# US 2021/0330552 A1 · Sterilization fluid path with barrier removal

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- Number: US 2021/0330552 A1
- Document ID: US20210330552A1
- Status: Published application
- Kind: A1
- Application number: 17/369,666
- Filed: 2021-07-07
- Published: 2021-10-28
- Earliest claimed: 2018-03-08
- Assignees: Flex Ltd.
- Applicants: Flex Ltd.
- Inventors: Eyal BARMAIMON; Lior SHTRAM; Shai FINKMAN; Christian RIVA; Tommaso BORGHI; David WARD
- Web page: https://patentgrep.com/patent/US20210330552A1

## CPC

- A61J 1/1443: {Containers with means for dispensing liquid medicaments in a filtered or sterile way, e.g. with bacterial filters}
- A61L 2/07: Steam
- A61L 2/18: Liquid substances
- A61L 2/20: Gaseous substances, e.g. vapours
- A61L 2/26: Accessories
- A61M 5/14248: {of the skin patch type}
- A61L 2103/15: Laboratory, medical or dentistry appliances, e.g. catheters or sharps
- A61L 2103/23: {Containers other than laboratory or medical, e.g. bottles or mail}
- A61L 2202/18: Aseptic storing means
- A61M 2005/14252: {with needle insertion means}
- A61M 2005/14573: {with a replaceable reservoir for quick connection/disconnection with a driving system}
- 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
- 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)}

## Abstract

A device and method is disclosed for assembling a container holder in a clean environment, aseptically adding a solution to a primary container, inserting the primary container into the container holder, applying a first barrier to the container holder, sterilizing the container holder comprising the primary container and the applied first barrier to provide a sterilized container holder, assembling a fluid path module in a clean environment, the assembling comprising applying a second barrier to a first end of the sterilized fluid path module, sterilizing the fluid path module to provide a sterilized fluid path module and assembling a delivery device comprising the sterilized container holder and the sterilized fluid path module.

## Claims

### Claim 1

A delivery device comprising:
a sterilized container holder comprising:
a sterilized primary container comprising an aseptically added solution;
a first barrier; and
a sterilized fluid path module comprising:
a sterilized penetration needle;
a sterilized channel;
a sterilized user needle; and
a second barrier at a first end of the sterilized fluid path module.

### Claim 2 (depends on 1)

The delivery device of claim 1, further comprising a third barrier at a second end of the sterilized fluid path module.

### Claim 3 (depends on 1)

The delivery device of claim 1, wherein the sterilized fluid path module is configured to connect to the sterilized container holder via the sterilized penetration needle.

### Claim 4 (depends on 1)

The delivery device of claim 1, wherein at least one of the first barrier and the second barrier is a septum material.

### Claim 5 (depends on 4)

The delivery device of claim 4, wherein the septum material is at least one of an aluminum foil, Tyvek and a thermoplastic elastomer (TPE).

### Claim 6

A sterilized fluid path module comprising:
a sterilized penetration needle;
a sterilized channel;
a sterilized user needle; and
a second barrier at a first end of the sterilized fluid path module.

### Claim 7 (depends on 6)

The sterilized fluid path module of claim 6, further comprising a drive module.

### Claim 8 (depends on 6)

The sterilized fluid path module of claim 6, further comprising a third barrier at a second end of the sterilized fluid path module.