Containers for parenteral fluids

• US 6,398,771 B1
• Filed: 10/19/1999
• Issued: 06/04/2002
• Est. Priority Date: 04/10/1996
• Status: Expired due to Term

• Current Assignee: Fresenius Kabi Oncology PLC (Fresenius SE & Co. KGaA)
• Original Assignee: Pharmacia AB (Pharmacia Corp.)
• Inventors: Gustafsson, Bo, Lundmark, Stefan, Brooling, Cathrine, Berglund, Kjell, Skolling, Otto
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Bianco, Patricia
• Application Number:
  US09/420,242
• Time in Patent Office: 959 Days
• Field of Search: 604/408, 604/410, 604/411, 604/415, 604/416, 604/82, 604/85, 206/219, 206/221, 383/38, 383/210, 383/211
• US Class Current: 604/410
• CPC Class Codes: A61J 1/00 Containers specially adapted for medical or pharmaceutical purposes capsules or the like for oral use A61J3/07; specially adapted for surgical or diagnostic appliances or instruments A61B50/30; containers for radioactive substances G21F5/00
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/2024 having peelable seals
• CPC Class Codes: A61J 1/2093 Containers having several compartments for products to be mixed
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: B32B 2307/412 Transparent
• CPC Class Codes: B32B 2307/7244 Oxygen barrier
• CPC Class Codes: B32B 2323/04 Polyethylene
• CPC Class Codes: B32B 2323/10 Polypropylene
• CPC Class Codes: B32B 2367/00 Polyesters, e.g. PET, i.e. polyethylene terephthalate
• CPC Class Codes: B32B 2439/00 Containers; Receptacles closures therefor B32B2435/00
• CPC Class Codes: B32B 27/08 of synthetic resin
• CPC Class Codes: B32B 27/306 comprising vinyl acetate or vinyl alcohol (co)polymers
• CPC Class Codes: B32B 27/32 comprising polyolefins comprising vinyl (co)polymers or acrylic (co)polymers B32B27/30
• CPC Class Codes: B32B 27/36 comprising polyesters
• CPC Class Codes: B32B 7/02 Physical, chemical or physicochemical properties
• CPC Class Codes: B32B 7/12 using interposed adhesives or interposed materials with bonding properties
• CPC Class Codes: B65D 81/268 the absorber being enclosed in a small pack, e.g. bag, included in the package

Abstract

A flexible transparent container for improved storage of oxygen sensitive parenterally administerable agents comprising an inner, primary container enclosed in a substantially oxygen impermeable outer envelope with an oxygen absorber, capable of consuming essentially all residual oxygen after the outer envelope is sealed, and for sufficient period also the oxygen penetrating said envelope. The inner container is made of a polypropylene containing flexible polymeric material compatible with lipophilic agents capable of forming both permanent and peelable seals, while the envelope is made of a substantially water impermeable flexible multilayered polymeric material comprising a first outer substantially water impermeable polymeric film with oxygen barrier forming capacity, assembled with a second, inner polymeric film with a supplementary oxygen barrier forming capacity. The container essentially maintains its characteristics after being subjected to sterilization by steam or radiation.

Claims

1. A method of preparing a flexible transparent container for improved storage of oxygen sensitive parenterally administerable agents wherein the container comprises an inner, primary container enclosed in a substantially oxygen impermeable outer envelope with an oxygen absorber, capable of consuming essentially all residual oxygen after the outer envelope is sealed, as well as the oxygen penetrating said envelope wherein:

(i) the inner container is made of a polypropylene containing flexible polymeric material compatible with lipophilic agents capable of forming both permanent and peelable seals;

(ii) the envelope is made of a substantially water impermeable flexible multilayered polymeric material comprising;

a) a first outer substantially water impermeable polymeric film with oxygen barrier forming capacity, assembled with

b) a second, inner polymeric film with a supplementary oxygen barrier forming capacity;

and in that the container essentially maintains its characteristics after being subjected to sterilization by steam or radiations,

the method of preparing comprising the steps of;

a) introducing a flexible polymeric multilayered material and forming a bag shaped sealed inner container by welding together its polypropylene containing sealing layers and optionally forming at least two chambers by forming at least one partitioning peelable seal seam;

b) providing a side of said inner container with at least one temporary opening;

c) filling the inner container with at least one parenterally administerable fluid through said temporary opening;

d) sealing the temporary opening at the side of said inner container by welding permanent seams;

e) enclosing the filled and sealed container in an oxygen barrier forming envelope together with an oxygen absorber; and

f) sealing the envelope by means of welding and finally, sterilizing the container.

2. The method according to claim 1, wherein the inner primary container is made of a multilayered film comprising;

a) an outer layer containing a copolyester;

b) an inner sealant layer containing polypropylene, a propylene ethylene copolymer or a mixture of polypropylene or polyethylene, and

c) an interior layer containing a thermoplastic elastomer.

3. A method of preparing a flexible transparent container, the method characterized by the steps of:

a) introducing a flexible polymeric multilayered material and forming a bag shaped sealed inner container by welding together its polypropylene containing sealing layers and optionally forming at least two chambers by forming at least one partitioning peelable seal seam;

b) providing a side of said inner container with at least one temporary opening;

c) filling the inner container with at least one parenterally administerable fluid through said temporary opening;

d) sealing the temporary opening at the side of said inner container by welding permanent seams;

e) enclosing the filled and sealed container in an oxygen barrier forming envelope together with an oxygen absorber; and

f) sealing the envelope by means of welding and finally, sterilizing the container.

4. A method according to claim 3, characterized by introducing a sheet-formed flexible polymeric material and attaching to it a sealed port system for fluid communication by means of welding, whereupon a bag shaped inner container is formed with the said port system in its bottom by welding two side seams and a top seam.

5. A method according to claim 4, wherein one of the side seams is a weak welding capable of providing at least one temporary opening by means of the filling equipment.

6. A method according to claim 5, wherein the temporary openings are sealed by welding a permanent seam subsequent to the filling of the inner container.

7. A method according to claim 6 characterized by forming at least two chambers by welding at least one peelable seal seam at a lower temperature and/or pressure than the permanent weldings.

8. A method according to claim 6 characterized by sterilizing the container by steam.

9. A method according to claim 5 characterized by forming at least two chambers by welding at least one peelable seal seam at a lower temperature and/or pressure than the permanent weldings.

10. A method according to claim 5 characterized by sterilizing the container by steam.

11. A method according to claim 4, wherein the temporary openings consist of provisional filling ports capable of being sealingly connected to the fluid dispensing means of the filling equipment.

12. A method according to claim 11, wherein said filling ports are tubings attached to a side seam in connection to its welding.

13. A method according to claim 12, wherein the side of the inner container with the provisional filling ports or filling orifices are cut off subsequent to the filling, whereupon the side of the bag is re-sealed by welding a permanent seam.

14. A method according to claim 13 characterized by forming at least two chambers by welding at least one peelable seal seam at a lower temperature and/or pressure than the permanent weldings.

15. A method according to claim 13 characterized by sterilizing the container by steam.

16. A method according to claim 11, wherein the side of the inner container with the provisional filling ports or filling orifices are cut off subsequent to the filling, whereupon the side of the bag is re-sealed by welding a permanent seam.

17. A method according to claim 16 characterized by forming at least two chambers by welding at least one peelable seal seam at a lower temperature and/or pressure than the permanent weldings.

18. A method according to claim 10 characterized by sterilizing the container by steam.

19. A method according to claim 11 characterized by forming at least two chambers by welding at least one peelable seal seam at a lower temperature and/or pressure than the permanent weldings.

20. A method according to claim 11 characterized by sterilizing the container by steam.

21. A method according to claim 4, wherein at least one filling orifice is formed in a side seam of the inner container with a shape corresponding to a filling nozzle of the filling equipment in order to provide sealing connection during the filling procedure.

22. A method according to claim 21, wherein the side of the inner container with the provisional filling ports or filling orifices are cut off subsequent to the filling, whereupon the side of the bag is re-sealed by welding a permanent seam.

23. A method according to claim 21 characterized by forming at least two chambers by welding at least one peelable seal seam at a lower temperature and/or pressure than the permanent weldings.

24. A method according to claim 21 characterized by sterilizing the container by steam.

25. A method according to claim 4 characterized by forming at least two chambers by welding at least one peelable seal seam at a lower temperature and/or pressure than the permanent weldings.

26. A method according to claim 4 characterized by sterilizing the container by steam.

27. A method according to claim 3 characterized by forming at least two chambers by welding at least one peelable seal seam at a lower temperature and/or pressure than the permanent weldings.

28. A method according to claim 27 characterized by sterilizing the container by steam.

29. A method according to claim 3 characterized by sterilizing the container by steam.