitudinal cross-section view of the vial and vial cap of FIG. 5.
  • FIG. 7 is a longitudinal cross-section view of another vial and an example vial- filling coupling in accordance with some embodiments.
  • FIG. 8 shows the vial-filling coupling and vial of FIG. 7 with the vial-filling coupling in position on the vial in preparation for filling the vial.
  • FIG. 9 shows the vial-filling coupling and vial of FIG. 7 with a needle of the vial- filling coupling pierced through the septum of the vial-filling coupling and the septum of the vial, and fluid being filled into the vial.
  • FIG. 10 shows the vial-filling coupling and vial of FIG. 7 separated from each other after the filling of the vial.
  • the vial system 100 includes a vial 110, a primary cap 120, and a cover 130.
  • the vial 110 can be made of any suitable material including, but not limited to, glass, polymers, and metals, without limitation.
  • the vial 110 can be used to contain pharmaceuticals, other medical fluids such as blood or saline, powders, liquids, and so on.
  • the vial 110 can be used to protect any material from contamination.
  • the vial 110 is used to maintain the sterility of its contents.
  • the depicted vial system 100 is sterile.
  • the vial 110 includes a rim 112 that defines an opening to an interior 114 of the vial 110.
  • the primary cap 120 includes a peripheral portion that is engaged with the rim 112 of the vial 110. In this example, the primary cap 120 can be snapped into engagement with the rim 112.
  • the primary cap 120 has a plurality of flexible tabs encircling the open end of the primary cap 120 by which the primary cap 120 can be snapped into engagement with the rim 112.
  • the primary cap 120 can be made of a thermoplastic, metal, and any other suitable material. In some embodiments, there is a fluid seal positioned between the primary cap 120 and the vial 110.
  • the primary cap 120 defines an opening 122 within the peripheral portion of the primary cap 120.
  • the opening 122 is defined by female threads.
  • the cover 130 is removably attached to the primary cap 120.
  • the cover 130 is positioned to cover the opening 122 of the primary cap 120, and to seal the interior 114 of the vial 110 closed.
  • the cover 130 is a film or metal foil that is adhered to the primary cap 120.
  • the cover 130 is integrated with the primary cap 120 so that the primary cap 120 can be manufactured (e g., molded) to include a tear-away portion that functions like the cover 130.
  • the cover 130 includes a tab 132 extending away from the vial 110.
  • the tab 132 can be grasped in order to peel the cover 130 of from the primary cover 120.
  • the vial system 100 also includes a septum cap 140.
  • the septum cap 140 includes a central septum portion 142 that is elastomeric and configured to be pierced by a syringe needle in order to access a material within the interior 114 of vial 110. The septum cap 140 can be engaged with the primary cap 120 after the cover 130 is removed.
  • the septum cap 140 also includes a cap portion 144 that surrounds the septum cap 140.
  • a neck portion 146 extends from the cap portion 144.
  • the neck portion 146 includes a male thread that is configured to be threaded into engagement with the female thread of the primary cap 120 (as best seen in FIG. 6).
  • the septum cap 140 can be engaged with the primary cap 120 in other ways such as, but not limited to, snapping into engagement, ratcheting into engagement, and the like.
  • the septum cap 140 also includes a seal member 148 that fluidly seals between the septum cap 140 and the primary cap 120. Further, in the depicted embodiment the septum cap 140 also includes one or more engagement features 149. The one or more engagement features 149 can be used to manipulate the septum cap 140 into secure engagement with the primary cap 120. In the depicted embodiment, the one or more engagement features 149 are recess(es) in the top of the septum cap 140. Other types of engagement features can be included such as, but not limited to, flats, knurling, slots, and the like.
  • a method can be used to fill the vial 110 of the vial system 100.
  • Such a method can include removing, in a cleanroom environment, the cover 130 from the primary cap 120 to expose the second opening 122 and the interior 114 of the vial 110 to the cleanroom environment.
  • the vial system 100 is sterile (or at least the interior 114 of the vial 110 is sterile) at the point that the cover 130 is removed in the cleanroom environment.
  • the method can include filling, in the cleanroom environment and through the second opening 112, at least a portion of the interior 114 of the vial 110 with the pharmaceutical substance (or whatever substance is to be filled into the interior 114 of the vial 110).
  • the method includes engaging, in the cleanroom environment, the septum cap 140 with the primary cap 120 to seal the pharmaceutical substance within the vial 110.
  • no cover 130 is included. Instead, the septum cap 140 would be removed from the primary cap 120, then the vial 110 would be filled, and then the septum cap 140 would be replaced into engagement with the primary cap 120.
  • the primary cap 120 and the septum cap 140 can be manufactured (e.g., molded) as a single component (e.g., with a living hinge between them).
  • the septum cap 140 includes female threads and the primary cap 120 includes male threads.
  • FIGs. 7-10 are a sequence of illustrations that depict the use of an example vial- filling coupling 200 to fill an example vial 300.
  • the vial-filling coupling 200 includes a septum 210.
  • the vial 300 includes a septum 310.
  • the depicted process of filling the vial 300 using the vial-filling coupling 200 can be performed in a sterile manner without requiring a sterile environment or isolator.
  • the vial-filling coupling 200 includes the septum 210, a housing 220, an injection member 230, a needle 240, a spring 250, a latch 260, a seal 270, and a retainer 280.
  • the needle 240 is fixedly attached to, and extends from, the injection member 230.
  • the injection member 230 includes a connection site (e.g., a barbed fitting in this example) to which a tube or other type of fluid conduit can be attached.
  • the septum 210 is fixedly attached to the housing 220.
  • the septum 210 and/or the septum 310 includes an annular sealing projection that extends from the outer surface of the septum 210/310.
  • an annular sealing projection can help facilitate a leak-resistant fluid seal between the septums 210 and 310 when the two septums 210/310 are in contact with each other (e.g., as shown in FIGs. 8 and 9).
  • the injection member 230 is movably coupled in relation to the housing 220. That is, the injection member 230 is longitudinally translatable between a retracted configuration (FIGs. 7 and 10) and an extended configuration (FIGs. 8 and 9). In the retracted configuration, the tip of the needle 240 (and the entire needle 240) is fully within the housing 220 (where it can stay sterile). In the extended configuration, a tip portion of the needle 240 extends through the septum 210 and out of the housing 220. If the vial-filling coupling 200 is engaged with the vial 300 as the needle 240 is transitioned to its extended configuration, the needle 240 will pierce both the septum 210 and the septum 310 of the vial 300 (as shown in FIG. 9). In that configuration, a fluid 400 can be injected into the vial 300 via the vial-filling coupling 200.
  • the latch 260 is movably coupled to the housing 220.
  • the latch 260 includes a portion that releasably engages with a groove defined by the injection member 230. Accordingly, the latch 260 is reconfigurable relative to the housing 220 between (i) a latched position (as shown in the FIGs. 7-10) in which the injection member 230 is retained by the latch 260 in either its extended or retracted configuration, and (ii) an unlatched position (when a thumb pad of the latch 260 is depressed toward the housing 220 to disengage the latch 260 from the groove of the injection member 230) in which the injection member 230 is free to translate relative to the housing 220.
  • the latch 260 is spring biased toward its latched position.
  • the portion of the latch 260 that engages with the groove of the injection member 230 is beveled so that simply pushing the injection member 230 toward its extended configuration will cause the latch 260 to become disengaged from the groove of the injection member 230.
  • the spring 250 acts between the housing 220 and the injection member 230, and thereby biases the injection member 230 toward its retracted configuration.
  • the spring 250 is in the interior space defined by the housing 220 (between the septum 210 and the seal 270).
  • the retainer 280 limits the travel of the injection member 230 to go no farther than its retracted configuration.
  • the seal 270 in combination with the septum 210 keeps the interior space of the housing 220 (in which the needle 240 resides while the injection member 230 is in its retracted configuration) clean and/or sterile.
  • the seal 270 is disposed between the housing 220 and the injection member 230.
  • the seal 270 can be coupled within a groove defined by the injection member 230 or by the housing 220.
  • the vial-filling coupling 200 includes a second latch that can serve to releasably couple the vial-filling coupling 200 to the vial 300.

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  • 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)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

L'invention concerne un système de flacon comprenant : un flacon comprenant un rebord qui définit une ouverture vers l'intérieur du flacon ; un capuchon primaire comprenant une partie périphérique conçue pour venir en prise avec le rebord du flacon, le capuchon primaire définissant une seconde ouverture à l'intérieur de la partie périphérique ; et un couvercle fixé de manière amovible au capuchon primaire et recouvrant la seconde ouverture, le couvercle pouvant être retiré du capuchon primaire pour dégager la seconde ouverture.
PCT/US2023/035225 2022-10-18 2023-10-16 Flacons et procédés de remplissage de flacons WO2024086108A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202263417152P 2022-10-18 2022-10-18
US63/417,152 2022-10-18

Publications (1)

Publication Number Publication Date
WO2024086108A1 true WO2024086108A1 (fr) 2024-04-25

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ID=90738224

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2023/035225 WO2024086108A1 (fr) 2022-10-18 2023-10-16 Flacons et procédés de remplissage de flacons

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WO (1) WO2024086108A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20010025672A1 (en) * 1998-02-26 2001-10-04 Thibault Jean Claude Vial transferset and method
US6499617B1 (en) * 2000-07-17 2002-12-31 Brocco Diagnostics, Inc. Rotary seal stopper
US20060091098A1 (en) * 2002-08-16 2006-05-04 Jacques Thilly Closure system for a vial, vial, method of closing and filling a vial and stand for a vial
US20140209603A1 (en) * 2011-06-08 2014-07-31 Antoine Aneas Stopping device and container comprising such a device
US10315808B2 (en) * 2015-10-28 2019-06-11 Greif International Holding Bv Container closure cap and container closure

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20010025672A1 (en) * 1998-02-26 2001-10-04 Thibault Jean Claude Vial transferset and method
US6499617B1 (en) * 2000-07-17 2002-12-31 Brocco Diagnostics, Inc. Rotary seal stopper
US20060091098A1 (en) * 2002-08-16 2006-05-04 Jacques Thilly Closure system for a vial, vial, method of closing and filling a vial and stand for a vial
US20140209603A1 (en) * 2011-06-08 2014-07-31 Antoine Aneas Stopping device and container comprising such a device
US10315808B2 (en) * 2015-10-28 2019-06-11 Greif International Holding Bv Container closure cap and container closure

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