Method and apparatus for cleaning containers to be sealed and containing a filler from oxygen gas

Abstract

The method of manufacturing a sealed container for containing a non-gaseous filler, which filler is to be protected from Oxygen gas, comprises the following steps in the indicated sequence: 1.) filling said filler into said container; 2.) evacuating said container substantially without evaporating parts of said filler; 3.) filling Nitrogen gas into said container; 4.) sealing the container. The method can be used in-line. The apparatus for cleaning filled containers containing a non-gaseous filler, comprises at least one holder for holding said containers; at least one pump adapted for evacuating said containers; a Nitrogen reservoir for supplying Nitrogen gas to be filled into said containers; a process control unit adapted to allowing for an evacuation of said containers by means of said at least one pump and subsequentially filling said Nitrogen gas into said containers.

1 . Method for cleaning a container containing a non-gaseous filler, which filler is to be protected from Oxygen gas, and which container is to be sealed, the method comprising the following steps in the indicated sequence: 
 A) evacuating said container substantially without evaporating parts of said filler;    B) filling Nitrogen gas into said container.    
   
   
       2 . Method according to  claim 1 , wherein the sequence of the steps A) and B) is performed at least two times.  
   
   
       3 . Method according to  claim 2 , further comprising the step 
 C) leaving said Nitrogen gas in the container for at least 0.2 s after a first and before a second sequence of steps A) and B).    
   
   
       4 . Method according to  claim 3 , wherein after said second sequence of steps A) and B), a sequence C),A),B) is performed.  
   
   
       5 . Method according to  claim 1 , wherein said container is a vial.  
   
   
       6 . Method according to  claim 1 , wherein said container is made substantially of a glass.  
   
   
       7 . Method according to  claim 1 , wherein the filler comprises a drug.  
   
   
       8 . Method according to  claim 1 , wherein the filler is liquid.  
   
   
       9 . Method according to  claim 1 , wherein the filler is a granulate or a powder.  
   
   
       10 . Method according to  claim 1 , comprising the step of transporting said container during said steps A) and B).  
   
   
       11 . Method according to  claim 1 , wherein said Nitrogen gas is purified Nitrogen gas.  
   
   
       12 . Method according to  claim 1 , wherein for said pressure p is valid p≦300 mbar.  
   
   
       13 . Method according to  claim 1 , wherein for said pressure is valid p≦80 mbar.  
   
   
       14 . Method according to  claim 1 , wherein the method's steps are performed while said container is on a transport arrangement.  
   
   
       15 . Method of manufacturing a sealed container for containing a non-gaseous filler, which filler is to be protected from Oxygen gas, said method comprising the following steps in the indicated sequence: 
 1.) filling said filler into said container;    2.) evacuating said container substantially without evaporating parts of said filler;    3.) filling Nitrogen gas into said container;    4.) sealing the container.    
   
   
       16 . Method according to  claim 15 , furthermore comprising, after step 3.), another step 2.) followed by another step 3.).  
   
   
       17 . Method according to  claim 15 , furthermore comprising, after step 4.), the step of analyzing an amount of Oxygen gas contained in said container.  
   
   
       18 . Method according to  claim 15 , wherein the method's steps are performed while said container is on a transport arrangement.  
   
   
       19 . Method for achieving an Oxygen percentage by volume below a threshold percentage in a container containing an oxidation-sensitive non-gaseous filler, wherein the container is to be sealed, comprising the following steps in the indicated sequence: 
 A) evacuating said container substantially without evaporating parts of said filler;    B) filling Nitrogen gas into said container.    
   
   
       20 . Method according to  claim 19 , wherein said threshold percentage is 2%.  
   
   
       21 . Apparatus for cleaning filled containers containing a non-gaseous filler, comprising 
 at least one holder for holding said containers;    at least one pump adapted to evacuating said containers;    a Nitrogen reservoir for supplying Nitrogen gas to be filled into said containers;    a process control unit adapted to allowing for an evacuation of said containers by means of said at least one pump and subsequentially filling said Nitrogen gas into said containers.    
   
   
       22 . Apparatus according to  claim 21 , furthermore comprising a filling apparatus for filling said filler into each of said containers.  
   
   
       23 . Apparatus according to  claim 21 , furthermore comprising a sealing apparatus for sealing said containers.  
   
   
       24 . Apparatus according to  claim 21 , wherein said filler is sensitive to Oxygen gas, the apparatus furthermore comprising a residual gas monitor for obtaining a quantity representative of an amount of Oxygen gas contained in said container.  
   
   
       25 . Apparatus according to  claim 21 , furthermore comprising a transport arrangement for moving said containers.  
   
   
       26 . Apparatus according to  claim 25 , wherein said transport arrangement comprises a conveyor.  
   
   
       27 . Apparatus according to  claim 25 , wherein said transport arrangement comprises a carrousel.