Glass vial with increased chemical stability

Abstract

A method of forming a glass vial includes: locally heating one end of a glass tube; removing the locally heated end of the glass tube to form the glass vial having a closed base; and further forming the base of the glass vial, the further forming including generating a purge gas flow within the formed glass vial with the aid of a purge gas.

What is claimed is: 
     
         1 . A method of forming a glass vial, the method comprising:
 locally heating one end of a glass tube;   removing the locally heated end of the glass tube to form the glass vial having a closed base; and   further forming the base of the glass vial, wherein the further forming includes generating a purge gas flow within the formed glass vial with the aid of a purge gas.   
     
     
         2 . The method of  claim 1 , wherein the formed glass vial comprises an entry opening and the purge gas flows in or out centrally through the entry opening. 
     
     
         3 . The method of  claim 2 , wherein the purge gas flows in the formed glass vial out or in eccentrically such that a backpressure develops. 
     
     
         4 . The method of  claim 1 , wherein the purge gas flow guides borates out of the glass vial. 
     
     
         5 . The method of  claim 4 , wherein the borates evaporate out of the base during forming of the base. 
     
     
         6 . The method of  claim 1 , wherein the generating the purge gas flow forms a plurality of purge gas flow components within the formed glass vial. 
     
     
         7 . The method of  claim 6 , wherein the plurality of purge gas flow components comprises at least an incoming purge gas flow component, a cleaning purge gas flow component, and an exiting purge gas flow component. 
     
     
         8 . The method of  claim 7 , wherein the incoming purge gas flow is a high pressure gas flow component. 
     
     
         9 . The method of  claim 7 , wherein the cleaning purge gas flow component comprises purge gas mixed with evaporated borates and other constituents of glass forming the glass tube. 
     
     
         10 . The method of  claim 7 , wherein the incoming purge gas flow forces the cleaning purge gas flow toward the entry opening. 
     
     
         11 . The method of  claim 1 , further comprising filling the glass vial with a liquid active pharmaceutical ingredient formulation, the base comprising a boron-containing multicomponent glass and the glass vial comprising a vial opening and having a total volume of <4.5 mL, a filling level of the glass vial with the active pharmaceutical ingredient formulation is not more than 0.25 and a concentration of boron ions, measured at a measurement site below a plane of a middle of the glass vial using a concentration depth profile at a depth in a range from 10 to 30 nm, has a value, averaged over measurements of the concentration depth profile, that has an excess increase of not more than 30% compared to a concentration of boron ions measured using a concentration depth profile at a depth in a range from 10 to 30 nm with a measurement site in the plane of the middle of the glass vial, where the position of the plane of the middle of the glass vial is determined from an underside of the base of the glass vial in a direction of the vial opening. 
     
     
         12 . The method of  claim 11 , wherein the concentration of boron ions, measured at the measurement site below the plane of the middle of the glass vial using the concentration depth profile at the depth in the range from 10 to 30 nm, has a value, averaged over the measurements of the concentration depth profile, that has an excess increase of not more than 25% compared to the concentration of boron ions measured using the concentration depth profile at the depth in the range from 10 to 30 nm with the measurement site in the plane of the middle of the glass vial. 
     
     
         13 . The method of  claim 11 , wherein the concentration depth profile assumes a plateau value for boron ions from a depth of 150 nm downward. 
     
     
         14 . The method of  claim 11 , wherein the glass of an inner wall of the glass vial is monophasic down to a depth of at least 200 nm. 
     
     
         15 . The method of  claim 11 , wherein a surface of an inner wall of the glass vial at least one of does not have any coating or has not been etched. 
     
     
         16 . The method of  claim 11 , wherein the liquid active pharmaceutical ingredient formulation contains at least one of a therapeutic protein, a monoclonal antibody, or a vaccine. 
     
     
         17 . The method of  claim 11 , further comprising sealing the glass vial with a seal. 
     
     
         18 . The method of  claim 17 , wherein the seal is a sterile seal. 
     
     
         19 . The method of  claim 1 , further comprising filling the glass vial with a liquid active pharmaceutical ingredient formulation, the glass vial comprising a vial opening and a side wall connected to the base, the base and the side wall comprising a multicomponent glass comprising SiO 2 , the glass vial having a total volume of <4.5 mL, a filling level of the glass vial with the active pharmaceutical ingredient formulation is not more than 0.25, the glass at the base at an inner wall has a composition having a higher SiO 2  content than at the side wall and at a transition of the side wall to the base. 
     
     
         20 . The method of  claim 19 , wherein a concentration of silicon ions, measured at a measurement site on an inside of the base of the glass vial using a concentration depth profile at a depth in a range from 5 to 15 nm, has a value, averaged over measurements of the concentration depth profile, that has an excess increase of at least 10% compared to a concentration of silicon ions measured using a concentration depth profile at a depth in a range from 5 to 15 nm with a measurement site in a plane of a middle of the glass vial.