Automated workstation for the secure preparation of a final product for medical or pharmaceutical use

Abstract

An automated workstation ( 10 ) for the preparation, from different substances, each of which is contained in a vessel, of a final product for medical or pharmaceutical use packaged in a container, includes at least an isolated chamber ( 16 ) which delimits different internal functional areas, a loading area ( 18 ) including rapid decontamination elements, a lock device for introducing the vessels and containers into the loading area ( 18 ), an area ( 20 ) for storing the filled vessels and containers which communicates with the loading area ( 18 ), a transfer area ( 24 ), an area ( 22 ) for preparing the final products which communicates at least with the storage area via the transfer area, and which includes the rapid decontamination elements, a lock device ( 26 ) for unloading the final products from the workstation; and at least one robot or one programmable logic controller for handling the objects contained in the storage area and/or in the preparation area.

1 . Automated workstation ( 10 ) for the preparation, starting from different substances, in powder and/or liquid form, each of which is contained in a vessel such as a vial (F) or a bag, of a final product for medical or pharmaceutical use of a determined composition and/or in determined quantities, the final product being packaged in a container such as an IV bag for intravenous IV use or a syringe (S), the workstation comprising at least:
 an isolated chamber ( 16 ) which delimits different internal functional areas;   a loading area ( 18 ), in particular for the vessels and containers, comprising means for rapidly decontaminating the loading area ( 18 ) and its contents, said loading area ( 18 ) being isolated from the outside;   a lock device for introducing the vessels and containers into the loading area ( 18 );   a storage area ( 20 ), for storing the filled vessels and containers, which communicates with the loading area ( 18 );   a transfer area ( 24 );   a preparation area ( 22 ), for preparing the final products, which communicates at least with said storage area ( 20 ) via said transfer area ( 24 ), and which comprises means for rapidly decontaminating the preparation area and its contents, said preparation area being isolated from the outside;   a lock device ( 26 ) for unloading the final products from the workstation ( 10 );   and at least one robot (R 1 , R 2 ) or one programmable logic controller for handling the objects contained in the storage area ( 20 ) and/or in the preparation area ( 22 ).   
     
     
         2 . Automated workstation according to  claim 1 , characterized in that it comprises at least two robots (R 1 , R 2 ), or programmable logic controllers for handling objects, one of which is arranged in the storage area ( 20 ) and the other one of which is arranged in the preparation area ( 22 ). 
     
     
         3 . Automated workstation according to  claim 1 , characterized in that said loading area ( 18 ) also communicates with said preparation area ( 22 ). 
     
     
         4 . Automated workstation according to  claim 1 , characterized in that it comprises labelling means ( 30 ), arranged in the storage area, which comprise a printer, in particular for printing labels in situ designed to be affixed to the vessels and/or containers. 
     
     
         5 . Automated workstation according to according to  claim 1 , characterized in that it comprises refrigerated storage means arranged in the storage area ( 20 ). 
     
     
         6 . Automated workstation according to  claim 1 , characterized in that it comprises means for packaging the final products in a protective envelope ( 500 ), these packaging means being arranged in the final product preparation area. 
     
     
         7 . Automated workstation according to  claim 1 , characterized in that it is housed in a flexible protective and isolating tent ( 40 ). 
     
     
         8 . Automated workstation according to  claim 1 , characterized in that, for the preparation of the products, it contains closed needle-less transfer systems each of which mechanically prevents environmental pollutants from being transferred into the said system and hazardous substances or vapour concentrations from escaping towards the outside of the said system. 
     
     
         9 . Automated workstation according to  claim 1 , characterized in that it comprises analysis, checking and validation means which make it possible for a final product, after it has been prepared and before it leaves the automated station ( 10 ), to verify the conformity of the said final product. 
     
     
         10 . Automated workstation according to  claim 9 , characterized in that the checking and validation of the product is performed without taking a sample directly from the final container, using the Raman spectrometry technology. 
     
     
         11 . Automated workstation according to  claim 9 , characterized in that said verification includes a weight verification. 
     
     
         12 . Automated workstation according to  claim 1 , characterized in that two of said areas are separated by a rotating vertical carrousel ( 58 ) forming a rotating door with multiple shelving units which making it possible to transfer different elements and components from one area to the other area. 
     
     
         13 . Automated workstation according to  claim 12 , characterized in that the carrousel ( 58 ) forming a rotating door has two opposing faces, each of the said opposite faces being fitted, with a preparation wheel ( 300 ) equipped with preparation means. 
     
     
         14 . Automated workstation according to  claim 1 , characterized in that the introduction lock device is allows for the bio-decontamination of all the external or outside surfaces of all the elements and components that are placed inside the lock device by spraying suitable decontamination products.