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JP-7855100-B2 - Gas-permeable sealing member and assembly method for drug containers

JP7855100B2JP 7855100 B2JP7855100 B2JP 7855100B2JP-7855100-B2

Inventors

  • チェン－チー・チョウ
  • ミン－ダー・ユー
  • レンヨ・フォーング
  • ワエル・ミスマー

Assignees

  • アムジエン・インコーポレーテツド

Dates

Publication Date
20260507
Application Date
20250226
Priority Date
20170721

Claims (7)

  1. A container assembly, A container having an internal volume and an end surface, wherein the opening is formed on the end surface and communicates with the internal volume, A septum including a proximal end and an distal end, A container assembly comprising a septum, wherein the base portion extends through the opening into the internal volume of the container, the tip portion includes a flange positioned outside the base portion and a tip-side opposing end surface configured to be penetrated or pierced by a needle, at least the end portion of the flange contacts the end surface of the container and is made of a first material, and at least the base portion and the tip-side opposing end surface are made of a second material, the first material being permeable to a gaseous sterilizer and the second material being less permeable to the gaseous sterilizer than the first material.
  2. The container assembly according to claim 1, wherein the gaseous sterilizer comprises at least one of ethylene oxide or vapor.
  3. The container assembly according to claim 1, wherein the tip of the septum is entirely made from the second material, except for the end portion of the flange.
  4. The container assembly according to claim 1 , wherein a portion of the tip of the septum is made of a second material.
  5. A container assembly according to any one of claims 1 to 4, comprising a stopper slidably disposed within the internal volume of the container, and a drug disposed between the stopper and the septum.
  6. A container assembly according to any one of claims 1 to 5, comprising a fluoropolymer film that completely covers the septum, in addition to the base-side opposing surface of the end portion of the flange and the outer peripheral surface of the end portion of the flange.
  7. A container assembly according to any one of claims 1 to 6, comprising a fastener that engages with the opposing tip surface of the septum and the outer surface of the container to fix the flange to the end surface of the container, wherein the fastener allows the gaseous sterilizer to pass through.

Description

Cross-reference of related applications: Priority is claimed in the specification of U.S. Provisional Patent Application No. 62/535,777, filed on 21 July 2017, and its entirety is expressly incorporated herein by reference. This disclosure relates, in general, to drug containers, and more specifically, to the assembly and sterilization of such containers in dispensing. Many drug containers or vials contain an opening covered by a septum, sometimes called a stopper. The septum can typically be punctured with a needle or other sharp object to seal the drug within the container and provide fluid communication with the drug. Conventional septums are typically constructed from materials with very low gas permeability and/or water permeability to prevent the ingress of contaminants and leakage of the drug composition. Nevertheless, a risk of contamination exists along the interface where the septum contacts the container. Some drug containers are filled under sterile or aseptic conditions, sealed with a septum, and then stored in medical-grade packaging until use by the patient or healthcare provider. Under these circumstances, the risk of contamination at the interface between the septum and the container is low. In other situations, drug containers may be exposed to non-sterile or non-aseptic conditions during the filling process, creating a risk of contamination at the interface between the septum and the container after the filling process. One such situation is when a manufacturer attaches a pre-filled drug container to a drug delivery device, such as a wearable injector or pen-type injector, for the purpose of creating a pre-filled and pre-loaded drug delivery device. Contamination can occur, for example, during transport of the pre-filled drug container between the filling facility and the attachment facility, and/or within the area of the attachment facility that is not operating under sterile or aseptic conditions. To address this contamination risk, manufacturers often sterilize the drug delivery device near the end of the assembly process. However, at this stage, the available sterilization methods may be limited. This is because certain sterilization methods may have adverse effects on the drug in the container and/or the materials used to construct the container. Radiation sterilization (e.g., gamma ray sterilization or electron beam sterilization) can cause oxidation of the drug and/or discoloration of the glass of the container. Gas sterilization methods such as ethylene oxide (EtO) and steam treatment may not cause damage to the drug or container material, but they are often ineffective in killing bacteria or spores inoculated at the interface between the conventional septum and the container. Conventional septums have very low gas permeability, preventing gaseous disinfectants from reaching the interface between the septum and the container. Even prolonged ethylene oxide treatment (e.g., up to 30 hours) has been found ineffective in sterilizing the interface between the conventional septum and the container. Furthermore, prolonged ethylene oxide treatment presents significant manufacturing challenges, as it requires extended aeration cycles (e.g., 30–60 days) to extract residual ethylene oxide from other components of the container and drug delivery device. A schematic cross-sectional view of one embodiment of a drug delivery device based on the principles of this disclosure is shown.Figure 1 shows an exploded view of the container assembly, with the container and stopper shown in a cross-sectional view.Figure 2A shows an assembly diagram of the container assembly, with the container, stopper, and fasteners shown in cross-sectional view.Figures 1 to 2B show top perspective views of the septum.Figure 3A is a bottom perspective view of the septum.This is a cross-sectional view of one embodiment of a septum constructed in accordance with the principles of this disclosure.This is a cross-sectional view of another embodiment of a septum constructed in accordance with the principles of this disclosure.This is a cross-sectional view of yet another embodiment of a septum constructed in accordance with the principles of this disclosure.This is a cross-sectional view of yet another embodiment of a septum constructed in accordance with the principles of this disclosure.This is a partial cross-sectional view of an embodiment of the septum shown in Figure 5, which is coated with a resin film.An exploded view of another embodiment of the container assembly is shown, with the container, stopper, and annular sealing member shown in cross-sectional view.Figure 9A shows an assembly diagram of the container assembly, with the container, stopper, annular sealing member, and fasteners shown in cross-sectional view.Figures 9A and 9B show upper perspective views of the annular sealing member. This disclosure generally relates to protecting drugs stored in containers (e.g., vials or ampoules) from microorganisms and oth