# US 2014/0190926 A1 · Synthetic resin cap and method of manufacturing synthetic resin cap

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- Number: US 2014/0190926 A1
- Document ID: US20140190926A1
- Status: Published application
- Kind: A1
- Application number: 14/202,995
- Filed: 2014-03-10
- Published: 2014-07-10
- Earliest claimed: 2008-09-30
- Assignees: Daikyo Seiko, Ltd.
- Applicants: Daikyo Seiko, Ltd.
- Inventors: Nobuo SUDO
- Web page: https://patentgrep.com/patent/US20140190926A1

## CPC

- B65D 53/06: Sealings formed by liquid or plastic material
- A61J 1/1412: {Containers with closing means, e.g. caps}
- B29C 45/0001: {characterised by the choice of material}
- B29C 45/1701: {using a particular environment during moulding, e.g. moisture-free or dust-free}
- B29D 99/0096: {Producing closure members for containers, e.g. closure caps or stoppers}
- B65D 51/002: {Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means}
- B65D 51/20: Caps, lids, or covers co-operating with an inner closure arranged to be opened by piercing, cutting, or tearing {(B65D51/185 takes precedence; co-operating with an auxiliary container for additional articles or materials B65D51/28)}
- A61J 1/1406: {Septums, pierceable membranes}
- B29C 45/0053: {combined with a final operation, e.g. shaping (injection-compression moulding B29C45/561)}
- B29L 2031/565: {for containers}
- B29L 2031/712: {Containers; Packaging elements or accessories, Packages (closures therefor B29L2031/56; ink or toner cartridges B29L2031/7678; squeeze tubes B29L2023/20; suitcases B29L2031/7418)}
- 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
- 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
- B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00)
- B29D: PRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE (making granules B29B9/00; making preforms B29B11/00)
- B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES

## Abstract

At a medicament manufacturer B, a mouth of a vial body 11 or syringe cartridge 51, in which a medicament 16 is sealed with a plug, is enclosed using a cap 15 or 50 under an environment of a predetermined cleanliness (for example, class M6.5 (the JIS method) or higher). In advance of this enclosure, the cap 15 or 51 has been manufactured at a container manufacturer A by molding with a molding material, which is free of any powdery material, under an environment having cleanliness not lower than the predetermined cleanliness. A cap for enclosing a mouth of a vial body or syringe cartridge sealed with a plug and a manufacturing method of the cap can be provided accordingly.

## Claims

### Claim at position 1

1-4. (canceled)

### Claim 5

A clean bag comprising synthetic resin caps for enclosing, under an environment of a predetermined cleanliness, an opening of a vial body or syringe cartridge filled with a medicament and sealed with a plug,
wherein the synthetic resin cap comprises a molded synthetic resin,
the synthetic cap has no powdery material when the synthetic resin is in a melting state and in a molded state,
the synthetic cap is manufactured and enclosed in the clean bag under clean environment,
a plurality of the synthetic resin caps are enclosed in the clean bag under clean environment without being washed before the enclosure in the clean bag,
the synthetic resin caps enclosed in the clean bag each are ready for closing in a clean room of the opening of the vial body or the syringe cartridge having been filled with a medicament and sealed with a plug, without being washed before closing the opening of the vial body or the syringe cartridge.

### Claim 6 (depends on 5)

The clean bag comprising synthetic resin caps according to claim 5, wherein the clean environment has cleanliness of Class M6.5 or higher determined by the corresponding JIS method.

### Claim 7 (depends on 5)

The clean bag comprising synthetic resin caps according to claim 5, wherein the clean bag is a sterilizable bag.

### Claim 8 (depends on 5)

A vial body or a syringe cartridge filled with a medicament and sealed with a plug, comprising the synthetic resin cap taken from the clean bag comprising the plurality of the synthetic resin caps according to claim 5,
wherein the opening of the vial body or the syringe cartridge filled with a medicament and sealed with a plug is closed in the clean room where the vial body or the syringe cartridge is sealed with the plug, with the synthetic resin cap taken from the clean bag.

### Claim 9 (depends on 5)

A vial body or a syringe cartridge filled with a medicament and sealed with a plug, comprising the synthetic resin cap taken from the clean bag comprising the plurality of the synthetic resin caps according to claim 5,
wherein the clean bag is a sterilizable bag, and
the synthetic resin caps in the clean bag have been sterilized in the bag before being taken from the clean bag.

### Claim 10

A method of manufacturing a clean bag comprising synthetic resin caps for enclosing in a clean room, an opening of a vial body or a syringe cartridge having been filled with a medicament and sealed with a plug, which comprises:
manufacturing the synthetic resin cap by molding a synthetic resin under clean environment; and
enclosing a plurality of the synthetic resin caps in the clean bag under clean environment,
wherein the synthetic resin cap has no powdery material when the synthetic resin is in a melting state and in a molded state,
the plurality of the synthetic resin caps are enclosed in the clean bag without being washed before the enclosure in the clean bag, and
the synthetic resin caps enclosed in the clean bag each are ready for closing in a clean room of the opening of the vial body or the syringe cartridge having been filled with the medicament and sealed with the plug, without being washed before closing the opening of the vial body or the syringe cartridge.

### Claim 11 (depends on 10)

The method according to claim 10, wherein the clean environment has cleanliness of Class M6.5 or higher determined by the corresponding JIS method.

### Claim 12 (depends on 10)

The method according to claim 10, wherein the clean bag is a sterilizable bag.

### Claim 13

A method of manufacturing a vial body or a syringe cartridge filled with a medicament and sealed with a plug, comprising one synthetic resin cap, the method comprising:
manufacturing a synthetic resin cap by molding a synthetic resin under clean environment;
enclosing a plurality of the synthetic resin caps in a clean bag under clean environment; and
closing with the synthetic resin cap taken from the clean bag enclosing the plurality of synthetic resin caps, an opening of the vial body or the syringe cartridge filled with a medicament and sealed with a plug in the clean room where the vial body or the syringe cartridge filled with a medicament is sealed with the plug,
wherein the synthetic resin cap has no powdery material when the synthetic resin is in a melting state and in a molded state,
the plurality of the synthetic resin caps are enclosed in the clean bag without being washed before the enclosure in the clean bag.

### Claim 14 (depends on 13)

The method according to claim 13, wherein the clean environment has cleanliness of Class M6.5 or higher determined by the corresponding JIS method.

### Claim 15 (depends on 13)

The method according to claim 13, the method further comprising a step of sterilizing the clean bag comprising the plurality of the synthetic resin caps before the step of closing the opening of the vial body or the syringe cartridge filled with a medicament and sealed with a plug, with the synthetic resin cap,
wherein the clean bag is a sterilizable bag.