Abstract: The present invention involves removing container covers within a controlled environment enclosure without using gloves. Apparatus has articulated arm apparatus and gripping apparatus and may further comprise controller. Articulated arm apparatus may be configurable for holding and moving container in three dimensions; and gripping apparatus may be configured for gripping and/or moving container cover sealing the container. Method comprises moving container using articulated arm apparatus while holding gripping area of container cover substantially stationary using gripping apparatus, optionally moving the gripping apparatus. Apparatus may further comprise sensor configured for supplying information to controller for determining location of container cover gripping area and orientation of container cover. Method may further comprise inspecting container cover using sensor. Container may be moved along path and within space determined by controller.

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, which may 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.

Abstract: An apparatus and method are presented for removing container covers within a controlled environment enclosure without using gloves. The apparatus comprises an articulated arm apparatus and a gripping apparatus and can further comprise a controller. The articulated arm apparatus can be configurable for holding and moving a container in three dimensions; and the gripping apparatus can be configured for gripping a container cover sealing the container. The method comprises moving the container using the articulated arm apparatus while holding a gripping area of the container cover substantially stationary using the gripping apparatus. The apparatus can further comprise a sensor configured for supplying information to the controller for determining the location of the container cover gripping area and an orientation of the container cover. The method can further comprise inspecting the container cover using the sensor. The container can be moved along a path and within a space determined by the controller.

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.

Abstract: An apparatus and method are presented for removing container covers within a controlled environment enclosure without using gloves. The apparatus comprises an articulated arm apparatus and a gripping apparatus and can further comprise a controller. The articulated arm apparatus can be configurable for holding and moving a container in three dimensions; and the gripping apparatus can be configured for gripping a container cover sealing the container. The method comprises moving the container using the articulated arm apparatus while holding a gripping area of the container cover substantially stationary using the gripping apparatus. The apparatus can further comprise a sensor configured for supplying information to the controller for determining the location of the container cover gripping area and an orientation of the container cover. The method can further comprise inspecting the container cover using the sensor. The container can be moved along a path and within a space determined by the controller.

Abstract: An apparatus and method are presented for removing container covers within a controlled environment enclosure with pre-sterilized nested containers without using gloves. The apparatus comprises an articulated arm apparatus and a gripping apparatus for the pre-sterilized nested containers and can further comprise a controller. The articulated arm apparatus can be configurable for holding and moving a container in three dimensions; and the gripping apparatus can be configured for gripping a container cover sealing the container. The method comprises providing the pre-sterilized nested containers in the form of a container having a plurality of decontaminated parts, moving the container using the articulated arm apparatus while holding a gripping area of the container cover substantially stationary using the gripping apparatus.

Abstract: Systems and methods permit gloveless filling containers with a product. A filling arm is disposed within the chamber. An optical sensor is configured to locate and target openings of the containers within the chamber. Locations of the openings are used to guide the filling arm to fill the containers with a product.

Abstract: Systems and methods for aseptically filling pharmaceutical containers with pharmaceutical fluid are disclosed. In one general aspect, these are based on an aseptically sealable chamber that includes a transfer wall to which pre-sealed pharmaceutical source and receiving containers are mounted aseptically. A robotic arm and a syringe store are disposed within the chamber along with a sterilizing facility for establishing in the chamber an aseptic condition. The robotic arm can grip and operate syringes to inject and/or extract pharmaceutical products from the containers by piercing their closures with the needles of the syringes.

Abstract: Systems and methods permit filling containers with a product. A filling arm is disposed within a chamber. An optical sensor is configured to sense openings of the containers within the chamber. Locations of the sensed openings are used to guide the filling arm to fill the containers with a product.

Abstract: A hermetically sealed multi-axis articulated arm apparatus for use within a sealable isolator chamber comprises a rotational shaft that passes through an opening in the chamber, a sealing member disposed within the chamber for sealing the shaft to an inner surface of the chamber, a plurality of interconnected hermetically sealed arm segments, operably attached to the linear motion shaft; an end effector operably attached to a terminal arm segment among the plurality of arm segments, and at least one fully enclosed drive system for driving and controlling the shaft and the plurality of arm segments. The linear motion shaft may have a sealing member in the form of a bellows. The materials for the parts of the apparatus exposed to the atmosphere of the chamber are compatible with an aseptic and cleanable environment and the surfaces of the arm segments are shaped to avoid pooling of contaminants.

Abstract: An apparatus and method are presented for removing container covers within a controlled environment enclosure with pre-sterilized nested containers without using gloves. The apparatus comprises an articulated arm apparatus and a gripping apparatus for the pre-sterilized nested containers and can further comprise a controller. The articulated arm apparatus can be configurable for holding and moving a container in three dimensions; and the gripping apparatus can be configured for gripping a container cover sealing the container. The method comprises providing the pre-sterilized nested containers in the form of a container having a plurality of decontaminated parts, moving the container using the articulated arm apparatus while holding a gripping area of the container cover substantially stationary using the gripping apparatus.

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.

Abstract: A hermetically sealed multi-axis articulated arm apparatus for use within a sealable isolator chamber comprises a rotational shaft that passes through an opening in the chamber, a sealing member disposed within the chamber for sealing the shaft to an inner surface of the chamber, a plurality of interconnected hermetically sealed arm segments, operably attached to the linear motion shaft; an end effector operably attached to a terminal arm segment among the plurality of arm segments, and at least one fully enclosed drive system for driving and controlling the shaft and the plurality of arm segments. The linear motion shaft may have a sealing member in the form of a bellows. The materials for the parts of the apparatus exposed to the atmosphere of the chamber are compatible with an aseptic and cleanable environment and the surfaces of the arm segments are shaped to avoid pooling of contaminants.

Abstract: An apparatus and method are presented for removing container covers within a controlled environment enclosure without using gloves. The apparatus comprises an articulated arm apparatus and a gripping apparatus and can further comprise a controller. The articulated arm apparatus can be configurable for holding and moving a container in three dimensions; and the gripping apparatus can be configured for gripping a container cover sealing the container. The method comprises moving the container using the articulated arm apparatus while holding a gripping area of the container cover substantially stationary using the gripping apparatus. The apparatus can further comprise a sensor configured for supplying information to the controller for determining the location of the container cover gripping area and an orientation of the container cover. The method can further comprise inspecting the container cover using the sensor. The container can be moved along a path and within a space determined by the controller.

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.

Abstract: Systems and methods for aseptically filling pharmaceutical containers with pharmaceutical fluid are disclosed. In one general aspect, these are based on an aseptically sealable chamber that includes a transfer wall to which pre-sealed pharmaceutical source and receiving containers are mounted aseptically. A robotic arm and a syringe store are disposed within the chamber along with a sterilizing facility for establishing in the chamber an aseptic condition. The robotic arm can grip and operate syringes to inject and/or extract pharmaceutical products from the containers by piercing their closures with the needles of the syringes.

Abstract: An apparatus and method are presented for removing container covers within a controlled environment enclosure without using gloves. The apparatus comprises an articulated arm apparatus and a gripping apparatus and can further comprise a controller. The articulated arm apparatus can be configurable for holding and moving a container in three dimensions; and the gripping apparatus can be configured for gripping a container cover sealing the container. The method comprises moving the container using the articulated arm apparatus while holding a gripping area of the container cover substantially stationary using the gripping apparatus. The apparatus can further comprise a sensor configured for supplying information to the controller for determining the location of the container cover gripping area and an orientation of the container cover. The method can further comprise inspecting the container cover using the sensor. The container can be moved along a path and within a space determined by the controller.

Abstract: Systems and methods for aseptically filling pharmaceutical containers with pharmaceutical fluid are disclosed. In one general aspect, these are based on an aseptically sealable chamber that includes a transfer wall to which pre-sealed pharmaceutical source and receiving containers are mounted aseptically. A robotic arm and a syringe store are disposed within the chamber along with a sterilizing facility for establishing in the chamber an aseptic condition. The robotic arm can grip and operate syringes to inject and/or extract pharmaceutical products from the containers by piercing their closures with the needles of the syringes.

Abstract: A hermetically sealed multi-axis articulated arm apparatus for use within a sealable isolator chamber comprises a rotational shaft that passes through an opening in the chamber, a sealing member disposed within the chamber for sealing the shaft to an inner surface of the chamber, a plurality of interconnected hermetically sealed arm segments, operably attached to the linear motion shaft; an end effector operably attached to a terminal arm segment among the plurality of arm segments, and at least one fully enclosed drive system for driving and controlling the shaft and the plurality of arm segments. The linear motion shaft may have a sealing member in the form of a bellows. The materials for the parts of the apparatus exposed to the atmosphere of the chamber are compatible with an aseptic and cleanable environment and the surfaces of the arm segments are shaped to avoid pooling of contaminants.

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.