Use of a device and a method for preparing mixtures of pharmaceutical substances

Abstract

A method for the preparing mixtures of pharmaceutical or biopharmaceutical substances ( 11, 11″ ) includes arranging a preparation container ( 3, 3′, 3″ ) already made up with ingredients in a receptacle ( 2 ) of a device ( 1, 1′, 1″ ) feeding a fluid ( 10 ) from a storage container ( 4, 4″ ) into the preparation container ( 3, 3″ ) via a feed line ( 6 ), preparing the ingredients with the fluid ( 10, 10″ ) into a substance mixture ( 11, 11″ ), and removing the substance mixture ( 11, 11″ ) from the preparation container ( 3, 3′, 3″ ) into a receiving container via a discharge line ( 12, 12′, 12″ ). A device also is provided for carrying out the method.

What is claimed is: 
     
         1 . A method preparing mixtures of pharmaceutical or biopharmaceutical substances ( 11 ,  11 ″) comprising the steps:
 a) arranging a preparation container ( 3 ,  3 ′,  3 ″) already made up with ingredients in a receptacle ( 2 ) of a device ( 1 ,  1 ′,  1 ″); 
 b) feeding a fluid ( 10 ) from a storage container ( 4 ,  4 ″) into the preparation container ( 3 ,  3 ″) via a feed line ( 6 ); 
 c) preparing the ingredients with the fluid ( 10 ,  10 ″) into a substance mixture ( 11 ,  11 ″); and 
 d) removing the substance mixture ( 11 ,  11 ″) from the preparation container ( 3 ,  3 ′,  3 ″) into a receiving container ( 13 ,  13 ′,  13 ″) via a discharge line ( 12 ,  12 ′,  12 ″). 
 
     
     
         2 . The method of  claim 1 , wherein the pharmaceutical or biopharmaceutical substances are medicaments that are individual to a patient. 
     
     
         3 . The method of  claim 1 , wherein after arranging the preparation container ( 3 ,  3 ′,  3 ″) in the receptacle ( 2 ) of the device ( 1 ,  1 ′,  1 ″), the method further comprises using a reading unit ( 17 ) for reading out a coding ( 16 ) of the preparation container ( 3 ), calling up from a memory parameters necessary for carrying out the method and making the coding ( 16 ) and the parameters available to a monitoring and controlling unit ( 5 ). 
     
     
         4 . A method for preparing mixtures of pharmaceutical or biopharmaceutical substances ( 11 ′) comprising the steps:
 a) arranging a preparation container ( 3 ″) in a receptacle of a device ( 1 ″), 
 b) feeding ingredients from a plurality of ingredient storage containers ( 23 ,  24 ,  25 ,  26 ) into the preparation container ( 3 ″), 
 c) feeding a fluid ( 10 ″) from a fluid storage container ( 4 ″) into the preparation container ( 3 ″) via a feed line ( 6 ″), 
 d) preparing the ingredients with the fluid ( 10 ″) into a substance mixture ( 11 ″), and 
 e) removing the substance mixture ( 11 ″) from the preparation container ( 3 ″) into a receiving container ( 3 ″) via a discharge line ( 12 ″). 
 
     
     
         5 . The method of  claim 4  wherein the pharmaceutical or biopharmaceutical substances are medicaments that are individual to a patient. 
     
     
         6 . The method of  claim 4 , wherein after arranging the preparation container ( 3 ,  3 ′,  3 ″) in the receptacle ( 2 ) of the device ( 1 ,  1 ′,  1 ″), the method further comprises using a reading unit ( 17 ) for reading out a coding ( 16 ) of the preparation container ( 3 ), calling up from a memory parameters necessary for carrying out the method and making the coding ( 16 ) and the parameters available to a monitoring and controlling unit ( 5 ). 
     
     
         7 . A device ( 1 ,  1 ′,  1 ″) for the preparation of mixtures of pharmaceutical or biopharmaceutical substances ( 11 ,  11 ″), comprising:
 a preparation container ( 3 ,  3 ′,  3 ″) with ingredients; 
 a receptacle ( 2 ) configured to receive the preparation container ( 3 ,  3 ′,  3 ″), a storage container ( 4 ,  4 ″) with a fluid ( 10 ,  10 ″) that can be fed in a monitored manner to the preparation container ( 3 ,  3 ′,  3 ″) via a feed line ( 6 ); 
 a receiving container that communicates with the preparation container ( 3 ,  3 ′,  3 ″) via a discharge line ( 12 ,  12 ′,  12 ″); and 
 at least one sterile filter ( 22 ), or at least one virus filter or at least one combination of a sterile filter and a virus filter arranged upstream or downstream of the preparation container ( 3 ,  3 ′,  3 ″). 
 
     
     
         8 . The device of  claim 7 , wherein the preparation container ( 3 ,  3 ′,  3 ″) has the at least one sterile filter ( 22 ) or the at least one virus filter or the at least one combination of a sterile filter and a virus filter. 
     
     
         9 . The device of  claim 7 , the preparation container ( 3 ,  3 ′,  3 ″) a pad, on or in which the sterile filter or the virus filter or the combination of the sterile filter and the virus filter is arranged. 
     
     
         10 . The device of  claim 7 , wherein the preparation container ( 3 ,  3 ′,  3 ″) and the receiving container ( 13 ,  13 ′,  13 ″) are welded to one another by way of a hose connection. 
     
     
         11 . The device of  claim 7 , wherein at least one of the preparation container ( 3 ,  3 ′,  3 ″) and the receiving container ( 13 ,  13 ′,  13 ″) has at least one sensor for determining a parameter of the prepared substance mixture. 
     
     
         12 . The device of  claim 7 , the at least one sterile filter ( 22 ), the at least one virus filter or the at least one combination of a sterile filter and a virus filter is connected fixedly to the receiving container ( 13 ,  13 ′,  13 ″). 
     
     
         13 . The device of  claim 12 , further comprising a mixing nozzle connected to the receiving container or to the at least one sterile filter ( 22 ), the at least one virus filter or the at least one combination of a sterile filter.