# US 10,441,708 B2 · Intermediate product for producing pre-filled dual-chamber syringes or cartridges and method of producing said intermediate product

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- Number: US 10,441,708 B2
- Document ID: US10441708B2
- Status: Granted
- Kind: B2
- Application number: 14/910,187
- Filed: 2014-07-23
- Published: 2016-06-16
- Granted: 2019-10-15
- Earliest claimed: 2013-08-05
- Assignees: Orofino Pharmaceuticals Group S.R.L.
- Applicants: OROFINO PHARMACEUTICALS GROUP S.r.l.
- Inventors: Ernesto Orofino
- Web page: https://patentgrep.com/patent/US10441708B2

## CPC

- A61M 5/002: {Packages specially adapted therefor, e.g. packages for syringes or needles or kits for diabetics}
- A61J 1/062: {Carpules}
- A61J 1/2093: {Containers having several compartments for products to be mixed}
- A61J 1/2096: {Combination of a vial and a syringe for transferring or mixing their contents}
- A61M 5/008: {Racks for supporting syringes or needles}
- B65B 3/003: {Filling medical containers such as ampoules, vials, syringes or the like}
- B65B 5/068: {in trays (B65B5/061 - B65B5/065 take precedence)}
- A61M 2207/00: Methods of manufacture, assembly or production
- A61M 2209/045: for filling, e.g. for filling reservoirs
- B65B 2220/14: Adding more than one type of material or article to the same package
- B65B 2220/16: Packaging contents into primary and secondary packaging
- B65B 2230/02: Containers having separate compartments isolated from one another (B65B29/10 and B65B2220/16 take precedence)
- 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)}
- 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
- 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)

## Abstract

An intermediate product (1) for producing a plurality of pre-filled dual-chamber syringes or cartridges includes a support template (2) having an array of support seats and partially pre-filled tubular containment bodies (3), each inserted in a respective support seat. Each of the tubular containment bodies (3) 10 extends between a first (4) and a second opening (5). A sterile package (20-23) encloses the support template (2) and the tubular containment bodies (3) in sterile manner. The interiors of the tubular containment bodies (3) include a first stopper (6) and a second stopper (7) arranged in such a manner as to define therebetween a first containment chamber (8) in the tubular containment body (3) and adapted to slide inside the tubular containment 20 body. A liquid substance is contained inside the first containment chamber (8).

## Claims

### Claim 1

An intermediate product for producing a plurality of pre-filled dual-chamber syringes or cartridges, comprising:
a support template comprising an array of support seats;
a plurality of partially pre-filled tubular containment bodies, each of the tubular containment bodies being inserted in a respective support seat, each of the tubular containment bodies extending between a first opening and a second opening;
a sterile package inside which the support template and the plurality of tubular containment bodies are enclosed in sterile manner; the sterile package comprising:
a containment tray, the support template being accommodated inside the containment tray, the containment tray comprising an opening rim in which the sterile package comprises a closure film fastened flush to said rim and resting on an end portion of said tubular containment bodies:
a first sterile pouch containing the containment tray;
wherein the tubular containment bodies comprise in the interior thereof:
a first stopper and a second stopper arranged to define therebetween in the tubular containment body a first containment chamber and adapted to slide inside the tubular containment body;
a first liquid substance contained inside the first containment chamber;
wherein the first stopper is spaced from the first opening to define between the first stopper and the first opening a second containment chamber, the second containment chamber being empty and adapted to be filled with a second substance to be mixed inside the containment body with said first liquid substance in order to reconstitute an injectable solution.

### Claim 2 (depends on 1)

An intermediate product according to claim 1, wherein:
the first stopper comprises at least one bypass channel; or
the containment body comprises an internal wall equipped with a recess adapted to define a bypass channel, and the recess is located between the first stopper and the first opening.

### Claim 3 (depends on 1)

An intermediate product according to claim 1, wherein the tubular containment body is made in a single piece.

### Claim 4 (depends on 1)

An intermediate product according to claim 1, wherein the second stopper comprises a fastening element adapted to fasten a plunger to the second stopper such that the second stopper can slide inside the containment body under action of the plunger.

### Claim 5 (depends on 1)

An intermediate product according to claim 1, wherein the package comprises a second sterile pouch which encloses the first sterile pouch.

### Claim 6

A production method for an intermediate product for producing a plurality of pre-filled dual-chamber syringes or cartridges, comprising in sequence the steps of:
providing a starting product comprising a support template comprising an array of support seats, the starting product comprising a plurality of tubular containment bodies each of the tubular containment bodies being inserted in a respective support seat, each of the tubular containment bodies extending along a vertical axis between a first opening and a second opening, the containment bodies comprising a first stopper inserted inside the containment body between the first opening and the second opening, the second opening being located at a higher level relative to the first opening;
dosing a first liquid substance through the second opening;
inserting a second stopper through the second opening to define a first containment chamber of the first liquid substance between the first stopper and the second stopper;
enclosing the support template and said plurality of tubular containment bodies inside a sterile package;
wherein the sterile package comprises a containment tray, and wherein the step of enclosing the support template comprises a step of inserting the template inside the containment tray and of closing the containment tray; and
wherein the containment tray comprises an opening rim and wherein the step of closing said containment tray comprises a step of fastening a closure film flush with the rim.

### Claim 7 (depends on 6)

A production method according to claim 6, wherein the enclosing step comprises a step of enclosing the containment tray inside a sterile pouch.

### Claim 8 (depends on 7)

A production method according to claim 7, wherein the enclosing step comprises a step of enclosing the first sterile pouch in a second sterile pouch.

### Claim 9 (depends on 6)

A production method according to claim 6, wherein the starting product comprises said containment tray, wherein the support template is contained in the containment tray in the starting product, and wherein the method comprises, before the dosing step, a step of extracting the support template from the containment tray.

### Claim 10 (depends on 6)

A production method according to claim 6, wherein between the dosing step and the inserting step, the method is free of a lyophilization step.