Method for protecting and unprotecting the fluid path in a controlled environment enclosure

Abstract

A controlled environment enclosure comprises a robotic arm manipulation system used to protect and unprotect a fluid path within the controlled environment enclosure. The apparatus allows the fluid path to be protected against dangerous decontamination vapors and chemicals before the controlled environment enclosure is decontaminated, the method not requiring the use of gloves or other means that degrade the integrity of the controlled environment enclosure. The apparatus similarly allows the fluid path to be unprotected for use without the use of gloves, the method not requiring the use of gloves or other means that degrade the integrity of the controlled environment enclosure when decontaminated is completed. The apparatus and method allow for the protecting, unprotecting and decontaminating sequences to be automated

1 . An apparatus for protection and unprotection of a pharmaceutical dispensing fluid path extending from a pharmaceutical source end to a pharmaceutical dispensing end, the fluid path dispensing end terminated by a fill needle with removable sheath within a controlled environment enclosure requiring apparati structured and arranged for aseptic processing, comprising:
 a remotely operated manipulation system for protection and/or unprotection of the fluid path; and   a removal station that includes a surface operative to interact with part of the sheath.   
     
     
         2 . The apparatus of  claim 1  wherein the remotely operated manipulation system includes a robotic arm manipulation system. 
     
     
         3 . The apparatus of  claim 1  wherein the remotely operated manipulation system includes a robot end tool including at least one surface that is shaped to hold the fill needle. 
     
     
         4 . The apparatus of  claim 1  wherein the removal station includes means for heating the sheath. 
     
     
         5 . An apparatus for protection and unprotection of a fluid path in a pharmaceutical fluid dispensing system, comprising:
 a controlled environment enclosure adapted to operate with a fluid path extending from a pharmaceutical source end to a pharmaceutical dispensing end, the dispensing end terminated by a fill needle with removable sheath;   a remotely operated manipulation system for protection and/or unprotection of the fluid path; and   a removal station disposed within the controlled environment enclosure, the removal station including a surface operative to interact with part of the sheath.   
     
     
         6 . The apparatus of  claim 5  wherein the remotely operated manipulation system includes a robotic arm manipulation system. 
     
     
         7 . The apparatus of  claim 5  wherein the remotely operated manipulation system includes a robot end tool including at least one surface that is shaped to hold the end tool. 
     
     
         8 . The apparatus of  claim 5  wherein the controlled environment enclosure includes means for transferring a fluid in the fluid path. 
     
     
         9 . The apparatus of  claim 8  wherein the means for transferring a fluid includes a pump. 
     
     
         10 . The apparatus of  claim 9  wherein the pump is a peristaltic pump. 
     
     
         11 . The apparatus of  claim 8  wherein the means for transferring a fluid includes a fluid container. 
     
     
         12 . The apparatus of  claim 5  wherein the removal station includes means for heating the sheath. 
     
     
         13 . The apparatus of  claim 6  wherein the remotely operated manipulation system further comprises a controller for communicating control instructions to the robotic arm manipulation system. 
     
     
         14 . An apparatus for operating a pharmaceutical fluid dispensing system, comprising:
 a controlled environment enclosure adapted to operate with a fluid path extending from a pharmaceutical source end to a pharmaceutical dispensing end, the dispensing end terminated by a fill needle with removable sheath;   a robotic manipulation system for positioning the fluid path for filing of pharmaceutical containers;   a controller for remotely operating the robotic manipulation system for positioning the fluid path for filing of pharmaceutical containers; and   a removal station disposed within the controlled environment enclosure, the removal station including a surface operative to interact with part of the sheath.   
     
     
         15 . The apparatus of  claim 14  wherein the remotely operated robotic manipulation system includes a robot arm having a robot end tool including at least one surface that is shaped to hold the end tool. 
     
     
         16 . The apparatus of  claim 14  wherein the controlled environment enclosure includes means for transferring a fluid in the fluid path. 
     
     
         17 . The apparatus of  claim 16  wherein the means for transferring a fluid includes a pump. 
     
     
         18 . The apparatus of  claim 17  wherein the pump is a peristaltic pump. 
     
     
         19 . The apparatus of  claim 16  wherein the means for transferring a fluid includes a fluid container. 
     
     
         20 . The apparatus of  claim 14  wherein the removal station includes means for heating the sheath.