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 and a swab 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 apparatus allows the fluid path to be unprotected without the use of gloves or other means that degrade the integrity of the controlled environment enclosure when decontamination is completed. The apparatus and method allow for the protecting, unprotecting and decontaminating sequences to be automated. In some embodiments the fluid path comprises a fill needle that can removably and aseptically be sealed with a disposable monolithic injection moulded polymeric fill needle sheath. The apparatus and method further allow for the use of a swab disposed in a swab holder that is aseptically and removably sealable to a swab cap to protect the swab against decontamination vapors.

What is claimed is: 
     
         1 . A fluid handling assembly for automatically carrying out a fluid handling process in an aseptic environment, comprising:
 a first sheath portion including:
 an implement portion disposed within the first sheath portion for use in the process, 
 a first locking mechanism portion, 
 a first sealing portion, and 
 a first bearing surface positioned at least generally normal to a locking axis, 
   a second sheath portion including:
 a second locking mechanism portion configured to mate with the first locking mechanism portion when the first and second locking mechanism portions are moved towards each other along the locking axis, 
 a second sealing portion disposed to aseptically seal with the first sealing portion when the first and second locking mechanism portions are mutually mated, and 
 a second bearing surface positioned at least generally normal to the locking axis and facing toward the first bearing surface, and 
   wherein the first and second sheath portions define a sealed cavity that aseptically encapsulates the implement portion when the first and second locking mechanism portions are mutually mated.   
     
     
         2 . A fluid handling assembly for automatically carrying out a fluid handling process in an aseptic environment, comprising;
 a first sheath portion including:
 a swab disposed within the first sheath portion for use in the fluid handling process, and 
 a first sealing portion, 
   a second sheath portion including:
 a second sealing portion disposed to aseptically seal with the first sealing portion, and 
   wherein the first and second sheath portions define a sealed cavity that aseptically encapsulates the swab when the first and second sealing portions are mutually mated.   
     
     
         3 . The fluid handling assembly of  claim 2  wherein the first and second sealing portions comprise clamping members. 
     
     
         4 . The fluid handling assembly of  claim 3  wherein the clamping members include a spring loaded member. 
     
     
         5 . The fluid handling assembly of  claim 3  wherein the clamping members include locating eyelets. 
     
     
         6 . The fluid handling assembly of  claim 3  further comprising a swab package having a cap, wherein the first and second sheath portions further includes a mating portion for engaging with the swab package cap. 
     
     
         7 . The fluid handling assembly of  claim 6  wherein the clamping members include clips configured to engage the swab package cap. 
     
     
         8 . The fluid handling assembly of  claim 6  wherein the swab package further includes a swab holder removably attached to the cap. 
     
     
         9 . An apparatus for protection and unprotection of a fluid path within a controlled environment enclosure, comprising:
 a. a fluid path terminated by a fill needle with a removable sheath;   b. a remotely operated manipulation system for protection and/or unprotection of the fluid path; and   c. a removal station that includes a surface operative to interact with part of the sheath.   
     
     
         10 . The apparatus of  claim 9  wherein the remotely operated manipulation system includes a robotic arm manipulation system. 
     
     
         11 . The apparatus of  claim 9  wherein the remotely operated manipulation system includes a robot end tool including at least one surface that is shaped to hold the fill needle. 
     
     
         12 . The apparatus of  claim 9  wherein the fluid path is a pre-sterilized unit.