# US 2021/0276749 A1 · System and method for purging oxygen from medical vials

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- Number: US 2021/0276749 A1
- Document ID: US20210276749A1
- Status: Published application
- Kind: A1
- Application number: 17/327,953
- Filed: 2021-05-24
- Published: 2021-09-09
- Earliest claimed: 2017-10-06
- Assignees: Hikma Pharmaceuticals USA Inc.
- Applicants: Hikma Pharmaceuticals USA Inc.
- Inventors: Simon Freed; David C. Woodruff
- Web page: https://patentgrep.com/patent/US20210276749A1

## CPC

- B65B 31/041: {the nozzles acting from above on containers or wrappers open at their top (B65B31/044 take precedence)}
- B65B 3/003: {Filling medical containers such as ampoules, vials, syringes or the like}
- B65B 7/2821: {applying plugs or threadless stoppers (for bottles or jars B67B1/04)}
- A61L 2103/23: {Containers other than laboratory or medical, e.g. bottles or mail}
- B65B 31/027: {closed by a stopper}
- B65B 31/042: {the nozzles being arranged for insertion into, and withdrawal from, the container or wrapper}
- B65B 31/046: {the nozzles co-operating, or being combined, with a device for opening or closing the container or wrapper (B65B31/06 takes precedence)}
- B65B 55/027: {Packaging in aseptic chambers}
- B65B 55/10: by liquids or gases
- B67C 7/0086: {Sterilisation being restricted to the area of application of the closure}
- 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)
- 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)
- B67C: CLEANING, FILLING WITH LIQUIDS OR SEMILIQUIDS, OR EMPTYING, OF BOTTLES, JARS, CANS, CASKS, BARRELS, OR SIMILAR CONTAINERS, NOT OTHERWISE PROVIDED FOR; FUNNELS

## Abstract

A medical vial filling system is adapted to fill a medical vial with a solution and cap the filled medical vial. A purging system includes a manifold disposed between a filling station and a capping station. The manifold includes a filling inlet port and a plurality of output ports. The output ports are positioned in a space proximate the filling station and in a space over the transport mechanism. A stoppering block includes a capping chamber for receiving a bushing positioned at the capping station. The stoppering block comprises a stoppering inlet port, a first nozzle opening into the capping chamber and a second nozzle extending into the capping chamber and directed into the medical vial when the medical vial is position in the capping station. A supply of non-reactive gas at the filling inlet port directs flow of the non-reactive gas out the manifold outlet ports to evacuate air and substitute the non-reactive gas in the filled medical vial and at the stoppering inlet port directs flow of the non-reactive gas in a flood zone surround a space above the medical vials when the medical vial is positioned in the capping station and in a stream directed into the medical vial when the medical vial is positioned in the capping station.

## Claims

### Claim 1

A method to purge oxygen and substitute a non-reactive gas in medical vials, comprising:
providing a medical vial filling system adapted to transfer a medical vial between a filling station that fills the medical vial with a solution and a capping station that inserts a plug in the filled medical vial;
directing a flow of a non-reactive gas in a space above and around the medical vial when the medical vial is positioned in the filling station;
directing a flow of the non-reactive gas in an enclosed space through which the medical vial passes while being transferred between the filling station and the capping station; and
directing a flow of the non-reactive gas in a flood zone surrounding a space above the medical vial when the medical vial is positioned in the capping station and in a nozzle stream directed into the medical vial when the medical vial is positioned in the capping station.

### Claim 2 (depends on 1)

The method of claim 1 wherein volume of the non-reactive gas in the flood zone to volume of the non-reactive gas in the nozzle stream is in a ratio of at least 3:1.

### Claim 3 (depends on 1)

The method of claim 1 wherein volume of the non-reactive gas in the flood zone to volume of the non-reactive gas in the nozzle stream is in a ratio of about 5:1.

### Claim 4 (depends on 1)

The method of claim 1 wherein directing a flow of the non-reactive gas in a space above and around the medical vial when the medical vial is positioned in the filling station comprises the medical vial filling system including a manifold defining a chamber having outlet ports dispensing the non-reactive gas.

### Claim 5 (depends on 4)

The method of claim 4 wherein the medical vial filling system lifts the medical vial into the chamber and including a filling nozzle for dispensing the solution into the medical vial while the non-reactive gas is dispersed in the chamber.

### Claim 6 (depends on 1)

The method of claim 1 wherein directing a flow of the non-reactive gas in an enclosed space comprises providing a manifold disposed between the filling station and the capping station, the manifold including a filling inlet port and a plurality of output ports, the output ports positioned in a space over which the medical vial is transferred.

### Claim 7 (depends on 1)

The method of claim 1 wherein the medical vial filling system comprises a stoppering block at the capping station and including a capping chamber for receiving the medical vial positioned at the capping station, the stoppering block comprising a stoppering inlet port, a first nozzle opening into the capping chamber and a second nozzle extending into the capping chamber and directed into the medical vial when the medical vial is positioned in the capping station to provide the flood zone and the nozzle stream.

### Claim 8

A method to purge oxygen and substitute a non-reactive gas in medical vials, comprising:
providing a medical vial filling system adapted to transfer a medical vial between a filling station that fills the medical vial with a solution and a capping station that inserts a plug in the filled medical vial;
providing a manifold in the medical vial filling system disposed between the filling station and the capping station, the manifold including an inlet port and a plurality of output ports, the output ports positioned in a space above and around the medical vial when the medical vial is positioned in the filling station and in an enclosed space through which the medical vial passes while being transferred between the filling station and the capping station; and
providing a supply of a non-reactive gas at the inlet port whereby the non-reactive gas flows out the manifold outlet ports to evacuate oxygen and substitute the non-reactive gas in the filled medical vial.

### Claim 9 (depends on 8)

The method of claim 8 further comprising providing a stoppering block at the capping station, the stoppering block comprising a stoppering inlet port, a first nozzle opening above the medical vial when the medical vial is positioned in the capping station and a second nozzle directed into the medical vial when the medical vial is positioned in the capping station, and
providing a supply of an non-reactive gas at the stoppering inlet port to direct flow of the non-reactive gas in a flood zone surrounding a space above the medical vials when the medical vial is positioned in the capping station and in a stream directed into the medical vial when the medical vial is positioned in the capping station.

### Claim 10 (depends on 9)

The method of claim 9 wherein volume of the non-reactive gas in the flood zone to volume of the non-reactive gas in the nozzle stream is in a ratio of at least 3:1.

### Claim 11 (depends on 9)

The method of claim 9 wherein volume of the non-reactive gas in the flood zone to volume of the non-reactive gas in the nozzle stream is in a ratio of about 5:1.

### Claim 12 (depends on 8)

The method of claim 8 wherein the manifold includes a filling chamber having select ones of the outlet ports and wherein the medical vial filling system lifts the medical vial into the filling chamber and including a filling nozzle for dispensing the solution into the medical vial while the non-reactive gas is dispersed in the chamber.

### Claim 13 (depends on 8)

The method of claim 8 wherein the manifold includes select ones of the plurality of output ports positioned in a space over which the medical vial is transferred.

### Claim 14

A medical vial filling system adapted to fill a medical vial with a solution and cap the filled medical vial comprising:
a transport mechanism including a plurality of bushings, each bushing for selectively carrying a medical vial, in use, between a filling station that fills the medical vial with a solution and a capping station that inserts a plug in the filled medical vial;
a manifold disposed between the filling station and the capping station, the manifold including a filling inlet port and a plurality of output ports, the output ports positioned in a space proximate the filling station and in a space over the transport mechanism; and
a stoppering block including a capping chamber for receiving a bushing positioned at the capping station, the stoppering block comprising a stoppering inlet port, a first nozzle opening into the capping chamber and a second nozzle extending into the capping chamber and directed into the medical vial when the medical vial is positioned in the capping station,
whereby a supply of a non-reactive gas at the filling inlet port directs flow of the non-reactive gas out the manifold outlet ports to evacuate air and substitute the non-reactive gas in the filled medical vial and at the stoppering inlet port directs flow of the non-reactive gas in a flood zone surrounding a space above the medical vials when the medical vial is positioned in the capping station and in a stream directed into the medical vial when the medical vial is positioned in the capping station.

### Claim 15 (depends on 14)

The medical vial filling system of claim 14 comprising a rotary dial machine and the transport mechanism comprises a circular rail supporting the bushings.

### Claim 16 (depends on 15)

The medical vial filling system of claim 15 wherein the rotary dial machine indexes the bushings and alternately lifts the vial in at least the filling station and the capping station.

### Claim 17 (depends on 14)

The medical vial filling system of claim 14 wherein volume of the non-reactive gas in the flood zone to volume of the non-reactive gas in the nozzle stream is in a ratio of at least 3:1.

### Claim 18 (depends on 14)

The medical vial filling system of claim 14 wherein volume of the non-reactive gas in the flood zone to volume of the non-reactive gas in the nozzle stream is in a ratio of about 5:1.

### Claim 19 (depends on 14)

The medical vial filling system of claim 14 wherein the manifold includes a filling chamber at the filling station having select ones of the outlet ports and wherein the medical vial filling system lifts the medical vial into the filling chamber and including a filling nozzle for dispensing the solution into the medical vial while the non-reactive gas is dispersed in the filling chamber.

### Claim 20 (depends on 14)

The medical vial filling system of claim 14 further comprising a pair of access panels extending downward from opposite sides of the manifold that traverse space between the filling station and the capping station on opposite sides of the transport mechanism.

### Claim 21 (depends on 14)

The medical vial filling system of claim 14 further comprising a funnel at the capping station for delivering a plug to the filled medical vial and wherein the funnel includes a plurality of sidewall openings to back purge oxygen from the funnel during a capping operation.
