Apparatus and method for asepticaly filling pharmaceutical containers with a pharmaceutical fluid using rotary stage

Abstract

A system for filling nested pharmaceutical containers with a pharmaceutical fluid is disclosed. In one general aspect, it comprises a sterilizable chamber containing a planar rotary stage with a fiducial locating structure for holding a pharmaceutical container nest. The chamber has a rotatable cover removal station, a rotatable filling station with a dispenser head, and camera guided vacuum pickup facilities for handling container and closure nests. An associated method for filling the containers comprises establishing an aseptic condition within the chamber; removing covers from a container tub and a container closure tub by operating both the rotary stage and the cover removal station. The vacuum pickup facility transfers into the fiducial locating structure a container nest bearing pharmaceutical containers. The fluid is dispensed into the containers by operating both the rotary stage and the filling station. A container closure nest is placed on the container nest in the fiducial locating structure with closures in correspondence with containers. A ram in the chamber forces the closures into the containers.

1 - 23 . (canceled) 
     
     
         24 . A container assembly for holding nested pharmaceutical container parts, comprising:
 a container comprising:
 a bottom, 
 a top lip that provides a horizontal top sealing surface that has a peripheral outline, and 
 sidewalls located between the bottom and the top lip, 
   a peelable container cover consisting of a sheet of flexible material sealed to the sealing surface of the top lip of the rectangular container to seal the contents of the container, and   a cover removal fixture on the container cover.   
     
     
         25 . The assembly of  claim 24  wherein the sealed peelable container cover includes a portion that extends outside of the peripheral outline of the top sealing surface of the container, and the cover removal fixture is on the portion of the peelable container cover that extends outside of the peripheral outline of the top sealing surface of the container. 
     
     
         26 . The assembly of  claim 24  wherein the container is rectangular and includes four sidewalls. 
     
     
         27 . The assembly of claim  1  wherein the cover removal fixture includes an appendage to allow it to be engaged by an engagement tool. 
     
     
         28 . The assembly of  claim 24  wherein the cover removal fixture includes a ball-shaped appendage to allow it to be engaged by an engagement tool. 
     
     
         29 . The assembly of  claim 24  wherein the peelable container cover is heat sealed to the sealing surface of the top lip of the rectangular container to seal the contents of the container against decontamination. 
     
     
         30 . The assembly of  claim 24  wherein the peelable container cover is sealed to the sealing surface of the top lip of the rectangular container to seal the contents of the container against decontamination using a chemical agent. 
     
     
         31 . The assembly of  claim 24  wherein the peelable container cover is sealed to the sealing surface of the top lip of the rectangular container to seal the contents of the container against decontamination using a radiation. 
     
     
         32 . The assembly of  claim 24  wherein the peelable container cover is sealed to the sealing surface of the top lip of the rectangular container to seal the contents of the container against decontamination using plasma. 
     
     
         33 . The assembly of  claim 24  wherein the peelable cover is made of a plastic material. 
     
     
         34 . The assembly of  claim 24  wherein the peelable cover is made of an impermeable laminated foil. 
     
     
         35 . The assembly of  claim 24  wherein the peelable cover is made of a polymeric membrane. 
     
     
         36 . The assembly of  claim 24  wherein the cover removal fixture is clipped to a portion of the peelable container cover that extends outside of the peripheral outline of the top sealing surface of the container. 
     
     
         37 . The assembly of  claim 24  wherein the sealed container holds sterilized pharmaceutical containers or closures. 
     
     
         38 . A method for removing within a controlled environment enclosure a container cover from a sealed container, the sealed container being sealed by the container cover, the method comprising:
 providing the container in the controlled environment enclosure with the cover sealed to a sealing surface of a lip of the container to seal the contents of the container against decontamination, the cover having a cover removal fixture,   decontaminating the sealed container in the controlled environment enclosure,   engaging the cover removal fixture with an engagement tool, and   removing the cover from the container using the engagement tool.   
     
     
         39 . The method of  claim 38  wherein the engaging engages a ball-shaped appendage on the cover removal fixture. 
     
     
         40 . The method of  claim 39  wherein the engaging engages the ball-shaped appendage with a fork-shaped engagement tool. 
     
     
         41 . The method of  claim 38  wherein the engaging engages the cover removal fixture with a fork-shaped engagement tool. 
     
     
         42 . The method of  claim 38  wherein the providing includes providing sterilized pharmaceutical containers or closures in the sealed container before the decontaminating. 
     
     
         43 . The method of  claim 38  wherein the attaching takes place before the container is in the controlled environment enclosure. 
     
     
         44 . The method of  claim 38  wherein the decontaminating the sealed container in the controlled environment enclosure takes place before the removing the cover. 
     
     
         45 . The method of  claim 38  wherein the removing the cover includes moving the engagement tool relative to the container. 
     
     
         46 . The method of  claim 38  wherein the removing the cover includes moving both the container and the engagement tool. 
     
     
         47 . The method of  claim 38  further comprising attaching the cover removal fixture to the cover before providing the container in the controlled environment enclosure.