METHOD FOR PROTECTING AND UNPROTECTING THE FLUID PATH IN A CONTROLLED ENVIRONMENT ENCLOSURE

    公开(公告)号:US20190056420A1

    公开(公告)日:2019-02-21

    申请号:US15898653

    申请日:2018-02-18

    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.

    PURGEABLE PHARMACEUTICAL FILL NEEDLE

    公开(公告)号:US20220387988A1

    公开(公告)日:2022-12-08

    申请号:US17887667

    申请日:2022-08-15

    Abstract: The present invention involves a fill needle system for aseptically dispensing a pharmaceutical fluid in an aseptic chamber comprises a fill needle tubing in fluid communication with a pharmaceutical fluid source via flexible tubing and extending through a fill needle hub; a fill needle dispensing tip disposed at a dispensing end of the fill needle tubing; a fill needle sheath shaped and arranged to removably mate with and seal aseptically to the fill needle hub to form an aseptically sealed volume enclosing the dispensing tip; and a fluid pressure pulse induction system disposed and configured to compress the flexible tubing in order to dislodge droplets of pharmaceutical fluid retained on the dispensing tip after halting dispensing of the pharmaceutical fluid. An associated method of dispensing pharmaceutical fluid comprises operating the fluid pressure pulse induction system to dislodge the droplets. The system may comprise a controller for automatically controlling the dispensing and droplet dislodging.

    APPARATUS AND METHOD FOR ASEPTICALY FILLING PHARMACEUTICAL CONTAINERS WITH A PHARMACEUTICAL FLUID USING ROTARY STAGE

    公开(公告)号:US20200223573A1

    公开(公告)日:2020-07-16

    申请号:US16370526

    申请日:2019-03-29

    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.

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