INTERMEDIATE PRODUCT FOR PRODUCING PRE-FILLED DUAL-CHAMBER SYRINGES OR CARTRIDGES AND METHOD OF PRODUCING SAID INTERMEDIATE PRODUCT

• US 20160166760A1
• Filed: 07/23/2014
• Published: 06/16/2016
• Est. Priority Date: 08/05/2013
• Status: Active Grant

• Current Assignee: Orofino Pharmaceuticals Group Srl
• Original Assignee: Orofino Pharmaceuticals Group Srl
• Inventors: OROFINO, Ernesto
• Granted Patent: US 10,441,708 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61J 1/062 Carpules
• CPC Class Codes: A61J 1/2093 Containers having several compartments for products to be mixed
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: A61M 5/008 Racks for supporting syringes or needles A61M5/001 takes precedence
• CPC Class Codes: B65B 2220/14 Adding more than one type of material or article to the same package
• CPC Class Codes: B65B 2220/16 Packaging contents into primary and secondary packaging
• CPC Class Codes: B65B 2230/02 Containers having separate compartments isolated from one another B65B29/10 and B65B2220/16 take precedence
• CPC Class Codes: B65B 3/003 Filling medical containers such as ampoules, vials, syringes or the like
• CPC Class Codes: B65B 5/068 in trays B65B5/061 - B65B5/065 take precedence

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

1. An intermediate product (1) for producing a plurality of pre-filled dual-chamber syringes or cartridges, comprising:

a support template (2) comprising an array of support seats;

a plurality of partially pre-filled tubular containment bodies (3), each inserted in a respective support seat, each of the tubular containment bodies (3) extending between a first (4) and a second opening (5);

a sterile package (20-23) inside which the support template (2) and the plurality of tubular containment bodies (3) are enclosed in sterile manner;

in which the tubular containment bodies (3) comprise in the interior thereof;

a first (6) and a second stopper (7) arranged in such a manner as to define therebetween in the tubular containment body (3) a first containment chamber (8) and adapted to slide inside the tubular containment body (3);

a first liquid substance contained inside the first containment chamber (8);

in which the first stopper (6) is spaced from the first opening (4) in such a manner as to define between the first stopper (6) and the first opening (4) a second containment chamber (9) which is empty and adapted to be filled with a second substance intended to be mixed inside the containment body with said first liquid substance in order to reconstitute an injectable solution.

2. An intermediate product (1) according to claim 1, in which:

the first stopper (6) comprises at least one bypass channel;

or

the containment body (3) comprises an internal wall equipped with a recess (10) adapted to define a bypass channel, and in which the recess is located between the first stopper (6) and the first opening (4).

3. An intermediate product (1) according to any one of the preceding claims, in which the tubular containment body (3) is made in a single piece.

4. An intermediate product (1) according to any one of the preceding claims, in which the second stopper (7) comprises a fastening element adapted to fasten a plunger (52) to the second stopper (7) in such a manner that the second stopper (7) can slide inside the containment body (3) under the action of the plunger (52).

5. An intermediate product (1) according to any one of the preceding claims, in which the sterile package (20-23) comprises a containment tray (20), and in which the support template (2) is accommodated inside the containment tray (20).

6. An intermediate product (1) according to any one of the preceding claims, in which the containment tray (20) comprises an opening rim (25) and in which the sterile package (20-23) comprises a closure film (21) fastened flush to said rim (25) and resting on an end portion of said tubular containment bodies (3).

7. An intermediate product (1) according to claim 5, in which the package (20-23) comprises a first sterile pouch (22) which contains the containment tray (20).

8. An intermediate product (19) according to claim 7, in which the package (20-23) comprises a second sterile pouch (23) which encloses the first sterile pouch (22).

16. A method for filling (200) a dual-chamber syringe or cartridge, comprising the steps of:

providing (201) an intermediate product (1) according to claim 1, in which the second opening (5) is located above the first opening (4);

removing (202) the sterile package (20-23);

turning over (204) the support template (2) such that the first opening (4) is located above the second opening (5);

dosing (206) through the first opening (4) a second substance intended during use to be mixed inside the containment body (3) with said first substance in order to reconstitute an injectable solution;

sealing (207) the first opening (4).

17. A method for filling (200) a dual-chamber syringe or cartridge according to claim 16, in which the step of sealing (207) the first opening (4) comprises a step of attaching a closure means (50) to the first opening (4) and fastening a crimp closure (51) to the containment body (3) in the vicinity of the first opening (4) to lock the closure means (50) to the tubular body (3).

18. A filling method (200) according to claim 16 or claim 17, in which the sterile package (20-23) comprises a containment tray (20) which accommodates the support template (2) and in which the method (200) comprises, before the dosing step (206), a step of taking (203) the template (2) out of the containment tray (20).

19. A filling method (200) according to claim 17, in which the containment tray (20) has an opening rim (25) closed by a closure means (21) fastened flush to the opening rim and in which the step of removing (202) the sterile package (20-23) comprises a step of removing the closure means (21).

20. A filling method (200) according to claim 19, in which:

the sterile package (20-23) comprises at least one sterile pouch (22,23) containing the containment tray (20) and the support template (2);

the step of removing (202) the sterile package (20-23) comprises a step of opening and removing said at least one sterile pouch (22,23).

21. A production method (200) according to any one of preceding claims 16 to 20, in which between the dosing (206) and sealing (207) steps there is no step of lyophilizing the second substance.

9. A production method (100) for an intermediate product (1) for producing a plurality of pre-filled dual-chamber syringes or cartridges, comprising in sequence the steps of:

providing (101) a starting product comprising a support template (2) comprising an array of support seats, the starting product comprising a plurality of tubular containment bodies (3) each inserted in a respective support seat, each of the tubular containment bodies (3) extending along a vertical axis between a first (4) and a second (5) opening, the containment bodies (3) comprising a first stopper (6) inserted inside the containment body (3) between the first (4) and the second (5) opening, the second opening (5) being located at a higher level relative to the first opening (4);

dosing (104) a first liquid substance through the second opening (5);

inserting (105) a second stopper (7) through the second opening to define a first containment chamber (8) of the first liquid substance between the first stopper (6) and the second stopper (7);

enclosing (106) the support template (2) and said plurality of tubular containment bodies (3) inside a sterile package (20-23).

10. A production method (100) according to claim 9, in which the sterile package (20-23) comprises a containment tray (20), and in which the step of enclosing (106) the support template (2) comprises a step of inserting the template (2) inside the containment tray (20) and of closing the containment tray.

11. A production method (100) according to claim 10, in which the containment tray (20) comprises an opening rim (25) and in which the step of closing said containment tray (20) comprises a step of fastening a closure film (21) flush with the rim (25).

12. A production method (100) according to claim 11, in which the enclosing step (106) comprises a step of enclosing the containment tray (20) inside a sterile pouch (22).

13. A production method (100) according to claim 12, in which the enclosing step (106) comprises a step of enclosing the first sterile pouch (22) in a second sterile pouch (23).

14. A production method (100) according to any one of preceding claims 9 to 13, in which the starting product comprises said containment tray (20), in which the support template (2) is contained in the containment tray (20) in the starting product, and in which the method (100) comprises, before the dosing step (104), a step of extracting (103) the support template (2) from the containment tray (20).

15. A production method (100) according to any one of preceding claims 9 to 14, in which between the dosing (104) and inserting (105) steps there is no lyophilization step.

22. A pre-filled dual-chamber syringe or cartridge comprising:

a tubular containment body (3) made in a single piece which extends between a first (4) and a second opening (5);

a first (6) and a second stopper (7) arranged in such a manner as to define therebetween in the tubular containment body (3) a first containment chamber (8) and suitable for sliding inside the tubular containment body (3);

a first liquid substance contained inside the first filling chamber (8);

a closure means removably attached to the first opening (4);

in which the first stopper (6) is spaced from the first opening (4) in such a manner as to define between the first stopper (6) and the first opening (4) and inside said tubular body a second containment chamber (9) filled with a second highly active substance suitable to be mixed inside the containment body with said first liquid substance in order to reconstitute an injectable solution.

23. A pre-filled dual-chamber syringe or cartridge according to claim 22, in which said second highly active substance is a beta-lactam antibiotic or a cytotoxic antitumor agent or a hormone or a biological preparation.