# US 11,305,026 B2 · Systems and approaches for sterilizing a drug delivery device

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- Number: US 11,305,026 B2
- Document ID: US11305026B2
- Status: Granted
- Kind: B2
- Application number: 16/179,450
- Filed: 2018-11-02
- Published: 2019-05-09
- Granted: 2022-04-19
- Earliest claimed: 2017-11-03
- Assignees: Amgen Inc.
- Applicants: Amgen Inc.
- Inventors: Loic Barbedette; Shaun Devitt; Wael Mismar
- Web page: https://patentgrep.com/patent/US11305026B2

## CPC

- A61L 2/08: Radiation
- A61L 2/081: Gamma radiation
- A61L 2/087: Particle radiation, e.g. electron-beam, alpha or beta radiation
- A61L 2/26: Accessories
- A61M 5/008: {Racks for supporting syringes or needles}
- A61M 5/285: {with sealing means to be broken or opened}
- B65B 3/003: {Filling medical containers such as ampoules, vials, syringes or the like}
- B65B 55/08: by irradiation
- G21F 1/02: Selection of uniform shielding materials
- G21F 1/06: Ceramics; Glasses; Refractories (cermets G21F1/08)
- G21F 1/08: Metals; Alloys; Cermets, i.e. sintered mixtures of ceramics and metals
- A61L 2103/23: {Containers other than laboratory or medical, e.g. bottles or mail}
- A61M 5/001: {Apparatus specially adapted for cleaning or sterilising syringes or needles}
- A61M 5/002: {Packages specially adapted therefor, e.g. packages for syringes or needles or kits for diabetics}
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- B65B: MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING (bundling and pressing devices for cigars A24C1/44; devices for tensioning and securing binders adapted to be supported by the article or articles to be bound B25B25/00; applying closure members to bottles, jars or similar containers B67B1/00-B67B6/00; concurrent cleaning, filling and closing of bottles B67C7/00; emptying bottles, jars, cans, casks, barrels or similar containers B67C9/00)
- G21F: PROTECTION AGAINST X-RADIATION, GAMMA RADIATION, CORPUSCULAR RADIATION OR PARTICLE BOMBARDMENT; TREATING RADIOACTIVELY CONTAMINATED MATERIAL; DECONTAMINATION ARRANGEMENTS THEREFOR (radiation protection by pharmaceutical means A61K8/00, A61Q17/04; in cosmonautic vehicles B64G1/54; combined with a reactor G21C11/00; combined with X-ray tubes H01J35/16; combined with X-ray apparatus H05G1/02)

## Abstract

A shielding member for use in sterilizing drug container assemblies includes a housing. The housing includes a first shielding portion and a second shielding portion. The first shielding portion includes a first and second surfaces and a plurality of first bore portions extending between. The second shielding portion having a first and second surfaces and a plurality of second bore portions corresponding to and aligned with the plurality of first bore portions. The first and second bore portions cooperate to form a plurality of receptacles including a plurality of openings in the first surface of the first shielding portion of the housing. The receptacles are sized and configured to receive drug container assemblies, each comprising a container with a container contact region and a seal member disposed adjacent the container contact region to seal the contents of the container at a sealing interface, such that each drug container assembly is exposed out of the housing through one of the openings.

## Claims

### Claim 1

An irradiation shielding member for use in sterilizing a portion of each of the plurality of drug container assemblies by irradiation, the irradiation shielding member comprising:
a housing comprising a first shielding portion and a second shielding portion,
the first shielding portion including a first surface, a second surface opposite the first surface, and a plurality of first bore portions extending between the first and second surfaces,
the second shielding portion having a first surface and a second surface opposite the first surface, the first surface of the second shielding portion coupled to the second surface of the first shielding portion, and a plurality of second bore portions corresponding to and aligned with the plurality of first bore portions,
wherein the first and second bore portions cooperate to form a plurality of receptacles including a plurality of openings in the first surface of the first shielding portion of the housing,
the plurality of receptacles sized and configured to receive the plurality of drug container assemblies, each of the plurality of drug container assemblies comprising a container with a drug contacting surface, a drug contact region, and a seal member disposed adjacent the container contact region to seal the contents of the container at a sealing interface, such that each of the plurality of drug container assemblies is exposed out of the housing through the openings and the container contact region and at least a portion of the seal member are disposed within the first bore portions,
wherein the irradiation shielding member is configured to permit sterilization by an irradiation exposure of the sealing interface of each of the plurality of container assemblies while restricting sterilization by the irradiation exposure to the drug contacting surface of each of the plurality of container assemblies, the irradiation exposure is non-parallel relative to the first surface of the first shielding portion;
wherein the first shielding portion is a single component; and
wherein each of the plurality of first bore portions has a first diameter, and each of the plurality of second bore portions has a second diameter that is greater than the first diameter.

### Claim 2 (depends on 1)

The irradiation shielding member of claim 1, wherein the first shielding portion forms a blocking region to restrict a sterilizing beam from impacting the container during sterilization.

### Claim 3 (depends on 1)

The irradiation shielding member of claim 1, wherein the housing is constructed from a material or materials with atomic elements having low atomic numbers.

### Claim 4 (depends on 1)

The irradiation shielding member of claim 1, wherein the housing is constructed of aluminum, a ceramic, boron nitride, a polymer, polyethylene, or acrylonitrile butadiene styrene.

### Claim 5 (depends on 1)

The irradiation shielding member of claim 1, wherein the first and second shielding portions are integrally connected.

### Claim 6 (depends on 1)

The irradiation shielding member of claim 1, wherein the first and second shielding portions are separate components.

### Claim 7 (depends on 6)

The irradiation shielding member of claim 6, wherein the first and second shielding portions are removably attached with one or more fasteners, couplers, hinges, and/or clasping devices.

### Claim 8 (depends on 1)

The irradiation shielding member of claim 1, wherein the housing defines a shoulder at the interface between the first shielding portion and the second shielding portion, the shoulder for restricting propagation of a sterilizing beam during sterilization.

### Claim 9 (depends on 1)

The irradiation shielding member of claim 1, wherein each of the receptacles has a longitudinal axis equal to a longitudinal axis of the drug container assemblies.

### Claim 10 (depends on 1)

The irradiation shielding member of claim 1, wherein the first surface of the second shielding portion is removably coupled to the second surface of the first shielding portion.

### Claim 11

An irradiation shielding member for use in sterilizing a portion of a drug container assembly by irradiation, the irradiation shielding member comprising:
a housing comprising a first shielding portion and a second shielding portion,
the first shielding portion including a first surface, a second surface opposite the first surface, and a first bore portion extending between the first and second surfaces, the first bore portion being cylindrical,
the second shielding portion having a first surface and a second surface opposite the first surface, the first surface of the second shielding portion coupled to the second surface of the first shielding portion, and a second bore portion corresponding to and aligned with the first bore portion,
wherein the first and second bore portions cooperate to form a receptacle including an opening in the first surface of the first shielding portion of the housing,
the receptacle sized and configured to receive a drug container assembly comprising a container with a drug contacting surface, a container contact region, and a seal member disposed adjacent the container contact region to seal the contents of the container at a sealing interface, such that the drug container assembly is exposed out of the housing through the opening and the container contact region and at least a portion of the seal member are disposed within the first bore portion,
wherein the irradiation shielding member is configured to permit sterilization by an irradiation exposure of the sealing interface of the container assembly while restricting sterilization by the irradiation exposure to the drug contacting surface of the container assembly, the irradiation exposure is non-parallel relative to the first surface of the first shielding portion;
wherein the first shielding portion is a single component; and
wherein each of the plurality of first bore portions has a first diameter, and each of the plurality of second bore portions has a second diameter that is greater than the first diameter.

### Claim 12 (depends on 11)

The irradiation shielding member of claim 11, wherein the first shielding portion forms a blocking region to restrict a sterilizing beam from impacting the container during sterilization.

### Claim 13 (depends on 11)

The irradiation shielding member of claim 11, wherein the housing is constructed from a material or materials with atomic elements having low atomic numbers.

### Claim 14 (depends on 11)

The irradiation shielding member of claim 11, wherein the housing is constructed of aluminum, a ceramic, boron nitride, a polymer, polyethylene, or acrylonitrile butadiene styrene.

### Claim 15 (depends on 11)

The irradiation shielding member of claim 11, wherein the first and second shielding portions are integrally connected.

### Claim 16 (depends on 11)

The irradiation shielding member of claim 11, wherein the first and second shielding portions are separate components.

### Claim 17 (depends on 16)

The irradiation shielding member of claim 16, wherein the first and second shielding portions are removably attached with one or more fasteners, couplers, hinges, and/or clasping devices.

### Claim 18 (depends on 11)

The irradiation shielding member of claim 11, wherein the housing defines a shoulder at the interface between the first shielding portion and the second shielding portion, the shoulder for restricting propagation of a sterilizing beam during sterilization.

### Claim 19 (depends on 11)

The irradiation shielding member of claim 11, wherein the receptacle has a longitudinal axis equal to a longitudinal axis of the drug container assembly.