Primary Packaging for Storage and Administration of Medical and Pharmaceutical Compounds

Abstract

A primary packaging for storage and/or administration of medical or pharmaceutical compounds includes a container that has a predetermined filling volume for receiving a medical or pharmaceutical compound. The container is permanently closed at a first end and has an integrally formed, circumferential flange portion at an open second end. The container has a cylindrical barrel that extends between the first end and the flange portion such that the barrel has an inner diameter and outer diameter corresponding to that of a standardized syringe for a nominal volume of the standardized syringe corresponding to the predetermined filling volume. Furthermore, a cross-sectional shape of the flange portion corresponds to the cross-sectional shape of a flange of a standardized vial. The primary packaging also includes a closure element that is adapted to fit tightly on the flange portion and into the barrel for sealing the open second end of the container.

1 - 18 . (canceled) 
     
     
         19 . A device comprising:
 a container with a cylindrical barrel, a permanently closed first end and an open second end, wherein a circumferential flange portion is integrally formed around the open second end and extends radially from the open second end;   a closure element with a fitting portion and a support portion, wherein the fitting portion fits tightly into the open second end, wherein the support portion seals the open second end by contacting an upper surface of the flange portion; and   an aluminum cap that surrounds the closure element and the flange portion of the container, wherein the aluminum cap has a central opening.   
     
     
         20 . The device of  claim 19 , further comprising:
 a plastics element releasably fitted over the aluminum cap so as to provide access to the closure element through the central opening when the plastics element is flipped off.   
     
     
         21 . The device of  claim 19 , further comprising:
 a plastics element with a flat lower surface that rests on the support portion of the closure element, wherein the aluminum cap surrounds the plastics element, the closure element and the flange portion of the container.   
     
     
         22 . The device of  claim 21 , wherein the plastics element includes a gripping portion that passes through the central opening of the aluminum cap and extends axially upwards. 
     
     
         23 . The device of  claim 19 , wherein the aluminum cap includes a breaking point located where the aluminum cap engages the flange portion of the container. 
     
     
         24 . The device of  claim 19 , wherein the closure element is a cylindrical plunger stopper. 
     
     
         25 . The device of  claim 19 , wherein the circumferential flange portion has dimensions that comply with specifications of ISO 8362-1 standard for an injection vial flange. 
     
     
         26 . The device of  claim 19 , wherein the cylindrical barrel has dimensions that comply with specifications of ISO 11040-4 standard for a prefilled syringe barrel. 
     
     
         27 . A device comprising:
 a container with a cylindrical barrel, a permanently closed first end and an open second end, wherein a circumferential flange portion is integrally formed into the open second end and extends radially from the open second end;   a closure element that fits tightly into the open second end, wherein the closure element has a threaded attachment means; and   a needle extraction system with a plunger rod, wherein a first end of the plunger rod can be screwed into the threaded attachment means.   
     
     
         28 . The device of  claim 27 , wherein the plunger rod is releasably attachable to the closure element. 
     
     
         29 . The device of  claim 27 , wherein a cannula extends axially through the plunger rod and protrudes out of both axial ends of the plunger rod. 
     
     
         30 . The device of  claim 27 , wherein the plunger rod has an outer diameter that is smaller than an inner diameter of the barrel, and wherein the plunger rod has a finger flange disposed at a second end opposite the first end. 
     
     
         31 . The device of  claim 27 , wherein the needle extraction system has a cylindrical tube section that extends substantially coaxially with the plunger rod, wherein the plunger rod is attached inside the cylindrical tube section, wherein the plunger rod has an outer diameter that is smaller than an inner diameter of the barrel, wherein the cylindrical tube section has an inner diameter that is larger than an outer diameter of the barrel, and wherein the plunger rod slides inside the barrel while the cylindrical tube section slides down around the outside of the barrel. 
     
     
         32 . The device of  claim 27 , wherein the plunger rod has an outer diameter that is smaller than an inner diameter of the barrel, wherein the plunger rod is attached inside a cylindrical tube section of the needle extraction system, wherein the cylindrical tube section has an inner diameter that is larger than an outer diameter of the barrel, and wherein the plunger rod fits inside the barrel while the cylindrical tube section fits around an outer surface of the barrel. 
     
     
         33 . The device of  claim 32 , wherein the cylindrical tube section has a radially outwardly extending finger flange disposed at its open end adjacent to an end of the plunger rod inside the cylindrical tube section, and wherein the finger flange has a radially inwardly extending projection that slides along the outer surface of the barrel. 
     
     
         34 . A method comprising:
 fitting a plunger stopper tightly into a first open end of a container, wherein the container has a barrel, a permanently closed second end and a circumferential flange portion formed around the first open end, wherein the barrel has an inner diameter, and wherein the plunger stopper has a female threaded hole with a thin bottom portion between the female threaded hole and a bottom side of the plunger stopper; and   partially screwing a male threaded end of a plunger rod into the female threaded hole, wherein the plunger rod has an outer diameter that is smaller than the inner diameter of the barrel, wherein a cannula extends axially through the plunger rod and protrudes through both the male threaded end and a top axial end of the plunger rod, and wherein the thin bottom portion is not penetrated by the cannula that protrudes from the male threaded end of the plunger rod.   
     
     
         35 . The method of  claim 34 , wherein the inner diameter of the barrel complies with the ISO 11040-4 standard for a prefilled syringe barrel. 
     
     
         36 . The method of  claim 34 , wherein the plunger rod has a finger flange attached to the top axial end. 
     
     
         37 . The method of  claim 34 , wherein the top axial end of the plunger rod is attached inside a tube section, wherein the tube section has an inner diameter that is larger than an outer diameter of the barrel, and wherein the plunger rod fits inside the barrel while the tube section fits around an outer surface of the barrel. 
     
     
         38 . The method of  claim 37 , wherein the tube section has a radially outwardly extending finger flange disposed at its open end adjacent to the male threaded end of the plunger rod inside the tube section, and wherein the finger flange has a radially inwardly extending projection that slides along the outer surface of the barrel.