Systems, devices and methods for aseptic processing

Abstract

Certain exemplary embodiments can provide a system comprising an automatic container positioner that, in an operative embodiment, positions a container for introduction of a filling to the container via a filling inlet of the container. In certain embodiments, the container can be located in a critical zone positioned in an airflow encountering no Class 100 contaminant generators upstream from the critical zone. In certain embodiments, the positioner can be located downstream of the filling inlet of the container.

1 . A method comprising a plurality of activities comprising: 
 via a system comprising an autoclaveable automatic non-electrically-driven container positioner, automatically transporting a container within a critical zone located in an airflow that encounters no Class  100  contaminant generators upstream from the critical zone, the container positioner located downstream from a filling inlet of the container; and    automatically introducing a filling to the container via the filling inlet of the container.    
   
   
       2 . The method of  claim 1 , further comprising: 
 preloading the container into the system.    
   
   
       3 . The method of  claim 1 , further comprising: 
 providing the container to the container positioner.    
   
   
       4 . The method of  claim 1 , further comprising: 
 preloading a closure into the system.    
   
   
       5 . The method of  claim 1 , further comprising: 
 shielding the container from contamination.    
   
   
       6 . The method of  claim 1 , further comprising: 
 shielding the container from contamination when outside the critical zone.    
   
   
       7 . The method of  claim 1 , further comprising: 
 shielding a closure from contamination.    
   
   
       8 . The method of  claim 1 , further comprising: 
 shielding a closure from contamination when outside the critical zone.    
   
   
       9 . The method of  claim 1 , further comprising: 
 providing a closure to the container.    
   
   
       10 . The method of  claim 1 , further comprising: 
 positioning a closure on the container.    
   
   
       11 . The method of  claim 1 , further comprising: 
 positioning a closure on the container while the container is within the critical zone.    
   
   
       12 . The method of  claim 1 , further comprising: 
 automatically positioning a closure on the container.    
   
   
       13 . The method of  claim 1 , further comprising: 
 closing the container.    
   
   
       14 . The method of  claim 1 , further comprising: 
 securing a closure on the container.    
   
   
       15 . The method of  claim 1 , further comprising: 
 crimping a closure onto the container.    
   
   
       16 . The method of  claim 1 , further comprising: 
 crimping a closure onto the container when the container is outside the critical zone.    
   
   
       17 . The method of  claim 1 , further comprising: 
 automatically crimping a closure onto the container.    
   
   
       18 . The method of  claim 1 , wherein the container is sterile.  
   
   
       19 . The method of  claim 1 , wherein the container remains covered until entry into the critical zone.  
   
   
       20 . The method of  claim 1 , wherein the container remains sterile until said introducing activity.  
   
   
       21 . The method of  claim 1 , wherein a closure for the container is sterile.  
   
   
       22 . The method of  claim 1 , wherein a closure for the container remains sterile until placed in contact with the container.  
   
   
       23 . The method of  claim 1 , wherein the container positioner is driven pneumatically.  
   
   
       24 . The method of  claim 1 , wherein during normal operation, the container is isolated from a human operator of the system.  
   
   
       25 . The method of  claim 1 , wherein during normal operation, the container is isolated from contaminants.  
   
   
       26 . The method of  claim 1 , wherein the system weighs less than about 300 pounds.  
   
   
       27 . The method of  claim 1 , wherein the container positioner weighs less than about 60 pounds.  
   
   
       28 . The method of  claim 1 , wherein components of the system are manually assembleable to form an operative embodiment of the system.  
   
   
       29 . The method of  claim 1 , wherein components of the system are manually assembleable without tools to form an operative embodiment of the system.  
   
   
       30 . The method of  claim 1 , wherein the system is adapted to be contained within a standard laboratory hood.  
   
   
       31 . The method of  claim 1 , wherein no components of the system are located downstream from the container positioner.  
   
   
       32 . The method of  claim 1 , wherein no moving components of the system are located downstream from the container positioner.  
   
   
       33 . A system comprising: 
 an autoclaveable automatic non-electrically-driven container positioner that, in an operative embodiment, positions a container for introduction of a filling to the container via a filling inlet of the container, the container located in a critical zone positioned in an airflow encountering no Class  100  contaminant generators upstream from the critical zone, said container positioner located downstream of the filling inlet of the container.    
   
   
       34 . The system of  claim 33 , further comprising a container storage subassembly.  
   
   
       35 . The system of  claim 33 , further comprising a container storage subassembly adapted to provide a container to said container positioner.  
   
   
       36 . The system of  claim 33 , further comprising a container storage subassembly adapted to receive a container from said container positioner.  
   
   
       37 . The system of  claim 33 , further comprising an automatic filling subsystem for introducing the filling to the container.  
   
   
       38 . The system of  claim 33 , further comprising an automatic and intermittent filling subsystem for introducing the filling to the container, said filling subsystem comprising a manually removable filling needle coupled via a disposable tubing to a pumping device.  
   
   
       39 . The system of  claim 33 , further comprising a closure storage subassembly.  
   
   
       40 . The system of  claim 33 , further comprising a closure storage subassembly adapted to provide a closure to a closure positioning subassembly.  
   
   
       41 . The system of  claim 33 , further comprising a closure positioning subassembly.  
   
   
       42 . The system of  claim 33 , further comprising a fluidically-driven closure positioning subassembly.  
   
   
       43 . The system of  claim 33 , further comprising a closure positioning subassembly adapted to position a closure over the container.  
   
   
       44 . The system of  claim 33 , further comprising a closure positioning subassembly adapted to position a closure on the container.  
   
   
       45 . The system of  claim 33 , further comprising a closure positioning subassembly adapted to position a closure in the container.  
   
   
       46 . The system of  claim 33 , further comprising a closing subassembly adapted to secure a closure to the container.  
   
   
       47 . The system of  claim 33 , further comprising a fluidically-driven closing subassembly adapted to secure a closure to the container.  
   
   
       48 . The system of  claim 33 , wherein said container positioner is adapted to position a container in a fill location.  
   
   
       49 . The system of  claim 33 , wherein said container positioner is adapted to position a container in a fill location located in the critical zone.  
   
   
       50 . The system of  claim 33 , wherein said container positioner is adapted to advance a container after introduction of the filling into the container.  
   
   
       51 . The system of  claim 33 , wherein said container positioner is adapted to advance a container through the critical zone.  
   
   
       52 . The system of  claim 33 , wherein said container positioner is adapted to remove a container from a fill location.  
   
   
       53 . The system of  claim 33 , wherein said container positioner is pneumatically driven.  
   
   
       54 . The system of  claim 33 , wherein said system comprises no hinges upstream in the airflow from the critical zone.  
   
   
       55 . The system of  claim 33 , wherein the container is shielded from contamination before entering the critical zone.  
   
   
       56 . The system of  claim 33 , wherein the container is shielded from contamination after leaving the critical zone.  
   
   
       57 . The system of  claim 33 , wherein the container is shielded from contamination when outside the critical zone.  
   
   
       58 . The system of  claim 33 , wherein said system comprises no gears located upstream in the airflow from the critical zone.  
   
   
       59 . The system of  claim 33 , wherein said system is portable.  
   
   
       60 . The system of  claim 33 , wherein said system is decontaminateable.  
   
   
       61 . The system of  claim 33 , wherein said system is decontaminateable in an operable embodiment prior to operation.  
   
   
       62 . The system of  claim 33 , wherein said system is decontaminateable in an operable embodiment after operation.  
   
   
       63 . The system of  claim 33 , wherein said system is decontaminateable without the use of chemical disinfectants.  
   
   
       64 . The system of  claim 33 , wherein the system is manually introduceable to an autoclave.  
   
   
       65 . The system of  claim 33 , wherein said system conforms to an FDA document entitled “Guideline on Sterile Drug Products Produced by Aseptic Processing” published June 1987.  
   
   
       66 . The system of  claim 33 , wherein said system conforms to an FDA document entitled “Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice” (Draft—August 2003).  
   
   
       67 . The system of  claim 33 , wherein during normal operation, said system is isolated from a human operator of said system.  
   
   
       68 . The system of  claim 33 , wherein during normal operation, said system is isolated from contaminants.  
   
   
       69 . The system of  claim 33 , wherein during normal operation, said system is shielded from contaminant entry into critical zone perpendicularly to the airflow.  
   
   
       70 . The system of  claim 33 , wherein said system weighs less than about 300 pounds.  
   
   
       71 . The system of  claim 33 , wherein said system is manually assembleable to form an operative embodiment of said system.  
   
   
       72 . The system of  claim 33 , wherein said system is manually assembleable without tools to form an operative embodiment of said system.  
   
   
       73 . The system of  claim 33 , wherein said system is adapted to be contained within a standard laboratory hood.  
   
   
       74 . The system of  claim 33 , wherein during normal operation, said system is incapable of breaking the container.  
   
   
       75 . The system of  claim 33 , wherein during normal operation, said system is incapable of crushing the container.  
   
   
       76 . The system of  claim 33 , wherein during normal operation, no components of said system are located downstream in the airflow from the critical zone.